20-F/A

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 20-F/A

(Amendment No. 1)

(Mark One)

¨ Registration statement pursuant to Section 12(b) or 12(g) of the Securities Exchange Act of 1934

or

x Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the fiscal year ended December 31, 2009

or

¨ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the transition period from to

or

¨ Shell company report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of event requiring this shell company report

Commission file number 001-33295

3SBio Inc.

(Exact Name of Registrant as Specified in Its Charter)

Cayman Islands

(Jurisdiction of Incorporation or Organization)

No. 3 A1, Road 10

Shenyang Economy & Technology Development Zone

Shenyang 110027

People’s Republic of China

(Address of Principal Executive Offices)

Bo Tan, Chief Financial officer

No. 3 A1, Road 10

Shenyang Economy & Technology Development Zone

Shenyang 110027

People’s Republic of China

Telephone (China): 86.24.2581.1820

Email:  ir@3sbio.com

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

Securities registered or to be registered pursuant to Section 12(b) of the Act:

Title of Each Class	Name of Each Exchange on Which Registered
American Depositary Shares, each representing seven ordinary shares, par value US$0.0001 per share	The NASDAQ Stock Market LLC

Securities registered or to be registered pursuant to Section 12(g) of the Act:

None

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:

None

Indicate the number of outstanding shares of each of the Issuer’s classes of capital or common stock as of the close of the period covered by the annual report.

150,641,461 ordinary shares, par value US$0.0001, as of December 31, 2009

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.     Yes  ¨    No  x

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.    Yes  ¨    No  x

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  x    No  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer      Accelerated filer   x

   Non-accelerated filer 

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

U.S. GAAP x    International Financial Reporting Standards as issued by the International Accounting Standards Board      Other  

Indicate by check mark which financial statement item the registrant has elected to follow.

Item 17  ¨    Item 18  x

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Securities Exchange Act of 1934).    Yes¨    No  x

EXPLANATORY NOTE

3SBio Inc. (“Registrant”) hereby amends its Annual Report on Form 20-F for the fiscal year ended December 31, 2009 previously filed with the Securities and Exchange Commission (the  “Commission” ) on June 25, 2010 (“Original 20-F Filing”).

Summary of Changes

This Amendment No. 1, and Amendments  No.2 and No.3 as separately filed, to the Original 20-F Filing on Form 20-F/A (respectively “Amendment No. 1”, “Amendment No. 2”, and “Amendment No. 3”, and, together, "Amendments") are being filed with respect to:

(1)Exhibit 4.7 “Sanitary Piping System Contract between Shenyang Sunshine Pharmaceutical Company Limited and Shanghai Macroprocess Technology Co. Ltd.” and

(2) Exhibit 4.8 “Installation Contract for the Core Cleanroom Area of the New Plant between Shenyang Sunshine Pharmaceutical Company Limited, and, Suntec Cleanroom & HVAC Engineering Co. Ltd. and Suntec (Suzhou) Cleanroom System Co. Ltd.”

in response to the review comments by the Commission regarding the confidential treatment request, by:

Adding to the Original 20-F Filing all contents of the Appendices of Exhibit 4.7and theAppendices of Exhibit 4.8 except those files not subject to public filing as permitted by the approval of the confidential treatment request, (such contents as hereby publicly filed, respectively, “Exhibit 4.7 Appendices Public Documents”, and “Exhibit 4.8 Appendices Public Documents”).

EDGAR File Number Limitation

Due to the number of files technically allowable in the Edgar system in a single filing being limited,  the Exhibit 4.7 Appendices Public Documents and Exhibit 4.8 Appendices Public Documents are filed in three Amendments of No. 1 to 3.

Specific Changes in this Amendment:

·   Exhibit 4.7:

(1)   The description of the Appendices, appearing at the end of Exhibit 4.7 “English Translation of the Contract Form”, is revised.

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(2)   An Index to Exhibit 4.7 Appendices Public Documents and the English translation copy of each of the Exhibit 4.7 Appendices Public Documents are added to and as a part of the publicly filed Exhibit 4.7.

Confidential Contents Omitted

IN THE CONTRACT FORM AND THE APPENDICES, “ ***** ” INDICATES THAT CERTAIN MATERIAL, WITH ASTERISKS AS PLACEHOLDERS, HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIALS HAVE BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

Limited Amendment

Except as specifically and expressly disclosed in this filing, this Amendment No. 1 does not, and does not purport to, amend, update or restate any information in any Items or sections of the Original 20-F Filing, or reflect any events having occurred after the filing of the Original 20-F Filing on June 25, 2010.

All statements in this Explanatory Note are subject to and qualified by the full contents of the Amendment No. 1 .

______________________________________________________________________

PART III

ITEM 19.                          EXHIBITS

Exhibit Number	Description of Exhibits
1.1	Amended and Restated Memorandum of Association of 3SBio Inc. (incorporated by reference to Exhibit 3.1 from our F-1 registration statement (File No. 333-140099), as amended, initially filed with the Commission on January 19, 2007)
1.2	Amended and Restated Articles of Association of 3SBio Inc. (incorporated by reference to Exhibit 3.2 from our F-1 registration statement (File No. 333-140099), as amended, initially filed with the Commission on January 19, 2007)
2.1	Form of Share Certificate of 3SBio Inc. (incorporated by reference to Exhibit 4.1 from our F-1 registration statement (File No. 333-140099), as amended, initially filed with the Commission on January 19, 2007)
2.2	Form of Deposit Agreement, including Form of ADR, of 3SBio Inc. (incorporated by reference to Exhibit 4.2 from our F-1 registration statement (File No. 333-140099), as amended, initially filed with the Commission on January 19, 2007)
4.1	2006 Stock Plan adopted by 3SBio Inc., dated as of September 5, 2006 (incorporated by reference to Exhibit 10.1 from our F-1 registration statement (File No. 333-140099), as amended, initially filed with the Commission on January 19, 2007)
4.2**	First Amendment to 2006 Stock Plan
4.3**	2010 Equity Incentive Plan

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4.4	Form Purchase Contract for FCS between Shenyang Sunshine Pharmaceutical Company Limited and Shanghai Weike Biochemical Reagent Co., Ltd. (incorporated by reference to Exhibit 4.2 from our annual report on Form 20-F for the year ended December 31, 2008, filed with the Commission on April 21, 2009)
4.5**	Form Purchase Agreement for BPT-6 culture medium between Shenyang Sunshine Pharmaceutical Company Limited and Invitrogen Trading (Shanghai) Company Limited, dated May 13, 2009 (portions of this exhibit have been omitted and filed separately with the Commission pursuant to a request for confidential treatment.)
4.6	Form of Distribution Agreement (incorporated by reference to Exhibit 10.15 from our F-1 registration statement (File No. 333-140099), as amended, initially filed with the Commission on January 19, 2007)
4.7*	Sanitary Piping System Contract between Shenyang Sunshine Pharmaceutical Company Limited and Shanghai Macroprocess Technology Co. Ltd., dated Mar.30, 2009 (portions of this exhibit have been omitted and filed separately with the Commission pursuant to a request for confidential treatment; and, this exhihit as filed in this Amendment amends and replaces the existing Exhibit 4.7 in the Original 20-F Filing in its entirety.)
4.8#	Installation Contract for the Core Cleanroom Area of the New Plant between Shenyang Sunshine Pharmaceutical Company Limited, and, Suntec Cleanroom & HVAC Engineering Co. Ltd. and Suntec (Suzhou) Cleanroom System Co. Ltd., dated  July 3, 2009 (portions of this exhibit have been omitted and filed separately with the Commission pursuant to a request for confidential treatment; and, this exhihit as filed in the Amendment No.2 and Amendment No..3 amends and replaces the existing Exhibit 4.8 in the Original 20-F Filing in its entirety.)

8.1**		List of Subsidiaries of 3SBio Inc.
11.1		Code of Ethics (incorporated by reference to Exhibit 11.1 from our annual report on Form 20-F for the year ended December 31, 2006, filed with the Commission on June 29, 2007)
12.1**		CEO Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
12.2**		CFO Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
12.3*		CEO Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
12.4*		CFO Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
13.1**		CEO Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
13.2**		CFO Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
13.3*		CEO Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
13.4*		CFO Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
15.1**		Consent of Ernst & Young Hua Ming
15.2**		Consent of KPMG
*	Filed herewith.
**	Filed with the Original 20-F Filing.
#	Filed in Amendment No.2 and Amendment No.3

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SIGNATURES

The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this annual report on its behalf.

3SBio Inc.
By:	/s/ Dr. Jing Lou
Name:	Dr. Jing Lou
Title:	Chief Executive Officer
Date: November 3, 2011

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EX-4.7

Exhibit 4.7

English Translation of the Contract Form

1. “ ***** ” INDICATES THAT CERTAIN MATERIAL, WITH ASTERISKS AS PLACEHOLDERS, HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIALS HAVE BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

2. Except as described above, below this line is the English translation of the original text of the contract form.

Shenyang Sunshine Pharmaceutical Company Limited

(SUNSHINE)

Sanitary Piping System Contract

Owner	Contractor
Shenyang Sunshine Pharmaceutical  Company Limited	Shanghai Macroprocess Technology Co. Ltd.
A1 No.3, Road 10, Economic & Technological Development Zone, Shenyang	Room 101, Building A, No.168 LuoYang Rd., Shanghai
Postal Code:110027	Postal Code:201100
Telephone: 024 25811820-371	Telephone: 021 55290429
Fax: 024 25811821-113	Fax: 021 54306718
E-mail: pangy@3sbio.com	E-mail:vincentzhang@macroprocess.com

1

Exhibit 4.7

English Translation of the Contract Form

1. “ ***** ” INDICATES THAT CERTAIN MATERIAL, WITH ASTERISKS AS PLACEHOLDERS, HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIALS HAVE BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

2. Except as described above, below this line is the English translation of the original text of the contract form.

Contract

(Contract No.: WW0905)

Owner：Shenyang Sunshine Pharmaceutical Company Limited (SUNSHINE)

Contractor: Shanghai Macroprocess Technology Co. Ltd.

Signing Date: Mar. 30, 2009

In accordance with the Contract Law of the People's Republic of China as well as other relevant laws and administrative regulations,, based on the principles of mutual benefit and negotiation on equal basis, both parties have come to an agreement of Sanitary piping system on the following terms.

1  Scope of Supply and Price:

Total Amount: RMB**********, say **********RMB Only. For detailed information refer to the appendix 1 The main materials and equipment is quoted at RMB **********, and accessories and technical service is quote at RMB **********.

The contract value comprises all items signed in bidding documents, including appendix 1, design drawings and meeting memos confirmed by both parties.Any quantities in excess of Priced Bill of Quantities shall be charged according to corresponding unit price of materials provided in the contract. If the corresponding unit price is not provided in the contract, both parties should settle the issue by friendly negotiation，or owner could purchase those materials if the negotiation fails.

2  Delivery:

Owner’s site

2

Exhibit 4.7

English Translation of the Contract Form

1. “ ***** ” INDICATES THAT CERTAIN MATERIAL, WITH ASTERISKS AS PLACEHOLDERS, HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIALS HAVE BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

2. Except as described above, below this line is the English translation of the original text of the contract form.

3 Project Scope:

Contractor’s scope of work includes engineering design, procurement, installation, construction, commissioning, training and as-built documentation submission to owner for the following systems: purified water loop, water for injection loop, pure steam piping system, clean gas piping system, material system, CIP system and piping systems for other mediums. It’s Contractor’s responsibility to provide DQ, FS, FAT, IQ/OQ documents and IQ/OQ execution on related piping system. Contractor shall assist Owner to execute PQ. For detailed scope, see drawings and Materials List.

4 Transportation & Destination & Cost:

Contractor shall be responsible for delivering all materials to Owner’s site and bearing transportation cost.

5  Project Duration:

Kick-off date: July 8, 2009

Completion date: Contractor shall complete the commissioning, IQ/OQ and submit completion acceptance application to owner before Oct.30, 2009.

6 Project Management and Construction:

(1) All notices from Contractor shall be signed by the project manager and generated in two copies. All notices will get effective with Owner’s approval. Project manager should organize and conduct construction according to construction proposal approved by owner.

(2) Contractor should change unqualified project manager and unqualified personnel within 7 working days after written notice from Owner.

(3) Contractor should construct according to project schedule approved by Owner, and accept the inspection and supervision by owner. If actual schedule is not in compliance with approved schedule, Contractor should present improvement measures according to the Owner’s requirement. Those measures should be implemented after Owner’s approval. Contractor has no right to claim extra expense for improvement measures or project delay, in case of the fact which results the unconformity of the schedule by Contractor.

3

Exhibit 4.7

English Translation of the Contract Form

1. “ ***** ” INDICATES THAT CERTAIN MATERIAL, WITH ASTERISKS AS PLACEHOLDERS, HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIALS HAVE BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

2. Except as described above, below this line is the English translation of the original text of the contract form.

(4) Owner has the right to suspend the construction work due to quality nonconformity. Contractor should be responsible for related cost and project delay.

(5) If owner thinks that it is necessary to suspend project construction, owner should issue the written solution advice within 48 hours after suspending request. Contractor should suspend construction and protect finished project. After the carrying out of Owner’s solution advice, Contractor should submit written application to restart construction. Owner should reply in written document within 48 hours.

(6) Contractor should obey Chinese safety laws and regulations to ensure the safety of site staff and products. Contractor should be responsible for the safety accidents occurred due to contractor’s fault, as well as related economic losses.

(7)  Project period should be extended correspondingly due to the following facts confirmed by Owner:

(7-1) The site condition is not qualified for construction according to the meeting memo No.1 of the sunshine project technical communication meeting.

(7-2) Owner does not issue any order or approval in time as per contract.

(7-3) Design change or additional work resulting from owner.

(7-4) Project period should be extended one day, if water or power supply failure which is not caused by Contractor lasts over 8 hours in a week.

(7-5) Construction suspension caused by Owner’s orders.

(7-6) Force Majeure.

7 Owner’s Responsibility:

(1) Owner should complete the following work within defined time.

4

Exhibit 4.7

English Translation of the Contract Form

1. “ ***** ” INDICATES THAT CERTAIN MATERIAL, WITH ASTERISKS AS PLACEHOLDERS, HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIALS HAVE BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

2. Except as described above, below this line is the English translation of the original text of the contract form.

1.1 Provide relevant documents of site condition to Contractor. It’s owner’s liability to guarantee the authenticity of these documents. Assist the application and approval of the temporary warehouses and the water and power supply break etc.

1.2 Owner should provide the water, electrical power and gas to the construction site within a distance of 100 meters. Water and power supply are provided by Owner without extra expense.

1.3 Organize Contractor and other design companies & construction companies to review drawings and construction coordination.

(2) Owner should issue the written notification of Design Change 2 days ahead.

8 Contractor’s responsibility:

(1) Contractor should ensure that the project design is in full compliance with related codes and regulations, as well as Owner’s requirements. Based on the technical requirements and basic design drawings provided by Owner, Contractor should conduct the necessary design work complying with GMP requirement. Design documents should be reviewed and approved by Owner. Design and legal responsibility of Contractor defined in the contract cannot be alleviated even with the Owner’s approval of the design documents, excluding the conditions that Owner refuses the suggestion from Contractor.

(2) Contractor should provide the lighting used in construction if needed, and be responsible for the safety of site staff, and obey government’s regulations such as construction noise, environmental protection and safety production etc. Before the handover of the complete project, Contractor should be responsible for the protection of project. Any damage or loss occurs during construction period, Contractor should afford the cost on repair and change to meet Owner’s requirement. Contractor should ensure that the construction site is clean according to environmental hygienic management regulations to meet Owner’s requirements before handover. Contractor should take safety protective measures before access to construction and start the construction work after Owner’s approval at flammable or explosive place. For any reconstruction work because of contractor, the cost should be charged by Contractor. Contractor should take the coordination of projects defined in contract, as well as other construction companies. Contractor should obey engineering construction safety regulations. For any losses or damages of equipments, facilities and materials on the construction site caused by incomplete safety managements or inappropriate safeguard, Contractor should be responsible for repairing, modification and compensation.

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Exhibit 4.7

English Translation of the Contract Form

1. “ ***** ” INDICATES THAT CERTAIN MATERIAL, WITH ASTERISKS AS PLACEHOLDERS, HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIALS HAVE BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

2. Except as described above, below this line is the English translation of the original text of the contract form.

(3) No subcontract or contract transferring without written approval of Owner,

9 Materials and Equipments Supply

(1) Contractor should provide all the materials and equipments in the scope of Contract. Contractor will charge 5% of the total value of the systems and equipments in contract’s scope purchased by Owner as project management fee.

(2) If materials and equipments purchased by Contractor don’t comply with design, standard, brand and contract requirements, Owner can request Contractor to disassemble or repurchase to reinstall. And the cost occurred in this process is charged by Contractor. In addition, project period won’t be extended accordingly.

(3) All the materials and equipments supplied by Contractor could only be used after Owner’s approval. However, Owner’s approval cannot alleviate Contractor’s responsibility on materials and equipments.

(4) Accessories in the bidding documents signed by Contractor are all the accessories materials in the contract scope. On the condition that points of use in the piping system won’t be changed, those materials are included in the contract materials. This contract is a turnkey project, so the extra materials will not charge extra cost. If Owner requires the change, both parties should sign a complementary contract in which contract material price is the same as the price defined in this contract. Contractor should be responsible for project period extension caused by the lack of materials.

10 Reasonable consumption and calculation mode: consumption caused by transportation should be charged by Contractor.

11 Packaging standard, package material, recycle and cost: Contractor should assure that the package complies with national norms, and packaging material should not be recycled.

6

Exhibit 4.7

English Translation of the Contract Form

1. “ ***** ” INDICATES THAT CERTAIN MATERIAL, WITH ASTERISKS AS PLACEHOLDERS, HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIALS HAVE BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

2. Except as described above, below this line is the English translation of the original text of the contract form.

12  Project Acceptance

(1) Contractor should conduct the inspection of inner project first, and then inform Owner in written form 48 hours before concealment or project section acceptance. The written notice for Owner includes the content, time and place of the concealment and section acceptance. Contractor should prepare acceptance report. If acceptance is passed, Owner will make signature on the report, then Contractor can carry on the following construction. But if acceptance is not passed, Contractor should make modification in the limited time for reacceptance.

(2) Before handover of the system, Owner should organize the training and designate the operators to attend the training. Contractor arranges the technical personnel to train Owner’ designated operation personnel on the operation instructions.

(3) Contractor should provide Owner with as-built documents and completion acceptance report within 30 days after the project completion acceptance is passed.

(4) On condition that either Chinese or European GMP inspection of Owner’s plant is passed, the sanitary piping project will be recognized as 100% acceptance. Occurrence of any of the following conditions will be recognized as the 100% acceptance of this sanitary piping project.

1) More than 12 months after the completion of project, Owner has not carried out official GMP inspection .

2)   When carrying out GMP inspection, the inspection officials present some nonconformities of the system but Contractor can promptly modify them to meet the GMP requirements and won’t be the reject item. However, Contractor should modify promptly for free.

3)    When carrying out GMP inspection of this sanitary Piping system, the inspection officials have not presented any objection officially which results GMP inspection will not be passed.

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Exhibit 4.7

English Translation of the Contract Form

1. “ ***** ” INDICATES THAT CERTAIN MATERIAL, WITH ASTERISKS AS PLACEHOLDERS, HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIALS HAVE BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

2. Except as described above, below this line is the English translation of the original text of the contract form.

4)    After the handover of this project with the successful completion acceptance of the project and before official GMP inspection, the project suffers force majeure or man-made damages which cannot be recovered.

13 Terms of Payment:

1) Within 5 working days after the signature of the contract, Owner should pay [10% of the contract amount as down payment by T/T.

2) Before the delivery of the main materials, Contractor should invite the related persons of Owner to check the goods at supplier’s site. If materials are qualified, Owner should pay 50% of the contract amount by T/T within 3 days against shipping advice.

3) After main materials arrival at the construction site, the acceptance should be conducted by Owner within 3 days. Once the main materials are qualified,  Owner should pay 10% of the contract amount by T/T within 5 working days after the acceptance;

4) Within 5 working days from the date of the project completion acceptance, Owner will pay 10% of contract amount by T/T ;

5) Within 5 working days after the submission of qualification documents, as-built documents, Owner should pay the remaining 20% of the contract amount by T/T against the bank guarantee with 10% of contract amount issued by Contractor bank.

14 Invoice:  VAT invoice should be opened for all main materials and equipments, and engineering service invoice should be opened for all accessories and technical service. After receiving the down payment, Contractor should open engineering installation invoice with the same value. After the owner accepts the main materials, Contractor should open VAT invoice with the same value. After receiving acceptance payment, Contractor should open invoice with the value of remained items.

15、Responsibility: Contractor should assure that the design and installation of sanitary piping project should comply with Chinese and European GMP requirements. Owner has the responsibility to provide the training for the whole sanitary piping system for free. If Owner refuses to accept Contractor’s advice, owner should issue a written document to show that Contractor won’t be responsible for this advice.

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Exhibit 4.7

English Translation of the Contract Form

1. “ ***** ” INDICATES THAT CERTAIN MATERIAL, WITH ASTERISKS AS PLACEHOLDERS, HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIALS HAVE BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

2. Except as described above, below this line is the English translation of the original text of the contract form.

16 Guarantee of Quality:

Contractor should ensure that the design, installation, commissioning, qualification and materials should be in accordance with the quality requirements, specifications and performance defined in the contract. Contractor should execute the project with correct installation, reasonable operation and maintenance, and guarantee the project with good performance within 12 months from the date of project completion acceptance. 10% of the contract value will be treated as guarantee, and the guarantee period is 12 months from the date of the project completion acceptance. During the guarantee period, all repair and change of unqualified materials and equipments from Contractor is free of charge. And all related cost should be charged by Contractor. Contractor should ensure the response within 24 hours after receiving Owner’s written notice. If necessary, Contractor should arrive at Owner’s site to present solutions within 48 hours. When official GMP inspection is carried out, Contractor has the obligations to arrange expert  to assist for 5 working days only.

17 Liability:

If the project cannot be completed on project completion date defined in the contract or the postponed project completion date approved by Owner because of Contractor, Owner can deduct 0.5% of the contract value as penalty per day. If project is delayed for over 10 days, Owner has the right to terminate the contract and take the related measures. The related losses or cost should be charged by Contractor. Engineering quality cannot meet the quality standard defined in the contract (including but not limited to GMP requirements) because of contractor, Contractor has the responsibility to reconstruct the project to meet the agreed quality requirements for free. If the requirements still cannot be met, or cannot be finished in time, Owner may arrange another construction company to continue this project, and cost will be charged by contractor.

18 Confidentiality:

During execution of contract, Contractor shall know Owner’s process, drawings and equipments, but not limit to figures, steps, operation process and parameters etc. Contractor has the obligation to keep them confidential.

9

Exhibit 4.7

English Translation of the Contract Form

1. “ ***** ” INDICATES THAT CERTAIN MATERIAL, WITH ASTERISKS AS PLACEHOLDERS, HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIALS HAVE BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

2. Except as described above, below this line is the English translation of the original text of the contract form.

(1) Contractor promises not to reveal technical information and documents concerning this project to any third party within 5 years since the contract is valid. Otherwise, Owner has the right to claim for compensation to Contractor and take legal action on Contractor. Both parties agree that the compensation amount is two times of the contract amount. Contractor has obligations to assure that the construction staff obey this confidential article and afford legal responsibilities. Without permission of Owner, Contractor won’t allow other company staff to enter the construction site. Otherwise RMB1000.00 will be fined.

(2) All the drawings, documents and special technology concerning this project belong to the owner. Regarding all the technical documents from Contractor such as the design, technology and management specification during the project construction, Owner has the obligations to keep them confidential.

19 Force Majeure:

Any Party encounters force majeure during executing the contract, contract period should be extended according to the impact of force majeure. The party should send a written notice to the other party immediately after suffering the force majeure, and submit related authoritative certifications to the other party within 14 days after the occurrence of the force majeure. On condition that force majeure lasts for over 90 days, both parties should present steps or changes to further continue the contract at the right time through friendly reconciliation. Contractor should do his utmost promptly to repair the damaged work to meet the technical requirements specified in the contract.

20 Dispute:

Disputes may be resolved through friendly negotiation during execution of the contract. When parties disagree to negotiation or negotiation failed, either of parties can take another to the local people’s court of the project site. The lawsuit loser will afford the Litigation costs. Before the dispute is finally resolved, the contract cannot be suspended.

21 Termination of the Contract:

If Contractor does not execute the contract according to the contract terms, Owner may send Contractor a written notice to request Contractor to execute the contract. If Contractor has not changed the incorrect action within a week, Owner could inform Contractor to cancel the contract. Before an agreement is achieved, Contractor cannot stop the work. Contractor should pay all the expense caused by himself.

If cancellation of the contract is caused by Owner, Owner should pay Contractor the related expense as per actual work scope and progress.

10

Exhibit 4.7

English Translation of the Contract Form

1. “ ***** ” INDICATES THAT CERTAIN MATERIAL, WITH ASTERISKS AS PLACEHOLDERS, HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIALS HAVE BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

2. Except as described above, below this line is the English translation of the original text of the contract form.

22 Contract Documents:

Documents comprised this contract are listed by their priority explanation as follows:

1. Contract

2. Appendices

3. Owner’s Requirements and design change.

23 Contract Appendices:

(1) Appendix 1:  Materials, Services and Equipments

(2) Appendix 2: Design Drawings

(3) Appendix 3: Meeting Memo

(4) Appendix 4: URS clarification

(5) Appendix 5: Bidding documents

24 Contract valid:

This original contract is in four copies. Both parties hold two copies.  Contract is valid after signature and stamp of both parties’ representatives. Contract should be started to execute after receiving Owner’s down payment.

Below is blank

11

Exhibit 4.7

English Translation of the Contract Form

1. “ ***** ” INDICATES THAT CERTAIN MATERIAL, WITH ASTERISKS AS PLACEHOLDERS, HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIALS HAVE BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

2. Except as described above, below this line is the English translation of the original text of the contract form.

Owner:

Company Name: Shenyang Sunshine Pharmaceutical Company Limited (SUNSHINE)

Company Add.: A1 No.3, Road 10, Economic & Technological Development Zone， Shenyang。

Agent:

Phone No.

Fax:024-25811821-113

Opening Bank:Bank of China, shenyang Tiexi Branch

Tax No.:830760270708091001

Postal code: 110027

Stamp:

Contractor:

Company Name:

Shanghai Macroprocess Technology Co. Ltd.

Company Add.: Room 101, Building A, No.168 LuoYang Rd., Shanghai

Agent:

Phone ： 021-55290429

Fax: 021-54306718

12

Exhibit 4.7

English Translation of the Contract Form

1. “ ***** ” INDICATES THAT CERTAIN MATERIAL, WITH ASTERISKS AS PLACEHOLDERS, HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIALS HAVE BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

2. Except as described above, below this line is the English translation of the original text of the contract form.

Opening bank: ICBC Shanghai Meilong Branch

Account no：**********

Postal code: 201100

Stamp:

13

Exhibit 4.7

English Translation of the Contract Form

1. “ ***** ” INDICATES THAT CERTAIN MATERIAL, WITH ASTERISKS AS PLACEHOLDERS, HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIALS HAVE BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

2. Except as described above, below this line is the English translation of the original text of the contract form.

APPENDICES:

Notes:

(1) Each Appendix may refer to, and consist of, not a single document but a category of related documents and files. A summary with brief description is provided below.

(2) All the documents that comprise the Appendices except those files not subject to public filing as permitted by the approval of the confidential treatment request, (all such public documents, “Exhibit 4.7 Appendices Public Documents”), are filed as a part of Exhibit 4.7 in this Amendment.

The Index to Exhibit 4.7 Appendices Public Documents, filed in this Amendment, contains the list of Exhibit 4.7 Appendices Public Documents and the descriptions thereof.

Appendix 1 Materials, Services and Equipments：The breakdown list of materials, equipment and services and itemized price quotes. (NOTE:  IN EACH OF THE 5 FILES OF THIS APPENDIX, “*****” INDICATES THAT  PRICE-RELATED INFORMATION HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. )

***** Appendix 2 Design Drawings: the design drawings, which provides defining requirements and explanations as to the project.  (**** NOTE:  ALL 19 DOCUMENTS UNDER THIS APPENDIX HAVE BEEN OMITTED, FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. )

Appendix 3 Meeting Memo: Memo which memorializes the meetings of the parties as to specific technical requirements of the project.

Appendix 4 URS clarification: URS refers to user specifications, and includethe replies by the Contractor. URS is part of the solicitation of bids.  URS provides specifications on the project and serve as the main evaluation tool for selection as the Owner evaluates the bids based on the extent of satisfaction of URS.

14

Exhibit 4.7

English Translation of the Contract Form

1. “ ***** ” INDICATES THAT CERTAIN MATERIAL, WITH ASTERISKS AS PLACEHOLDERS, HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIALS HAVE BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

2. Except as described above, below this line is the English translation of the original text of the contract form.

Appendix 5 Bidding documents: Solicitation of bids and bidding documents from the Contractor, including:

1. Bidding Document 1

2. Supplemental Translation to Bidding Document 1

3. Bidding Document 2

4. Supplemental Translation to Bidding Document 2

5. Bidding Document 3

6. Supplemental Translation to Bidding Document 3

15

EX-4.7.1

__________________________________________________

Index to

Exhibit 4.7 Appendices Public Documents

__________________________________________________

Notes:

ñNames of the folders, subfolders, and documents are underlined as below. This Index describes, but EDGAR system may not show, the original folder structure.

1.  Appendix 1 Materials, Services and Equipments (REDACTED) folder：

This folder contains the supply, construction range, price and total price of purified water, injection water, and pure steam system, material system, and gas supply system, including the amount and specifications of the materials, providers, standards, and expense standards such as validation expenses, installation fee and auxiliary material expenses. There are, in total, 5 second-level files and 0 second-level subfolder.

(a)(Ex 4.7.2) Quotation for PW&WFI&PS k1.xls file:

This file contains the supply, construction range, price and total price of purified water, injection water, and pure steam system, including the amount and specifications of the materials, providers, standards, and expense standards such as validation expenses, installation fee and auxiliary material expenses.

(b)(Ex 4.7.3) QUOTATION - COOLING WATER and Misc.xls file:

This file contains the supply, construction range, price and total price of cooling water, water supply, and public system, including the amount and specifications of the materials, providers, standards, and expense standards such as validation expenses, installation fee and auxiliary material expenses.

(c)(Ex 4.7.4) QUOTATION FOR GAS K.xls file:

This file contains the supply, construction range, price and total price of the process gas system, including the amount and specifications of the materials, providers, standards, and expense standards such as validation expenses, installation fee and auxiliary material expenses.

(d)(Ex 4.7.5) QUOTATION FOR MATERIALS, CIP AND K.xls file:

This file contains the supply, construction range, price and total price of material pipeline system, including the amount and specifications of the materials, providers, standards, and expense standards such as validation expenses, installation fee and auxiliary material expenses.

(e)(Ex 4.7.6) TOTAL PRICE OF PIPELINE.xls file:

This file contains the price summarization for the above three systems, and the description for the price and total price.

3.(Ex 4.7.7) Appendix 3 Meeting Memo.doc file

This file contains meeting memo which refers to other covenants related to the implementation requirements for the project and contracts during the technical communication procedure.

4.(Ex 4.7.8) Appendix 4 URS Clarification.xls file：

This file contains specific design requirements, design standards, main parameter and index requirements, after-sale service requirements, devices and material requirements, and acceptance standards which are put forth by Yofoto company on the factory construction, as well as specific measures and methods responded by the construction party for the requirements proposed by Yofoto company item by item.

5.(Ex 4.7.9) Bidding Document 1.pdf file:

This file is the bidding document of process batching system.

6. (Ex 4.7.10) Bidding Document 2.pdf file:

This file is the bidding document of compressed air and process gas system.

7.(Ex 4.7.11) Bidding Document 3.pdf file:

This file is the bidding document of process injection water, purified water, and pure steam system.

8.(Ex 4.7.12) Supplemental Translation to Bidding Document 1 file:

This file contains English translation for certain portions in the Bidding Document 1 that have no accompanying English text.

9.(Ex 4.7.13) Supplemental Translation to Bidding Document 2 file:

This file contains English translation for certain portions in the Bidding Document 2 that have no accompanying English text.

10. (Ex 4.7.14) Supplemental Translation to Bidding Document 3 file:

This file contains English translation for certain portions in the Bidding Document 3 that have no accompanying English text.

EX-4.7.2

Exhibit 4.7.2 - Quotation for PW, WFI and PS

沈阳三生制药有限责任公司

Bid Schedule of Price

Item	Scope of Supply	Price (RMB)
1	Price Breakdown for  PW Distribution System	***
2	Price Breakdown for  WFI Distribution System	***
3	Price Breakdown for PS Distribution System	***
4	Automatic Control System FOR WATER	***
5	Insulation Fee	***
6	Piping surport	***
	Subtotal  1 for Material	***
7	Welding Point Cost	***
8	Cost of  Welding Point marking  (100% of total welding point )  20RMB /point	***
9	Endoscopic Check (20% of total welding point ) 80 RMB /point	***
10	X-ray Check ( 100% of total hand-welding point,all welded samples ) 180 RMB /point	***
11	Insurance and Transportation	***
	Subtotal 2 for Piping fabrication	***
12	Detail Design, Shop Drawings and As-built Drawings	***
13	Quotation For Validation Activities	***
14	Project Management & Supervision	***
15	COMPANY Management	***
	Subtotal 3 for Project Service	***
	Subtotal 1, 2, 3,	***
	Tax   （for main materials part issue added-value tax, for the others issue project invoice）	***
	Total Price	***

沈阳三生制药有限责任公司

Price Breakdown for PW Distribution System
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price  (RMB)	Total Price  (RMB)
1	prified water storage tank (including accessories)	10m3, heat preservation	316L	1	RITAI		***	***
2	purified water-circulating pump	20T/hr,55m lift  downward exaust gas mouth	316L	2	ALFA LAVAL		***	***
3	tubing heat exchanger	44T heat cycling 1h,25ºC-85ºC	316L	1	NEUMO/ABC		***	***
4	temperature transmitter	4-20 mA output	316L	3	SOTU		***	***
5	pressure gage	0-6 kgf/cm2, 1 1/2”	316L	2	BRIGHT		***	***
6	conductivity apparatus	4-20 mA output		2	BURKERT		***	***
7	flowmeter	4-20 mA output,DN50		2	YAKOGAWA		***	***
8	frequency transformer	7.5KW		1	SIEMENS		***	***
9	frequency transformer	11KW		1	SIEMENS		***	***
10	pneumatic diaphragm valve	DN50	316L	2	GEMU	casting Ra≤0.4	***	***
11	pneumatic diaphragm valve	DN40	316L	6	GEMU	casting Ra≤0.4	***	***
12	pneumatic T-diaphragm valve	DN50/40	316L	4	GEMU	casting Ra≤0.4	***	***
13	pneumatic T-diaphragm valve	DN50/25	316L	4	GEMU	casting Ra≤0.4	***	***
14	diaphragm valve	DN65	316L	2	GEMU	casting Ra≤0.4	***	***
15	T-diaphragm valve	DN65/15	316L	1	GEMU	casting Ra≤0.4	***	***
16	T-diaphragm valve	DN50/15	316L	8	GEMU	casting Ra≤0.4	***	***
17	diaphragm valve	DN15	316L	9	GEMU	casting Ra≤0.4	***	***
18	flange	DN50	316L	4	CHINA		***	***
19	clamping head	DN76.1	316L	2	King Lai	SMS,Ra≤0.6	***	***
20	clamping head	DN63.5	316L	12	King Lai	SMS,Ra≤0.6	***	***
21	clamping head	DN51	316L	5	King Lai	SMS,Ra≤0.6	***	***
22	clamping head	DN38	316L	15	King Lai	SMS,Ra≤0.6	***	***
23	clamping head	DN25	316L	8	King Lai	SMS,Ra≤0.6	***	***
24	clamping head	DN19	316L	3	King Lai	SMS,Ra≤0.6	***	***
25	clamping head	DN15	316L	21	King Lai	SMS,Ra≤0.6	***	***
26	snap ring	DN76.1	304	2	King Lai	ISO	***	***
27	snap ring	DN63.5	304	12	King Lai	ISO	***	***
28	snap ring	DN51	304	5	King Lai	ISO	***	***
29	snap ring	DN38	304	24	King Lai	ISO	***	***
30	snap ring	DN25	304	8	King Lai	ISO	***	***
31	snap ring	DN19	304	32	King Lai	ISO	***	***
32	gasket ring	DN76.1	PTFE	2	King Lai	ISO	***	***
33	gasket ring	DN63.5	PTFE	12	King Lai	ISO	***	***
34	gasket ring	DN51	PTFE	5	King Lai	ISO	***	***
35	gasket ring	DN38	PTFE	24	King Lai	ISO	***	***
36	gasket ring	DN25	PTFE	8	King Lai	ISO	***	***
37	gasket ring	DN19	PTFE	3	King Lai	ISO	***	***
38	gasket ring	DN15	PTFE	21	King Lai	ISO	***	***
39	(WCW) reducing tee	DN63.5/51	316L	1	King Lai	SMS,Ra≤0.6	***	***
40	(WCW) reducing tee	DN63.5/38	316L	3	King Lai	SMS,Ra≤0.6	***	***
41	(WCW) Long reducing tee	DN63.5/38	316L	1	King Lai	SMS,Ra≤0.6	***	***

沈阳三生制药有限责任公司

42	(WCW) reducing tee	DN51/38	316L	6	King Lai	SMS,Ra≤0.6	***	***
43	(WCW) Long reducing tee	DN51/38	316L	2	King Lai	SMS,Ra≤0.6	***	***
44	(WCW) reducing tee	DN63.5/38	316L	2	King Lai	SMS,Ra≤0.6	***	***
45	(WCW) reducing tee	DN38/19	316L	3	King Lai	SMS,Ra≤0.6	***	***
46	(WCW) reducing tee	DN38/15	316L	4	King Lai	SMS,Ra≤0.6	***	***
47	(WCW) reducing tee	DN25/15	316L	4	King Lai	SMS,Ra≤0.6	***	***
48	(WCW) tee	DN19	316L	1	King Lai	SMS,Ra≤0.6	***	***
49	90° bend	DN76.1	316L	5	King Lai	SMS,Ra≤0.6	***	***
50	90° bend	DN63.5	316L	28	King Lai	SMS,Ra≤0.6	***	***
51	90° bend	DN51	316L	168	King Lai	SMS,Ra≤0.6	***	***
52	90° bend	DN38	316L	19	King Lai	SMS,Ra≤0.6	***	***
53	90° bend	DN25	316L	8	King Lai	SMS,Ra≤0.6	***	***
54	90° bend	DN15	316L	31	King Lai	SMS,Ra≤0.6	***	***
55	45° bend	DN51	316L	2	King Lai	SMS,Ra≤0.6	***	***
56	concentric reducer	DN76.1/63.5	316L	2	King Lai	SMS,Ra≤0.6	***	***
57	eccentric reducer	DN63.5/51	316L	3	King Lai	SMS,Ra≤0.6	***	***
58	concentric reducer	DN63.5/38	316L	1	King Lai	SMS,Ra≤0.6	***	***
59	pipe	DN76.1	316L	6	King Lai	SMS,Ra≤0.6	***	***
60	pipe	DN63.5	316L	36	King Lai	SMS,Ra≤0.6	***	***
61	pipe	DN51	316L	348	King Lai	SMS,Ra≤0.6	***	***
62	pipe	DN38	316L	18	King Lai	SMS,Ra≤0.6	***	***
63	pipe	DN25	316L	18	King Lai	SMS,Ra≤0.6	***	***
64	pipe	DN15	316L	18	King Lai	SMS,Ra≤0.6	***	***
65	pneumatic control valve	DN50	stainless steel	1	BURKERT		***	***
66	pneumatic angle seat valve	DN40	stainless steel	4	BURKERT		***	***
67	pneumatic angle seat valve	DN25	stainless steel	4	BURKERT		***	***
68	ball valve	DN50	316	5	King Lai		***	***
69	steam trap	DN25 ball float steam trap	cast iron	1	Spirax Sarco		***	***
70	Y-filter	DN50	carbon steel	1	Spirax Sarco		***	***
71	clamping head	DN51	304	20	King Lai	SMS,Ra≤0.8	***	***
72	clamping head	DN38	304	12	King Lai	SMS,Ra≤0.8	***	***
73	clamping head	DN25	304	14	King Lai	SMS,Ra≤0.8	***	***
74	reducing tee	DN51/38	304	1	King Lai	SMS,Ra≤0.8	***	***
75	reducing tee	DN38/25	304	1	King Lai	SMS,Ra≤0.8	***	***
76	tee	DN25	304	2	King Lai	SMS,Ra≤0.8	***	***
77	pipe	DN51	304	6	King Lai	SMS,Ra≤0.8	***	***
78	pipe	DN38	304	6	King Lai	SMS,Ra≤0.8	***	***
79	pipe	DN25	304	6	King Lai	SMS,Ra≤0.8	***	***
	the above is the configuration list and quotation of tubings and fittings of purified water duct type cleanroom system							***

沈阳三生制药有限责任公司

Price Breakdown for WFI Distribution System
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price (RMB)	Total Price (RMB)
1	water for injection storage tank (including accessories)	10m3, pressure vessel	316L	1	RITAI		***	***
2	water for injection circulating pump	20T/hr,55m lift  downward exaust gas mouth	316L	1	ALFA LAVAL		***	***
3	water for injection circulating pump	20T/hr,55m lift  downward exaust gas mouth	316L	1	ALFA LAVAL		***	***
4	tubing heat exchanger	10T/H, 75ºC-85ºC.2T, heat cycling 1h,85ºC-121ºC	316L	1	NEUMO/ABC		***	***
5	tubing heat exchanger	10T/H, 75ºC-85ºC.2T, heat cycling 1h,85ºC-121ºC	316L	1	NEUMO/ABC		***	***
6	tubing heat exchanger	6T/H,85-30ºC,7ºC cooling medium	316L	2	NEUMO/ABC		***	***
7	tubing heat exchanger	6T/H,85-30ºC,7ºC cooling medium	316L	1	NEUMO/ABC		***	***
8	tubing heat exchanger	6T/H,85-30ºC,7ºC cooling medium	316L	1	NEUMO/ABC		***	***
9	temperature transmitter	4-20 mA output	316L	10	E+H		***	***
10	pressure gage	0-6 kgf/cm2,1 1/2”	316L	2	BRIGHT		***	***
11	conductivity apparatus	4-20 mA output		2	METTLER TOLEDO		***	***
12	TOC tester			2	METTLER TOLEDO		***	***
13	flowmeter	4-20 mA output,DN65		1	YAKOGAWA		***	***
14	flowmeter	4-20 mA output,DN50		1	YAKOGAWA		***	***
15	flowmeter	4-20 mA output,DN40		2	YAKOGAWA		***	***
16	flowmeter	4-20 mA output,DN25		1	YAKOGAWA		***	***
17	frequency transformer	7.5KW		1	SIEMENS		***	***
18	frequency transformer	11KW		1	SIEMENS		***	***
19	steam trap	DN20	316L	1	Spirax Sarco		***	***
20	pneumatic adjustable diaphragm valve	DN40	316L	2	GEMU	casting Ra≤0.4	***	***
21	pneumatic adjustable diaphragm valve	DN25	316L	1	GEMU	casting Ra≤0.4	***	***
22	pneumatic T-diaphragm valve	DN65	316L	1	GEMU	casting Ra≤0.4	***	***
23	pneumatic T-diaphragm valve	DN50	316L	2	GEMU	casting Ra≤0.4	***	***
24	pneumatic T-diaphragm valve	DN40	316L	13	GEMU	casting Ra≤0.4	***	***
25	pneumatic T-diaphragm valve	DN50/40	316L	3	GEMU	casting Ra≤0.4	***	***
26	pneumatic T-diaphragm valve	DN50/25	316L	4	GEMU	casting Ra≤0.4	***	***
27	pneumatic T-diaphragm valve	DN40/25	316L	6	GEMU	casting Ra≤0.4	***	***
28	diaphragm valve	DN80	316L	1	GEMU	casting Ra≤0.4	***	***
29	diaphragm valve	DN65	316L	1	GEMU	casting Ra≤0.4	***	***
30	diaphragm valve	DN50	316L	1	GEMU	casting Ra≤0.4	***	***
31	diaphragm valve	DN25	316L	1	GEMU	casting Ra≤0.4	***	***
32	diaphragm valve	DN15	316L	16	GEMU	casting Ra≤0.4	***	***
33	T-diaphragm valve	DN65/15	316L	2	GEMU	casting Ra≤0.4	***	***

沈阳三生制药有限责任公司

Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price  (RMB)	Total Price (RMB)
34	T-diaphragm valve	DN50/20	316L	1	GEMU	casting Ra≤0.4	***	***
35	T-diaphragm valve	DN50/15	316L	2	GEMU	casting Ra≤0.4	***	***
36	T-diaphragm valve	DN40/20	316L	4	GEMU	casting Ra≤0.4	***	***
37	T-diaphragm valve	DN40/15	316L	2	GEMU	casting Ra≤0.4	***	***
38	T-diaphragm valve	DN25/20	316L	1	GEMU	casting Ra≤0.4	***	***
39	T-diaphragm valve	DN25/15	316L	1	GEMU	casting Ra≤0.4	***	***
40	cold water point control panel		stainless steel	8	CHINA		***	***
41	flange	DN65	316L	2	CHINA		***	***
42	flange	DN50	316L	2	CHINA		***	***
43	flange	DN40	316L	4	CHINA		***	***
44	flange	DN25	316L	2	CHINA		***	***
45	clamping head	DN76.1	316L	5	NEUMO	ASME BPE PM,Ra≤0.5	***	***
46	clamping head	DN63.5	316L	10	NEUMO	ASME BPE PM,Ra≤0.5	***	***
47	clamping head	DN51	316L	8	NEUMO	ASME BPE PM,Ra≤0.5	***	***
48	clamping head	DN38	316L	18	NEUMO	ASME BPE PM,Ra≤0.5	***	***
49	clamping head	DN25	316L	20	NEUMO	ASME BPE PM,Ra≤0.5	***	***
50	clamping head	DN19	316L	32	NEUMO	ASME BPE PM,Ra≤0.5	***	***
51	clamping head	DN15	316L	26	NEUMO	ASME BPE PM,Ra≤0.5	***	***
52	snap ring	DN76.1	304	5	NEUMO	ASME BPE PM,Ra≤0.5	***	***
53	snap ring	DN63.5	304	10	NEUMO	ASME BPE PM,Ra≤0.5	***	***
54	snap ring	DN51	304	10	NEUMO	ASME BPE PM,Ra≤0.5	***	***
55	snap ring	DN38	304	24	NEUMO	ASME BPE PM,Ra≤0.5	***	***
56	snap ring	DN25	304	32	NEUMO	ASME BPE PM,Ra≤0.5	***	***
57	snap ring	DN19	304	67	NEUMO	ASME BPE PM,Ra≤0.5	***	***
58	gasket ring	DN76.1	PTFE	5	NEUMO	ASME BPE PM,Ra≤0.5	***	***
59	gasket ring	DN63.5	PTFE	10	NEUMO	ASME BPE PM,Ra≤0.5	***	***
60	gasket ring	DN51	PTFE	10	NEUMO	ASME BPE PM,Ra≤0.5	***	***
61	gasket ring	DN38	PTFE	24	NEUMO	ASME BPE PM,Ra≤0.5	***	***
62	gasket ring	DN25	PTFE	32	NEUMO	ASME BPE PM,Ra≤0.5	***	***
63	gasket ring	DN19	PTFE	35	NEUMO	ASME BPE PM,Ra≤0.5	***	***
64	gasket ring	DN15	PTFE	32	NEUMO	ASME BPE PM,Ra≤0.5	***	***
65	(WWW) reducing tee	DN76.1/38	316L	1	NEUMO	ASME BPE PM,Ra≤0.5	***	***
66	(WWW) reducing tee	DN63.5/51	316L	1	NEUMO	ASME BPE PM,Ra≤0.5	***	***
67	(WWW) reducing tee	DN63.5/38	316L	7	NEUMO	ASME BPE PM,Ra≤0.5	***	***
68	(WCW) Long reducing tee	DN63.5/38	316L	3	NEUMO	ASME BPE PM,Ra≤0.5	***	***
69	(WWW) reducing tee	DN51/38	316L	3	NEUMO	ASME BPE PM,Ra≤0.5	***	***
70	(WCW) Long reducing tee	DN51/38	316L	3	NEUMO	ASME BPE PM,Ra≤0.5	***	***
71	(WWW) reducing tee	DN51/25	316L	2	NEUMO	ASME BPE PM,Ra≤0.5	***	***
72	(WCW)long	DN38	316L	4	NEUMO	ASME BPE PM,Ra≤0.5	***	***
73	(WWW) reducing tee	DN25/19	316L	7	NEUMO	ASME BPE PM,Ra≤0.5	***	***
74	(WWW) reducing tee	DN40/15	316L	3	NEUMO	ASME BPE PM,Ra≤0.5	***	***
75	(WWW) reducing tee	DN25/15	316L	10	NEUMO	ASME BPE PM,Ra≤0.5	***	***
76	(WCW) tee	DN25	316L	2	NEUMO	ASME BPE PM,Ra≤0.5	***	***
77	(WCW) tee	DN19	316L	3	NEUMO	ASME BPE PM,Ra≤0.5	***	***
78	(WWW) reducing tee	DN63.5/38	316L	3	NEUMO	ASME BPE PM,Ra≤0.5	***	***
79	(WWW) reducing tee	DN51/25	316L	1	NEUMO	ASME BPE PM,Ra≤0.5	***	***
80	bend	DN76.1	316L	5	NEUMO	ASME BPE PM,Ra≤0.5	***	***

沈阳三生制药有限责任公司

Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price  (RMB)	Total Price (RMB)
81	bend	DN63.5	316L	32	NEUMO	ASME BPE PM,Ra≤0.5	***	***
82	bend	DN51	316L	98	NEUMO	ASME BPE PM,Ra≤0.5	***	***
83	bend	DN38	316L	107	NEUMO	ASME BPE PM,Ra≤0.5	***	***
84	bend	DN25	316L	21	NEUMO	ASME BPE PM,Ra≤0.5	***	***
85	bend	DN19	316L	21	NEUMO	ASME BPE PM,Ra≤0.5	***	***
86	bend	DN15	316L	28	NEUMO	ASME BPE PM,Ra≤0.5	***	***
87	45° bend	DN63.5	316L	1	NEUMO	ASME BPE PM,Ra≤0.5	***	***
88	45° bend	DN51	316L	1	NEUMO	ASME BPE PM,Ra≤0.5	***	***
89	concentric reducer	DN76.1/63.5	316L	1	NEUMO	ASME BPE PM,Ra≤0.5	***	***
90	eccentric reducer	DN63.5/51	316L	4	NEUMO	ASME BPE PM,Ra≤0.5	***	***
91	pipe	DN76.1	316L	6	NEUMO	ASME BPE PM,Ra≤0.5	***	***
92	pipe	DN63.5	316L	96	NEUMO	ASME BPE PM,Ra≤0.5	***	***
93	pipe	DN51	316L	258	NEUMO	ASME BPE PM,Ra≤0.5	***	***
94	pipe	DN38	316L	204	NEUMO	ASME BPE PM,Ra≤0.5	***	***
95	pipe	DN25	316L	48	NEUMO	ASME BPE PM,Ra≤0.5	***	***
96	pipe	DN19	316L	12	NEUMO	ASME BPE PM,Ra≤0.5	***	***
97	pipe	DN15	316L	12	NEUMO	ASME BPE PM,Ra≤0.5	***	***
98	pneumatic control valve	DN50	stainless steel	3	Burkert		***	***
99	pneumatic control valve	DN40	stainless steel	2	Burkert		***	***
100	pneumatic control valve	DN25	stainless steel	1	Burkert		***	***
101	pneumatic angle seat valve	DN25	stainless steel	8	GEMU		***	***
102	ball valve	DN50	316	16	King Lai		***	***
103	ball valve	DN40	316	6	King Lai		***	***
104	ball valve	DN25	316	1	King Lai		***	***
105	steam trap	DN25	cast steel	2	Spirax Sarco		***	***
106	Y-filter	DN50	cast steel	1	CHINA		***	***
107	Y-filter	DN40	cast steel	1	CHINA		***	***
108	clamping head	DN51	304	14	King Lai	SMS,Ra≤0.8	***	***
109	clamping head	DN38	304	10	King Lai	SMS,Ra≤0.8	***	***
110	clamping head	DN25	304	20	King Lai	SMS,Ra≤0.8	***	***
111	reducing tee	DN51/25	304	1	King Lai	SMS,Ra≤0.8	***	***
112	reducing tee	DN38/25	304	1	King Lai	SMS,Ra≤0.8	***	***
113	tee	DN25	304	6	King Lai	SMS,Ra≤0.8	***	***
114	pipe	DN51	304	18	King Lai	SMS,Ra≤0.8	***	***
115	pipe	DN38	304	12	King Lai	SMS,Ra≤0.8	***	***
116	pipe	DN25	304	30	King Lai	SMS,Ra≤0.8	***	***
	the above is the configuration list and quotation of tubings and fittings of water for injection duct type cleanroom system							***

沈阳三生制药有限责任公司

Price Breakdown for PS Distribution System
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price  (RMB)	Total Price (RMB)
1	pressure gage	0-6 kgf/cm2,1 1/2”	316L	1	Bright		***	***
2	thermometer	0ºC-160ºC,1 1/2”	316L	1	Sotu		***	***
3	steam trap	DN20	316	17	Spirax Sarco		***	***
4	pneumatic ball valve	DN25	316	5	KINGLAI		***	***
5	pneumatic ball valve	DN15	316	6	KINGLAI		***	***
6	pneumatic ball valve	DN65	316	1	KINGLAI		***	***
7	pneumatic ball valve	DN25	316	28	KINGLAI		***	***
8	pneumatic ball valve	DN20	316	6	KINGLAI		***	***
9	pneumatic ball valve	DN15	316	18	KINGLAI		***	***
10	clamping head	DN63.5	316L	2	NEUMO	ASME BPE PM,Ra≤0.5	***	***
11	clamping head	DN25	316L	143	NEUMO	ASME BPE PM,Ra≤0.5	***	***
12	clamping head	DN19	316L	58	NEUMO	ASME BPE PM,Ra≤0.5	***	***
13	snap ring	DN63.5	304	2	NEUMO	ASME BPE PM,Ra≤0.5	***	***
14	snap ring	DN38	304	2	NEUMO	ASME BPE PM,Ra≤0.5	***	***
15	snap ring	DN25	304	143	NEUMO	ASME BPE PM,Ra≤0.5	***	***
16	snap ring	DN19	304	58	NEUMO	ASME BPE PM,Ra≤0.5	***	***
17	gasket ring	DN63.5	PTFE	2	NEUMO	ASME BPE PM,Ra≤0.5	***	***
18	gasket ring	DN38	PTFE	2	NEUMO	ASME BPE PM,Ra≤0.5	***	***
19	gasket ring	DN25	PTFE	143	NEUMO	ASME BPE PM,Ra≤0.5	***	***
20	gasket ring	DN19	PTFE	58	NEUMO	ASME BPE PM,Ra≤0.5	***	***

沈阳三生制药有限责任公司

Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price  (RMB)	Total Price (RMB)
21	(WCW) reducing tee	DN63.5/38	316L	2	NEUMO	ASME BPE PM,Ra≤0.5	***	***
22	(WWW) reducing tee	DN63.5/51	316L	1	NEUMO	ASME BPE PM,Ra≤0.5	***	***
23	(WWW) reducing tee	DN51/25	316L	13	NEUMO	ASME BPE PM,Ra≤0.5	***	***
24	(WWW) reducing tee	DN51/19	316L	2	NEUMO	ASME BPE PM,Ra≤0.5	***	***
25	(WWW) reducing tee	DN25/19	316L	22	NEUMO	ASME BPE PM,Ra≤0.5	***	***
26	(WCW) tee	DN25	316L	18	NEUMO	ASME BPE PM,Ra≤0.5	***	***
27	(WCW) tee	DN19	316L	6	NEUMO	ASME BPE PM,Ra≤0.5	***	***
28	bend	DN63.5	316L	12	NEUMO	ASME BPE PM,Ra≤0.5	***	***
29	bend	DN51	316L	69	NEUMO	ASME BPE PM,Ra≤0.5	***	***
30	bend	DN38	316L	8	NEUMO	ASME BPE PM,Ra≤0.5	***	***
31	bend	DN25	316L	127	NEUMO	ASME BPE PM,Ra≤0.5	***	***
32	bend	DN19	316L	49	NEUMO	ASME BPE PM,Ra≤0.5	***	***
33	大小头 concentric reducer	DN63.5/51	316L	1	NEUMO	ASME BPE PM,Ra≤0.5	***	***
34	大小头 concentric reducer	DN51/25	316L	1	NEUMO	ASME BPE PM,Ra≤0.5	***	***
35	大小头 concentric reducer	DN51/19	316L	1	NEUMO	ASME BPE PM,Ra≤0.5	***	***
36	pipe	DN63.5	316L	12	NEUMO	ASME BPE PM,Ra≤0.5	***	***
37	pipe	DN51	316L	162	NEUMO	ASME BPE PM,Ra≤0.5	***	***
38	pipe	DN38	316L	12	NEUMO	ASME BPE PM,Ra≤0.5	***	***
39	pipe	DN25	316L	102	NEUMO	ASME BPE PM,Ra≤0.5	***	***
40	pipe	DN19	316L	36	NEUMO	ASME BPE PM,Ra≤0.5	***	***
	the above is the configuration list and quotation of tubings and fittings of pure steam  duct type cleanroom system							***

沈阳三生制药有限责任公司

Quotation for Control System
Item	Scope of Supply	Order No.	Specification	Manufacturer	Quantity	(RMB) Unit Price	(RMB) Price
1	lead rail	6ES7 390-1AF30-0AA0	530mm standard lead rail	SIEMENS	2	***	***
2	power source	6ES7 307-1EA00-0AA0	PS 307 5 A  power source	SIEMENS	2	***	***
3	CPU	6ES7 315-2EH13-0AB0	315-2 PN/DP 256KB RAM； MPI/PROFIBUS DP；PROFINET interface	SIEMENS	1	***	***
4	expansion card	6ES7 953-8LF11-0AA0	MMC  64 kB	SIEMENS	1	***	***
5	interface module	6ES7 365-0BA01-0AA0	IM365interface module	SIEMENS	1	***	***
6	DI module	6ES7 321-1BH02-0AA0	16 dots digital input 24VDC (20 pin)	SIEMENS	2	***	***
7	DO module	6ES7 322-1BH01-0AA0	16 dots digital output 24VDC (20 pin)	SIEMENS	4	***	***
8	AI module	6ES7 331-7KF02-0AB0	8 channels analog input (20 pin)	SIEMENS	6	***	***
9	AO module	6ES7 332-5HF00-0AB0	8 channels analog output (40 pin)	SIEMENS	4	***	***
10	connector	6ES7 392-1AJ00-0AA0	20pin， screw connector	SIEMENS	15	***	***
11	connector	6ES7 392-1AM00-0AA0	40pin， screw connector	SIEMENS	5	***	***
12	frequency transformer		MM420 7.5KW	SIEMENS	4	***	***
13	frequency transformer operation panel	6SE6 400-0BP00-0AA0	BOP operation panel	SIEMENS	4	***	***
14	switch power supply	6EP1 334-3BA00	SITOP 24V/10A	SIEMENS	1	***	***
15	controller cabinet		2000×800×600 (including electric elements such as electric relay and connector)	shanghai	1	***	***
16	upper computer		Core 2\1024MB\160G\19"LCD	DELL	1	***	***
17	upper computer software	6AV6 381-1BE06-2AV0	WINCC V6.2 RT(1024p) dot	SIEMENS	1	***	***
18	printe		A4 laser printer	HP	1	***	***
19	touch screen	6AV6 643-0CD01-1AX1	MP 277 10" Touch 64K color	SIEMENS	1	***	***
20	exchange board	6 RJ45口	industrial etherdevice switch	MOXA	1	***	***
21	quantum programming cable	6ES7 972-0CB20-0XA0	PLC USB quantum programming cable	SIEMENS	1	***	***
22	netting twine						***
23	cable						***
24	cable						***
25	cable						***
26	cable tray						***
first	materials for control system						***
second	Programme Cost（ (30 working days of one person)						***
third	Intallation Cost (10 working days of 3 persons)						***
fourth	Commissioning Cost ( 10 working days of 2 persons, including accommodation and transportation)						***

沈阳三生制药有限责任公司

Configuration list for  PW Bank
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Remarks
1	purified water storage tank	10m3 non-pressure vessel, horizontal type	316L	1	RiTai	Internal polishing Ra<0.5um，external matte processing Ra<0.8um
2	respirator	10“ 0.22um	316L	1	PALL
3	spray ball	DN40	316L	3	Alfa Laval	fixed type
4	content gauge	4-20 mA output		1	E+H	capacitance
5	temperature transmitter	DN40,4-20 mA output		1	SOTU	insulation displacement connection
6	pressure sensor	DN40,4-20 mA output		1	BRIGHT	insulation displacement connection
7	pneumatic ball valve	DN40	316L	1	King Lai
8	pneumatic ball valve	DN20	316L	3	King Lai
9	pneumatic diaphragm valve	DN40	316L	1	GEMU
10	diaphragm valve	DN15	316L	1	GEMU
11	steam trap	DN20  ball float steam trap	cast steel	1	Spirax Sarco
12	clamping head	DN38	316L	3	King Lai	SMS,Ra≤0.6
13	clamping head	DN19	316L	8	King Lai	SMS,Ra≤0.6
14	snap ring	DN38	304	6	King Lai	SMS,Ra≤0.6
15	snap ring	DN19	304	10	King Lai	SMS,Ra≤0.6
16	gasket ring	DN38	PTFE	6	King Lai	SMS,Ra≤0.6
17	gasket ring	DN19	PTFE	10	King Lai	SMS,Ra≤0.6
18	reducing tee	DN38/19	316L	4	King Lai	SMS,Ra≤0.6
19	tee	DN19	316L	2	King Lai	SMS,Ra≤0.6
	the above is the  configuration list of purified water storage tank
Configuration list for  WFI Bank
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Remarks
1	water storage tank	10m3 non-pressure vessel, horizontal type, heat preservation	316L	1	RiTai	Internal polishing Ra<0.5um，external matte processing Ra<0.8um
2	respirator	10“ 0.22um	316L	1	PALL
3	electric heating set			1	CHINA
4	spray ball	DN50	316L	1	Alfa Laval	fixed type
5	spray ball	DN40	316L	2	Alfa Laval	fixed type
6	content gauge	4-20 mA output	316L	1	E+H	capacitance

沈阳三生制药有限责任公司

Configuration list for  WFI Bank
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Remarks
7	pressure sensor	DN40,4-20 mA output	316L	1	BRIGHT	insulation displacement connection
8	temperature transmitter	DN40,4-20 mA output	316L	2	SOTU	insulation displacement connection
9	rupture disk	­0.5-4bar	316L	1	FIKE
10	steam trap	DN20 ball float steam trap	carbon steel	1	Spirax Sarco
11	pneumatic ball valve	DN40	316L	1	King Lai
12	pneumatic ball valve	DN20	316L	1	King Lai
13	ball valve	DN20	316L	1	King Lai
14	pneumatic diaphragm valve	DN40	316L	1	GEMU
15	diaphragm valve	DN15	316L	1	GEMU
16	pressure reducing valve	DN20		1	China
17	clamping head	DN40	316L	3	NEUMO	ASME BPE-EP
18	clamping head	DN19	316L	8	NEUMO	ASME BPE-EP
19	snap ring	DN40	304	6	NEUMO	ASME BPE-EP
20	snap ring	DN19	304	6	NEUMO	ASME BPE-EP
21	gasket ring	DN40	PTFE	6	NEUMO	ASME BPE-EP
22	gasket ring	DN19	PTFE	6	NEUMO	ASME BPE-EP
23	reducing tee	DN38/19	316L	2	NEUMO	ASME BPE-EP
24	tee	DN19	316L	1	NEUMO	ASME BPE-EP
	the above is the  configuration list of water for injection

沈阳三生制药有限责任公司

Quotation For Validation Activities
No.		Scope		Quotation(RMB)
1	water system	PW storage and distribution system	DQ，TM,RA	***
2			FAT,SAT	***
3			IQ	***
4			OQ	***
5			PQ protocol	***
6		WFI storage and distribution system	DQ，TM,RA	***
7			FAT,SAT	***
8			IQ	***
9			OQ	***
10			PQ protocol	***
11		Pure steam distribution system	DQ，TM,RA	***
12			FAT,SAT	***
13			IQ，OQ	***
14			PQ protocol	***
15		Automatic water control system FOR WATER	Validation of water control system	***
Total Price				***
Remarks
		1)The cost of trips and living in client site are included in above price。
		2）The fee of validation instruments are included in above price.
		3）The calibration work for instruments and sensors in the systems is not validation work.
		4）Period of validity of this quotation: within 3 months

沈阳三生制药有限责任公司

Welding Point Cost
Item	Supply Scope	Location		Quantity	Unit Price  (RMB)	Total Price  (RMB)
1	purified water system		automatic welding spot	1789	***	***
2	water for injection system		automatic welding spot	1089	***	***
3	pure steam system		automatic welding spot	1929	***	***
	Total Price					***

沈阳三生制药有限责任公司

Insulation Price List
		Clean Area Piping Insulation  Pipe-in-Pipe Asbestos Insulated			Non-clean Area Piping Insulation Stainless Steel Jacket Asbestos Insulated
		（m）quantity	unit price	total	（m）quantity	unit price	total
1	WFI pipe	1104	***	***	1532	***	***
2	PS pipe	1146	***	***	178	***	***
		Total：		***	Total：		***
Total							***

沈阳三生制药有限责任公司

Accessories List

Bakelite Bracket(set)

Stainless steel Plate (set)

Ceiling Access Pipe(set)

V Bar carbon steel(Piece)

Argon fee

Square steel fee

Pickling fee

quantity

unit price

total

quantity

unit price

total

quantity

unit price

total

quantity

unit price

total

price

price

price

1

PW pipe network

40

***

***

24

***

***

124

***

***

190

***

***

***

***

***

2

WFI pipe network

58

***

***

58

***

***

46

***

***

245

***

***

***

***

***

3

PS pipe network

52

***

***

52

***

***

18

***

***

110

***

***

***

***

***

Total:

***

Total:

***

Total:

***

Total:

***

***

***

***

Total：

***

EX-4.7.3

Exhibit 4.7.3 - Quotation for Cooling Water and Misc.

沈阳三生制药有限责任公司

Bid Schedule of Price

Item	Scope of Supply	Price (RMB)
1	Price Breakdown for  KS Distribution System	***
2	Price Breakdown for  Cooling Water Distribution System	***
3	Price Breakdown for  PW Water Distribution System	***
4	Price Breakdown for  Public Energy Distribution System	***
5	Insulation Fee	***
6	Piping surport	***
	Subtotal 1 for Material	***
7	Welding Point Cost	***
8	Cost of  Welding Point marking  (100% of total welding point )  20RMB /point	***
9	Endoscopic Check (20% of total welding point ) 80 RMB /point	***
10	X-ray Check ( 100% of total hand-welding point,all welded samples ) 180 RMB /point	***
11	Insurance and Transportation	***
	Subtotal 2 for Piping fabrication	***
12	Detail Design, Shop Drawings and As-built Drawings	***
13	Project Management & Supervision	***
14	COMPANY Management	***
	Subtotal 3 for Project Service	***
	Subtotal 1, 2, 3,	***
	Tax   （for main materials part issue added-value tax, for the others issue project invoice）	***
	Total Price	***

沈阳三生制药有限责任公司

 

Price Breakdown for KS Distribution System

Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price (RMB)	Total Price (RMB)
1	pressure gage	0-6 kgf/cm2,1 1/2”	316L	1	Bright		***	***
2	thermometer	0ºC-160ºC,1 1/2”	316L	1	Sout		***	***
3	steam trap	DN25	cast steel	4	Spirax Sarco		***	***
4	steam trap	DN20	cast steel	24	Spirax Sarco		***	***
5	pneumatic ball valve	DN20	316	24	KINGLAI		***	***
6	manual ball valve	DN65	316	1	KINGLAI		***	***
7	manual ball valve	DN25	316	5	KINGLAI		***	***
8	manual ball valve	DN20	316	25	KINGLAI		***	***
9	clamping head	DN63.5	316L	3	KINGLAI	SMS,Ra≤0.6	***	***
10	clamping head	DN25	316L	19	KINGLAI	SMS,Ra≤0.6	***	***
11	clamping head	DN19	316L	195	KINGLAI	SMS,Ra≤0.6	***	***
12	snap ring	DN63.5	304	3	KINGLAI	SMS,Ra≤0.6	***	***
13	snap ring	DN38	304	2	KINGLAI	SMS,Ra≤0.6	***	***
14	snap ring	DN25	304	19	KINGLAI	SMS,Ra≤0.6	***	***
15	snap ring	DN19	304	195	KINGLAI	SMS,Ra≤0.6	***	***
16	gasket ring	DN63.5	PTFE	3	KINGLAI	SMS,Ra≤0.6	***	***
17	gasket ring	DN38	PTFE	2	KINGLAI	SMS,Ra≤0.6	***	***
18	gasket ring	DN25	PTFE	19	KINGLAI	SMS,Ra≤0.6	***	***
19	gasket ring	DN19	PTFE	195	KINGLAI	SMS,Ra≤0.6	***	***
20	(WCW) reducing tee	DN63.5/38	316L	2	KINGLAI	SMS,Ra≤0.6	***	***
21	(WWW) reducing tee	DN63.5/38	316L	2	KINGLAI	SMS,Ra≤0.6	***	***
22	(WWW) reducing tee	DN63.5/25	316L	1	KINGLAI	SMS,Ra≤0.6	***	***
23	(WWW) reducing tee	DN38/19	316L	25	KINGLAI	SMS,Ra≤0.6	***	***
24	(WWW) reducing tee	DN25/19	316L	4	KINGLAI	SMS,Ra≤0.6	***	***
25	(WCW) tee	DN25	316L	5	KINGLAI	SMS,Ra≤0.6	***	***
26	(WCW) tee	DN19	316L	29	KINGLAI	SMS,Ra≤0.6	***	***
27	bend	DN51	316L	7	KINGLAI	SMS,Ra≤0.6	***	***
28	bend	DN38	316L	39	KINGLAI	SMS,Ra≤0.6	***	***
29	bend	DN25	316L	18	KINGLAI	SMS,Ra≤0.6	***	***
30	bend	DN19	316L	112	KINGLAI	SMS,Ra≤0.6	***	***
31	concentric reducer	DN63.5/38	316L	1	KINGLAI	SMS,Ra≤0.6	***	***
32	concentric reducer	DN38/25	316L	3	KINGLAI	SMS,Ra≤0.6	***	***
33	pipe	DN51	316L	30	KINGLAI	SMS,Ra≤0.6	***	***
34	pipe	DN38	316L	120	KINGLAI	SMS,Ra≤0.6	***	***
35	pipe	DN25	316L	48	KINGLAI	SMS,Ra≤0.6	***	***
36	pipe	DN19	316L	180	KINGLAI	SMS,Ra≤0.6	***	***
	the above is the configuration list and quotation of tubings and fittings of purified water of KS distribution duct type cleanroom system							***

沈阳三生制药有限责任公司

Price Breakdown for Cooling Water Distribution System

Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price (RMB)	Total Price (RMB)
1	self-priming pump	Q=6m3  H30m	304	2	Shangcheng		***	***
2	plate heat exchanger	1m2 exchange area	304	1	ALFA LAVAL		***	***
3	pneumatic angle seat valve	DN25	304	1	BURKET		***	***
4	electric capacity type liquidometer			1	E+H		***	***
5	thermometer (3mm length)	0~100°C	stainless steel	1	Sotu		***	***
6	temperature transmitter	0~100°C	stainless steel	1	Sotu		***	***
7	pressure gage	0-6kgf/cm2, 1”	stainless steel	9	Bright		***	***
8	ball valve	DN40	316	10	King Lai		***	***
9	ball valve	DN25	316	4	King Lai		***	***
10	ball valve	DN15	316	80	King Lai		***	***
11	clamping head	DN40	304	25	King Lai	SMS,Ra≤0.8	***	***
12	clamping head	DN25	304	22	King Lai	SMS,Ra≤0.8	***	***
13	clamping head	DN15	316L	176	King Lai	SMS,Ra≤0.8	***	***
14	snap ring	DN40	304	74	King Lai	SMS,Ra≤0.8	***	***
15	snap ring	DN15	304	497	King Lai	SMS,Ra≤0.8	***	***
16	gasket ring	DN40	PTFE	45	King Lai	SMS,Ra≤0.8	***	***
17	gasket ring	DN25	PTFE	29	King Lai	SMS,Ra≤0.8	***	***
18	gasket ring	DN15	PTFE	497	King Lai	SMS,Ra≤0.8	***	***
19	tee	DN38	304	7	King Lai	SMS,Ra≤0.8	***	***
20	reducing tee	DN38/25	304	7	King Lai	SMS,Ra≤0.8	***	***
21	reducing tee	DN25/15	304	87	King Lai	SMS,Ra≤0.8	***	***
22	reducing tee	DN38/15	304	89	King Lai	SMS,Ra≤0.8	***	***
23	concentric reducer	DN25/15	316L	5	King Lai	SMS,Ra≤0.8	***	***
24	concentric reducer	DN40/15	317L	7	King Lai	SMS,Ra≤0.8	***	***
25	bend	DN38	304	82	King Lai	SMS,Ra≤0.8	***	***
26	bend	DN25	304	32	King Lai	SMS,Ra≤0.8	***	***
27	bend	DN15	304	9	King Lai	SMS,Ra≤0.8	***	***
28	pipe	DN38	304	274	King Lai	SMS,Ra≤0.8	***	***
29	pipe	DN25	304	144	King Lai	SMS,Ra≤0.8	***	***
30	DK19 insulation displacement connection one side, 2 inside silk the other side	custom made	stainless steel	320	CHINA		***	***
31	air tube plug	10mm	stainless steel	320	CHINA		***	***
32	air tube	10mm	PE	400	CHINA		***	***
33	DK40 insulation displacement connection one side, DN40 outside silk the other side	custom made	stainless steel	4	CHINA		***	***
34	DN25 insulation displacement connection one side,DN25 outside silk the other side	custom made	stainless steel	2	CHINA		***	***
	the above is the configuration list and quotation of tubings and fittings of cooling water system							***

沈阳三生制药有限责任公司

Price Breakdown for RO Water Distribution System

Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price (RMB)	Total Price (RMB)
1	water pump	Q=6m3  H=40m	316	1	GRUNDFOS		***	***
2	P PW buffer water tank	1000L	316L	1	shanghai ritai		***	***
3	buffer water tank	300L	316L	1	shanghai ritai		***	***
4	respirator	5"	316L	2	PALL		***	***
5	electric capacity type liquidometer		316L	1	E+H		***	***
6	float ball liquid level switch		stainless steel	1	CHINA		***	***
7	pressure gage	0-6kgf/cm2, 1”	stainless steel	1	Bright		***	***
8	pressure transmitter	0-6kgf/cm2, 1”	不stainless steel	1	Bright		***	***
9	diaphragm valve	DN40	316L	3	GEMU		***	***
10	diaphragm valve	DN25	316L	2	GEMU		***	***
11	ball valve	DN25	316L	10	King Lai	SMS,Ra≤0.6	***	***
12	back-pressure valve	DN25	316L	1	King Lai	SMS,Ra≤0.6	***	***
13	clamping head	DN25	316L	26	King Lai	SMS,Ra≤0.6	***	***
14	clamping head	DN40	316L	12	King Lai	SMS,Ra≤0.6	***	***
15	snap ring	DN25	304	42	King Lai	SMS,Ra≤0.6	***	***
16	gasket ring	DN25	PTFE	30	King Lai	SMS,Ra≤0.6	***	***
17	gasket ring	DN40	PTFE	12	King Lai	SMS,Ra≤0.6	***	***
18	tee	DN25	316L	11	King Lai	SMS,Ra≤0.6	***	***
19	reducing tee	DN40/25	316L	1	King Lai	SMS,Ra≤0.6	***	***
20	bend	DN25	316L	86	King Lai	SMS,Ra≤0.6	***	***
21	bend	DN40	316L	15	King Lai	SMS,Ra≤0.6	***	***
22	pipe	DN25	316L	252	King Lai	SMS,Ra≤0.6	***	***
23	pipe	DN40	316L	12	King Lai	SMS,Ra≤0.6	***	***

the above is the configuration list and quotation of tubings and fittings of RO water distribution system ***

沈阳三生制药有限责任公司

 

Price Breakdown for Public Energy Pipe

Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price (RMB)	Total Price (RMB)
1	pneumatic adjustable angle seat valve	DN50	stainless steel	2	Burkert		***	***
2	pneumatic angle seat valve	DN50	stainless steel	2	Burkert		***	***
3	pneumatic angle seat valve	DN25	stainless steel	13	Burkert	International A Line	***	***
4	flange	DN50	304 stainless steel	8	CHINA	PN16	***	***
5	filter	DN25	cast iron	21	SPIRAX SARCO	International A Line	***	***
6	relief valve	DN20	304 stainless steel	16	CHINA	International A Line	***	***
7	manual ball valve	DN25	304 stainless steel	8	King Lai		***	***
8	manual ball valve	DN50	304 stainless steel	4	King Lai		***	***
9	manual ball valve	DN25	304 stainless steel	51	King Lai		***	***
10	manual ball valve	DN20	304 stainless steel	58	King Lai		***	***
11	free float type steam trap	DN20	304 stainless steel	23	SPIRAX SARCO	International A Line	***	***
12	back-pressure valve	DN50	304 stainless steel	4	SPIRAX SARCO	International A Line	***	***
13	back-pressure valve	DN20	304 stainless steel	8	SPIRAX SARCO	International A Line	***	***
14	bend	DN50	SS304	36	King Lai	SMS,Ra≤0.8	***	***
15	bend	DN25	SS304	178	King Lai	SMS,Ra≤0.8	***	***
16	bend	DN20	SS316	65	King Lai	SMS,Ra≤0.8	***	***
17	pipe	DN50	SS304	64	King Lai	SMS,Ra≤0.8	***	***
18	pipe	DN40	SS304	204	King Lai	SMS,Ra≤0.8	***	***
19	pipe	DN25	SS304	216	King Lai	SMS,Ra≤0.8	***	***
20	pipe	DN20	SS316L	275	King Lai	SMS,Ra≤0.8	***	***
21	flange	DN25	304 stainless steel	48	CHINA	PN16	***	***
22	flange	DN20	304 stainless steel	96	CHINA	PN16	***	***

the above is the configuration list and quotation of tubings and fittings of public energy channel ***

沈阳三生制药有限责任公司

 

Welding Point Cost

Item	Supply Scope	Location		Quantity	Unit Price (RMB)	Total Price (RMB)
1	KS distribution system		automatic welding spot	809	***	***
2	cooling water system		automatic welding spot	1063	***	***
3	water charging system		automatic welding spot	352	***	***
4	public energy system pipe installation		automatic welding spot	582	***	***
			manual welding spot	198	***	***
5	fountain and sanitary apparatus in place and installation					***

 Total Cost ***

沈阳三生制药有限责任公司

 

Insulation Price List
		Clean Area Piping Insulation  Pipe-in-Pipe Asbestos Insulated			Non-clean Area Piping Insulation Stainless Steel Jacket Asbestos Insulated
		（m）quantity	unit price	total	（m）quantity	unit price	total
1	Pk distribution	0	***	***	378	***	***
2	industrial steam and cooling water insulation	200	***	***	40	***	***
		Total：		***	Total：		***
Total							***

沈阳三生制药有限责任公司

 

Accessories List

Bakelite Bracket(set)

Stainless steel Plate (set)

Ceiling Access Pipe(set)

V Bar carbon steel(Piece)

Argon fee

Square steel fee

Pickling fee

quantity

unit price

total

quantity

unit price

total

quantity

unit price

total

quantity

unit price

total

price

price

price

1

Pk distribution system

46

***

***

46

***

***

4

***

***

114

***

***

***

***

***

2

cooling water pipe system

120

***

***

120

***

***

20

***

***

150

***

***

***

***

***

3

PW Water transportation system

50

***

***

50

***

***

8

***

***

60

***

***

***

***

***

4

public energy and appliance installation

35

***

***

100

***

***

***

***

***

Total

***

Total

***

Total

***

Total

***

***

***

***

Total：

***

EX-4.7.4

Exhibit 4.7.4 - Quotation for Gas K

沈阳三生制药有限责任公司

Bid Schedule of Price
Item	Scope of Supply	Price (RMB)
1	Price Breakdown for  CA Distribution System	***
2	Price Breakdown for  N2 Distribution System	***
3	Price Breakdown for  O2 Distribution System	***
4	Price Breakdown for  CO2 Distribution System	***
5	Piping surport	***
	Subtotal 1 for Material	***
6	Welding Point Cost	***
7	Cost of  Welding Point marking  (100% of total welding point )  20RMB /point	***
8	Endoscopic Check (20% of total welding point ) 80 RMB /point	***
9	X-ray Check ( 100% of total hand-welding point,all welded samples ) 180 RMB /point	***
10	Insurance and Transportation	***
	Subtotal 2 for Piping fabrication	***
11	Detail Design, Shop Drawings and As-built Drawings	***
12	Quotation For Validation Activities	***
13	Project Management & Supervision	***
14	COMPANY Management	***
	Subtotal 3 for Project Service	***
	Subtotal 1, 2, 3,	***
	Tax （for main materials part issue added-value tax, for the others issue project invoice）	***
	Total Price	***

沈阳三生制药有限责任公司

Price Breakdown for CA Distribution System
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price (RMB)	Total Price (RMB)
1	pressure gage	0-2kgf/cm2, 1”	stainless steel	4	Bright		***	***
2	pressure gage	0-10kgf/cm2, 1”	stainless steel	5	Bright		***	***
3	pressure reducing valve	1Bar～～0.8Bar   1”	stainless steel	1	Spirax Sarco		***	***
4	DK15 insulation displacement connection one side, 1 inside silk the other side	custom made	stainless steel	90	CHINA		***	***
5	air tube plug	1 outside silk trusting 8mm air tube	stainless steel	90	CHINA		***	***
6	air tube	8mm	PE	200	CHINA		***	***
7	ball valve	DN25	316	11	King Lai		***	***
8	ball valve	DN65	316	1	King Lai		***	***
9	ball valve	DN25	316	5	King Lai		***	***
10	ball valve	DN15	316	109	King Lai		***	***
11	check valve	DN25	304	1	King Lai	SMS,Ra≤0.8	***	***
12	clamping head	DN63.5	304	2	King Lai	SMS,Ra≤0.8	***	***
13	clamping head	DN51	304	1	King Lai	SMS,Ra≤0.8	***	***
14	clamping head	DN25	304	79	King Lai	SMS,Ra≤0.8	***	***
15	clamping head	DN15	316L	148	King Lai	SMS,Ra≤0.8	***	***
16	gasket ring	DN63.5	304	1	King Lai	SMS,Ra≤0.8	***	***
17	gasket ring	DN51	304	85	King Lai	SMS,Ra≤0.8	***	***
18	gasket ring	DN25	304	49	King Lai	SMS,Ra≤0.8	***	***
19	gasket ring	DN15	304	267	King Lai	SMS,Ra≤0.8	***	***
20	gasket ring	DN63.5	PTFE	1	King Lai	SMS,Ra≤0.8	***	***
21	gasket ring	DN51	PTFE	85	King Lai	SMS,Ra≤0.8	***	***
22	gasket ring	DN25	PTFE	49	King Lai	SMS,Ra≤0.8	***	***
23	gasket ring	DN15	PTFE	267	King Lai	SMS,Ra≤0.8	***	***
24	tee	DN63.5	304	10	King Lai	SMS,Ra≤0.8	***	***

沈阳三生制药有限责任公司

Price Breakdown for CA Distribution System
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price (RMB)	Total Price (RMB)
25	reducing tee（WCW)	DN63.5/51	304	1	King Lai	SMS,Ra≤0.8	***	***
26	reducing tee	DN63.5/38	304	1	King Lai	SMS,Ra≤0.8	***	***
27	reducing tee	DN63.5/19	304	1	King Lai	SMS,Ra≤0.8	***	***
28	reducing tee	DN51/38	304	2	King Lai	SMS,Ra≤0.8	***	***
29	reducing tee	DN51/25	304	2	King Lai	SMS,Ra≤0.8	***	***
30	reducing tee	DN51/19	304	1	King Lai	SMS,Ra≤0.8	***	***
31	reducing tee	DN38/25	304	10	King Lai	SMS,Ra≤0.8	***	***
32	reducing tee	DN38/19	304	4	King Lai	SMS,Ra≤0.8	***	***
33	tee	DN25/25	304	14	King Lai	SMS,Ra≤0.8	***	***
34	reducing tee	DN25/19	304	37	King Lai	SMS,Ra≤0.8	***	***
35	tee	DN19	304	2	King Lai	SMS,Ra≤0.8	***	***
36	reducing tee	DN25/15	304	87	King Lai	SMS,Ra≤0.8	***	***
37	clamping head	DN63.5/51	304	1	King Lai	SMS,Ra≤0.8	***	***
38	clamping head	DN51/25	304	1	King Lai	SMS,Ra≤0.8	***	***
39	clamping head	DN38/25	304	3	King Lai	SMS,Ra≤0.8	***	***
40	clamping head	DN25/19	316L	7	King Lai	SMS,Ra≤0.8	***	***
41	clamping head	DN25/15	316L	4	King Lai	SMS,Ra≤0.8	***	***
42	angle head	DN63.5	304	17	King Lai	SMS,Ra≤0.8	***	***
43	angle head	DN51	304	27	King Lai	SMS,Ra≤0.8	***	***
44	angle head	DN38	304	36	King Lai	SMS,Ra≤0.8	***	***
45	angle head	DN25	304	137	King Lai	SMS,Ra≤0.8	***	***
46	angle head	DN15	316L	7	King Lai	SMS,Ra≤0.8	***	***
47	angle head	DN19	316L	132	King Lai	SMS,Ra≤0.8	***	***
48	pipe	DN63.5	304	24	King Lai	SMS,Ra≤0.8	***	***

沈阳三生制药有限责任公司

Price Breakdown for CA Distribution System
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price (RMB)	Total Price (RMB)
49	pipe	DN51	304	54	King Lai	SMS,Ra≤0.8	***	***
50	pipe	DN38	304	96	King Lai	SMS,Ra≤0.8	***	***
50	pipe	DN25	304	492	King Lai	SMS,Ra≤0.8	***	***
50	pipe	DN15	316L	72	King Lai	SMS,Ra≤0.8	***	***
53	flanged ball valve	DN20	stainless steel	25	CHINA		***	***
54	flanged ball valve	DN50	stainless steel	18	CHINA		***	***
55	flanged ball valve	DN50	stainless steel	5	CHINA		***	***
56	flange	DN20	stainless steel	44	CHINA		***	***
57	flange	DN50	stainless steel	36	CHINA		***	***
58	flat gasket	DN20	stainless steel	44	CHINA		***	***
59	flat gasket	DN50	stainless steel	36	CHINA		***	***
	the above is the configuration list and quotation of tubings and fittings of oxygen pipe system							***

沈阳三生制药有限责任公司

Price Breakdown for N2 Distribution System
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price (RMB)	Total Price (RMB)
1	buffer tank	800L     6Bar	304	3	CHINA		***	***
2	filter	10“ 0.45um	304	3	PALL		***	***
3	relief valve	DN25	stainless steel	3	CHINA		***	***
4	pressure gage	0-4kgf/cm2, 1”	stainless steel	3	BRIGHT		***	***
5	pressure gage	0-2kgf/cm2, 1”	stainless steel	5	BRIGHT		***	***
6	electro connecting pressure gauge	0-4kgf/cm2, 1”	stainless steel	3	CHINA		***	***
7	pressure reducing valve	1Bar～～0.8Bar   1”	stainless steel	3	Spirax Sarco		***	***
8	steel cylinder flexible tube	DN15	stainless steel	12	CHINA		***	***
9	一 DK15 insulation displacement connection one side, 1 inside silk the other side	custom made	stainless steel	90	CHINA		***	***
10	air tube plug	1 outside silk trusting 8mm air tube	stainless steel	90	CHINA		***	***
11	air tube	8mm	PE	200	CHINA		***	***
12	ball valve	DN25	316L	11	King Lai	SMS,Ra≤0.8	***	***
13	ball valve	DN15	316L	80	King Lai	SMS,Ra≤0.8	***	***
14	back-pressure valve	DN25	304	3	King Lai	SMS,Ra≤0.8	***	***
15	pneumatic ball valve	DN20	304	12	King Lai	SMS,Ra≤0.8	***	***
16	clamping head	DN25	304	45	King Lai	SMS,Ra≤0.8	***	***

沈阳三生制药有限责任公司

Price Breakdown for N2 Distribution System
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price (RMB)	Total Price (RMB)
17	clamping head	DN15	316L	178	King Lai	SMS,Ra≤0.8	***	***
18	clamping head	DN19	316L	27	King Lai	SMS,Ra≤0.8	***	***
19	snap ring	DN25	304	47	King Lai	SMS,Ra≤0.8	***	***
20	snap ring	DN15	304	172	King Lai	SMS,Ra≤0.8	***	***
21	snap ring	DN19	304	25	King Lai	SMS,Ra≤0.8	***	***
22	gasket ring	DN38	PTFE	15	King Lai	SMS,Ra≤0.8	***	***
23	gasket ring	DN25	PTFE	32	King Lai	SMS,Ra≤0.8	***	***
24	gasket ring	DN15	PTFE	172	King Lai	SMS,Ra≤0.8	***	***
25	gasket ring	DN19	PTFE	27	King Lai	SMS,Ra≤0.8	***	***
26	reducing tee	DN25/25	304	7	King Lai	SMS,Ra≤0.8	***	***
27	reducing tee	DN25/15	304	76	King Lai	SMS,Ra≤0.8	***	***
28	reducing tee	DN25/19	304	6	King Lai	SMS,Ra≤0.8	***	***
29	concentric reducer	DN25/19	304	8	King Lai	SMS,Ra≤0.8	***	***
30	concentric reducer	DN25/15	304	4	King Lai	SMS,Ra≤0.8	***	***
31	bend	DN25	304	53	King Lai	SMS,Ra≤0.8	***	***
32	bend	DN19	304	28	King Lai	SMS,Ra≤0.8	***	***
33	bend	DN15	304	5	King Lai	SMS,Ra≤0.8	***	***
34	pipe	DN25	304	264	King Lai	SMS,Ra≤0.8	***	***
35	pipe	DN19	316L	102	King Lai	SMS,Ra≤0.8	***	***
	the above is the configuration list and quotation of tubings and fittings of nitrogen pipe system							***

沈阳三生制药有限责任公司

Price Breakdown for O2 Distribution System
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price (RMB)	Total Price (RMB)
1	buffer tank	800L     6Bar	304	2	CHINA		***	***
2	filter	10“ 0.45um	304	2	PALL		***	***
3	relief valve	DN25	stainless steel	2	CHINA		***	***
4	pressure gage	0-4kgf/cm2, 1”	stainless steel	2	BRIGHT		***	***
5	pressure gage	0-2kgf/cm2, 1”	stainless steel	4	BRIGHT		***	***
6	electro connecting pressure gauge	0-4kgf/cm2, 1”	stainless steel	2	CHINA		***	***
7	pressure reducing valve	1Bar～～0.8Bar   1”	stainless steel	2	Spirax Sarco		***	***
8	steel cylinder flexible tube	DN15	stainless steel	12	CHINA		***	***
9	DK15 insulation displacement connection one side, 1 inside silk the other side	custom made	stainless steel	90	CHINA		***	***
10	air tube plug	1 outside silk trusting 8mm air tube	stainless steel	90	CHINA		***	***
11	air tube	8mm	PE	200	CHINA		***	***
12	ball valve	DN25	316	8	King Lai	SMS,Ra≤0.8	***	***
13	ball valve	DN15	316	80	King Lai	SMS,Ra≤0.8	***	***
14	back-pressure valve	DN25	304	2	King Lai	SMS,Ra≤0.8	***	***
15	pneumatic ball valve	DN20	304	12	King Lai	SMS,Ra≤0.8	***	***
16	clamping head	DN25	304	33	King Lai	SMS,Ra≤0.8	***	***
17	clamping head	DN15	304	103	King Lai	SMS,Ra≤0.8	***	***
18	clamping head	DN19	304	27	King Lai	SMS,Ra≤0.8	***	***

沈阳三生制药有限责任公司

Price Breakdown for O2 Distribution System
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price (RMB)	Total Price (RMB)
19	snap ring	DN25	304	30	King Lai	SMS,Ra≤0.8	***	***
20	snap ring	DN15	304	170	King Lai	SMS,Ra≤0.8	***	***
21	snap ring	DN19	304	24	King Lai	SMS,Ra≤0.8	***	***
22	gasket ring	DN38	PTFE	10	King Lai	SMS,Ra≤0.8	***	***
23	gasket ring	DN25	PTFE	30	King Lai	SMS,Ra≤0.8	***	***
24	gasket ring	DN15	PTFE	170	King Lai	SMS,Ra≤0.8	***	***
25	gasket ring	DN19	PTFE	24	King Lai	SMS,Ra≤0.8	***	***
26	reducing tee	DN25/25	304	6	King Lai	SMS,Ra≤0.8	***	***
27	reducing tee	DN25/15	304	76	King Lai	SMS,Ra≤0.8	***	***
28	reducing tee	DN25/19	304	8	King Lai	SMS,Ra≤0.8	***	***
29	concentric reducer	DN25/19	304	4	King Lai	SMS,Ra≤0.8	***	***
30	concentric reducer	DN25/15	304	4	King Lai	SMS,Ra≤0.8	***	***
31	bend	DN25	304	52	King Lai	SMS,Ra≤0.8	***	***
32	bend	DN19	304	5	King Lai	SMS,Ra≤0.8	***	***
33	bend	DN15	304	5	King Lai	SMS,Ra≤0.8	***	***
34	pipe	DN25	304	264	King Lai	SMS,Ra≤0.8	***	***
	the above is the configuration list and quotation of tubings and fittings of oxygen pipe system							***

沈阳三生制药有限责任公司

Price Breakdown for CO2 Distribution System
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price (RMB)	Total Price (RMB)
1	buffer tank	800L     6Bar	304	2	CHINA		***	***
2	filter	10“ 0.45um	304	2	PALL		***	***
3	relief valve		stainless steel	2	CHINA		***	***
4	pressure gage	0-4kgf/cm2, 1”	stainless steel	2	BRIGHT		***	***
5	pressure gage	0-2kgf/cm2, 1”	stainless steel	6	BRIGHT		***	***
6	electro connecting pressure gauge	0-4kgf/cm2, 1”	stainless steel	2	CHINA		***	***
7	pressure reducing valve	1Bar～～0.8Bar   1”	stainless steel	2	Spirax Sarco		***	***
8	steel cylinder flexible tube	DN15	stainless steel	8	CHINA		***	***
9	DK15 insulation displacement connection one side, 1 inside silk the other side		stainless steel	122	CHINA		***	***
10	air tube plug	8mm	stainless steel	122	CHINA		***	***
11	air tube	8mm	PE	200	CHINA		***	***
12	ball valve	DN25	316L	8	King Lai		***	***
13	ball valve	DN15	316L	225	King Lai		***	***
14	back-pressure valve	DN25	304	2	King Lai	SMS,Ra≤0.8	***	***
15	pneumatic ball valve	DN20	304	8	King Lai	SMS,Ra≤0.8	***	***
16	clamping head	DN25	304	32	King Lai	SMS,Ra≤0.8	***	***

沈阳三生制药有限责任公司

Price Breakdown for CO2 Distribution System
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price (RMB)	Total Price (RMB)
17	clamping head	DN15	304	225	King Lai	SMS,Ra≤0.8	***	***
18	clamping head	DN19	304	18	King Lai	SMS,Ra≤0.8	***	***
19	snap ring	DN25	304	28	King Lai	SMS,Ra≤0.8	***	***
20	snap ring	DN15	304	246	King Lai	SMS,Ra≤0.8	***	***
21	snap ring	DN19	304	16	King Lai	SMS,Ra≤0.8	***	***
22	gasket ring	DN38	PTFE	10	King Lai	SMS,Ra≤0.8	***	***
23	gasket ring	DN25	PTFE	18	King Lai	SMS,Ra≤0.8	***	***
24	gasket ring	DN15	PTFE	246	King Lai	SMS,Ra≤0.8	***	***
25	gasket ring	DN19	PTFE	16	King Lai	SMS,Ra≤0.8	***	***
26	reducing tee	DN25/25	304	6	King Lai	SMS,Ra≤0.8	***	***
27	reducing tee	DN25/15	304	93	King Lai	SMS,Ra≤0.8	***	***
28	reducing tee	DN25/19	304	4	King Lai	SMS,Ra≤0.8	***	***
29	concentric reducer	DN25/19	304	5	King Lai	SMS,Ra≤0.8	***	***
30	concentric reducer	DN25/15	304	8	King Lai	SMS,Ra≤0.8	***	***
31	bend	DN25	304	57	King Lai	SMS,Ra≤0.8	***	***
32	bend	DN19	304	5	King Lai	SMS,Ra≤0.8	***	***
33	bend	DN15	304	8	King Lai	SMS,Ra≤0.8	***	***
34	pipe	DN25	304	294	King Lai	SMS,Ra≤0.8	***	***
35	pipe	DN15	316L	42	King Lai	SMS,Ra≤0.8	***	***
	the above is the configuration list and quotation of tubings and fittings of carbon dioxide gas pipe system							***

沈阳三生制药有限责任公司

Quotation For Validation Activities
No.	Scope		Quotation(RMB)
5	Compressed air distribution system	DQ，TM,RA	***
6		SAT	***
7		IQ,OQ	***
8		PQ protocol	***
9	Nitrogen distribution system	DQ，TM,RA	***
10		SAT	***
11		IQ,OQ	***
12		PQ protocol	***
13	Carbon dioxide distribution system	DQ，TM,RA	***
14		SAT	***
15		IQ,OQ	***
16		PQ protocol	***
17	Carbon dioxide distribution system	DQ，TM,RA	***
18		SAT	***
19		IQ,OQ	***
20		PQ protocol	***
Total Cost			***
Remarks
	1)The cost of trips and living in client site are included in above price。
	2） The fee of validation instruments are included in above price.
	3） The calibration work for instruments and sensors in the systems is not validation work.
	4）period of validity of this quotation: within 3 months

沈阳三生制药有限责任公司

Welding Point Cost
Item	Supply Scope	Location		Quantity	Unit Price (RMB)	Total Price (RMB)
6	compressed-air system		automatic welding spot	1607	***	***
7	nitrogen system		automatic welding spot	764	***	***
8	oxygen system		automatic welding spot	617	***	***
9	carbon-dioxide system		automatic welding spot	753	***	***
	Total Cost					***

沈阳三生制药有限责任公司

Accessories List

Bakelite Bracket(set)

Stainless steel Plate (set)

Ceiling Access Pipe(set)

V Bar carbon steel(Piece)

Argon fee

方钢费 Square steel fee

Pickling fee

quantity

unit price

total

quantity

unit price

total

quantity

unit price

total

quantity

unit price

***

price

price

price

1

compressed-air system

155

***

***

155

***

***

54

***

***

285

***

***

***

***

***

2

nitrogen system

100

***

***

100

***

***

26

***

***

47

***

***

***

***

***

3

oxygen system

100

***

***

100

***

***

25

***

***

45

***

***

***

***

***

4

carbon-dioxide system

100

***

***

100

***

***

25

***

***

45

***

***

***

***

***

Total

***

Total

***

Total

***

Total

***

***

***

***

Total :

***

EX-4.7.5

Exhibit 4.7.5 - Quotation for Cooling Water and Misc.

沈阳三生制药有限责任公司

Bid Schedule of Price
Item	Scope of Supply	Price (RMB)
1	Price Breakdown for Solution System	***
2	Price Breakdown for  CIP System	***
3	Automatic Control System	***
4	Piping surport	***
	Subtotal 1 for Material	***
5	Welding Point Cost	***
6	Cost of  Welding Point marking  (100% of total welding point )  20RMB /point	***
7	Endoscopic Check (20% of total welding point ) 80 RMB /point	***
8	X-ray Check ( 100% of total hand-welding point,all welded samples ) 180 RMB /point	***
9	Insurance and Transportation	***
	Subtotal 2 for Piping fabrication	***
10	Detail Design, Shop Drawings and As-built Drawings	***
11	Quotation For Validation Activities	***
12	Quotation For Validation Activities	***
13	Project Management & Supervision	***
14	COMPANY Management	***
	Subtotal 3 for Project Service	***
	Subtotal 1, 2, 3,	***
	Tax （for main materials part issue added-value tax, for the others issue project invoice）	***
	Total Price	***

 

沈阳三生制药有限责任公司

Price Breakdown for Solution Pipe
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price (RMB)	Total Price (RMB)
1	flexible tube	DN25	SENTRY SANITARY	14	Saint-Gobain	ASME BPE	***	***
2	flexible tube	DN40	SENTRY SANITARY	22	Saint-Gobain	ASME BPE	***	***
3	flexible tube	DN15	SENTRY SANITARY	9	Saint-Gobain	ASME BPE	***	***
4	flexible tube	DN50	304  stainless steel	4	made in China		***	***
5	bend	DN25	SS316L	16	NEUMO	ASME BPE PM,Ra≤0.5	***	***
6	bend	DN40	SS316L	36	NEUMO	ASME BPE PM,Ra≤0.5	***	***
7	pipe	DN25	SS316L	30	NEUMO	ASME BPE PM,Ra≤0.5	***	***
8	pipe	DN40	SS316L	72	NEUMO	ASME BPE PM,Ra≤0.5	***	***
9	snap ring	DN40	SS304	40	NEUMO	ASME BPE	***	***
10	clamping head	DN40	SS316L	55	NEUMO	ASME BPE PM,Ra≤0.5	***	***
11	clamping head	DN25	SS316L	25	NEUMO	ASME BPE PM,Ra≤0.6	***	***
12	gasket	DN40	PTFE	42	NEUMO	BPE CLP	***	***
13	gasket	DN25	PTFE	18	NEUMO	BPE CLP	***	***
14	manual diaphragm valve	DN40	SS316L	16	Gemu	casting Ra≤0.4	***	***
30	manual diaphragm valve	DN25	316L	6	GEMU	casting Ra≤0.4	***	***
15	manual diaphragm valve	DN15	SS316L	10	Gemu	casting Ra≤0.4	***	***
16	pneumatic diaphragm valve	DN25	SS316L	22	Gemu	casting Ra≤0.4	***	***
17	pneumatic diaphragm valve	DN40	SS316L	8	Gemu	casting Ra≤0.4	***	***
	the above is the configuration list and quotation of tubings and fittings of materials transportation pipe system and public energy pipe							***

沈阳三生制药有限责任公司

PriceBreakdownforCIPPipe
Item	SupplyScope	Specification	Material	Quantity	Manufacturer	Standard	UnitPrice (RMB)	TotalPrice (RMB)
1	reflux pump	flow 8m3/h  lift 30m	SS316L	6	GRACO America		***	***
2	flow switch	DN40	SS316L	6	E+H		***	***
3	clamping head	DN40	SS316L	54	NEUMO	ASME BPE Ra<0.5µm	***	***
4	clamping head	DN25	SS316L	63	NEUMO	ASME BPE Ra<0.5µm	***	***
5	snap ring	DN40	SS304	117	NEUMO	BPE CLP	***	***
6	gasket	DN40	PTFE	54	NEUMO	BPE CLP	***	***
7	gasket	DN25	PTFE	63	NEUMO	BPE CLP	***	***
8	pipe	DN25	SS316L	204	NEUMO	ASME BPE Ra<0.5µm	***	***
9	pipe	DN40	SS316L	180	NEUMO	ASME BPE Ra<0.5µm	***	***
10	bend	DN25	SS316L	109	NEUMO	ASME BPE Ra<0.5µm	***	***
11	bend	DN40	SS316L	95	NEUMO	ASME BPE Ra<0.5µm	***	***
12	tee	DN40	SS316L	21	NEUMO	ASME BPE Ra<0.5µm	***	***
13	tee	DN40*25	SS316L	10	NEUMO	ASME BPE Ra<0.5µm	***	***
14	manual diaphragm valve	DN40	SS316L	8	GEMU	casting Ra≤0.4	***	***
15	manual diaphragm valve	DN25	SS316L	5	GEMU	casting Ra≤0.4	***	***
16	pneumatic diaphragm valve	DN25	SS316L	24	GEMU	casting Ra≤0.4	***	***
17	pneumatic diaphragm valve	DN40	SS316L	12	GEMU	casting Ra≤0.4	***	***
	the above is the configuration list and quotation of tubings and fittings of CIP pipe							***

Quotation for Control System
Item	Scope of Supply	Order No.	Specification	Manufacturer	Quantity	(RMB)  Unit Price	(RMB) Price
1	lead rail	6ES7 390-1AF30-0AA0	530mm standard lead rail	SIEMENS	2	***	***
2	power source	6ES7 307-1EA00-0AA0	PS 307  5 A  power source	SIEMENS	2	***	***
3	CPU	6ES7 315-2EH13-0AB0	315-2 PN/DP 256KB RAM； MPI/PROFIBUS DP；PROFINET	SIEMENS	1	***	***
4	expansion card	6ES7 953-8LF11-0AA0	MMC  64 kB	SIEMENS	1	***	***
5	interface module	6ES7 365-0BA01-0AA0	IM365 interface module	SIEMENS	1	***	***
6	DI module	6ES7 321-1BH02-0AA0	16 dots digital input 24VDC (20 pin)	SIEMENS	1	***	***
7	DO module	6ES7 322-1BH01-0AA0	16 dots digital output 24VDC (20 pin)	SIEMENS	5	***	***
8	AI module	6ES7 331-7KF02-0AB0	8 channels analog input (20 pin)	SIEMENS	4	***	***
9	AO module	6ES7 332-5HF00-0AB0	8 channels analog output (40 pin)	SIEMENS	1	***	***
10	connector	6ES7 392-1AJ00-0AA0	20bin,  screw connector	SIEMENS	10	***	***
11	connector	6ES7 392-1AM00-0AA0	40bin,screw connector	SIEMENS	1	***	***
12	frequency transformer		MM420 1.5KW	SIEMENS	4	***	***
13	frequency transformer operation panel	6SE6 400-0BP00-0AA0	BOP operation panel	SIEMENS	4	***	***
14	switch power supply	6EP1 334-3BA00	SITOP 24V/10A	SIEMENS	1	***	***
15	controller cabinet		2000×800×600 (including electric elements such as electric relay and connector)	shanghai	1	***	***
16	control cabinet		wall mounting type (including electric elements such as button and connector)	shanghai	1	***	***
17	touch screen	6AV6 643-0CD01-1AX1	MP 277 10" Touch 64K  color	SIEMENS	3	***	***
18	switchboard	6 RJ45 mouth	industrial etherdevice switch	MOXA	1	***	***
19	netting twine		utp-five categories	AMP	100	***	***
20	cable		RVV 2*1.0 (meter)	WUXI	4000	***	***
21	cable		RVVp 2*1.0(meter)	WUXI	2000	***	***
22	cable		RVVP3*6+1 (meter)	WUXI	300	***	***
23	cable tray		150*75 (meter)	WUXI	250	***	***
一、	materials for control system					***
二、	Programme Cost (30 working days of one person)					***
三、	Intallation Cost (10 working days of 3 persons)					***
四、	Commissioning Cost( 10 working days of 2 persons, including accommodation and transportation)					***
***						***

Quotation for Control System
Item	Scope of Supply	Order No.	Specification	Manufacturer	Quantity	(RMB)  Unit Price	(RMB) Price
1	lead rail	6ES7 390-1AF30-0AA0	530mm standard lead rail	SIEMENS	2	***	***
2	power source	6ES7 307-1EA00-0AA0	PS 307 5 A  power source	SIEMENS	2	***	***
3	CPU	6ES7 315-2EH13-0AB0	315-2 PN/DP 256KB RAM； MPI/PROFIBUS DP；PROFINET	SIEMENS	1	***	***
4	expansion card	6ES7 953-8LF11-0AA0	MMC  64 kB	SIEMENS	1	***	***
5	interface module	6ES7 365-0BA01-0AA0	IM365 interface module	SIEMENS	1	***	***
6	DI module	6ES7 321-1BH02-0AA0	16 dots digital input 24VDC (20 pin)	SIEMENS	1	***	***
7	DO module	6ES7 322-1BH01-0AA0	16 dots digital output 24VDC (20 pin)	SIEMENS	5	***	***
8	AI module	6ES7 331-7KF02-0AB0	8 channels analog input (20 pin)	SIEMENS	4	***	***
9	AO module	6ES7 332-5HF00-0AB0	88 channels analog output (40 pin)	SIEMENS	1	***	***
10	connector	6ES7 392-1AJ00-0AA0	20bin,  screw connector	SIEMENS	10	***	***
11	connector	6ES7 392-1AM00-0AA0	40bin screw connector	SIEMENS	1	***	***
12	frequency transformer		MM420 1.5KW	SIEMENS	3	***	***
13	frequency transformer operation panel	6SE6 400-0BP00-0AA0	BOP operation panel	SIEMENS	4	***	***
14	switch power supply	6EP1 334-3BA00	SITOP 24V/10A	SIEMENS	1	***	***
15	controller cabinet		2000×800×600(including electric elements such as electric relay and connector)	shanghai	1	***	***
16	control cabinet		wall mounting type (including electric elements such as button and connector)	shanghai	1	***	***
17	touch screen	6AV6 643-0CD01-1AX1	MP 277 10" Touch 64K color	SIEMENS	3	***	***
18	switchboard	6 RJ45口 mouth	industrial etherdevice switch	MOXA	1	***	***
19	netting twine		utp-five categories	AMP	100	***	***
20	cable		RVV 2*1.0 (meter)	WUXI	4000	***	***
21	cable		RVVp 2*1.0(meter)	WUXI	2000	***	***
22	cable		RVVP3*6+1 (meter)	WUXI	300	***	***
23	cable tray		150*75(meter)	WUXI	250	***	***
一、	materials for control system					***
二、	Programme Cost (30 working days of one person)					***
三、	Intallation Cost (10 working days of 3 persons)					***
四、	Commissioning Cost( 10 working days of 2 persons, including accommodation and transportation)					***
***						***
Total Price of EPO+TPO control system						***

沈阳三生制药有限责任公司

Quotation For Validation Activities
No.		Scope		Quotation(RMB)
1	Material system	EPO preparation system	DQ，TM,RA	***
2			FAT,SAT	***
3			IQ	***
4			OQ	***
5		TPO preparation system	DQ，TM,RA	***
6			FAT,SAT	***
7			IQ	***
8			OQ	***
9		CIP CIP system	DQ，TM,RA	***
10			FAT,SAT	***
11			IQ	***
12			OQ	***
13		Automatic control system	Validation of control system	***
Total Price				***
Remarks ：
		1)The cost of trips and living in client site are included in above price。
		2） The fee of validation instruments are included in above price.
		3） The calibration work for instruments and sensors in the systems is not validation work.
		4）period of validity of this quotation: within 3 months

沈阳三生制药有限责任公司

Welding Point Cost
Item	Supply Scope	Location		Quantity	Unit Price (RMB)	Total Price (RMB)
1	materials transportation pipe		automatic welding spot	1192	***	***
2	CIP		automatic welding spot	1675	***	***
	Total Price					***

沈阳三生制药有限责任公司

Accessories List

Bakelite Bracket(set)

Stainless steel Plate (set)

Ceiling Access Pipe(set)

V Bar carbon steel(Piece)

Argon fee

Square steel fee

Pickling fee

quantity

unit price

total

quantity

unit price

total

quantity

unit price

total

quantity

unit price

total

price

price

price

1

materials transportation and CIP pipe

80

***

***

80

***

***

55

***

***

60

***

***

***

***

***

Total

***

Total

***

：Total

***

Total

***

***

***

***

Total：

***

EX-4.7.6

Exhibit 4.7.6 - Total Price of Pipeline

Total         Price
Item	System	Price (RMB)
1	quotation of water system	***
2	quotation of material  system	***
3	quotation of gas system	***
4	quotation of synergic system	***
	Total:1, 2, 3,   4	***
	Total Price	***
	RMB

Bid Schedule of Price
Item	Scope of Supply	Price (RMB)
1	Price Breakdown for  PW Distribution System	***
2	Price Breakdown for  WFI Distribution System	***
3	Price Breakdown for PS Distribution System	***
4	Automatic Control System FOR WATER	***
5	Insulation Fee	***
6	Piping surport	***
	Subtotal 1 for Material	***
7	Welding Point Cost	***
8	Cost of  Welding Point marking  (100% of total welding point )  20RMB /point	***
9	Endoscopic Check (20% of total welding point ) 80 RMB /point	***
10	X-ray Check ( 100% of total hand-welding point,all welded samples ) 180 RMB /point	***
11	Insurance and Transportation	***
	Subtotal 2 for Piping fabrication	***
12	Detail Design, Shop Drawings and As-built Drawings	***
13	Quotation For Validation Activities	***
14	Project Management & Supervision	***
15	COMPANY Management	***
	Subtotal 3 for Project Service	***
	Subtotal 1, 2, 3,	***
	Tax   （for main materials part issue added-value tax, for the others issue project invoice）	***
	Total Price	***

Bid Schedule of Price
Item	Scope of Supply	Price (RMB)
1	Price Breakdown for Solution System	***
2	Price Breakdown for  CIP System	***
3	Automatic Control System	***
4	Piping surport	***
	Subtotal 1 for Material	***
5	Welding Point Cost	***
6	Cost of  Welding Point marking  (100% of total welding point )  20RMB /point	***
7	Endoscopic Check (20% of total welding point ) 80 RMB /point	***
8	X-ray Check ( 100% of total hand-welding point,all welded samples ) 180 RMB /point	***
9	Insurance and Transportation	***
	Subtotal 2 for Piping fabrication	***
10	Detail Design, Shop Drawings and As-built Drawings	***
11	Quotation For Validation Activities	***
12	Quotation For Validation Activities	***
13	Project Management & Supervision	***
14	COMPANY Management	***
	Subtotal 3 for Project Service	***
	Subtotal 1, 2, 3,	***
	Tax   （for main materials part issue added-value tax, for the others issue project invoice）	***
	Total Price	***

Bid Schedule of Price                                                    价格一览表
Item	Scope of Supply	Price (RMB)
1	Price Breakdown for  CA Distribution System	***
2	Price Breakdown for  N2 Distribution System	***
3	Price Breakdown for  O2 Distribution System	***
4	Price Breakdown for  CO2 Distribution System	***
5	Piping surport	***
	Subtotal 1 for Material	***
6	Welding Point Cost	***
7	Cost of  Welding Point marking  (100% of total welding point )  20RMB /point	***
8	Endoscopic Check (20% of total welding point ) 80 RMB /point	***
9	X-ray Check ( 100% of total hand-welding point,all welded samples ) 180 RMB /point	***
10	Insurance and Transportation	***
	Subtotal 2 for Piping fabrication	***
11	Detail Design, Shop Drawings and As-built Drawings	***
12	Quotation For Validation Activities	***
13	Project Management & Supervision	***
14	COMPANY Management	***
	Subtotal 3 for Project Service	***
	Subtotal 1, 2, 3,	***
	Tax   （for main materials part issue added-value tax, for the others issue project invoice）	***
	Total Price	***

Bid Schedule of Price                                                    价格一览表
Item	Scope of Supply	Price (RMB)
1	Price Breakdown for  KS Distribution System	***
2	Price Breakdown for  Cooling Water Distribution System	***
3	Price Breakdown for  PW Water Distribution System	***
4	Price Breakdown for  Public Energy Distribution System	***
5	Insulation Fee	***
6	Piping surport	***
	Subtotal 1 for Material	***
7	Welding Point Cost	***
8	Cost of  Welding Point marking  (100% of total welding point )  20RMB /point	***
9	Endoscopic Check (20% of total welding point ) 80 RMB /point	***
10	X-ray Check ( 100% of total hand-welding point,all welded samples ) 180 RMB /point	***
11	Insurance and Transportation	***
	Subtotal 2 for Piping fabrication	***
12	Detail Design, Shop Drawings and As-built Drawings	***
13	Project Management & Supervision	***
14	COMPANY Management	***
	Subtotal 3 for Project Service	***
	Subtotal 1, 2, 3,	***
	Tax （for main materials part issue added-value tax, for the others issue project invoice）	***
	Total Price	***

EX-4.7.7

Exhibit 4.7.7 - Appendix 3 Meeting Memo

Memorandum

Feb. 17th

Scoping and technical disclosure of purification system project

Yofoto and Macroprocess

1. Macroprocess has received the drawings and technical parameter of processing equipments Yofoto provided in order to design the equipment pipes of cleanroom.

2. Before Macroprocess enters into the construction site, Yofoto shall provide water and electricity for temporary purpose (separate power supply); and provide Macroprocess water producing room and gas source room as the closed construction buildings. Macroprocess shall provide the requirements in written form about water and electricity for temporary purpose; water preparation plant needs to be closed after water equipments enter into the plant.

3. Yofoto shall reserve the condensation water outlet sleeve 40 cm over the ground.

4. According to layout chart of STILMAS water preparation room Yofoto has provided, Macroprocess is responsible for designing the tubing of water preparation room utilities, and Suntec is responsible for getting ready.

Yofoto and Suntec:

1. Yofoto will provide the temporary construction area, blast pipe making section (air-conditioner room in second floor) and interface of water and electricity for temporary purpose before June 1st according to requirements before construction in written form Suntec provided. The ground is according with the national standard.

2. Suntec will provide the scheme for Yofoto in the mid-March.

3. All equipments in place will be in the charge of Suntec.

4. Yofoto will provide the drawings of refrigerator room and process pipe to Suntec.

5. The added construction content will be budgeted by Suntec to Yofoto.

6. After Yofoto confirms the contractor unit of fire protection, Yofoto and Suntec discuss the project boundary according to the relevant cleanroom fire protection content

Requirements of Yofoto to Macroprocess and Suntec:

1. The requirement of overall construction period is that enters into the construction site in the end of May, and in the end of October finishes the installation and debugging and transfers to Yofoto to check.

2. Time chart of construction period of Macroprocess and Suntec will be received before Feb.20th. (subject to the regulations of contract)

3. Mutual cooperation, and protection for semi-finished products

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4. Heat preservation problems: water room and clean area chooses pipe casing to preserve the heat; cold water pipe and air tube of common area and sandwich technique chooses rubber and plastic to preserve the heat, vapour and hot-water pipe choose centrifugal glass wool to preserve the heat, and chooses the model of packing exterior tin plate

Macroprocess and Suntec:

1. All technical exchange documents of both parties and owner party need to be copied to each other.

2. Construction time

Suntec enters into the construction site before June 2nd,delivers the working surface of two workshops of TPO and EPO to Macroprocess before Aug. 5th, delivers the working surface of pharmaceutics workshop to Macroprocess before Aug. 5th, and begins to cross constructions.

3. Construction scope

a) Pipelines in air-condition room is constructed by Suntec except the pure steam humidification pipelines are constructed by Macroprocess.

b) All cleaning pipelines and pipelines of cooling water system supplying c-pack are constructed by Macroprocess

c) The rest pipelines are divided by the cleanroom inside and outside, Macroprocess is responsible for the pipelines of the cleanroom inside and the pipelines that need to connected with the pipelines outdoor, and Macroprocess makes the top plate 50cm for pipelines; all the pipelines of outdoor and intercalation are in the charge of Suntec.

d) The equipments of all cleanroom condensate drain, common drain and public service are in the charge of Macroprocess.

e) Sentry sanitary pipelines are in the charge of Macroprocess, the rest pipelines are in the charge of Suntec, and both parties adopt the uniform insulation materials

f) Pipeline tapping of cleanroom adopts the principle of automatic open and automatic close.

Problems to be solved:

The situation of the relevant process equipments of Yofoto entering into the construction site will actually affect the process of construction period, the time of equipments entering into the construction site is:

1)      Majority of large scale equipments of pharmaceutics workshop has been entered.

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2) One imported autoclave cabinet has been entered, five autoclave cabinets made in China plan to enter into the construction site in the mid-August.

3) Imported washing machine will be arrived in the mid-September.

4)    Distilled water machine will be arrived in the mid-August.

5) The exact producing period and time of entering into the construction site of Morimatsu equipments are: two 1500 liters tank plan to be arrived in June 20th, four 600 liters tank plan to be arrived in June 30th, and CIP working station plans to be arrived in July 20th.

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February 18th

Construction content technical disclosure of gas andpublic service:

(一) Oxygen

1. Change the state of oxygen cylinder from 2 uses and 2 standbys to 3 uses and 3 standbys

2. Cancel the back-pressure valve at the end of point, and change to add the back-pressure valve to the main pipes.

3. Buffer tank pressure is set 1 bar, if the pressure is lower than 1 bar, it automatically switches to the standby cylinder, and sends the signal to person on duty to change the cylinder.

4. Set 0.45um microporous filter in the front of buffer tank back decompression pressure maintaining valve, and set ball valve front and back of filter.

5. Choose high-performance pressure maintaining valve, and guarantee the back pressure of pressure maintaining valve is from 0.7 bar to 0.8 bar.

6. 管路及设备材质选用304不锈钢ISO标准。

Pipelines and equipments materials adopt 304 stainless steel ISO standard.

7. Buffer tank is horizontal tank, according to the site situation choose tank height-diameter ratio, and may choose non-standard tank.

8. Yofoto is considering to adopt the liquified oxygen scheme, after confirmation notify Macroprocess.

 (in Feb. 25th: processing scheme among gas cylinders. Require Macroprocess to show provide two schemes of gas cylinder manifold and liquified oxygen for reference)

9. Root valve is directly connected with main pipeline, and adopt hose connection at the back of valve.

(二) Compressed air

1. Culture tank system uses air compressor one use one standby, and two air compressors share one aftertreatment system.

2. Instrument air system uses air compressor one use one standby, and two air compressors share one aftertreatment system.

3. Cancel the back-pressure valve at the end of point of culture tank system air supply, and change to add the back-pressure valve to the main pipes.

4. Choose high-performance pressure maintaining valve in culture tank system air supply, and guarantee the back pressure of pressure maintaining valve is from 0.7 bar to 0.8 bar.

5. Pipelines and equipments materials adopt 304 stainless steel ISO standard.

6. Culture tank system air supply root valve is directly connected with main pipeline, and adopt hose connection at the back of valve.

（三） CO2 system

1. Cancel the back-pressure valve at the end of point, and change to add the back-pressure valve to the main pipes.

2. Buffer tank pressure is set 1 bar, if the pressure is lower than 1 bar, it automatically switches to the standby cylinder, and sends the signal to person on duty to change the cylinder.

3. Set 0.45um microporous filter in the front of buffer tank back decompression pressure maintaining valve, and set ball valve front and back of filter.

4. Choose high-performance pressure maintaining valve, and guarantee the back pressure of pressure maintaining valve is from 0.7 bar to 0.8 bar.

5. Pipelines and equipments materials adopt 304 stainless steel ISO standard.

6. Buffer tank is horizontal tank, according to the site situation choose tank height-diameter ratio, and may choose non-standard tank.

7.           Root valve is directly connected with main pipeline, and adopt hose connection at the back of valve.

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(四) N2 system

1. Cancel the back-pressure valve at the end of point, and change to add the back-pressure valve to the main pipes.

2. Buffer tank pressure is set 1 bar, if the pressure is lower than 1 bar, it automatically switches to the standby cylinder, and sends the signal to person on duty to change the cylinder.

3. Set 0.45um microporous filter in the front of buffer tank back decompression pressure maintaining valve, and set ball valve front and back of filter.

4. Choose high-performance pressure maintaining valve, and guarantee the back pressure of pressure maintaining valve is from 0.7 bar to 0.8 bar.

5. Nitrogen pipelines and equipments used for embedment choose 316L material quality, the other pipelines and equipments materials choose 304 stainless steel, and set 0.45um microporous filter in the front of pressure maintaining valve.

6. Buffer tank is horizontal tank, according to the site situation choose tank height-diameter ratio, and may choose non-standard tank.

7.           Root valve is directly connected with main pipeline, and adopt hose connection at the back of valve.

（五） Cooling water system

1. Buried tank and parts of buried main pipelines are provided by Yofoto, and Macroprocess provides temperature transmitter, electric capacity type liquidometer, and other pipelines.

2. Equip with two high-performance self-priming pumps and one cooling heat exchanger, and control the water temperature not higher than 37°C

3.       Chilled water power pipeline is in the charge of Macroprocess.

4.           Maximum flow of c-pack cooling water is 2 ton per hour.

5. Pipelines and equipments materials adopt 304 stainless steel.

（六） Ro water

1. Subject to the drawings of March 10th, there are totally 9 Ro water points and one 1000 liter buffer tank.

2. Manually open the water supply pump, and stop the water supply pump by pressure control.

（七）       For buffer tank of oxygen, nitrogen, and carbon dioxide, Macroprocess shall provide the tank installation drawing before April 10th, and illustrate whether needs burying.

（八）       Macroprocess provides the admission passage and direction size of water rationing plant equipments, and the equipments of water rationing plant whether need foundation and the foundation size.

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February 18th

Scoping and technical disclosure of materials and CIP system project:

Yofoto and Morimatsu:

1. Macroprocess contracts the project cleaning pipelines, among which Morimatsu subcontracts CIP work station and 6 tank equipments; equipments include

1) two 1500 liters tanks and 4 600 liters tanks.

2) three CIP work stations:

a) EPO workshop: aiming at EPO and TPO fixed tanks

b) EPO workshop: EPO mobile tanks

c) TPO workshop: TPO mobile tanks

· Cancel the CIP of bovine serum culture tanks of two workshops (equipment No. 1109 and No.2109)

· Require the interlocking alarm and local control including CIP station control system.

Morimatsu and Macroprocess:

1. Construction scoping

Morimatsu is responsible for CIP station as a module (reference dimension of equipment:2500×1500×1200) and six tanks, Macroprocess is responsible for CIP inlet and outlet from module to tank and materials, and the specific location is decided according to the site situation.

2. Time of entering

In view of the size of tank and construction of purification, require that the time of entering of two 1500 liters tanks is June 20th, the time of entering of four 600l tanks is at the end of June, and the time of entering of CIP work station is July 20th

3. Control system of CIP station is in the charge of Morimatsu, but Morimatsu shall reserve the control port of Ethernet, in order to integrate the whole autonomous system.

4. All technical exchange documents of Macroprocess and Morimatsu with Yofoto need to be copied to each other.

5. Require Morimatsu show the process parameters of tank and CIP work station.

6. Validation documentations exchange

a) Aiming at CIP work station, Morimatsu is responsible for FAT, SAT, IQ, OQ, and documents.

b) The validation documentations of final project is in the charge of Macroprocess, and Macroprocess finally confirms the validation documentations Morimatsu provided.

c)validation documentations Morimatsu provided include: content, transaction file, technical documents (model selection documents, validation documentations, process documents), debugging documents, and certificates. Require Chinese and English contrast, once disagreement appeared, subject to Chinese.

Aiming at tank, require that there are Electropolishing procedures and site hardness and roughness detection before leaving the factory in validation documentations. Require that measuring elements equipped with tank have inspection certificates and site test scheme or report before leaving the factory.

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February 19th

CIPconfiguration and function requirements confirmed by Yofoto to Morimatsu:

1. Heat exchanger (straight tubular)

2. Water for injection tank (including respirator ), and respirator equips with temperature sensor (tt). Feed inlet equips withsample connection, and equips with tread.

3. Purified water, acid liquor, and alkali liquor sharing tank

4. Each tank of strong acid and strong base

5. CIP water delivery pump/ back water pump

6. Two measuring pumps

7. Liquid position: checking, displaying and recording of conductivity, pressure, flow and temperature

8. One waste water outlet

The order of cleaning is:

Purified water Alkali liquor Trocknen Acid neutralization Purified water WFI Trocknen

The liquid needed washing:

Tris HCL、6Murea、CBS；mobile tank: Tris HCL、6Murea、20% alcohol

Fixed tank: UF desalination liquid

Tank configuration and function requirements confirmed by Yofoto to Morimatsu:

1. 1500 liters tank equips with mobile athlon ladder stand for batch feeding, 600 liters tank equips with tread (both designed by Morimatsu)

2. Configuration tank equips with weight module and temperature sensor

3. CIP spray of tank adopts fixed spray ball with pressure gauge with TRIP connection

4. 1500 liters configuration tank equips with jacket cooling, 600 liters tank equips with no jackets, and both are with heat preservation

5. Configuration tank requires converter motor magnetic mixing.

6. All tanks are with tank foot valves

7. Drain mode of tank is the compressed air (draining out in one hour), set safety valve and filter in the inlet pipelines, and TRIP connector.

8. Sample connection and tank deck in conformity with CIP requirements in tank at least need three in-clamps (feed inlet, breath gate, and feeder nose), and design and manufacture according to the standards of ASME-BPE

Division of construction scope of Macroprocess and Morimatsu:

CIP work station:

Except for contents confirmed in 18th, aiming at WFI part, Macroprocess is responsible for using point U-type bend and pneumatic diaphragm valve (the specific information will be marked in the design scheme)

7 / 10

Tank:

Tank access jacket cooling system connection is in the charge of Macroprocess

Process requirements:

a) Cooling time is half an hour

b) Guarantee that reduce the temperature of liquid of tank from 30°C to 10°C～15°C

c) Cooling medium temperature: 7°C in and 12°C out.

(the specific information will be marked in the design scheme)

Aboutvalidation documentation:

1. SAT is responsible for Morimatsu, among which site inspection of instrument is in the charge of Macroprocess.

2. Validation documentations are compiled by Morimatsu, Morimatsu provides the specific scheme, after confirmed by Macroprocess and Yofoto, Morimatsu puts into effect.

Aboutscheme delivery time:

The drawings, quotation, and process parameters of equipments of Morimatsu shall be delivered to Macroprocess.

8 / 10

February 20th

Water system construction content disclosure

Purified water

1. The industrial steam Yofoto provided is 0.6 Mpa now.

2. Subject to the drawing of March 10th, there are totally 14 points of use.

Water for injection

1. Change the temperature of three washing workshops from 60°C circulation to 85°C circulation, and cancel four points of use and three heat exchangers.

2. Through calculating after modification, confirm that backwater of water for injection satisfies the requirements of GMP.

3. Point of use cancels the west CIP point of TPO workshop （5-D-1-09）.

Material pipeline:

1. Construction scope:

a) For 1500L configuration tank, Macroprocess responsible for the pipelines in front of the filter, and reserving the interface valves

b) The pipelines from the back end of buffer solution configuration room filter to tank of ultrafiltration room of EPO and TPO workshops.

c) The pipelines from tank of ultrafiltration room to filter of EPO and TPO workshops, and reserving the interface valves.

2. Sterilization problem: the pipelines from fixed tank to filter needs not sterilization; filter and mobile sterilization tank need direct sterilization in the sterilization cabinet.

3. There are three routes of tank deck design of configuration tank: compressed air, CIP, and WFI; there are two routes of tank deck design of tank: CIP and feed inlet.

Pure steam

1. Point of use cancels the west CIP point of TPO workshop （5-D-1-09）

2. The least significant end sets up steam trap in order to ensure the pipeline not waterlogging.

3. Sample point of pure steam for process use shall set up in the pure steam generator outlet and each point of use (confirmed in Feb. 25th )

4. Pure steam humidification pipelines of HVAC adopt ISO 316L standard. Polishing degree is 20-25Ra. sample point set up in the outlet of pure steam generator (confirmed in Feb. 25th ); the location of generator is the water producing room in the first floor, and there are 20 points of use (drawing confirmed in March 11th)

Brand recognition:

1. Pipelines and fittings

a) BPE:Neumo

b) ISO:KingLai

9 / 10

2. Heat exchanger: use vasa recta heat exchanger; it is confirmed by the price ratio of ABC and Neumo.

3. Alfalaval

Third, sanitary pump: Alfalaval

4. Non- sanitary pump: GRUNDFOS

5. Mettler-Toledo

Conductivity meter: Mettler-Toledo

6. Water tank:Ritai

7. Temperature sensor: Soto

8. Bright

Pressure sensor: Bright

9. Gas buffer tank: beautiful, brand not required.

Division of Stilmas and Macroprocess:

1. Macroproces provides the liquid-level device of water tank, and reserves the signal connection point to Stilmas.

2. Purified water and water for injection use the T pattern valve structure.

3. Stilmas shall provide cooling capacity of cooling water of 90°C water outlet for Macroprocess.

4. Stilmas shall provide ethernet network access signal to upper monitor, in order to ensure to display and record.

5. Purified water tank is tank of heat preservation.

Feb. 25th

The added confirmation contents:

1. Control of the relevant material system (control hardware included, Party A provides the process requirements which are confirmed before debugging)

2. Ultrafiltration buffer solution tank is designed according to CIP (not SIP)

3. The manufacturer provides site touch screen for PW, WFI, and PS units, PW, WFI, and PS distribution system adopts site touch screen operation provided by Macroprocess, and upper monitor is used for the display and record of the whole system operation state. In the control room of water producing workshop set up the emergency stop push button of the above systems.

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EX-4.7.8

Exhibit 4.7.8 - Appendix 4 URS Clarification

URS DEVIATION FORM

Project Name	Storage and Distribution System of Compressed Air and Process Gas
	URS Document: User Requirements on the Storage and Distribution System of Purifyed Water
	URS Document: User Requirements on the Distribution System of Purified Steam
	URS Document: User Requirements on the Storage and Distribution System of Water for Injection
Tenderer	Shanghai Macroprocess Co., Ltd

Document No.	Name	Requirements	Compliance	Non-compliance	Remark and Deviation Description
URS Document:User Requirements on the Storage and Distribution System of Purifyed Water
2	Scope of Supply of Party B
		The goods and works supplied by Party B shall be completely in accordance with the user requirements and appendices as well as related standards and specifications.	Y
		The scope of supply of Party B shall include the materials, auxiliary spare parts, auxiliary equipments, and all necessary materials and spare parts required to guarantee good performance of the whole project in accordace with this user requirement description.	Y
		Scope of supply is as follows:
		→  Supply and installation construction (including installation, welding connection, welding seam detection and treatment, pressurizing, degrease, acid cleaning and passivation, etc) of all installation materials (including pipeline, pipe fittings, water pump, storage tank, heat exchanger, valve, support, thermal insulation of pipeline and related auxiliary fittings, etc) used for the purified water storage and distribution system in this project.	Y
		→  Provide the as-built documents and validation documents (including the validation and confirmation documents required for certification).	Y		Provide all validation documents.
		→  Necessary expenses for approval by the government supervising department.(if necessary, it shall be included in the bidding documents).	？		Normally there is no other cost, but the cost resulting from regional difference shall be borne by Party A.
3	Scope of Work of Party B
		→  Design and calculation,  mainly including the design of pipeline layout as well as design of storage and distribution system of purified water.	Y		Refer to the attached schedule for designs
		→  Provide the data information and drawings relating to the disciplines of process, civil engineering, water supply & drainage, electization and instrument control, etc.	Y
		→  Packaging and transporting of materials used in the project.	Y
		→  Installation, inspection, testing and related debugging.	Y
		→  Related instructions and reviews on the taking over of public system.	Y
		→  All fittings, instruments and tools required for installation, inspection and debuging shall be provided by Party B.	Y
		→  Provide the completion documents and validation documents	Y
		→  Training on the operation, maintenance & repairing, and validation.	Y
		→  After-sales service	Y
4	Standards and Specifications to be based on
		a.Design, material, installation, inspection and testing shall be based the requirements of this project and shall also satisfy the standards of FDA, EU and China CGMP.	Y
		b.Automatic control system shall conform to GAMP5.	Y
		c.Related construction and acceptance specifications of pipeline works.	Y
		d.GMP Specification:.	Y
		a)FDA - 21 CFR Part 210, 211
		b)SFDA -Good Manufacturing Practices,1998 version and and new version to be released.
		c)Current lastest GMP in EU
		d)Related GMP Implementation Guidance
		e)The latest version of Chinese pharmacopoeia, EU pharmacopoeia, and U.S. Pharmacopoeia.
		f)ISPE，Volume 4，water and steam system，2005 version.
		g)The latest version of ASME BPE Standards.	N		The purified water system conforms to ISO Standard
		h)ISPE Pharmaceutical Engineering Guides for New and Renovated Facilities	Y
		i)V3 Sterile Manufacturing Facilities.	Y
		j)V6 Biopharmaceutical Manufacturing Facilities.	Y
		Party B shall detail the standards and specifications to be based on in his tender documents.
5	GMP Requirements
		→  Conform to the requirements of current FDA, EU and China GMP	Y
		→  All water system pipeline shall be able to be completely discharged, cleaned and sterilized.	Y
		→  All materials contacting with the products, purified water pipeline and pipe fittings must be 316L stainless steel.	Y
		→  All materials, instruments and equipments shall conform to cGMP.	Y
		→  All water systems shall have suitable sampling points which shall be easy to control, monitor and record the system status.	Y
		→  The purified water system shall be free of water backflow, and deal area shall also be avoided.	Y
		→  DQ, IQ, OQ and PQ shall be provided.	Y
		→  Welders shall hold related qualification certificates applicable to corrsponding works.	Y
		→  Welding machine and instrument are within the valid calibration period.	Y
		→  The clean pipeline shall adopt the automatic track welding method as far as possible.	Y
6	Storage and Distribution System of Purified Water
		Pipelines shall be installed through the welding connection method as far as possible to achieve the 3D standard, but welding seams shall be minimized and convenience of strilizing and operating shall also be taken into consideration. Installation of pipeline shall take account of simple and smooth connection for convenience of installation, maintenance and operation, and the requirements of safety and human environment shall also be taken into consideration.	Y		All of them are less than 3D.
		Intallation of pipellines shall be carried out strictly in accordance with the established and approved operation regulations (qualification confirmation of operators; cutting; welding connection; slope detection; endoscopy, ray detection; degrease; acid cleaning; passivation; pressurizing test, etc)	Y
		Sufficient support shall be made to the pipeline to avoid drooping or other deformations.	Y
		Method of sterilization:superheated water (121ºC) sterilization or purified steam sterilization is suitable to this system, and the method of sterilization can be controlled and selected from the control system interface.	N		PW system pasteurization
		Sanitary type distribution pipeline must be of hydraulics design to ensure that the ryznar index is not less than 4000 or flow rate is not less than 1m/s when each point of use of water has the minimum flow rate.	N		The standard value shall be 0.914m/s.
		The sampling point shall be equipped at least at the initial stage of distribution pipeline.	Y
		The fixed pipeline must be clearly indicated with the medium and flow direction in the pipeline.	Y
		The connection gasket shall be sandwich PTFE gasket.	Y
		a)Requirements of the purified water storage and distribution system.			Connect the equipment to each loading and sampling valve

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URS DEVIATION FORM

Project Name	Storage and Distribution System of Compressed Air and Process Gas
	URS Document: User Requirements on the Storage and Distribution System of Purifyed Water
	URS Document: User Requirements on the Distribution System of Purified Steam
	URS Document: User Requirements on the Storage and Distribution System of Water for Injection
Tenderer	Shanghai Macroprocess Co., Ltd

Document No.	Name	Requirements	Compliance	Non-compliance	Remark and Deviation Description
		Pipeline and Pipe Fittings
		316L stainless steel material, outer Ra<0.8µm, inner Ra<0.8µm, mechanical polishing, ISO 2037 standard (this standard shall be applicable to other parts unless otherwise specified).	N		Outer Ra<1.0µm
		Storage Tank
		All parts of tan contacting with the clean medium shall adoopt the 316L stainless steel material;	Y
		The manhole shall adopt the sanitary type manhole, with matt finishing outer surface. Other interfaces are required to be free of dead area.	Y
		The tank shall have thermal insulation function, and the outer layer shall be 304 stainless steel material.	Y
		The inner surface of tank shall be mechanical polishing Ra<0.８μm, and outer surface Ra<0.8μm.	N		Outer surface Ra<1.0μm
		The spray ball in tank shall adopt the fixed type spray ball.	N		Rotary-type
		The applicable standards of tank shall be the same with those applicable to corresponding pipelines and pipe fittings.	Y
		Bursting discs shall be applied.	N		Non-pressure vessel is unnecessary
		Heat Exchanger
		Adopt the straight way type double tube-sheet exchanger, free of dead area and with complete emptying function. Inner pipeline Ra<0.5μm. Integral material is 316L stainless steel.	Y
		Sanitation Ball Valve
		Adopt the GEMU sanitation ball valve, 316L material, and two-piece type diaphragm PTFE/EPDM; the material of diaphragm shall conform to the requirements of the latest version of U.S. Pharmacopoeia, with corresponding certifying documents to be provided; mechanical polishing of the surface contacting with medium Ra<0.8μm; quick clamp interface (welding connection shall be used as far as possible), and the interface size shall be matching with the pipeline system; gasket of clamp shall be PTFE material and shall also conform to the requirements of the latest version of U.S. Pharmacopoeia, with corresponding certifying documents to be provided. The outer surface shall be glass bead blasting treated. The pneumatic valve shall be equipped with the opening and closing indicator.	Y
		Liquidometer
		Adopt the E+H electric capacity type liquidometer. The part contacting with the medium shall be 316L stainless steel or other materials conforming to requirements of the latest version of U.S. Pharmacopoeia, with corresponding certifying documents to be provided. The material system shall be Mettler weighing module, while the support shall use 304 stainless steel.	Y
		Conductivity Meter
		Adopt the BURKERT or G+F. The precision shall not be less than 0.1µS/cm.	Y
		Flowmeter
		Adopt the Vortex Flowmeter.	Y
		Filter
		All filters and inspirator shall be 0.22μ, for all of which the on-line bubble point tests shall be taken into consideration; purified steam shall be connected to the front and reat simutaneously in sterilization. Adopt the PALL or Millipore products.	N		Electrical heating to avoid blocking in pasteurization; in-situ sterilization; providing positive pressure protection in discharge.
		Sanitary Pump
		316L material, quick clamp interface (the interface size shall match with the pipeline system), mechanical polishing inner surface, Ra<0.8μm，with bottom discharge opening, sealing SiC/SiC。	Y
		Thermal Insulation	N		Purified water system does not have the thermal insulation
		Stainless steel sheet or PV + rock wool (volume weight is more than 65kg/m3) shall be applied in water preparation room.
		Iron sheet + rock wool (volume weight is more than 65kg/m3) shall be applied in the technical sanwich layer.
		The clean room shall adopt the casng (pipe-in-pipe) form. The material of casing shall be 304 stainless steel, with outer surface Ra<0.8um.
		Support Material
		The possibly used support type materials include various specifications of movable support, stainless steel support, fixed plate, decorating plate, stainless steel square tube, angle bar, galvanized lead screw, and stainless steel screw bolt, etc; 304 stainless steel materials shall be applied in the clean area. Soft contact shall be made between the support and pipeline.	N		Self-developed supports shall be adopted in the clean room
		Welding Seam Detection
		Sanitary pipeline of the whole system shall be connected through automatic welding as fas as possible, and manual welding connection (if necessary) shall be approved by Party A. X-ray fault detection and endoscopy shall be applied for all manual welding connections. X-ray fault detection shall be done for all welding samples of the automatic welding connection part while endoscopy shall be applied for 20% of other automatic welding spots. The inspected welding spots layout shall be approved by Party A.	Y
		Degrease, Acid Cleaning, Passivation and Pressure Test
		Degrease, acid cleaning and passivation treatment shall be applied for all pipes, and then test the effects. Pressure test shall be applied for all pipes, with the testing pressure at least 1.5 times of the working pressure, and if the working pressure is less than 4bar, the pressure of 6bar shall be applied for testing.	Y
		Control Device
		The control system for the distribution system of water for injection, purified water and steam generator shall be combined with the control system ofpreparation equipment to adopt one set of control system.Two workshops of the material system shall adopt separate set of contron system respectively. The control system shall adopt the SIMENS brand.	N		Water system shall has one separate control system, but it can communicate with the equipment, and the equipment and system can be connected with the host computer.
		Electric control cabinet includes:PLC (CPU, Input/Output Module), touch screen (colorful) and other control components; power supply, switch, push button, contactor, relay, frequency converter,  indicator light and other electric components; cabinet body, terminal strip, cable and trunking, control software, recording instrument (8 channels), DP communication module, and other necessary components and parts.	N		Recording machine is not applied; data can be recorded and printed through computer.
		The sterilzing process of purified water system shall be full automatic control, and the sterilizing time shall be included in the PLC time counting. Recording curve shall be made for the key parameters (such as the electrical conductivity, flow rate and temperature, etc).	Y
		Sewerage, Funnel and Discharge
		Make the best use of non- immersive instrument, and if not available,  it must be of sanitary design.	Y
		The connection part of plug-type instrument must be of sanitary clamp connection type.	Y
		Filling material in the instrument shall not be mixed into the products in ccase of occurring leakage of the instrument.	Y
		Mark
		Each welding spot shall be marked.	Y
		b)Construction Specification and Acceptance

第2页/共9页

URS DEVIATION FORM

Project Name	Storage and Distribution System of Compressed Air and Process Gas
	URS Document: User Requirements on the Storage and Distribution System of Purifyed Water
	URS Document: User Requirements on the Distribution System of Purified Steam
	URS Document: User Requirements on the Storage and Distribution System of Water for Injection
Tenderer	Shanghai Macroprocess Co., Ltd

Document No.	Name	Requirements	Compliance	Non-compliance	Remark and Deviation Description
		Party B shall describe the organization and implementation specifications and procedures as well as acceptance procedures and standards for various works in the bidding documents.	Y
7	Design
		Party B' work must enable the complete set system meet the requirements of current GMP specifications prevailing in China, EU and the United States and also pass corresponding GMP Certifications.			The original designed pipe diameter is wrong, and please refer to the drawings and calculation sheet for specific designs.
8	Control, Debugging and Validation of Purified Water Storage and Distribution System
		Control, debugging and validation of operating control, debugging and validation of purified water storage and distribution system shall be completed by Party B.	Y
		In addition, supply, related documents and validation of instruments (including necessary pressure gauge and pressure transmitter, thermometer and temperature transmitter, flowmeter and flow transmitter, and conductivity meter, etc) and control devices (electric control cabinet including PLC, touch screen, recording instrument and other control components; and power supply, switch, push button, contactor, relay, frequency converter,  indicator light and other electric components) in the storage and distribution system of compressed air and process gas shall be completed by Party B.	Y
		The instruments shall be accurate and reliable and need to be calibrated, and the calibration shall be traceable.	Y
9	Traceability of Raw Materials, Spare Parts and Control System
		For all raw materials, spare parts, equipments, electricity, instrument and control system, original data shall be reserved and all of these items shall be tested to establish files for them to ensure their traceability. Traceability Matrix (TM) documents shall be established for each aspect of project implementation.	Y
		Each spare part, equipment, electric and intrument part shall be equipped with metal tag (with corresponding location number) for convenience of identification and operating.	Y
10	Process Guarantee
		Party B' work shall be sure to meet this user requirement as well as requirements specified in the appendices in the following aspects (include but not limited to):	Y
		ðMeet the requirements of GMP specifications in China, EU and the United States as well as various industry codes.
		ð Quality of water in circulation pipeline, storage tank and point of use.
		ðQuality of purified stram in distribution pipeline and point of use.
		ðFlow rate, pressure and temperature at the outlet of point of use.
		ðFlow rate and flow velocity of main circluation pipeline and distribution circulation pipeline in the water system.
		ðTemperature of water circulating pipeline;
		ðFunctional testing of the distribution pipeline;
		ðFunctional testing of PLC and control system.
11	Quality Project Plan (QPP)		Y
		In order to ensure compliance with the requirements of Party A, Party B shall implement the quality project plan and construction organization design at all stages of design, installation, testing, debugging and handing over, including the quality testing and control over the materials and spare parts supplied by partner-suppliers.
		Party B shall submit its quality project plan to Party A for recognition and approval within two weeks from the effective date of contract.
		Quality project plan shall include the non-destructive test, identification ad identification of raw materials, stage acceptance and final testing.
		Party B shall clearly indicate which tests need eye-witness of the representatives of Party A. Party A shall also decide which testing items need to be witnessed by his representatives.
		Party B shall issue test report and test certificate for each inspection and test (witnessed or not witnessed by the representatives of Party A), and these documents will be included in the final completion file package.
		All design, procurement, installation, testing, debugging, and implementation of document system  shall take consideration to meet the requirements of validation and certification.
		a)  Project Schedule Diagram
		Party B must prepare and analyze the detailed schedule diagram (including the design, procurement, installation, testing, debugging and handing over, etc) through a reasonable manner, which will be favorable to:  ① quality control, ② determination of critical working procedure and stage, optimization of working procedure, and ③ frequent inspection of working progress.
12	Quality Guarantee and Responsibility		Y
		→  The quality guarantee period of all goods supplied by Party B shall be at least one year (from the day of qualified final acceptance and debugging)
		→  Party B shall guarantee the safety, reliability, normativity and reasonableness of the design, procurement, installation, testing and debugging and shall bear full responsibility for them.
		→  Party B shall guarantee that all working contents and implementation must take account of the requirements and validation of Party B as well as related (China, EU and the United States) GMP Certification requirements.
13	Documents & Drawings		Y
		Documents will an integral part of the scope of work of Party B, so Party B shall pay the liquidated damages if submittal of documents is delayed or the submitted documents are incomplete. In case of failing to submit the documents even if a part of them, it is also deemed that the contract is not performed completely, which will be unacceptable.
		The goods and documents supplied by Party B must conform to the requirements of Party A and must also meet the requirements of current GMP Certification of China, the United States and EU.
		a)Form of Documents
		All documents and drawings shall clearly show the order number, work number, customer number and related drawing number, location number of equipment, pipe number, valve number and instrument number.
		The documents and drawings must be submitted to Party A in accordance with the requirements of attached schedule for recognition and approval. Documents and drawings shall be submitted in the form of hardcopy and softcopy in accordance with the time specified in the attached schedule. The softcopy of drawings shall be CAD form.
		The drawings shall adopt the metric unit.
		Language: All documents, drawings, instructions and operation maintenance manuals, etc shall be prepared in simplified Chinese and English.
		b)Document establishment / submittal time (progress) table.
14	After-sales Service and Training		Y
		The after-sales service must be in time and detailed and also solve the problems completely.
		During the quality guarantee period, Party B shall be responsible for repairing or replacement free of charge if the goods and working contents specified in the contract occur any problems within the scope of operating regulations; Party B shall provide lifelong repairing and maintenance in time after the quality guarantee period, and only material cost will be charged for the repairing work.

第3页/共9页

URS DEVIATION FORM

Project Name	Storage and Distribution System of Compressed Air and Process Gas
	URS Document: User Requirements on the Storage and Distribution System of Purifyed Water
	URS Document: User Requirements on the Distribution System of Purified Steam
	URS Document: User Requirements on the Storage and Distribution System of Water for Injection
Tenderer	Shanghai Macroprocess Co., Ltd

Document No.	Name	Requirements	Compliance	Non-compliance	Remark and Deviation Description
		Party B shall provide training to the staff of Party A free of charge (including training in factory and installation site), and the training contents shall include the working principle, framework, flow process, operation, maintenance & repairing, calibration and resolving of faults, etc of the whole system.
		Party B shall describe the method and manner of his technical commitment and after-sales service in his tendering documens.
15	Construction Period of the System		Y
		Installation and construction of the system is approximately to be commenced on July 1, 2009 and completed on September 30, 2009.
16	Quotation
		The quotation shall include all costs occurred within the scope of supply of the seller and the scope of work.
		The quotation shall include the separate price for each time and total price.
		The quotation of all equipments and main materials shall clearly show the main technical specification and manufacturer.
URS Document: User Requirements on the Storage and Distribution System of Water for Injection
2	Scope of Supply of Party B
		The goods and works supplied by Party B shall be completely in accordance with the user requirements and appendices as well as related standards and specifications.	Y
		The scope of supply of Party B shall include the materials, auxiliary spare parts, auxiliary equipments, and all necessary materials and spare parts required to guarantee good performance of the whole project in accordace with this user requirement description.	Y
		Scope of supply is as follows:
		●Supply and installation construction (including installation, welding connection, welding seam detection and treatment, pressurizing, degrease, acid cleaning and passivation, etc) of all installation materials (including pipeline, pipe fittings, water pump, storage tank, heat exchanger, valve, support, thermal insulation of pipeline and related auxiliary fittings, etc) used for the storage and distribution system of water for injection in this project.
		●  Provide the as-built documents and validation documents (including the validation and confirmation documents required for certification).
		●  Necessary expenses for approval by the government supervising department.(if necessary, it shall be included in the bidding documents).	N		Normally there is no other cost, but the cost resulting from regional difference shall be borne by Party A.
3	Scope of Work of Party B
		●  Design and calculation,  mainly including the design of pipeline layout as well as design of storage and distribution system of water for injection.	Y		Calculation and and design have been made, and refer to the attached schedules for details.
		●  Provide the data information and drawings relating to the disciplines of process, civil engineering, water supply & drainage, electization and instrument control, etc.	Y		It would be more reasonable to design the flow path and diameter of pipes in later period.
		●  Packaging and transporting of materials used in the project.	Y
		●  Installation, inspection, testing and related debugging.	Y
		●  Related instructions and reviews on the taking over of public system.	Y
		●  All fittings, instruments and tools required for installation, inspection and debuging shall be provided by Party B.	Y
		●  Provide the completion documents and validation documents	Y
		●  Training on the operation, maintenance & repairing, and validation.	Y
		●  After-sales service	Y
4	Standards and Specifications to be based on
		●  Design, material, installation, inspection and testing shall be based the requirements of this project and shall also satisfy the standards of FDA, EU and China CGMP.	Y
		●  Automatic control system shall conform to GAMP5.	Y
		●  Related construction and acceptance specifications of pipeline works.	Y
		●  GMP Specification:	Y
		■  FDA - 21 CFR Part 210, 211
		■SFDA -Good Manufacturing Practices,1998 version and and new version to be released.
		■Current lastest GMP in EU
		■Related GMP Implementation Guidance
		■The latest version of Chinese pharmacopoeia, EU pharmacopoeia, and U.S. Pharmacopoeia.
		■ISPE，Volume 4，water and steam system，2005 version.
		■The latest version of ASME BPE Standards.
		■ISPE Pharmaceutical Engineering Guides for New and Renovated Facilities
		■V3 Sterile Manufacturing Facilities.
		■V6 Biopharmaceutical Manufacturing Facilities.
		Party B shall detail the standards and specifications to be based on in his tender documents.
5	GMP Requirements
		● Conform to the requirements of current FDA, EU and China GMP	Y
		● All water system pipeline shall be able to be completely discharged, cleaned and sterilized.	Y
		● All materials contacting with the products, purified water pipeline and pipe fittings must be 316L stainless steel.	Y
		● All materials, instruments and equipments shall conform to cGMP.	Y
		● All water systems shall have suitable sampling points which shall be easy to control, monitor and record the system status.	Y		Each point of equipment connection is equipped with sampling valve.
		● The water for injection system shall be free of water backflow, and deal area shall also be avoided.	Y
		● DQ, IQ, OQ and PQ shall be provided.	Y
		● Welders shall hold related qualification certificates applicable to corrsponding works.	Y
		● Welding machine and instrument are within the valid calibration period.	Y
		l● The clean pipeline shall adopt the automatic track welding method as far as possible.	Y

第4页/共9页

URS DEVIATION FORM

Project Name	Storage and Distribution System of Compressed Air and Process Gas
	URS Document: User Requirements on the Storage and Distribution System of Purifyed Water
	URS Document: User Requirements on the Distribution System of Purified Steam
	URS Document: User Requirements on the Storage and Distribution System of Water for Injection
Tenderer	Shanghai Macroprocess Co., Ltd

Document No.	Name	Requirements	Compliance	Non-compliance	Remark and Deviation Description
6	Storage and Distribution System of Water for Injection
		Pipelines shall be installed through the welding connection method as far as possible to achieve the 3D standard, but welding seams shall be minimized and convenience of strilizing and operating shall also be taken into consideration. Installation of pipeline shall take account of simple and smooth connection for convenience of installation, maintenance and operation, and the requirements of safety and human environment shall also be taken into consideration.	Y
		Intallation of pipellines shall be carried out strictly in accordance with the established and approved operation regulations (qualification confirmation of operators; cutting; welding connection; slope detection; endoscopy, ray detection; degrease; acid cleaning; passivation; pressurizing test, etc)	Y
		Sufficient support shall be made to the pipeline to avoid drooping or other deformations.	Y
		Method of sterilization:superheated water (121ºC) sterilization or purified steam sterilization is suitable to this system, and the method of sterilization can be controlled and selected from the control system interface.	Y		Superheated water
		Sanitary type distribution pipeline must be of hydraulics design to ensure that the ryznar index is not less than 4000 or flow rate is not less than 1m/s when each point of use of water has the minimum flow rate.	N		The flow velocity is more than 0.914m/s (standard calculation)
		The sampling point shall be equipped at least at the initial stage of distribution pipeline.	Y		Sampling shall be made for each point of equipment connection.
		The fixed pipeline must be clearly indicated with the medium and flow direction in the pipeline.	Y
		The connection gasket shall be sandwich PTFE gasket.
		a)Requirements of the storage and distribution system of water for injection.
		Pipeline and Pipe Fittings of Water for Injection   and Installation
		316L stainless steel material, outer Ra<0.8µm, inner Ra<0.5µm, mechanical polishing + electro polishing, ASME BPE standard (this standard shall be applicable to other parts unless otherwise specified).	Y
		Storage Tank	Y
		■All parts of tank contacting with the clean medium shall adopt the 316L stainless steel material;
		■The manhole shall adopt the sanitary type manhole, with matt finishing outer surface. Other interfaces are required to be free of dead area.
		■The tank shall have thermal insulation function, and the outer layer shall be 304 stainless steel material.
		■The spray ball in storage tank shall adopt the fixed type spray ball.
		■The applicable standards of tank shall be the same with those applicable to corresponding pipelines and pipe fittings.
		■Bursting discs shall be applied.
		■  Electro polishing inner face of storage tank Ra<0.５μm, outer surface Ra<0.8μm。
		Heat Exchanger
		Adopt the straight way type double tube-sheet exchanger, free of dead area and with complete emptying function. Inner pipeline Ra<0.5μm. Integral material is 316L stainless steel.	Y
		Sanitation Ball Valve
		Adopt the GEMU sanitation ball valve, 316L material, and two-piece type diaphragm PTFE/EPDM; the material of diaphragm shall conform to the requirements of the latest version of U.S. Pharmacopoeia, with corresponding certifying documents to be provided; mechanical polishing of the surface contacting with medium Ra<0.5μm; quick clamp interface (welding connection shall be used as far as possible), and the interface size shall be matching with the pipeline system; gasket of clamp shall be PTFE material and shall also conform to the requirements of the latest version of U.S. Pharmacopoeia, with corresponding certifying documents to be provided. The outer surface shall be glass bead blasting treated. The pneumatic valve shall be equipped with the opening and closing indicator.	Y
		Liquidometer
		Adopt the E+H electric capacity type liquidometer. The part contacting with the medium shall be 316L stainless steel or other materials conforming to requirements of the latest version of U.S. Pharmacopoeia, with corresponding certifying documents to be provided. The material system shall be Mettler weighing module, while the support shall use 304 stainless steel.	Y
		Conductivity Meter
		Adopt the E+H or Mettler type. The precision shall not be less than 0.1µS/cm.	Y
		Flowmeter
		Adopt the Vortex Flowmeter.	Y
		Filter
		All filters and inspirators shall be 0.22μ, for all of which the on-line bubble point tests shall be taken into consideration; purified steam shall be connected to the front and reat simutaneously in sterilization. Adopt the PALL or Millipore products. The inspirator shall adopt electrical heating.	Y
		TOC
		Installed at the water return end.	Y
		Sanitary Pump
		316L material, quick clamp interface (the interface size shall match with the pipeline system), mechanical polishing inner surface, Ra<0.5μm，with bottom discharge opening, sealing SiC/SiC。	Y
		Thermal Insulation
		Stainless steel sheet or PV + rock wool (volume weight is more than 65kg/m3) shall be applied in water preparation room.	Y
		Iron sheet + rock wool (volume weight is more than 65kg/m3) shall be applied in the technical sanwich layer	Y
		The clean room shall adopt the casng (pipe-in-pipe) form. The material of casing shall be 304 stainless steel, with outer surface Ra<0.8um.	N		Outer surface Ra<1.6um
		Support Material
		The possibly used support type materials include various specifications of movable support, stainless steel support, fixed plate, decorating plate, stainless steel square tube, angle bar, galvanized lead screw, and stainless steel screw bolt, etc; 304 stainless steel materials shall be applied in the clean area. Soft contact shall be made between the support and pipeline.	N		Specially developed bakelite support shall be applied in the clean room.
		Welding Seam Detection
		Sanitary pipeline of the whole system shall be connected through automatic welding as fas as possible, and manual welding connection (if necessary) shall be approved by Party A. X-ray fault detection and endoscopy shall be applied for all manual welding connections. X-ray fault detection shall be done for all welding samples of the automatic welding connection part while endoscopy shall be applied for 20% of other automatic welding spots. The inspected welding spots layout shall be approved by Party A.	Y
		Degrease, Acid Cleaning, Passivation and Pressure Test
		Degrease, acid cleaning and passivation treatment shall be applied for all pipes, and then test the effects. Pressure test shall be applied for all pipes, with the testing pressure at least 1.5 times of the working pressure, and if the working pressure is less than 4bar, the pressure of 6bar shall be applied for testing.	Y

第5页/共9页

URS DEVIATION FORM

Project Name	Storage and Distribution System of Compressed Air and Process Gas
	URS Document: User Requirements on the Storage and Distribution System of Purifyed Water
	URS Document: User Requirements on the Distribution System of Purified Steam
	URS Document: User Requirements on the Storage and Distribution System of Water for Injection
Tenderer	Shanghai Macroprocess Co., Ltd

Document No.	Name	Requirements	Compliance	Non-compliance	Remark and Deviation Description
		Control Device
		The control system for the distribution system of water for injection, purified water and steam generator shall be combined with the control system ofpreparation equipment to adopt one set of control system.Two workshops of the material system shall adopt separate set of contron system respectively. The control system shall adopt the SIMENS brand.	N		Water system shall has one separate control system, but it can communicate with the equipment, and the equipment and system can be connected with the host computer.
		Electric control cabinet includes:PLC (CPU, Input/Output Module), touch screen (colorful) and other control components; power supply, switch, push button, contactor, relay, frequency converter,  indicator light and other electric components; cabinet body, terminal strip, cable and trunking, control software, recording instrument (8 channels), DP communication module, and other necessary components and parts.	N		Recording machine is not applied; data can be recorded and printed through computer.
		The sterilzing process of purified water system and water for injection distribution system shall be full automatic control, and the sterilizing time shall be included in the PLC time counting. Recording curve shall be made for the key parameters (such as the electrical conductivity, flow rate and temperature, etc).	Y
		Sewerage, Funnel and Discharge
		Make the best use of non- immersive instrument, and if not available,  it must be of sanitary design.	Y
		The connection part of plug-type instrument must be of sanitary clamp connection type.	Y
		Filling material in the instrument shall not be mixed into the products in ccase of occurring leakage of the instrument.	Y
		Mark
		Each welding spot shall be marked.	Y
		b)Construction Specification and Acceptance
		Party B shall describe the organization and implementation specifications and procedures as well as acceptance procedures and standards for various works in the bidding documents.	Y
7	Design
		Party B' work must enable the complete set system meet the requirements of current GMP specifications prevailing in China, EU and the United States and also pass corresponding GMP Certifications.	Y		Refer to the drawings for designs
8	Control, Debugging and Validation of the Storage and Distribution System of Water for Injection
		Control, debugging and validation of operating control, debugging and validation of purified water storage and distribution system shall be completed by Party B.	Y
		In addition, supply, related documents and validation of instruments (including necessary pressure gauge and pressure transmitter, thermometer and temperature transmitter, flowmeter and flow transmitter, and conductivity meter, etc) and control devices (electric control cabinet including PLC, touch screen, recording instrument and other control components; and power supply, switch, push button, contactor, relay, frequency converter,  indicator light and other electric components) in the storage and distribution system of compressed air and process gas shall be completed by Party B.
		The instruments shall be accurate and reliable and need to be calibrated, and the calibration shall be traceable.
9	Traceability of Raw Materials, Spare Parts and Control System		Y
		For all raw materials, spare parts, equipments, electricity, instrument and control system, original data shall be reserved and all of these items shall be tested to establish files for them to ensure their traceability. Traceability Matrix (TM) documents shall be established for each aspect of project implementation.
		Each spare part, equipment, electric and intrument part shall be equipped with metal tag (with corresponding location number) for convenience of identification and operating.
10	Process Guarantee		Y
		Party B' work shall be sure to meet this user requirement as well as requirements specified in the appendices in the following aspects (include but not limited to):
		●Meet the requirements of GMP specifications in China, EU and the United States as well as various industry codes.
		●Quality of water in circulation pipeline, storage tank and point of use.
		●Quality of purified steam in distribution pipeline and point of use.
		●Flow rate, pressure and temperature at the outlet of point of use.
		● Flow rate and flow velocity of main circluation pipeline and branch circulation pipeline in the water system.
		●Temperature of water circulating pipeline;
		●Functional testing of the distribution pipeline;
		●Functional testing of PLC and control system.
11	Quality Project Plan (QPP)		Y
		In order to ensure compliance with the requirements of Party A, Party B shall implement the quality project plan and construction organization design at all stages of design, installation, testing, debugging and handing over, including the quality testing and control over the materials and spare parts supplied by partner-suppliers.
		Party B shall submit its quality project plan to Party A for recognition and approval within two weeks from the effective date of contract.
		Quality project plan shall include the non-destructive test, identification ad identification of raw materials, stage acceptance and final testing.
		Party B shall clearly indicate which tests need eye-witness of the representatives of Party A. Party A shall also decide which testing items need to be witnessed by his representatives.
		Party B shall issue test report and test certificate for each inspection and test (witnessed or not witnessed by the representatives of Party A), and these documents will be included in the final completion file package.
		All design, procurement, installation, testing, debugging, and implementation of document system  shall take consideration to meet the requirements of validation and certification.
		a)Project Schedule Diagram
		Party B must prepare and analyze the detailed schedule diagram (including the design, procurement, installation, testing, debugging and handing over, etc) through a reasonable manner, which will be favorable to: ① quality control, ② determination of critical working procedure and stage, optimization of working procedure, and ③ frequent inspection of working progress.
12	Quality Guarantee and Responsibility		Y
		●The quality guarantee period of all goods supplied by Party B shall be at least one year (from the day of qualified final acceptance and debugging)
		●Party B shall guarantee the safety, reliability, normativity and reasonableness of the design, procurement, installation, testing and debugging and shall bear full responsibility for them.
		●Party B shall guarantee that all working contents and implementation must take account of the requirements and validation of Party B as well as related (China, EU and the United States) GMP Certification requirements.
13	Documents & Drawings		Y
		Documents will an integral part of the scope of work of Party B, so Party B shall pay the liquidated damages if submittal of documents is delayed or the submitted documents are incomplete. In case of failing to submit the documents even if a part of them, it is also deemed that the contract is not performed completely, which will be unacceptable.

第6页/共9页

URS DEVIATION FORM

Project Name	Storage and Distribution System of Compressed Air and Process Gas
	URS Document: User Requirements on the Storage and Distribution System of Purifyed Water
	URS Document: User Requirements on the Distribution System of Purified Steam
	URS Document: User Requirements on the Storage and Distribution System of Water for Injection
Tenderer	Shanghai Macroprocess Co., Ltd

Document No.	Name	Requirements	Compliance	Non-compliance	Remark and Deviation Description
		The goods and documents supplied by Party B must conform to the requirements of Party A and must also meet the requirements of current GMP Certification of China, the United States and EU.
		a)Form of Documents
		All documents and drawings shall clearly show the order number, work number, customer number and related drawing number, location number of equipment, pipe number, valve number and instrument number.
		The documents and drawings must be submitted to Party A in accordance with the requirements of attached schedule for recognition and approval. Documents and drawings shall be submitted in the form of hardcopy and softcopy in accordance with the time specified in the attached schedule. The softcopy of drawings shall be CAD form.
		The drawings shall adopt the metric unit.
		Language: All documents, drawings, instructions and operation maintenance manuals, etc shall be prepared in simplified Chinese and English.
		b)Document establishment / submittal time (progress) table.
14	After-sales Service and Training		Y
		The after-sales service must be in time and detailed and also solve the problems completely.
		During the quality guarantee period, Party B shall be responsible for repairing or replacement free of charge if the goods and working contents specified in the contract occur any problems within the scope of operating regulations; Party B shall provide lifelong repairing and maintenance in time after the quality guarantee period, and only material cost will be charged for the repairing work.
		Party B shall provide training to the staff of Party A free of charge (including training in factory and installation site), and the training contents shall include the working principle, framework, flow process, operation, maintenance & repairing, calibration and resolving of faults, etc of the whole system.
		Party B shall describe the method and manner of his technical commitment and after-sales service in his tendering documens.
15	Construction Period of the System		Y
		Installation and construction of the system is approximately to be commenced on July 1, 2009 and completed on September 30, 2009.
16	Quotation		Y
		The quotation shall include all costs occurred within the scope of supply of the seller and the scope of work.
		The quotation shall include the separate price for each time and total price.
		The quotation of all equipments and main materials shall clearly show the main technical specification and manufacturer.
URS Document: User Requirements on the Purified Steam Storage and Distribution System
2	Scope of Supply of Party B		Y
		The goods and works supplied by Party B shall be completely in accordance with the user requirements and appendices as well as related standards and specifications.
		The scope of supply of Party B shall include the materials, auxiliary spare parts, auxiliary equipments, and all necessary materials and spare parts required to guarantee good performance of the whole project in accordace with this user requirement description.
		Scope of supply is as follows:
		→ Supply and installation construction (including installation, welding connection, welding seam detection and treatment, pressurizing, degrease, acid cleaning and passivation, etc) of all installation materials (including pipeline, pipe fittings, water pump, storage tank, heat exchanger, valve, support, thermal insulation of pipeline and related auxiliary fittings, etc) used for the purified steam storage and distribution system in this project.
		→  Provide the as-built documents and validation documents (including the validation and confirmation documents required for certification).
		→  Necessary expenses for approval by the government supervising department.(if necessary, it shall be included in the bidding documents).
3	Scope of Work of Party B		Y
		→  Design and calculation,  mainly including the design of pipeline layout as well as design of storage and distribution system of purified steam.
		→  Provide the data information and drawings relating to the disciplines of process, civil engineering, water supply & drainage, electization and instrument control, etc.
		→  Packaging and transporting of materials used in the project.
		→  Installation, inspection, testing and related debugging.
		→  Related instructions and reviews on the taking over of public system.
		→  All fittings, instruments and tools required for installation, inspection and debuging shall be provided by Party B.
		→  Provide the completion documents and validation documents
		→  Training on the operation, maintenance & repairing, and validation.
		→  After-sales service
4	Standards and Specifications to be based on		Y
		a.Design, material, installation, inspection and testing shall be based the requirements of this project and shall also satisfy the standards of FDA, EU and China CGMP.
		b.Automatic control system shall conform to GAMP5.
		c.Related construction and acceptance specifications of pipeline works.
		d.GMP Specification:
		a)FDA - 21 CFR Part 210, 211
		b)SFDA -Good Manufacturing Practices,1998 version and and new version to be released.
		c)Current lastest GMP in EU
		d)Related GMP Implementation Guidance
		e) The latest version of Chinese pharmacopoeia, EU pharmacopoeia, and U.S. Pharmacopoeia.
		f)ISPE，Volume 4，water and steam system，2005 version.
		g) The latest version of ASME BPE Standards.
		h)ISPE Pharmaceutical Engineering Guides for New and Renovated Facilities
		i)V3 Sterile Manufacturing Facilities.
		j)V6 Biopharmaceutical Manufacturing Facilities.
		Party B shall detail the standards and specifications to be based on in his tender documents.

第7页/共9页

URS DEVIATION FORM

Project Name	Storage and Distribution System of Compressed Air and Process Gas
	URS Document: User Requirements on the Storage and Distribution System of Purifyed Water
	URS Document: User Requirements on the Distribution System of Purified Steam
	URS Document: User Requirements on the Storage and Distribution System of Water for Injection
Tenderer	Shanghai Macroprocess Co., Ltd

Document No.	Name	Requirements	Compliance	Non-compliance	Remark and Deviation Description
5	GMP Requirements		Y
		→  Conform to the requirements of current FDA, EU and China GMP
		→  All purified steam system pipeline shall be able to be completely discharged, cleaned and sterilized.
		→  All materials contacting with the products, purified steam pipeline and pipe fittings must be 316L stainless steel.
		→  All materials, instruments and equipments shall conform to cGMP.
		→  The system shall have suitable sampling points which shall be easy to control, monitor and record the system status.
		→  The purified steam system shall be free of water backflow, and deal area shall also be avoided.
		→  DQ, IQ, OQ and PQ shall be provided.
		→  Welders shall hold related qualification certificates applicable to corrsponding works.
		→  Welding machine and instrument are within the valid calibration period.
		→  The clean pipeline shall adopt the automatic track welding method as far as possible.
6	Distribution System of Purified Steam
		Pipelines shall be installed through the welding connection method as far as possible to achieve the 3D standard, but welding seams shall be minimized and convenience of strilizing and operating shall also be taken into consideration. Installation of pipeline shall take account of simple and smooth connection for convenience of installation, maintenance and operation, and the requirements of safety and human environment shall also be taken into consideration.	Y
		Intallation of pipellines shall be carried out strictly in accordance with the established and approved operation regulations (qualification confirmation of operators; cutting; welding connection; slope detection; endoscopy, ray detection; degrease; acid cleaning; passivation; pressurizing test, etc).	Y
		Sufficient support shall be made to the pipeline to avoid drooping or other deformations.	Y
		The sampling point shall be equipped at least at the initial stage of distribution pipeline.	Y
		The fixed pipeline must be clearly indicated with the medium and flow direction in the pipeline.	Y
		The connection gasket shall be sandwich PTFE gasket.	Y
		The lowest point and end of the system shall be equipped with steam trap and condensed water drainage.	Y
		a)Requirements of the purified steam distribution system.
		Pipeline & Pipe Fittings and Installation
		316L stainless steel material, outer Ra<0.8µm, inner Ra<0.5µm, mechanical polishing, ASME BPE standard (this standard shall be applicable to other parts unless otherwise specified).	Y
		Sanitation Ball Valve
		Adopt King Lai brand, 316L material, PTFE sealing material, mechanical polishing, inner surface Ra<0.5µm, outer Ra<0.8µm, quick clamp interface  (interface size shall matched with the pipeline system).	Y
		Thermal Insulation
		Stainless steel sheet or PV + rock wool (volume weight is more than 65kg/m3) shall be applied in water preparation room.	Y
		Iron sheet + rock wool (volume weight is more than 65kg/m3) shall be applied in the technical sanwich layer.	Y
		The clean room shall adopt the casng (pipe-in-pipe) form. The material of casing shall be 304 stainless steel, with outer surface Ra<0.8um.	N		Outer surface Ra<1.6um
		Support Material
		The possibly used support type materials include various specifications of movable support, stainless steel support, fixed plate, decorating plate, stainless steel square tube, angle bar, galvanized lead screw, and stainless steel screw bolt, etc; 304 stainless steel materials shall be applied in the clean area. Soft contact shall be made between the support and pipeline.	N		Specially developed bakelite support (high temperature resistance) shall be applied in the clean room.
		Welding Seam Detection	Y
		Sanitary pipeline of the whole system shall be connected through automatic welding as fas as possible, and manual welding connection (if necessary) shall be approved by Party A. X-ray fault detection and endoscopy shall be applied for all manual welding connections. X-ray fault detection shall be done for all welding samples of the automatic welding connection part while endoscopy shall be applied for 20% of other automatic welding spots. The inspected welding spots layout shall be approved by Party A.
		Degrease, Acid Cleaning, Passivation and Pressure Test	Y
		Degrease, acid cleaning and passivation treatment shall be applied for all pipes, and then test the effects. Pressure test shall be applied for all pipes, with the testing pressure at least 1.5 times of the working pressure, and if the working pressure is less than 4bar, the pressure of 6bar shall be applied for testing.
		Control Device
		The control system for the distribution system of water for injection, purified water and steam generator shall be combined with the control system ofpreparation equipment to adopt one set of control system.Two workshops of the material system shall adopt separate set of contron system respectively. The control system shall adopt the SIMENS brand.	N		Separate system, and data transmit and host computer control is available.
		Electric control cabinet includes:PLC (CPU, Input/Output Module), touch screen (colorful) and other control components; power supply, switch, push button, contactor, relay, frequency converter,  indicator light and other electric components; cabinet body, terminal strip, cable and trunking, control software, recording instrument (8 channels), DP communication module, and other necessary components and parts.	N		Record and print data through computer
		The sterilzing process of purified water system and water for injection system shall be full automatic control, and the sterilizing time shall be included in the PLC time counting. Recording curve shall be made for the key parameters (such as the electrical conductivity, flow rate, temperature, TOC, etc).	Y
		Sewerage, Funnel and Discharge	Y
		Make the best use of non- immersive instrument, and if not available,  it must be of sanitary design.
		The connection part of plug-type instrument must be of sanitary clamp connection type.
		Filling material in the instrument shall not be mixed into the products in ccase of occurring leakage of the instrument.
		Mark	Y
		Each welding spot shall be marked.
		b)Construction Specification and Acceptance	Y
		Party B shall describe the organization and implementation specifications and procedures as well as acceptance procedures and standards for various works in the bidding documents.
7	Design		Y
		Party B' work must enable the complete set system meet the requirements of current GMP specifications prevailing in China, EU and the United States and also pass corresponding GMP Certifications.
8	Control, Debugging and Validation of Storage and Distribution of Purified Steam System		Y
		Control, debugging and validation of operating control, debugging and validation of purified steam distribution system shall be completed by Party B.

第8页/共9页

URS DEVIATION FORM

Project Name	Storage and Distribution System of Compressed Air and Process Gas
	URS Document: User Requirements on the Storage and Distribution System of Purifyed Water
	URS Document: User Requirements on the Distribution System of Purified Steam
	URS Document: User Requirements on the Storage and Distribution System of Water for Injection
Tenderer	Shanghai Macroprocess Co., Ltd

Document No.	Name	Requirements	Compliance	Non-compliance	Remark and Deviation Description
		In addition, supply, related documents and validation of instruments (including necessary pressure gauge and pressure transmitter, thermometer and temperature transmitter, etc) and control devices (electric control cabinet including PLC, touch screen, recording instrument and other control components; and power supply, switch, push button, contactor, relay, frequency converter,  indicator light and other electric components) in the purified steam distribution system shall be completed by Party B.
		The instruments shall be accurate and reliable and need to be calibrated, and the calibration shall be traceable.
9	Traceability of Raw Materials, Spare Parts and Control System		Y
		For all raw materials, spare parts, equipments, electricity, instrument and control system, original data shall be reserved and all of these items shall be tested to establish files for them to ensure their traceability. Traceability Matrix (TM) documents shall be established for each aspect of project implementation.
		Each spare part, equipment, electric and intrument part shall be equipped with metal tag (with corresponding location number) for convenience of identification and operating.
10	Process Guarantee		Y
		Party B' work shall be sure to meet this user requirement as well as requirements specified in the appendices in the following aspects (include but not limited to):
		→  Meet the requirements of GMP specifications in China, EU and the United States as well as various industry codes.
		→  Quality of purified steam in distribution pipeline and point of use.
		→ Flow rate, pressure and temperature at the outlet of point of use.
		→  Functional testing of the distribution pipeline;
		→Functional testing of PLC and control system.
11	Quality Project Plan (QPP)		Y
		In order to ensure compliance with the requirements of Party A, Party B shall implement the quality project plan and construction organization design at all stages of design, installation, testing, debugging and handing over, including the quality testing and control over the materials and spare parts supplied by partner-suppliers.
		Party B shall submit its quality project plan to Party A for recognition and approval within two weeks from the effective date of contract.
		Quality project plan shall include the non-destructive test, identification ad identification of raw materials, stage acceptance and final testing.
		Party B shall clearly indicate which tests need eye-witness of the representatives of Party A. Party A shall also decide which testing items need to be witnessed by his representatives.
		Party B shall issue test report and test certificate for each inspection and test (witnessed or not witnessed by the representatives of Party A), and these documents will be included in the final completion file package.
		All design, procurement, installation, testing, debugging, and implementation of document system  shall take into consideration to meet the requirements of validation and certification.
		a)Project Schedule Diagram
		Party B must prepare and analyze the detailed schedule diagram (including the design, procurement, installation, testing, debugging and handing over, etc) through a reasonable manner, which will be favorable to: ① quality control, ② determination of critical working procedure and stage, optimization of working procedure, and ③ frequent inspection of working progress.
12	Quality Guarantee and Responsibility		Y
		→  The quality guarantee period of all goods supplied by Party B shall be at least one year (from the day of qualified final acceptance and debugging)
		→  Party B shall guarantee the safety, reliability, normativity and reasonableness of the design, procurement, installation, testing and debugging and shall bear full responsibility for them.
		→  Party B shall guarantee that all working contents and implementation must take account of the requirements and validation of Party B as well as related (China, EU and the United States) GMP Certification requirements.
13	Documents & Drawings		Y
		Documents will an integral part of the scope of work of Party B, so Party B shall pay the liquidated damages if submittal of documents is delayed or the submitted documents are incomplete. In case of failing to submit the documents even if a part of them, it is also deemed that the contract is not performed completely, which will be unacceptable.
		The goods and documents supplied by Party B must conform to the requirements of Party A and must also meet the requirements of current GMP Certification of China, the United States and EU.
		a)Form of Documents
		All documents and drawings shall clearly show the order number, work number, customer number and related drawing number, location number of equipment, pipe number, valve number and instrument number.
		The documents and drawings must be submitted to Party A in accordance with the requirements of attached schedule for recognition and approval. Documents and drawings shall be submitted in the form of hardcopy and softcopy in accordance with the time specified in the attached schedule. The softcopy of drawings shall be CAD form.
		The drawings shall adopt the metric unit.
		Language: All documents, drawings, instructions and operation maintenance manuals, etc shall be prepared in simplified Chinese and English.
		Document establishment / submittal time (progress) table.
14	After-sales Service and Training
		The after-sales service must be in time and detailed and also solve the problems completely.
		During the quality guarantee period, Party B shall be responsible for repairing or replacement free of charge if the goods and working contents specified in the contract occur any problems within the scope of operating regulations; Party B shall provide lifelong repairing and maintenance in time after the quality guarantee period, and only material cost will be charged for the repairing work.
		Party B shall provide training to the staff of Party A free of charge (including training in factory and installation site), and the training contents shall include the working principle, framework, flow process, operation, maintenance & repairing, calibration and resolving of faults, etc of the whole system.
		Party B shall describe the method and manner of his technical commitment and after-sales service in his tendering documens.
15	Construction Period of the System
		Installation and construction of the system is approximately to be commenced on July 1, 2009 and completed on September 30, 2009.
16	Quotation
		The quotation shall include all costs occurred within the scope of supply of the seller and the scope of work.
		The quotation shall include the separate price for each time and total price.
		The quotation of all equipments and main materials shall clearly show the main technical specification and manufacturer.

第9页/共9页

URS DEVIATION FORM

Project Name	Storage and Distribution System of Compressed Air and Process Gas
Reference	URS Document: User Requirements on the Storage and Distribution System of Compressed Air and Process Gas
Tenderer	Shanghai Macroprocess Co., Ltd

Document No.	Name	Requirements	Compliance	Non-compliance	Remark and Deviation Description
URS Document:User Requirements on the Storage and Distribution System of Compressed Air and Process Gas
3	Scope of Work of Party B
		●Design and calculation, mainly including the design of pipeline layout as well as design of storage and distribution system of compressed air and process gas.
		● Provide the data information and drawings relating to the disciplines of process, civil engineering, water supply & drainage, electization and instrument control, etc.
		● Packaging and transporting of materials used in the project.
		● Installation, inspection, testing and related debugging.
		● Related instructions and reviews on the taking over of public system.
		● All fittings, instruments and tools required for installation, inspection and debuging shall be provided by Party B.
		● Provide the completion documents and validation documents
		● Training on the operation, maintenance & repairing, and validation.
		● After-sales service
4	Standards and Specifications to be based on		Y
		● Design, material, installation, inspection and testing shall be based the requirements of this project and shall also satisfy the standards of FDA, EU and China CGMP.
		● Automatic control system shall conform to GAMP5.
		● Related construction and acceptance specifications of pipeline works.
		● GMP Specification.
		■ FDA - 21 CFR Part 210, 211
		■ SFDA -Good Manufacturing Practices,1998 version and and new version to be released.
		■ Current lastest GMP in EU
		■ Related GMP Implementation Guidance
		■ The latest version of Chinese pharmacopoeia, EU pharmacopoeia, and U.S. Pharmacopoeia.
		■ The latest version of ASME BPE Standards.
		■  ISPE Pharmaceutical Engineering Guides for New and Renovated Facilities
		■  V3 Sterile Manufacturing Facilities.
		■  V6 Biopharmaceutical Manufacturing Facilities.
5	GMP Requirements		Y
		●  Conform to the requirements of current FDA, EU and China GMP
		●  All materials, instruments and equipments shall conform to cGMP.
		●  DQ, IQ, OQ and PQ shall be provided.
		●  Welders shall hold related qualification certificates applicable to corrsponding works.
		●  Welding machine and instrument are within the valid calibration period.
		●  Pipeline shall adopt the automatic track welding method as far as possible.
6	Storage and Distribution System of Compressed Air and Process Gas
		a) Requirements of Storage and Distribution System of Compressed Air and Process Gas
		Material of Pipeline and Pipe Fittings	N		316L material for those lower than DN19
		304 stainless steel materials, outer Ra<0.8µm, inner Ra<0.8µm, mechanical polishing, ISO 2037 Standard (the following contents shall also adopt this standard, unless otherwise specified)	N		ISPO standard outer Ra<1.0µm
		Air Holder	Y
		304 stainless steel material, outer Ra<0.8µm, inner Ra<0.8µm
		Sanitation Ball Valve	Y
		Fluid media: compressed air and process gas. Adopt King Lai brand, 304 material, sealings material PTFE, mechanical polishing, inner surface Ra<0.8µm, outer Ra<0.8µm .
		Support Material
		The possibly used support type materials include various specifications of movable support, stainless steel support, fixed plate, decorating plate, stainless steel square tube, angle bar, galvanized lead screw, and stainless steel screw bolt, etc; 304 stainless steel materials shall be applied in the clean area. Soft contact shall be made between the support and pipeline.	N		Adopt the specially designed bakelite support
		Welding Seam Detection
		Pipeline of the whole system shall be connected through automatic welding as fas as possible, and manual welding connection (if necessary) shall be approved by Party A. X-ray fault detection and endoscopy shall be applied for all manual welding connections. X-ray fault detection shall be done for all welding samples of the automatic welding connection part while endoscopy shall be applied for 20% of other automatic welding spots. The inspected welding spots layout shall be approved by Party A.	Y
		Degrease, Acid Cleaning, Passivation and Pressure Test	Y
		Degrease, acid cleaning and passivation treatment as well as pressure test shall be applied for all pipes.
		Control Device
		Compressed air and process gas system shall adopt one set of control system. The control system shall adopt the SIMENS brand.	Y
		Electric control cabinet includes:PLC (CPU, Input/Output Module), touch screen (colorful) and other control components; power supply, switch, push button, contactor, relay, frequency converter,  indicator light and other electric components; cabinet body, terminal strip, cable and trunking, control software, recording instrument (8 channels), DP communication module, and other necessary components and parts.
		Mark	Y
		Each welding spot shall be marked.
		b) Construction Specification and Acceptance
		Party B shall describe the organization and implementation specifications and procedures as well as acceptance procedures and standards for various works in the bidding documents.
7	Design
		Party B' work must enable the complete set system meet the requirements of current GMP specifications prevailing in China, EU and the United States and also pass corresponding GMP Certifications.	N		Wide differences were found in the scope of design requirements after communication, so the design is being revised.
8	Control, Debugging and Validation		Y
		Operating control, debugging and validation of the storage and distribution system of compressed air and process gas shall be completed by Party B.
		In addition, supply, related documents and validation of instruments (including necessary pressure gauge and pressure transmitter, thermometer and temperature transmitter, flowmeter and flow transmitter, and conductivity meter, etc) and control devices (electric control cabinet including PLC, touch screen, recording instrument and other control components; and power supply, switch, push button, contactor, relay, frequency converter,  indicator light and other electric components) in the storage and distribution system of compressed air and process gas shall be completed by Party B.
		The instruments shall be accurate and reliable and need to be calibrated, and the calibration shall be traceable.

第1页/共2页

URS DEVIATION FORM

Project Name	Storage and Distribution System of Compressed Air and Process Gas
Reference	URS Document: User Requirements on the Storage and Distribution System of Compressed Air and Process Gas
Tenderer	Shanghai Macroprocess Co., Ltd

Document No.	Name	Requirements	Compliance	Non-compliance	Remark and Deviation Description
9	Traceability of Raw Materials, Spare Parts and Control System		Y
		For all raw materials, spare parts, equipments, electricity, instrument and control system, original data shall be reserved and all of these items shall be tested to establish files for them to ensure their traceability. Traceability Matrix (TM) documents shall be established for each aspect of project implementation.
		Each spare part, equipment, electric and intrument part shall be equipped with metal tag (with corresponding location number) for convenience of identification and operating.
10	Process Guarantee		Y
		ðMeet the requirements of GMP specifications in China, EU and the United States as well as various industry codes.
		ðFlow rate and pressure at the outlet of air holder and points of use of gas.
		ðFunctional testing of PLC and control system.
11	Quality Project Plan (QPP)		Y
		In order to ensure compliance with the requirements of Party A, Party B shall implement the quality project plan and construction organization design at all stages of design, installation, testing, debugging and handing over, including the quality testing and control over the materials and spare parts supplied by partner-suppliers.
		Party B shall submit its quality project plan to Party A for recognition and approval within two weeks from the effective date of contract.
		Quality project plan shall include the non-destructive test, identification ad identification of raw materials, stage acceptance and final testing.
		Party B shall clearly indicate which tests need eye-witness of the representatives of Party A. Party A shall also decide which testing items need to be witnessed by his representatives.
		Party B shall issue test report and test certificate for each inspection and test (witnessed or not witnessed by the representatives of Party A), and these documents will be included in the final completion file package.
		All design, procurement, installation, testing, debugging, and implementation of document system  shall take consideration to meet the requirements of validation and certification.
		a)Project Schedule Diagram
		Party B must prepare and analyze the detailed schedule diagram (including the design, procurement, installation, testing, debugging and handing over, etc) through a reasonable manner, which will be favorable to: ① quality control, ② determination of critical working procedure and stage, optimization of working procedure, and ③ frequent inspection of working progress.
12	Quality Guarantee and Responsibility		Y
		●  The quality guarantee period of all goods supplied by Party B shall be at least one year (from the day of qualified final acceptance and debugging)
		●Party B shall guarantee the safety, reliability, normativity and reasonableness of the design, procurement, installation, testing and debugging and shall bear full responsibility for them.
		●Party B shall guarantee that all working contents and implementation must take account of the requirements and validation of Party B as well as related (China, EU and the United States) GMP Certification requirements.
13	Documents & Drawings		Y
		Documents will an integral part of the scope of work of Party B, so Party B shall pay the liquidated damages if submittal of documents is delayed or the submitted documents are incomplete. In case of failing to submit the documents even if a part of them, it is also deemed that the contract is not performed completely, which will be unacceptable.
		The goods and documents supplied by Party B must conform to the requirements of Party A and must also meet the requirements of current GMP Certification of China, the United States and EU.
		a)Form of Documents
		All documents and drawings shall clearly show the order number, work number, customer number and related drawing number, location number of equipment, pipe number, valve number and instrument number.
		The documents and drawings must be submitted to Party A in accordance with the requirements of attached schedule for recognition and approval. Documents and drawings shall be submitted in the form of hardcopy and softcopy in accordance with the time specified in the attached schedule. The softcopy of drawings shall be CAD form.
		The drawings shall adopt the metric unit.
		Language: All documents, drawings, instructions and operation maintenance manuals, etc shall be prepared in simplified Chinese and English.
		b)Document establishment / submittal time (progress) table.
14	After-sales Service and Training		Y
		The after-sales service must be in time and detailed and also solve the problems completely.
		During the quality guarantee period, Party B shall be responsible for repairing or replacement free of charge if the goods and working contents specified in the contract occur any problems within the scope of operating regulations; Party B shall provide lifelong repairing and maintenance in time after the quality guarantee period, and only material cost will be charged for the repairing work.
		Party B shall provide training to the staff of Party A free of charge (including training in factory and installation site), and the training contents shall include the working principle, framework, flow process, operation, maintenance & repairing, calibration and resolving of faults, etc of the whole system.
		Party B shall describe the method and manner of his technical commitment and after-sales service in his tendering documens.
15	Construction Period of the System		Y
		Installation and construction of the system is approximately to be commenced on July 1, 2009 and completed on August 30, 2009.
16	Quotation		Y
		The quotation shall include all costs occurred within the scope of supply of the seller and the scope of work.
		The quotation shall include the separate price for each time and total price.
		The quotation of all equipments and main materials shall clearly show the main technical specification and manufacturer.

第2页/共2页

EX-4.7.9

Exhibit 4.7.9 - Appendix 5 - Bidding Document 1

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

第 1 部分

Part 1

投 标 书

Tender

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co., Ltd

上海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

T:021 54306717      F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

目 录

1. 报价书	2
1.1. 法定代表人资格证明书	2
1.2. 法人授权委托书	3
1.3. 授权代表人身份证复印件	4
1.4. 投标书	5
2.方案一 管材管件主为ALFA LAVAL	6
2.1. 报价一览表	6
2.2. 分项报价清单	8
2.2.1. 物料系统材料清单及报价	8
2.2.2. CIP 站材料清单及报价	15
2.2.3. EPO 线配液控制系统报价	18
2.2.4. TPO 配液控制系统报价	20
2.2.5. 罐体	22
2.2.6. 焊点费	34
2.2.7. 系统所用辅材数量清单	35
2.2.8. 验证服务报价	36
3.方案二 管材管件主为NEUMO	37
3.1. 报价一览表	37
3.2. 分项报价清单	39
3.2.1. 物料系统材料清单及报价	39
3.2.2. CIP 站材料清单及报价	45
3.2.3. EPO 线配液控制系统报价	48
3.2.4. TPO 配液控制系统报价	50
3.2.5. 罐体	52
3.2.6. 焊点费	65
3.2.7. 系统所用辅材数量清单	66
3.2.8. 验证服务报价	67

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

 

1. 报价书

1.1. 法定代表人资格证明书

法定代表人资格证明书

单位名称：上海朗脉科技有限公司

单位地址：上海市闵行区罗阳路168 号A 座1 层

经营期限：2007年7 月26 日到2017 年7 月25 日

姓    名：王伟

性    别： 男

年    龄： 36

职    务：法人代表

王伟先生系上海朗脉科技有限公司 的法定代表人,签署本招标项目的投 标文件,进行合同谈判,签署合同和处理与之有关的一切事务。

特此证明。

投标单位（盖章）： 上海朗脉科技有限公司

日期：2009-1-15

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

1.2. 法人授权委托书

法人授权委托书

沈阳三生制药有限责任公司:

本授权委托书声明： 我王伟先生系上海市闵行区罗阳路168 号A 座101 室的上海朗脉科技有限公司的法定代表人，现代表公司授权委托下面签字的 上海朗脉科技有限公司 的 销售经理张松为本公司的合法代理人，代表本公司参加沈阳三生制药有限责任公司组织的工艺配料系统项目的投标活动。代理人在本次投标中所签署的一切文件和处理与之相关的一切事务，我均予以承认。

代理人无转委权

本授权于2009 年1 月15 日签字生效，特此声明。

代理人：张松性别：男年龄：35

单位：上海朗脉科技有限公司职务：销售经理

地址：上海市闵行区罗阳路168 号A 座101 室

投标人：（公章）上海朗脉科技有限公司

法定代表人：（印鉴）

2009 年1 月15 日

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第3页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

1.3. 授权代表人身份证复印件

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第4页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

1.4. 投标书

投标书

致沈阳三生制药有限责任公司：

我们收到贵方   工艺配料系统 招标文件，经详细研究，我们决定参加该项目投标。并授权 张松销售经理 ，全权代表我投标方提交下述文件正本一份，副本叁份。并同时宣布愿意遵守下列条款：

1、承认和愿意按照招标文件中的各项规定和要求，提供工艺配料系统的供货、安装、调试及维保等。

2、投标总报价方案一 5,523,961.99 元（管件管材主选Alfa Laval），方案二· 5,502,881.38 元（管件管材主选NEUMO） 供货周期承诺 120 日历天，安装周期承诺 70 日历天，安装质量承诺 符合GMP 要求。

3、愿意按照《合同法》和《中华人民共和国招标投标法》履行自己的责任和义务。

4、如果我们投标函被接受，我们将履行招标文件中规定的每一项要求，按期、按质、按量完成任务。

5、我们愿意提供招标方在招标文件中要求的所有资料。

6、我们理解，最低报价不是中标的唯一条件。

7、我们同意按招标文件规定，交纳投标保证金，遵守有关招标的各项规定。

8、我方的投标书在开标后60 天内有效。

9、与本投标有关的一切往来通讯请寄：

地址： 上海市闵行区罗阳路168 号A 座101 室邮编：201100

电话： 021-54306717/ 13901375676 传真： 021-54306718 

投标方(公章)： 上海朗脉科技有限公司

授权代表人（签字或盖章）： 

日期：

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第5页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

2.方案一 管材管件主为ALFA LAVAL

2.1. 报价一览表

Item 序号	Scope of Supply 供货范围	Price (RMB) 价格
1	Price Breakdown for PRO Distribution System 配料系统材料清单及报价	1,727,854.53
2	Price Breakdown for CIP Distribution SystemCIP 系统材料清单及报价	1,453,306.31
3	EPO Automatic Control SystemEPO 自动化控制系统	228,195.00
3	TPO Automatic Control SystemTPO 自动化控制系统	216,195.00
4	Piping surport 辅助材料，洁净区用不锈钢支架，非洁净区用镀锌角铁	237,505.00
	Subtotal 1 for Material 材料费用	3,863,055.84
5	Welding Point Cost 焊点费用	287,100.00
6	Cost of Welding Point marking (100% of total welding point ) 20RMB /point 焊点刻码费用,100%自动焊点刻码,20元/焊点	35,880.00
7	Endoscopic Check ( 20% of total welding point ) 120 RMB /point 内窥镜检测，自动焊点的20%取样，80 元/焊点	31,104.00
8	X-ray Check ( 100% of total hand-welding point,all welded samples ) 180 RMB /point X -光检测，（100%手工焊点,所有焊样），180 元/ 焊点,	28,800.00
9	Insurance and Transportation 保险和运输	60,000.00
	Subtotal 2 for Piping fabrication 管道装配	442,884.00
11	Detail Design, Shop Drawings and As-built Drawings 详细设计，施工图纸和竣工文件	150,000.00
12	Quotation For Validation Activities 验证服务报价	425,000.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第6页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

13	COMPANY Management & Supervision 公司管理&监督	400,000.00
13	Project Management & Supervision 项目管理&监督	100,000.00
14	Commissioning 调试	50,000.00
	Subtotal 3 for Project Service 项目服务	1,125,000.00
	Subtotal 1, 2, 3,合计	5,430,939.84
	Tax 税金(主材部分开增值税，其他开工程发票）	93,022.15
	Total Price 总价	5,523,961.99

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第7页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

2.2. 分项报价清单

2.2.1. 物料系统材料清单及报价

Price Breakdown for PRO Distribution System

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
1	培养基配制罐1106	详细配置见罐清单	316L	1	RITAI		150,000.00	150,000.00
2	培养基配制罐1109	详细配置见罐清单	316L	1	RITAI		120,000.00	120,000.00
3	缓冲液配制罐1421	详细配置见罐清单	316L	1	RITAI		122,000.00	122,000.00
4	缓冲液暂存罐1301	详细配置见罐清单	316L	1	RITAI		80,000.00	80,000.00
5	气动隔膜阀	DN25	316L	13	GEMU		3,201.25	41,616.25
6	隔膜阀	DN40	316L	7	GEMU		3,538.75	24,771.25
7	隔膜阀	DN25	316L	32	GEMU		2,428.75	77,720.00
8	气动球阀	DN25	316L	4	King Lai		1,002.98	4,011.90
9	气动球阀	DN20	316L	4	King Lai		966.30	3,865.20
10	球阀	DN25	316L	4	King Lai		257.03	1,028.10
11	疏水器	DN20	316L	4	Spirax Sarco		2,875.00	11,500.00
12	过滤器	1.5T/h, 0.22um		1	PALL		12,250.00	12,250.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第8页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
13	过滤器	0.6T/h, 0.22um		3	PALL		8,125.00	24,375.00
14	温度变送器	DN20	316L	4	E+H		2,375.00	9,500.00
15	隔膜压力表	0~4kgf/cm2, 1″卡箍接口	316L	8	Bright		437.50	3,500.00
16	卫生软管	DN25	PTFE	12	SAINT-GOBAIN		2,293.75	27,525.00
17	卡接头	38	316L	8	Alfa Laval	ASME BPE-PM,Ra≤0.5	123.95	991.62
18	卡接头	25	316L	110	Alfa Laval	ASME BPE-PM,Ra≤0.5	118.73	13,060.24
19	卡环	38	304	8	Alfa Laval	ASME BPE-PM,Ra≤0.5	49.56	396.52
20	卡环	25	304	118	Alfa Laval	ASME BPE-PM,Ra≤0.5	49.56	5,848.64
21	密封圈	38	PTFE	8	Alfa Laval	ASME BPE-PM,Ra≤0.5	41.88	335.06
22	密封圈	25	PTFE	118	Alfa Laval	ASME BPE-PM,Ra≤0.5	46.51	5,487.69
23	焊接三通	DN25	316L	28	Alfa Laval	ASME BPE-PM,Ra≤0.5	174.19	4,877.27
24	焊接四通	DN25	316L	7	Alfa Laval	ASME BPE-PM,Ra≤0.5	1,030.28	7,211.98
25	90°弯头	38	316L	6	Alfa Laval	ASME BPE-PM,Ra≤0.5	155.94	935.65
26	90°弯头	25	316L	90	Alfa Laval	ASME BPE-PM,Ra≤0.5	150.99	13,588.94
27	管道	φ38	316L	6	Alfa Laval	ASME BPE-PM,Ra≤0.5	672.96	4,037.79
28	管道	φ25	316L	138	Alfa Laval	ASME BPE-PM,Ra≤0.5	529.34	73,049.08

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第9页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第10页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
46	管道	φ25	316L	12	Alfa Laval	ISO 2037,Ra≤0.5	125.53	1,506.35
47	管道	φ19	316L	12	Alfa Laval	ISO 2037,Ra≤0.5	102.22	1,226.68
一、	以上为EPO 工艺管线管材、管件配置及安装报价							866,550.11
1	培养基配制罐2106	详细配置见罐清单	316L	1	RITAI		150,000.00	150,000.00
2	培养基配制罐2109	详细配置见罐清单	316L	1	RITAI		120,000.00	120,000.00
3	缓冲液配制罐2421	详细配置见罐清单	316L	1	RITAI		122,000.00	122,000.00
4	缓冲液暂存罐2301	详细配置见罐清单	316L	1	RITAI		80,000.00	80,000.00
5	气动隔膜阀	DN25	316L	13	GEMU		3,201.25	41,616.25
6	隔膜阀	DN40	316L	7	GEMU		3,538.75	24,771.25
7	隔膜阀	DN25	316L	32	GEMU		2,428.75	77,720.00
8	气动球阀	DN25	316L	4	King Lai		1,002.98	4,011.90
9	气动球阀	DN20	316L	4	King Lai		966.30	3,865.20
10	球阀	DN25	316L	4	King Lai		257.03	1,028.10
11	疏水器	DN20	316L	4	Spirax Sarco		2,875.00	11,500.00
12	过滤器	1.5T/h, 0.22um		1	PALL		12,250.00	12,250.00
13	过滤器	0.6T/h, 0.22um		3	PALL		8,125.00	24,375.00
14	温度变送器	DN20	316L	4	E+H		2,375.00	9,500.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第11页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
15	隔膜压力表	0~4kgf/cm2,1″卡箍接口	316L	8	WIKA		437.50	3,500.00
16	卫生软管	DN25	PTFE	12	SAINT-GOBAIN		2,293.75	27,525.00
17	卡接头	38	316L	8	Alfa Laval	ASME BPE-PM,Ra≤0.5	123.95	991.62
18	卡接头	25	316L	110	Alfa Laval	ASME BPE-PM,Ra≤0.5	118.73	13,060.24
19	卡环	38	304	8	Alfa Laval	ASME BPE-PM,Ra≤0.5	49.56	396.52
20	卡环	25	304	118	Alfa Laval	ASME BPE-PM,Ra≤0.5	49.56	5,848.64
21	密封圈	38	PTFE	8	Alfa Laval	ASME BPE-PM,Ra≤0.5	41.88	335.06
22	密封圈	25	PTFE	118	Alfa Laval	ASME BPE-PM,Ra≤0.5	46.51	5,487.69
23	焊接三通	DN25	316L	28	Alfa Laval	ASME BPE-PM,Ra≤0.5	174.19	4,877.27
24	焊接四通	DN25	316L	7	Alfa Laval	ASME BPE-PM,Ra≤0.5	1,030.28	7,211.98
25	90°弯头	38	316L	6	Alfa Laval	ASME BPE-PM,Ra≤0.5	155.94	935.65
26	90°弯头	25	316L	90	Alfa Laval	ASME BPE-PM,Ra≤0.5	150.99	13,588.94
27	管道	φ38	316L	6	Alfa Laval	ASME BPE-PM,Ra≤0.5	672.96	4,037.79
28	管道	φ25	316L	120	Alfa Laval	ASME BPE-PM,Ra≤0.5	529.34	63,520.94
29	卡接头	38	316L	16	Alfa Laval	ISO 2037,Ra≤0.5	59.28	948.52
30	卡接头	25	316L	18	Alfa Laval	ISO 2037,Ra≤0.5	48.04	864.64

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第12页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第13页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第14页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

2.2.2. CIP 站材料清单及报价

Price Breakdown for CIP Distribution System

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
1	CIP 清洗罐	详细配置见罐清单	316L	1	RITAI		95,000.00	95,000.00
2	CIP 酸碱罐	详细配置见罐清单	316L	1	RITAI		79,000.00	79,000.00
3	气动球阀	DN40	316L	1	King Lai		1,280.80	1,280.80
4	气动隔膜阀	DN40	316L	15	GEMU		4,668.75	70,031.25
5	气动隔膜阀	DN25	316L	8	GEMU		3,201.25	25,610.00
6	隔膜阀	DN40	316L	2	GEMU		3,538.75	7,077.50
7	板式换热器一套	0.5m3,循环加热0.5 小时，40-80ºC	316L	4	Alfa Laval		33,750.00	135,000.00
8	温度变送器	DN20	316L	2	E+H		2,375.00	4,750.00
9	隔膜压力表	0～4kgf/cm21″卡箍接口	316L	1	CHINA		437.50	437.50
10	压力传感器	0～4kgf/cm21″卡箍接口	316L	1	CHINA		1,500.00	1,500.00
11	卫生离心泵	5T/h, 32m	316L	1	Alfa Laval		26,500.00	26,500.00
12	CIP 回流泵	8T/h, 25m	316L	3	Alfa Laval		62,500.00	187,500.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第15页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第16页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price	Total Price
序号	供货范围	规格	材料	数量	供应商	标准	单位价格(RMB)	总价(RMB)
30	90°弯头	38	316L	46	Alfa Laval	ISO 2037,Ra≤0.5	34.26	1,575.91
31	90°弯头	25	316L	16	Alfa Laval	ISO 2037,Ra≤0.5	26.95	431.25
32	管道	φ38	316L	96	Alfa Laval	ISO 2037,Ra≤0.5	178.44	17,129.79
33	管道	φ25	316L	6	Alfa Laval	ISO 2037,Ra≤0.5	125.53	753.18
一、	以上为CIP 清洗站管材、管件配置及报价							726,653.16
	两套合计							1,453,306.31

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第17页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

2.2.3. EPO 线配液控制系统报价

Quotation for Control System

序号 Item	供货范围 Scope of Supply	订货号 Order No.	规格 型号 Specification	厂家 Manufacturer	数量 Quantity	单价 (RMB) Unit Price	价格 (RMB) Price
1	导轨	6ES7 390-1AF30-0AA0	标准导轨 530mm	SIEMENS	2	228.00	456.00
2	电源	6ES7 307-1EA00-0AA0	PS 307 电源 5 A	SIEMENS	2	988.00	1976.00
3	CPU	6ES7 315-2EH13-0AB0	315-2 PN/DP 256KB RAM； MPI/PROFIBUS DP；PROFINET 接口	SIEMENS	1	13227.00	13227.00
4	扩展卡	6ES7 953-8LF11-0AA0	MMC 64 kB	SIEMENS	1	380.00	380.00
5	接口模块	6ES7 365-0BA01-0AA0	IM365 接口模块	SIEMENS	1	838.00	838.00
6	DI 模块	6ES7 321-1BH02-0AA0	16 点数字输入24V DC(20 针)	SIEMENS	1	1013.00	1013.00
7	DO 模块	6ES7 322-1BH01-0AA0	16 点数字输出24V DC(20 针)	SIEMENS	5	1409.00	7045.00
8	AI 模块	6ES7 331-7KF02-0AB0	8 通道模拟输入(20 针)	SIEMENS	4	3899.00	15596.00
9	AO 模块	6ES7 332-5HF00-0AB0	8 通道模拟输出(40 针)	SIEMENS	1	6065.00	6065.00
10	连接端子	6ES7 392-1AJ00-0AA0	20 针，螺钉型端子	SIEMENS	10	149.00	1490.00
11	连接端子	6ES7 392-1AM00-0AA0	40 针，螺钉型端子	SIEMENS	1	234.00	234.00
12	变频器		MM420 1.5KW	SIEMENS	4	2400.00	9600.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第18页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第19页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

2.2.4. TPO 配液控制系统报价

Quotation for Control System

序号 Item	供货范围 Scope of Supply	订货号 Order No.	规格 型号 Specification	厂家 Manufacturer	数量 Quantity	单价 (RMB)  Unit Price	价格 (RMB) Price
1	导轨	6ES7 390-1AF30-0AA0	标准导轨 530mm	SIEMENS	2	228.00	456.00
2	电源	6ES7 307-1EA00-0AA0	PS 307 电源 5 A	SIEMENS	2	988.00	1976.00
3	CPU	6ES7 315-2EH13-0AB0	315-2 PN/DP 256KB RAM； MPI/PROFIBUS DP；PROFINET 接口	SIEMENS	1	13227.00	13227.00
4	扩展卡	6ES7 953-8LF11-0AA0	MMC 64 kB	SIEMENS	1	380.00	380.00
5	接口模块	6ES7 365-0BA01-0AA0	IM365 接口模块	SIEMENS	1	838.00	838.00
6	DI 模块	6ES7 321-1BH02-0AA0	16 点数字输入24V DC(20 针)	SIEMENS	1	1013.00	1013.00
7	DO 模块	6ES7 322-1BH01-0AA0	16 点数字输出24V DC(20 针)	SIEMENS	5	1409.00	7045.00
8	AI 模块	6ES7 331-7KF02-0AB0	8 通道模拟输入(20 针)	SIEMENS	4	3899.00	15596.00
9	AO 模块	6ES7 332-5HF00-0AB0	8 通道模拟输出(40 针)	SIEMENS	1	6065.00	6065.00
10	连接端子	6ES7 392-1AJ00-0AA0	20 针，螺钉型端子	SIEMENS	10	149.00	1490.00
11	连接端子	6ES7 392-1AM00-0AA0	40 针，螺钉型端子	SIEMENS	1	234.00	234.00
12	变频器		MM420 1.5KW	SIEMENS	4	2400.00	9600.00
13	变频器操作面板	6SE6 400-0BP00-0AA0	BOP 面板	SIEMENS	4	300.00	1200.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第20页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

序号 Item	供货范围 Scope of Supply	订货号 Order No.	规格 型号 Specification	厂家 Manufacturer	数量 Quantity	单价 (RMB)  Unit Price	价格 (RMB) Price
14	开关电源	6EP1 334-3BA00	SITOP 24V/10A	SIEMENS	1	1500.00	1500.00
15	控制柜		2000×800× 600(含继电器、端子等柜内电气元件)	shanghai	1	14000.00	14000.00
16	控制箱		壁挂式（含按钮、端子等柜内电气元件）	shanghai	1	5000.00	5000.00
17	触摸屏	6AV6 643-0CD01-1AX1	MP 277 10" Touch 64K 颜色	SIEMENS	2	12000.00	24000.00
18	交换机	6 RJ45 口	工业以太网交换机	MOXA	1	1200.00	1200.00
19	网线		超五类双绞线	安普	100	5.00	500.00
20	电缆		RVV 2*1.0（米）	WUXI	4000	3.00	12000.00
21	电缆		RVVp 2*1.0（ 米）	WUXI	2000	4.00	8000.00
22	电缆		RVVP3*6+1（ 米）	WUXI	300	33.75	10125.00
23	桥架		150*75（米）	WUXI	200	68.75	13750.00
一、	控制系统所用材料					149195.00
二、	编程费 Programme Cost（1 人30 个工作日）					20000.00
三、	安装费用（3人10 个工作日）					15000.00
四、	调试费 Commissioning Cost（2 人10 个工作日，含住宿交通等）					32000.00
	总价 Total Price（RMB） :贰拾壹万陆仟壹佰玖拾伍 圆整					216195.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第21页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

2.2.5. 罐体

Configuration list for Bank

Configuration list for   PW Bank 培养基配制罐（1106）配置清单
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Remarks
序号	供货范围	规格	材料	数量	供应商	备注
1	培养基配制罐（1106）	1.5m3,压力容器,立式,带罐底阀，夹套冷却，磁力搅拌	316L	1	RiTai	内部抛光Ra<0.5um，外部亚光处理Ra<0.8um
2	呼吸器	10“ 0.22um	316L	1	PALL
3	喷淋球	DN25	316L	1	Alfa Laval	旋转式
4	称重模块	4-20 mA output		1	Mettler toledo
5	温度变送器	DN25,4-20 mA output		2	CHINA
6	压力传感器	DN25,4-20 mA output		1	CHINA
7	气动球阀	DN25	316L	1	King Lai
8	气动球阀	DN20	316L	1	King Lai
9	隔膜阀	DN25	316L	1	GEMU
10	隔膜阀	DN15	316L	1	GEMU
11	爆破片	0.5-4bar	316L	1	FIKE
12	疏水器	DN20	不锈钢	1	Spirax Sarco

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第22页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

13	卡接头	DN25	316L	3	Alfa Laval	ASME BPE-EP
14	卡接头	DN19	316L	6	Alfa Laval	ASME BPE-EP
15	卡环	DN25	304	6	Alfa Laval	ASME BPE-EP
16	卡环	DN19	304	8	Alfa Laval	ASME BPE-EP
17	密封圈	DN25	PTFE	6	Alfa Laval	ASME BPE-EP
18	密封圈	DN19	PTFE	8	Alfa Laval	ASME BPE-EP
19	变径三通	DN25/19	316L	1	Alfa Laval	ASME BPE-EP
	以上为培养基配制罐（1106）配置清单
Configuration list for PW Bank 培养基配制罐（1109）配置清单
Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Remarks 备注
1	培养基配制罐（1109）	0.5m3,压力容器,立式,带罐底阀，夹套冷却，磁力搅拌	316L	1	RiTai	内部抛光Ra<0.5um，外部亚光处理Ra<0.8um
2	呼吸器	10" 0.22um	316L	1	PALL
3	喷淋球	DN25	316L	1	Alfa Laval	旋转式
4	称重模块	4-20 mA output		1	Mettler toledo
5	温度变送器	DN25,4-20 mA output		2	CHINA
6	压力传感器	DN25,4-20 mA output		1	CHINA

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第23页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

7		气动球阀		DN25		316L			1	King Lai
8		气动球阀		DN20		316L			1	King Lai
9		隔膜阀		DN25		316L			1	GEMU
10		隔膜阀		DN15		316L			1	GEMU
11		爆破片		0.5-4bar		316L			1	FIKE
12		疏水器		DN20		不锈钢			1	Spirax Sarco
13		卡接头		DN25		316L			3	Alfa Laval	ASME BPE-EP
14		卡接头		DN19		316L			6	Alfa Laval	ASME BPE-EP
15		卡环		DN25		304			6	Alfa Laval	ASME BPE-EP
16		卡环		DN19		304			8	Alfa Laval	ASME BPE-EP
17		密封圈		DN25		PTFE			6	Alfa Laval	ASME BPE-EP
18		密封圈		DN19		PTFE			8	Alfa Laval	ASME BPE-EP
19		变径三通		DN25/19		316L			1	Alfa Laval	ASME BPE-EP
以上为培养基配制罐（1109）配置清单
Configuration list for PW Bank					缓冲液配制罐（1421）配置清单
Item	Supply Scope		Specification				Material	Quantity		Manufacturer	Remarks
序号	供货范围		规格				材料	数量		供应商	备注
1	缓冲液配制罐（1421）		0.6m3,压力容器,立式,带罐底阀，磁力搅拌，带保温				316L	1		RiTai	内部抛光Ra<0.5um，外部亚光处理Ra<0.8um

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第24页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

2	呼吸器	10" 0.22um	316L	1	PALL
3	喷淋球	DN25	316L	1	Alfa Laval	旋转式
4	称重模块	4-20 mA output		1	Mettler toledo
5	温度变送器	DN25,4-20 mA output		2	CHINA
6	压力传感器	DN25,4-20 mA output		1	CHINA
7	气动球阀	DN25	316L	1	King Lai
8	气动球阀	DN20	316L	1	King Lai
9	隔膜阀	DN25	316L	1	GEMU
10	隔膜阀	DN15	316L	1	GEMU
11	爆破片	0.5-4bar	316L	1	FIKE
12	疏水器	DN20	不锈钢	1	Spirax Sarco
13	卡接头	DN25	316L	3	Alfa Laval	ASME BPE-EP
14	卡接头	DN19	316L	6	Alfa Laval	ASME BPE-EP
15	卡环	DN25	304	6	Alfa Laval	ASME BPE-EP
16	卡环	DN19	304	8	Alfa Laval	ASME BPE-EP
17	密封圈	DN25	PTFE	6	Alfa Laval	ASME BPE-EP
18	密封圈	DN19	PTFE	8	Alfa Laval	ASME BPE-EP
19	变径三通	DN25/19	316L	1	Alfa Laval	ASME BPE-EP

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第25页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

	以上为缓冲液配制罐（1421）配置清单
Configuration list for PW Bank 缓冲液暂存罐（1301）配置清单
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Remarks
序号	供货范围	规格	材料	数量	供应商	备注
1	缓冲液暂存罐（1301）	0.6m3,压力容器,立式,带罐底阀，带保温	316L	1	RiTai	内部抛光Ra<0.5um，外部亚光处理Ra<0.8um
2	呼吸器	10" 0.22um	316L	1	PALL
3	喷淋球	DN25	316L	1	Alfa Laval	旋转式
4	温度变送器	DN25,4-20 mA output		1	CHINA
5	压力传感器	DN25,4-20 mA output		1	CHINA
6	气动球阀	DN25	316L	1	King Lai
7	气动球阀	DN20	316L	1	King Lai
8	隔膜阀	DN25	316L	1	GEMU
9	隔膜阀	DN15	316L	1	GEMU
10	爆破片	0.5-4bar	316L	1	FIKE
11	疏水器	DN20	不锈钢	1	Spirax Sarco
12	卡接头	DN25	316L	3	Alfa Laval	ASME BPE-EP
13	卡接头	DN19	316L	6	Alfa Laval	ASME BPE-EP

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第26页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

14		卡环		DN25		304			6	Alfa Laval	ASME BPE-EP
15		卡环		DN19		304			8	Alfa Laval	ASME BPE-EP
16		密封圈		DN25		PTFE			6	Alfa Laval	ASME BPE-EP
17		密封圈		DN19		PTFE			8	Alfa Laval	ASME BPE-EP
18		变径三通		DN25/19		316L			1	Alfa Laval	ASME BPE-EP
以上为缓冲液暂存罐（1301）配置清单及报价
Configuration list for PW Bank					培养基配制罐（2106）配置清单
Item	Supply Scope		Specification				Material	Quantity		Manufacturer	Remarks
序号	供货范围		规格				材料	数量		供应商	备注
1	培养基配制罐（2106）		1.5m3,压力容器,立式,带罐底阀，夹套冷却，磁力搅拌				316L	1		RiTai	内部抛光Ra<0.5um，外部亚光处理Ra<0.8um
2	呼吸器		10" 0.22um				316L	1		PALL
3	喷淋球		DN40				316L	1		Alfa Laval	旋转式
4	称重模块		4-20 mA output					1		Mettler toledo
5	温度变送器		DN25,4-20 mA output					2		CHINA
6	压力传感器		DN25,4-20 mA output					1		CHINA
7	气动球阀		DN25				316L	1		King Lai
8	气动球阀		DN20				316L	1		King Lai
9	隔膜阀		DN25				316L	1		GEMU

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第27页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

10	隔膜阀	DN15	316L	1	GEMU
11	爆破片	0.5-4bar	316L	1	FIKE
12	疏水器	DN20	不锈钢	1	Spirax Sarco
13	卡接头	DN25	316L	3	Alfa Laval	ASME BPE-EP
14	卡接头	DN19	316L	6	Alfa Laval	ASME BPE-EP
15	卡环	DN25	304	6	Alfa Laval	ASME BPE-EP
16	卡环	DN19	304	8	Alfa Laval	ASME BPE-EP
17	密封圈	DN25	PTFE	6	Alfa Laval	ASME BPE-EP
18	密封圈	DN19	PTFE	8	Alfa Laval	ASME BPE-EP
19	变径三通	DN25/19	316L	1	Alfa Laval	ASME BPE-EP
	以上为培养基配制罐（2106）配置清单
Configuration list for PW Bank 培养基配制罐（2109）配置清单
Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Remarks 备注
1	培养基配制罐（2109）	0.5m3,压力容器,立式,带罐底阀，夹套冷却，磁力搅拌	316L	1	RiTai	内部抛光Ra<0.5um，外部亚光处理Ra<0.8um
2	呼吸器	10 " 0.22um	316L	1	PALL
3	喷淋球	DN40	316L	1	Alfa Laval	旋转式

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第28页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

4	称重模块	4-20 mA output		1	Mettler toledo
5	温度变送器	DN25,4-20 mA output		2	CHINA
6	压力传感器	DN25,4-20 mA output		1	CHINA
7	气动球阀	DN25	316L	1	King Lai
8	气动球阀	DN20	316L	1	King Lai
9	隔膜阀	DN25	316L	1	GEMU
10	隔膜阀	DN15	316L	1	GEMU
11	爆破片	0.5-4bar	316L	1	FIKE
12	疏水器	DN20	不锈钢	1	Spirax Sarco
13	卡接头	DN25	316L	3	Alfa Laval	ASME BPE-EP
14	卡接头	DN19	316L	6	Alfa Laval	ASME BPE-EP
15	卡环	DN25	304	6	Alfa Laval	ASME BPE-EP
16	卡环	DN19	304	8	Alfa Laval	ASME BPE-EP
17	密封圈	DN25	PTFE	6	Alfa Laval	ASME BPE-EP
18	密封圈	DN19	PTFE	8	Alfa Laval	ASME BPE-EP
19	变径三通	DN25/19	316L	1	Alfa Laval	ASME BPE-EP
	以上为培养基配制罐（2109）配置清单
Configuration list for PW Bank 缓冲液配制罐（2421）配置清单

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第29页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Remarks 备注
1	缓冲液配制罐（2421）	0.6m3,压力容器,立式,带罐底阀，带保温，磁力搅拌	316L	1	RiTai	内部抛光Ra<0.5um，外部亚光处理Ra<0.8um
2	呼吸器	10 “ 0.22um	316L	1	PALL
3	喷淋球	DN40	316L	1	Alfa Laval	旋转式
4	称重模块	4-20 mA output		1	Mettler toledo
5	温度变送器	DN25,4-20 mA output		2	CHINA
6	压力传感器	DN25,4-20 mA output		1	CHINA
7	气动球阀	DN25	316L	1	King Lai
8	气动球阀	DN20	316L	1	King Lai
9	隔膜阀	DN25	316L	1	GEMU
10	隔膜阀	DN15	316L	1	GEMU
11	爆破片	0.5-4bar	316L	1	FIKE
12	疏水器	DN20	不锈钢	1	Spirax Sarco
13	卡接头	DN25	316L	3	Alfa Laval	ASME BPE-EP

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第30页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

14	卡接头	DN19	316L	6	Alfa Laval	ASME BPE-EP
15	卡环	DN25	304	6	Alfa Laval	ASME BPE-EP
16	卡环	DN19	304	8	Alfa Laval	ASME BPE-EP
17	密封圈	DN25	PTFE	6	Alfa Laval	ASME BPE-EP
18	密封圈	DN19	PTFE	8	Alfa Laval	ASME BPE-EP
19	变径三通	DN25/19	316L	1	Alfa Laval	ASME BPE-EP
	以上为缓冲液配制罐（2421）配置清单
Configuration list for PW Bank 缓冲液暂存罐（2301）配置清单
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Remarks
序号	供货范围	规格	材料	数量	供应商	备注
1	缓冲液暂存罐（2301）	0.6m3,压力容器,立式,带罐底阀，带保温	316L	1	RiTai	内部抛光Ra<0.5um，外部亚光处理Ra<0.8um
2	呼吸器	10 “ 0.22um	316L	1	PALL
3	喷淋球	DN40	316L	1	Alfa Laval	旋转式
5	温度变送器	DN25,4-20 mA output		1	CHINA
6	压力传感器	DN25,4-20 mA output		1	CHINA
7	气动球阀	DN25	316L	1	King Lai

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第31页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

8	气动球阀	DN20	316L	1	King Lai
9	隔膜阀	DN25	316L	1	GEMU
10	隔膜阀	DN15	316L	1	GEMU
11	爆破片	0.5-4bar	316L	1	FIKE
12	疏水器	DN20	不锈钢	1	Spirax Sarco
13	卡接头	DN25	316L	3	Alfa Laval	ASME BPE-PL
14	卡接头	DN19	316L	6	Alfa Laval	ASME BPE-PL
15	卡环	DN25	304	6	Alfa Laval	ASME BPE-PL
16	卡环	DN19	304	8	Alfa Laval	ASME BPE-PL
17	密封圈	DN25	PTFE	6	Alfa Laval	ASME BPE-PL
18	密封圈	DN19	PTFE	8	Alfa Laval	ASME BPE-PL
19	变径三通	DN25/19	316L	1	Alfa Laval	ASME BPE-PL
	以上为缓冲液暂存罐（2301）配置清单
Configuration list for CIP Bank   CIP 清洗罐配置清单
Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Remarks 备注
1	CIP 清洗罐	0.6m3,常压容器,立式,	316L	1	RiTai	内部抛光Ra<0.5um
2	呼吸器	10 “ 0.22um	316L	1	PALL

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第32页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

3	喷淋球	DN25	316L	1	Alfa Laval	旋转式
4	称重模块	4-20 mA output		1	Mettler toledo
5	隔膜阀	DN25	316L	1	GEMU
6	卡接头	DN25	316L	2	Alfa Laval	ISO 2037
7	卡环	DN25	304	2	Alfa Laval	ISO 2037
8	密封圈	DN25	PTFE	2	Alfa Laval	ISO 2037
	以上为CIP 清洗罐配置清单
Configuration list for CIP Bank   CIP 酸碱配制罐配置清单
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Remarks
序号	供货范围	规格	材料	数量	供应商	备注
1	CIP 酸碱罐	0.6m3,常压容器,立式,	316L	1	RiTai	保温，内部抛光Ra<0.5um
2	呼吸器	10 “ 0.22um	316L	1	PALL
3	喷淋球	DN25	316L	1	Alfa Laval	旋转式
4	隔膜阀	DN25	316L	1	GEMU
5	卡接头	DN25	316L	2	Alfa Laval	ISO 2037
6	卡环	DN25	304	2	Alfa Laval	ISO 2037
7	密封圈	DN25	PTFE	2	Alfa Laval	ISO 2037
	以上为CIP 酸碱罐配置清单

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第33页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

2.2.6. 焊点费

Welding Point Cost

Item 序号	Supply Scope 供货范围	Location 位置		Quantity 数量	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
1	配液系统		自动焊点	1312	150.00	196,800.00
2	CIP 系统		自动焊点	602	150.00	90,300.00
3	罐的安装			12		60,000.00
			总价			287,100.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第34页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

2.2.7. 系统所用辅材数量清单

Accessories List

		胶木支架（套包含连接件） Bakelite Bracket(set)			不锈钢底板（套） Stainless steel Plate (set)			穿墙套管（套） Ceiling Access Pipe(set)			固定用支架（个） V Bar carbon steel(Piece)			氩气费	钢平台	酸洗费
		数量	单价	合计	数量	单价	合计	数量	单价	合计	数量	单价	合计	价格	价格	价格
1	配料管道系统	85	45.00	3825.00	85	50.00	4250.00	14	120.00	1680.00	25	45.00	1125.00	18000.00	0.00	9000.00
2	CIP 管道系统	18	45.00	810.00	18	50.00	900.00	2	120.00	240.00	15	45.00	675.00	9000.00	180000.00	8000.00
		共计：Total		4635.00	共计：Total		5150.00	共计：Total		1920.00	共计：Total		1800.00	27000.00	180000.00	17000.00
								合计 Total：						237505.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第35页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

2.2.8. 验证服务报价

Quotation For Validation Activities

序号 No.	验证项目 Scope		报价 Quotation(RMB)
1	EPO 配制系统 EPO preparation system	DQ，TM,RA	20,000
2		FAT,SAT	15,000
3		IQ	15,000
4		OQ	25,000
6	TPO 配制系统 TPO preparation system	DQ，TM,RA	20,000
7		FAT,SAT	15,000
8		IQ	15,000
9		OQ	25,000
11	CIP 站 CIP system	DQ，TM,RA	20,000
12		FAT,SAT	15,000
13		IQ	15,000
14		OQ	25,000
11	控制系统 Automatic control system	控制系统验证Validation of control system	200,000
15	总价		425,000
	Remarks 备注：
	1) 包含本报价服务范围内的朗脉验证人员在客户现场的差旅食宿费用。 The cost of trips and living in client site are included in above price。
	2） 包含验证仪器费用。 The fee of validation instruments are included in above price.。
	3） 验证不包括系统中仪表和传感器的校准工作。 The calibration work for instruments and sensors in the systems is not validation work。
	4） 本报价有效期：3 个月内。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第36页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

3.方案二 管材管件主为NEUMO

3.1. 报价一览表

Item 序号	Scope of Supply 供货范围	Price (RMB) 价格
1	Price Breakdown for PRO Distribution System 配料系统材料清单及报价	1,706,773.92
2	Price Breakdown for CIP Distribution SystemCIP 系统材料清单及报价	1,453,306.31
3	EPO Automatic Control SystemEPO 自动化控制系统	228,195.00
3	TPO Automatic Control SystemTPO 自动化控制系统	216,195.00
4	Piping surport 辅助材料，洁净区用不锈钢支架，非洁净区用镀锌角铁	237,505.00
	Subtotal 1 for Material 材料费用	3,841,975.23
5	Welding Point Cost 焊点费用	287,100.00
6	Cost of Welding Point marking (100% of total welding point ) 20RMB /point 焊点刻码费用,100%自动焊点刻码,20元/焊点	35,880.00
7	Endoscopic Check ( 20% of total welding point ) 120 RMB /point 内窥镜检测，自动焊点的20%取样，80 元/焊点	31,104.00
8	X-ray Check ( 100% of total hand-welding point,all welded samples ) 180 RMB /point X -光检测，（100%手工焊点,所有焊样），180 元/ 焊点,	28,800.00
9	Insurance and Transportation 保险和运输	60,000.00
	Subtotal 2 for Piping fabrication 管道装配	442,884.00
11	Detail Design, Shop Drawings and As-built Drawings 详细设计，施工图纸和竣工文件	150,000.00
12	Quotation For Validation Activities 验证服务报价	425,000.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第37页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

13	COMPANY Management & Supervision 公司管理&监督	400,000.00
13	Project Management & Supervision 项目管理&监督	100,000.00
14	Commissioning 调试	50,000.00
	Subtotal 3 for Project Service 项目服务	1,125,000.00
	Subtotal 1, 2, 3,合计	5,409,859.23
	Tax 税金(主材部分开增值税，其他开工程发票）	93,022.15
	Total Price 总价	5,502,881.38

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第38页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

3.2. 分项报价清单

3.2.1. 物料系统材料清单及报价

Price Breakdown for PRO Distribution System

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格 (RMB)	Total Price 总价(RMB)
1	培养基配制罐1106	详细配置见罐清单	316L	1	RITAI		150,000.00	150,000.00
2	培养基配制罐1109	详细配置见罐清单	316L	1	RITAI		120,000.00	120,000.00
3	缓冲液配制罐1421	详细配置见罐清单	316L	1	RITAI		122,000.00	122,000.00
4	缓冲液暂存罐1301	详细配置见罐清单	316L	1	RITAI		80,000.00	80,000.00
5	气动隔膜阀	DN25	316L	13	GEMU		3,201.25	41,616.25
6	隔膜阀	DN40	316L	7	GEMU		3,538.75	24,771.25
7	隔膜阀	DN25	316L	32	GEMU		2,428.75	77,720.00
8	气动球阀	DN25	316L	4	King Lai		1,002.98	4,011.90
9	气动球阀	DN20	316L	4	King Lai		966.30	3,865.20
10	球阀	DN25	316L	4	King Lai		257.03	1,028.10
11	疏水器	DN20	316L	4	Spirax Sarco		2,875.00	11,500.00
12	过滤器	1.5T/h, 0.22um		1	PALL		12,250.00	12,250.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第39页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

13	过滤器	0.6T/h, 0.22um		3	PALL		8,125.00	24,375.00
14	温度变送器	DN20	316L	4	E+H		2,375.00	9,500.00
15	隔膜压力表	0～4kgf/cm2,1″卡箍接口	316L	8	Bright		437.50	3,500.00
16	卫生软管	DN25	PTFE	12	SAINT-GOBAIN		2,293.75	27,525.00
17	卡接头	38	316L	8	NEUMO	ASME BPE-PM,Ra≤0.5	180.46	1,443.67
18	卡接头	25	316L	110	NEUMO	ASME BPE-PM,Ra≤0.5	168.86	18,574.47
19	卡环	38	304	8	NEUMO	ASME BPE-PM,Ra≤0.5	76.08	608.66
20	卡环	25	304	118	NEUMO	ASME BPE-PM,Ra≤0.5	76.08	8,977.72
21	密封圈	38	PTFE	8	NEUMO	ASME BPE-PM,Ra≤0.5	16.08	128.66
22	密封圈	25	PTFE	118	NEUMO	ASME BPE-PM,Ra≤0.5	14.69	1,733.91
23	焊接三通	DN25	316L	28	NEUMO	ASME BPE-PM,Ra≤0.5	204.56	5,727.81
24	焊接四通	DN25	316L	7	NEUMO	ASME BPE-PM,Ra≤0.5	1,206.54	8,445.79
25	90°弯头	38	316L	6	NEUMO	ASME BPE-PM,Ra≤0.5	244.32	1,465.91
26	90°弯头	25	316L	90	NEUMO	ASME BPE-PM,Ra≤0.5	197.93	17,813.65
27	管道	φ38	316L	6	NEUMO	ASME BPE-PM,Ra≤0.5	463.75	2,782.52
28	管道	φ25	316L	138	NEUMO	ASME BPE-PM,Ra≤0.5	362.89	50,079.39
29	卡接头	38	316L	16	Alfa Laval	ISO 2037,Ra≤0.5	59.28	948.52
30	卡接头	25	316L	18	Alfa Laval	ISO 2037,Ra≤0.5	48.04	864.64

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第40页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

31	卡接头	19	316L	20	Alfa Laval	ISO 2037,Ra≤0.5	47.40	948.00
32	卡环	38	304	16	Alfa Laval	ISO 2037,Ra≤0.5	49.56	793.04
33	卡环	25	304	18	Alfa Laval	ISO 2037,Ra≤0.5	49.56	892.16
34	卡环	19	304	20	Alfa Laval	ISO 2037,Ra≤0.5	95.79	1,915.76
35	密封圈	38	PTFE	16	Alfa Laval	ISO 2037,Ra≤0.5	41.88	670.12
36	密封圈	25	PTFE	18	Alfa Laval	ISO 2037,Ra≤0.5	46.51	837.11
37	密封圈	19	PTFE	20	Alfa Laval	ISO 2037,Ra≤0.5	37.12	742.35
38	三通	DN38	316L	2	Alfa Laval	ISO 2037,Ra≤0.5	87.88	175.76
39	三通	DN25	316L	4	Alfa Laval	ISO 2037,Ra≤0.5	65.08	260.33
40	异径三通	DN25/19	316L	4	Alfa Laval	ISO 2037,Ra≤0.5	81.60	326.40
41	三通	DN19	316L	4	Alfa Laval	ISO 2037,Ra≤0.5	262.44	1,049.74
42	90°弯头	38	316L	12	Alfa Laval	ISO 2037,Ra≤0.5	34.26	411.11
43	90°弯头	25	316L	16	Alfa Laval	ISO 2037,Ra≤0.5	26.95	431.25
44	90°弯头	19	316L	12	Alfa Laval	ISO 2037,Ra≤0.5	220.33	2,643.95
45	管道	φ38	316L	36	Alfa Laval	ISO 2037,Ra≤0.5	178.44	6,423.67
46	管道	φ25	316L	12	Alfa Laval	ISO 2037,Ra≤0.5	125.53	1,506.35
47	管道	φ19	316L	12	Alfa Laval	ISO 2037,Ra≤0.5	102.22	1,226.68
一、	以上为EPO 工艺管线管材、管件配置及安装报价							854,511.78

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第41页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

1	培养基配制罐2106	详细配置见罐清单	316L	1	RITAI		150,000.00	150,000.00
2	培养基配制罐2109	详细配置见罐清单	316L	1	RITAI		120,000.00	120,000.00
3	缓冲液配制罐2421	详细配置见罐清单	316L	1	RITAI		122,000.00	122,000.00
4	缓冲液暂存罐2301	详细配置见罐清单	316L	1	RITAI		80,000.00	80,000.00
5	气动隔膜阀	DN25	316L	13	GEMU		3,201.25	41,616.25
6	隔膜阀	DN40	316L	7	GEMU		3,538.75	24,771.25
7	隔膜阀	DN25	316L	32	GEMU		2,428.75	77,720.00
8	气动球阀	DN25	316L	4	King Lai		1,002.98	4,011.90
9	气动球阀	DN20	316L	4	King Lai		966.30	3,865.20
10	球阀	DN25	316L	4	King Lai		257.03	1,028.10
11	疏水器	DN20	316L	4	Spirax Sarco		2,875.00	11,500.00
12	过滤器	1.5T/h, 0.22um		1	PALL		12,250.00	12,250.00
13	过滤器	0.6T/h, 0.22um		3	PALL		8,125.00	24,375.00
14	温度变送器	DN20	316L	4	E+H		2,375.00	9,500.00
15	隔膜压力表	0～4kgf/cm2,1″卡箍接口	316L	8	WIKA		437.50	3,500.00
16	卫生软管	DN25	PTFE	12	SAINT-GOBAIN		2,293.75	27,525.00
17	卡接头	38	316L	8	NEUMO	ASME BPE-PM,Ra≤0.5	180.46	1,443.67
18	卡接头	25	316L	110	NEUMO	ASME BPE-PM,Ra≤0.5	168.86	18,574.47

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第42页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

19	卡环	38	304	8	NEUMO	ASME BPE-PM,Ra≤0.5	76.08	608.66
20	卡环	25	304	118	NEUMO	ASME BPE-PM,Ra≤0.5	76.08	8,977.72
21	密封圈	38	PTFE	8	NEUMO	ASME BPE-PM,Ra≤0.5	16.08	128.66
22	密封圈	25	PTFE	118	NEUMO	ASME BPE-PM,Ra≤0.5	14.69	1,733.91
23	焊接三通	DN25	316L	28	NEUMO	ASME BPE-PM,Ra≤0.5	204.56	5,727.81
24	焊接四通	DN25	316L	7	NEUMO	ASME BPE-PM,Ra≤0.5	1,206.54	8,445.79
25	90°弯头	38	316L	6	NEUMO	ASME BPE-PM,Ra≤0.5	244.32	1,465.91
26	90°弯头	25	316L	90	NEUMO	ASME BPE-PM,Ra≤0.5	197.93	17,813.65
27	管道	φ38	316L	6	NEUMO	ASME BPE-PM,Ra≤0.5	463.75	2,782.52
28	管道	φ25	316L	120	NEUMO	ASME BPE-PM,Ra≤0.5	362.89	43,547.29
29	卡接头	38	316L	16	Alfa Laval	ISO 2037,Ra≤0.5	59.28	948.52
30	卡接头	25	316L	18	Alfa Laval	ISO 2037,Ra≤0.5	48.04	864.64
31	卡接头	19	316L	20	Alfa Laval	ISO 2037,Ra≤0.5	47.40	948.00
32	卡环	38	304	16	Alfa Laval	ISO 2037,Ra≤0.5	49.56	793.04
33	卡环	25	304	18	Alfa Laval	ISO 2037,Ra≤0.5	49.56	892.16
34	卡环	19	304	20	Alfa Laval	ISO 2037,Ra≤0.5	95.79	1,915.76
35	密封圈	38	PTFE	16	Alfa Laval	ISO 2037,Ra≤0.5	41.88	670.12
36	密封圈	25	PTFE	18	Alfa Laval	ISO 2037,Ra≤0.5	46.51	837.11
37	密封圈	19	PTFE	20	Alfa Laval	ISO 2037,Ra≤0.5	37.12	742.35

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第43页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

38	三通	DN38	316L	2	Alfa Laval	ISO 2037,Ra≤0.5	87.88	175.76
39	三通	DN25	316L	4	Alfa Laval	ISO 2037,Ra≤0.5	65.08	260.33
40	异径三通	DN25/19	316L	4	Alfa Laval	ISO 2037,Ra≤0.5	81.60	326.40
41	三通	DN19	316L	4	Alfa Laval	ISO 2037,Ra≤0.5	262.44	1,049.74
42	90°弯头	38	316L	12	Alfa Laval	ISO 2037,Ra≤0.5	34.26	411.11
43	90°弯头	25	316L	16	Alfa Laval	ISO 2037,Ra≤0.5	26.95	431.25
44	90°弯头	19	316L	12	Alfa Laval	ISO 2037,Ra≤0.5	220.33	2,643.95
45	管道	φ38	316L	60	Alfa Laval	ISO 2037,Ra≤0.5	178.44	10,706.12
46	管道	φ25	316L	12	Alfa Laval	ISO 2037,Ra≤0.5	125.53	1,506.35
47	管道	φ19	316L	12	Alfa Laval	ISO 2037,Ra≤0.5	102.22	1,226.68
二、	以上为TPO 工艺管线管材、管件配置及安装报价							852,262.14
	以上为工艺配料洁净管道系统管材，管件配置清单及报价							1,706,773.92

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第44页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

3.2.2. CIP 站材料清单及报价

Price Breakdown for CIP Distribution System

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格 (RMB)	Total Price 总价(RMB)
1	CIP 清洗罐	详细配置见罐清单	316L	1	RITAI		95,000.00	95,000.00
2	CIP 酸碱罐	详细配置见罐清单	316L	1	RITAI		79,000.00	79,000.00
3	气动球阀	DN40	316L	1	King Lai		1,280.80	1,280.80
4	气动隔膜阀	DN40	316L	15	GEMU		4,668.75	70,031.25
5	气动隔膜阀	DN25	316L	8	GEMU		3,201.25	25,610.00
6	隔膜阀	DN40	316L	2	GEMU		3,538.75	7,077.50
7	板式换热器一套	0.5m3,循环加热0.5 小时， 40-80ºC	316L	4	Alfa Laval		33,750.00	135,000.00
8	温度变送器	DN20	316L	2	E+H		2,375.00	4,750.00
9	隔膜压力表	0～4kgf/cm2 1″卡箍接口	316L	1	CHINA		437.50	437.50
10	压力传感器	0～4kgf/cm2 1″卡箍接口	316L	1	CHINA		1,500.00	1,500.00
11	卫生离心泵	5T/h, 32m	316L	1	Alfa Laval		26,500.00	26,500.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第45页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

12	CIP 回流泵	8T/h, 25m	316L	3	Alfa Laval		62,500.00	187,500.00
13	酸碱计量泵	0.1T/h, 18m	316L	1	Prominent		33,125.00	33,125.00
14	电导率仪	4-20 mA output		1	Mettler toledo		14,000.00	14,000.00
15	PH 计	4-20 mA output		1	Mettler toledo		14,625.00	14,625.00
16	卡接头	63.5	316L	1	Alfa Laval	ISO 2037,Ra≤0.5	79.01	79.01
17	卡接头	51	316L	1	Alfa Laval	ISO 2037,Ra≤0.5	62.67	62.67
18	卡接头	38	316L	36	Alfa Laval	ISO 2037,Ra≤0.5	59.28	2,134.16
19	卡接头	25	316L	18	Alfa Laval	ISO 2037,Ra≤0.5	48.04	864.64
20	卡环	63.5	304	1	Alfa Laval	ISO 2037,Ra≤0.5	72.04	72.04
21	卡环	51	304	1	Alfa Laval	ISO 2037,Ra≤0.5	58.72	58.72
22	卡环	38	304	38	Alfa Laval	ISO 2037,Ra≤0.5	49.56	1,883.46
23	卡环	25	304	24	Alfa Laval	ISO 2037,Ra≤0.5	49.56	1,189.55
24	密封圈	63.5	PTFE	1	Alfa Laval	ISO 2037,Ra≤0.5	53.38	53.38
25	密封圈	51	PTFE	1	Alfa Laval	ISO 2037,Ra≤0.5	46.51	46.51
26	密封圈	38	PTFE	38	Alfa Laval	ISO 2037,Ra≤0.5	41.88	1,591.53
27	密封圈	25	PTFE	24	Alfa Laval	ISO 2037,Ra≤0.5	46.51	1,116.14
28	三通	DN38	316L	18	Alfa Laval	ISO 2037,Ra≤0.5	65.08	1,171.48
29	异径三通	DN38/25	316L	10	Alfa Laval	ISO 2037,Ra≤0.5	100.27	1,002.71
30	90°弯头	38	316L	46	Alfa Laval	ISO 2037,Ra≤0.5	34.26	1,575.91

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第46页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

31	90°弯头	25	316L	16	Alfa Laval	ISO 2037,Ra≤0.5	26.95	431.25
32	管道	φ38	316L	96	Alfa Laval	ISO 2037,Ra≤0.5	178.44	17,129.79
33	管道	φ25	316L	6	Alfa Laval	ISO 2037,Ra≤0.5	125.53	753.18
一、	以上为CIP 清洗站管材、管件配置及报价							726,653.16
	两套合计							1,453,306.31

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第47页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

3.2.3. EPO 线配液控制系统报价

Quotation for Control System

序号 Item	供货范围 Scope of Supply	订货号 Order No.	规格 型号 Specification	厂家 Manufacturer	数量 Quantity	单价(RMB)   Unit Price	价格(RMB) Price
1	导轨	6ES7 390-1AF30-0AA0	标准导轨 530mm	SIEMENS	2	228.00	456.00
2	电源	6ES7 307-1EA00-0AA0	PS 307 电源 5 A	SIEMENS	2	988.00	1976.00
3	CPU	6ES7 315-2EH13-0AB0	315-2 PN/DP 256KB RAM； MPI/PROFIBUS DP；PROFINET 接口	SIEMENS	1	13227.00	13227.00
4	扩展卡	6ES7 953-8LF11-0AA0	MMC 64 kB	SIEMENS	1	380.00	380.00
5	接口模块	6ES7 365-0BA01-0AA0	IM365 接口模块	SIEMENS	1	838.00	838.00
6	DI 模块	6ES7 321-1BH02-0AA0	16 点数字输入24V DC(20 针)	SIEMENS	1	1013.00	1013.00
7	DO 模块	6ES7 322-1BH01-0AA0	16 点数字输出24V DC(20 针)	SIEMENS	5	1409.00	7045.00
8	AI 模块	6ES7 331-7KF02-0AB0	8 通道模拟输入(20 针)	SIEMENS	4	3899.00	15596.00
9	AO 模块	6ES7 332-5HF00-0AB0	8 通道模拟输出(40 针)	SIEMENS	1	6065.00	6065.00
10	连接端子	6ES7 392-1AJ00-0AA0	20 针，螺钉型端子	SIEMENS	10	149.00	1490.00
11	连接端子	6ES7 392-1AM00-0AA0	40 针，螺钉型端子	SIEMENS	1	234.00	234.00
12	变频器		MM420 1.5KW	SIEMENS	4	2400.00	9600.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第48页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

13	变频器操作面板	6SE6 400-0BP00-0AA0	BOP 面板	SIEMENS	4	300.00	1200.00
14	开关电源	6EP1 334-3BA00	SITOP 24V/10A	SIEMENS	1	1500.00	1500.00
15	控制柜		2000×800× 600(含继电器、端子等柜内电气元件)	shanghai	1	14000.00	14000.00
16	控制箱		壁挂式（含按钮、端子等柜内电气元件）	shanghai	1	5000.00	5000.00
17	触摸屏	6AV6 643-0CD01-1AX1	MP 277 10" Touch 64K 颜色	SIEMENS	3	12000.00	36000.00
18	交换机	6 RJ45 口	工业以太网交换机	MOXA	1	1200.00	1200.00
19	网线		超五类双绞线	安普	100	5.00	500.00
20	电缆		RVV 2*1.0（米）	WUXI	4000	3.00	12000.00
21	电缆		RVVp 2*1.0（ 米）	WUXI	2000	4.00	8000.00
22	电缆		RVVP3*6+1（ 米）	WUXI	300	33.75	10125.00
23	桥架		150*75（米）	WUXI	200	68.75	13750.00
一、	控制系统所用材料					161195.00
二、	编程费 Programme Cost（1 人30 个工作日）					20000.00
三、	安装费用（3人10 个工作日）					15000.00
四、	调试费 Commissioning Cost（2 人10 个工作日，含住宿交通等）					32000.00
	总价 Total Price（RMB） :贰拾贰万捌仟壹佰玖拾伍 圆整					228195.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第49页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

3.2.4. TPO 配液控制系统报价

Quotation for Control System

序号 Item	供货范围 Scope of Supply	订货号 Order No.	规格 型号 Specification	厂家 Manufacturer	数量 Quantity	单价(RMB)   Unit Price	价格(RMB) Price
1	导轨	6ES7 390-1AF30-0AA0	标准导轨 530mm	SIEMENS	2	228.00	456.00
2	电源	6ES7 307-1EA00-0AA0	PS 307 电源 5 A	SIEMENS	2	988.00	1976.00
3	CPU	6ES7 315-2EH13-0AB0	315-2 PN/DP 256KB RAM； MPI/PROFIBUS DP；PROFINET 接口	SIEMENS	1	13227.00	13227.00
4	扩展卡	6ES7 953-8LF11-0AA0	MMC 64 kB	SIEMENS	1	380.00	380.00
5	接口模块	6ES7 365-0BA01-0AA0	IM365 接口模块	SIEMENS	1	838.00	838.00
6	DI 模块	6ES7 321-1BH02-0AA0	16 点数字输入24V DC(20 针)	SIEMENS	1	1013.00	1013.00
7	DO 模块	6ES7 322-1BH01-0AA0	16 点数字输出24V DC(20 针)	SIEMENS	5	1409.00	7045.00
8	AI 模块	6ES7 331-7KF02-0AB0	8 通道模拟输入(20 针)	SIEMENS	4	3899.00	15596.00
9	AO 模块	6ES7 332-5HF00-0AB0	8 通道模拟输出(40 针)	SIEMENS	1	6065.00	6065.00
10	连接端子	6ES7 392-1AJ00-0AA0	20 针，螺钉型端子	SIEMENS	10	149.00	1490.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第50页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

11	连接端子	6ES7 392-1AM00-0AA0	40 针，螺钉型端子	SIEMENS	1	234.00	234.00
12	变频器		MM420 1.5KW	SIEMENS	4	2400.00	9600.00
13	变频器操作面板	6SE6 400-0BP00-0AA0	BOP 面板	SIEMENS	4	300.00	1200.00
14	开关电源	6EP1 334-3BA00	SITOP 24V/10A	SIEMENS	1	1500.00	1500.00
15	控制柜		2000×800× 600(含继电器、端子等柜内电气元件)	shanghai	1	14000.00	14000.00
16	控制箱		壁挂式（含按钮、端子等柜内电气元件）	shanghai	1	5000.00	5000.00
17	触摸屏	6AV6 643-0CD01-1AX1	MP 277 10" Touch 64K 颜色	SIEMENS	2	12000.00	24000.00
18	交换机	6 RJ45 口	工业以太网交换机	MOXA	1	1200.00	1200.00
19	网线		超五类双绞线	安普	100	5.00	500.00
20	电缆		RVV 2*1.0（米）	WUXI	4000	3.00	12000.00
21	电缆		RVVp 2*1.0（ 米）	WUXI	2000	4.00	8000.00
22	电缆		RVVP3*6+1（ 米）	WUXI	300	33.75	10125.00
23	桥架		150*75（米）	WUXI	200	68.75	13750.00
一、	控制系统所用材料					149195.00
二、	编程费 Programme Cost（1 人30 个工作日）					20000.00
三、	安装费用（3人10 个工作日）					15000.00
四、	调试费 Commissioning Cost（2 人10 个工作日，含住宿交通等）					32000.00
	总价 Total Price（RMB） :贰拾壹万陆仟壹佰玖拾伍 圆整					216195.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第51页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

3.2.5. 罐体

Configuration list for Bank

Configuration list for PW Bank
培养基配制罐（1106）配置清单
Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Remarks 备注
1	培养基配制罐（1106）	1.5m3,压力容器,立式,带罐底阀， 夹套冷却，磁力搅拌	316L	1	RiTai	内部抛光Ra<0.5um， 外部亚光处理 Ra<0.8um
2	呼吸器	10 “ 0.22um	316L	1	PALL
3	喷淋球	DN25	316L	1	Alfa Laval	旋转式
4	称重模块	4-20 mA output		1	Mettler toledo
5	温度变送器	DN25,4-20 mA output		2	CHINA
6	压力传感器	DN25,4-20 mA output		1	CHINA
7	气动球阀	DN25	316L	1	King Lai
8	气动球阀	DN20	316L	1	King Lai
9	隔膜阀	DN25	316L	1	GEMU
10	隔膜阀	DN15	316L	1	GEMU

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第52页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

11	爆破片	0.5-4bar	316L	1	FIKE
12	疏水器	DN20	不锈钢	1	Spirax Sarco
13	卡接头	DN25	316L	3	NEUMO	ASME BPE-EP
14	卡接头	DN19	316L	6	NEUMO	ASME BPE-EP
15	卡环	DN25	304	6	NEUMO	ASME BPE-EP
16	卡环	DN19	304	8	NEUMO	ASME BPE-EP
17	密封圈	DN25	PTFE	6	NEUMO	ASME BPE-EP
18	密封圈	DN19	PTFE	8	NEUMO	ASME BPE-EP
19	变径三通	DN25/19	316L	1	NEUMO	ASME BPE-EP
	以上为培养基配制罐（1106）配置清单
Configuration list for PW Bank
培养基配制罐（1109）配置清单
Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Remarks 备注
1	培养基配制罐（1109）	0.5m3,压力容器,立式,带罐底阀，夹套冷却，磁力搅拌	316L	1	RiTai	内部抛光Ra<0.5um， 外部亚光处理Ra<0.8um
2	呼吸器	10 “ 0.22um	316L	1	PALL

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第53页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

3	喷淋球	DN25	316L	1	Alfa Laval	旋转式
4	称重模块	4-20 mA output		1	Mettler toledo
5	温度变送器	DN25,4-20 mA output		2	CHINA
6	压力传感器	DN25,4-20 mA output		1	CHINA
7	气动球阀	DN25	316L	1	King Lai
8	气动球阀	DN20	316L	1	King Lai
9	隔膜阀	DN25	316L	1	GEMU
10	隔膜阀	DN15	316L	1	GEMU
11	爆破片	0.5-4bar	316L	1	FIKE
12	疏水器	DN20	不锈钢	1	Spirax Sarco
13	卡接头	DN25	316L	3	NEUMO	ASME BPE-EP
14	卡接头	DN19	316L	6	NEUMO	ASME BPE-EP
15	卡环	DN25	304	6	NEUMO	ASME BPE-EP
16	卡环	DN19	304	8	NEUMO	ASME BPE-EP
17	密封圈	DN25	PTFE	6	NEUMO	ASME BPE-EP
18	密封圈	DN19	PTFE	8	NEUMO	ASME BPE-EP
19	变径三通	DN25/19	316L	1	NEUMO	ASME BPE-EP
	以上为培养基配制罐（1109）配置清单

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第54页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

Configuration list for PW Bank
缓冲液配制罐（1421）配置清单
Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Remarks 备注
1	缓冲液配制罐（1421）	0.6m3,压力容器,立式,带罐底阀，磁力搅拌，带保温	316L	1	RiTai	内部抛光Ra<0.5um， 外部亚光处理Ra<0.8um
2	呼吸器	10 “ 0.22um	316L	1	PALL
3	喷淋球	DN25	316L	1	Alfa Laval	旋转式
4	称重模块	4-20 mA output		1	Mettler toledo
5	温度变送器	DN25,4-20 mA output		2	CHINA
6	压力传感器	DN25,4-20 mA output		1	CHINA
7	气动球阀	DN25	316L	1	King Lai
8	气动球阀	DN20	316L	1	King Lai
9	隔膜阀	DN25	316L	1	GEMU
10	隔膜阀	DN15	316L	1	GEMU
11	爆破片	0.5-4bar	316L	1	FIKE
12	疏水器	DN20	不锈钢	1	Spirax Sarco
13	卡接头	DN25	316L	3	NEUMO	ASME BPE-EP

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第55页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

14	卡接头	DN19	316L	6	NEUMO	ASME BPE-EP
15	卡环	DN25	304	6	NEUMO	ASME BPE-EP
16	卡环	DN19	304	8	NEUMO	ASME BPE-EP
17	密封圈	DN25	PTFE	6	NEUMO	ASME BPE-EP
18	密封圈	DN19	PTFE	8	NEUMO	ASME BPE-EP
19	变径三通	DN25/19	316L	1	NEUMO	ASME BPE-EP
	以上为缓冲液配制罐（1421）配置清单
Configuration list for PW Bank
缓冲液暂存罐（1301）配置清单
Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Remarks 备注
1	缓冲液暂存罐（1301）	0.6m3,压力容器,立式,带罐底阀，带保温	316L	1	RiTai	内部抛光Ra<0.5um， 外部亚光处理Ra<0.8um
2	呼吸器	10 “ 0.22um	316L	1	PALL
3	喷淋球	DN25	316L	1	Alfa Laval	旋转式
4	温度变送器	DN25,4-20 mA output		1	CHINA
5	压力传感器	DN25,4-20 mA output		1	CHINA
6	气动球阀	DN25	316L	1	King Lai

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第56页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

7	气动球阀	DN20	316L	1	King Lai
8	隔膜阀	DN25	316L	1	GEMU
9	隔膜阀	DN15	316L	1	GEMU
10	爆破片	0.5-4bar	316L	1	FIKE
11	疏水器	DN20	不锈钢	1	Spirax Sarco
12	卡接头	DN25	316L	3	NEUMO	ASME BPE-PL
13	卡接头	DN19	316L	6	NEUMO	ASME BPE-PL
14	卡环	DN25	304	6	NEUMO	ASME BPE-PL
15	卡环	DN19	304	8	NEUMO	ASME BPE-PL
16	密封圈	DN25	PTFE	6	NEUMO	ASME BPE-PL
17	密封圈	DN19	PTFE	8	NEUMO	ASME BPE-PL
18	变径三通	DN25/19	316L	1	NEUMO	ASME BPE-PL
	以上为缓冲液暂存罐（1301）配置清单及报价
Configuration list for PW Bank
培养基配制罐（2106）配置清单
Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity  数量	Manufacturer 供应商	Remarks 备注
1	培养基配制罐（2106）	1 .5m3,压力容器,立式,带罐底阀，夹	316L	1	RiTai	内部抛光Ra<0.5um， 外

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第57页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

		套冷却，磁力搅拌				部亚光处理Ra<0.8um
2	呼吸器	10 “ 0.22um	316L	1	PALL
3	喷淋球	DN40	316L	1	Alfa Laval	旋转式
4	称重模块	4-20 mA output		1	Mettler toledo
5	温度变送器	DN25,4-20 mA output		2	CHINA
6	压力传感器	DN25,4-20 mA output		1	CHINA
7	气动球阀	DN25	316L	1	King Lai
8	气动球阀	DN20	316L	1	King Lai
9	隔膜阀	DN25	316L	1	GEMU
10	隔膜阀	DN15	316L	1	GEMU
11	爆破片	0.5-4bar	316L	1	FIKE
12	疏水器	DN20	不锈钢	1	Spirax Sarco
13	卡接头	DN25	316L	3	NEUMO	ASME BPE-EP
14	卡接头	DN19	316L	6	NEUMO	ASME BPE-EP
15	卡环	DN25	304	6	NEUMO	ASME BPE-EP
16	卡环	DN19	304	8	NEUMO	ASME BPE-EP
17	密封圈	DN25	PTFE	6	NEUMO	ASME BPE-EP
18	密封圈	DN19	PTFE	8	NEUMO	ASME BPE-EP

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第58页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

19	变径三通	DN25/19	316L	1	NEUMO	ASME BPE-EP
	以上为培养基配制罐（2106）配置清单
Configuration list for PW Bank
培养基配制罐（2109）配置清单
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Remarks
序号	供货范围	规格	材料	数量	供应商	备注
1	培养基配制罐（2109）	0.5m3,压力容器,立式,带罐底阀，夹套冷却，磁力搅拌	316L	1	RiTai	内部抛光Ra<0.5um， 外部亚光处理Ra<0.8um
2	呼吸器	10“ 0.22um	316L	1	PALL
3	喷淋球	DN40	316L	1	Alfa Laval	旋转式
4	称重模块	4-20 mA output		1	Mettler toledo
5	温度变送器	DN25,4-20 mA output		2	CHINA
6	压力传感器	DN25,4-20 mA output		1	CHINA
7	气动球阀	DN25	316L	1	King Lai
8	气动球阀	DN20	316L	1	King Lai
9	隔膜阀	DN25	316L	1	GEMU
10	隔膜阀	DN15	316L	1	GEMU
11	爆破片	0.5-4bar	316L	1	FIKE

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第59页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

12	疏水器	DN20	不锈钢	1	Spirax Sarco
13	卡接头	DN25	316L	3	NEUMO	ASME BPE-EP
14	卡接头	DN19	316L	6	NEUMO	ASME BPE-EP
15	卡环	DN25	304	6	NEUMO	ASME BPE-EP
16	卡环	DN19	304	8	NEUMO	ASME BPE-EP
17	密封圈	DN25	PTFE	6	NEUMO	ASME BPE-EP
18	密封圈	DN19	PTFE	8	NEUMO	ASME BPE-EP
19	变径三通	DN25/19	316L	1	NEUMO	ASME BPE-EP
	以上为培养基配制罐（2109）配置清单
Configuration list for PW Bank 缓冲液配制罐（2421）配置清单
Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Remarks 备注
1	缓冲液配制罐（2421）	0.6m3,压力容器,立式,带罐底阀，带保温，磁力搅拌	316L	1	RiTai	内部抛光Ra<0.5um， 外部亚光处理Ra<0.8um
2	呼吸器	10 “ 0.22um	316L	1	PALL
3	喷淋球	DN40	316L	1	Alfa Laval	旋转式
4	称重模块	4-20 mA output		1	Mettler toledo

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第60页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

5	温度变送器	DN25,4-20 mA output		2	CHINA
6	压力传感器	DN25,4-20 mA output		1	CHINA
7	气动球阀	DN25	316L	1	King Lai
8	气动球阀	DN20	316L	1	King Lai
9	隔膜阀	DN25	316L	1	GEMU
10	隔膜阀	DN15	316L	1	GEMU
11	爆破片	0.5-4bar	316L	1	FIKE
12	疏水器	DN20	不锈钢	1	Spirax Sarco
13	卡接头	DN25	316L	3	NEUMO	ASME BPE-EP
14	卡接头	DN19	316L	6	NEUMO	ASME BPE-EP
15	卡环	DN25	304	6	NEUMO	ASME BPE-EP
16	卡环	DN19	304	8	NEUMO	ASME BPE-EP
17	密封圈	DN25	PTFE	6	NEUMO	ASME BPE-EP
18	密封圈	DN19	PTFE	8	NEUMO	ASME BPE-EP
19	变径三通	DN25/19	316L	1	NEUMO	ASME BPE-EP
	以上为缓冲液配制罐（2421）配置清单
Configuration list for PW Bank
缓冲液暂存罐（2301）配置清单

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第61页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Remarks 备注
1	缓冲液暂存罐（2301）	0.6m3,压力容器,立式,带罐底阀，带保温	316L	1	RiTai	内部抛光Ra<0.5um， 外部亚光处理Ra<0.8um
2	呼吸器	10“ 0.22um	316L	1	PALL
3	喷淋球	DN40	316L	1	Alfa Laval	旋转式
5	温度变送器	DN25,4-20 mA output		1	CHINA
6	压力传感器	DN25,4-20 mA output		1	CHINA
7	气动球阀	DN25	316L	1	King Lai
8	气动球阀	DN20	316L	1	King Lai
9	隔膜阀	DN25	316L	1	GEMU
10	隔膜阀	DN15	316L	1	GEMU
11	爆破片	0.5-4bar	316L	1	FIKE
12	疏水器	DN20	不锈钢	1	Spirax Sarco
13	卡接头	DN25	316L	3	NEUMO	ASME BPE-PL
14	卡接头	DN19	316L	6	NEUMO	ASME BPE-PL
15	卡环	DN25	304	6	NEUMO	ASME BPE-PL
16	卡环	DN19	304	8	NEUMO	ASME BPE-PL
17	密封圈	DN25	PTFE	6	NEUMO	ASME BPE-PL

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第62页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

18	密封圈	DN19	PTFE	8	NEUMO	ASME BPE-PL
19	变径三通	DN25/19	316L	1	NEUMO	ASME BPE-PL
	以上为缓冲液暂存罐（2301）配置清单

Configuration list for  CIP Bank
CIP 清洗罐配置清单
Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Remarks
序号	供货范围	规格	材料	数量	供应商	备注
1	CIP 清洗罐	0.6m3,常压容器,立式,	316L	1	RiTai	内部抛光Ra<0.5um
2	呼吸器	10“ 0.22um	316L	1	PALL
3	喷淋球	DN25	316L	1	Alfa Laval	旋转式
4	称重模块	4-20 mA output		1	Mettler toledo
5	隔膜阀	DN25	316L	1	GEMU
6	卡接头	DN25	316L	2	Alfa Laval	ISO 2037
7	卡环	DN25	304	2	Alfa Laval	ISO 2037
8	密封圈	DN25	PTFE	2	Alfa Laval	ISO 2037
	以上为CIP 清洗罐配置清单
Configuration list for  CIP Bank
CIP 酸碱配制罐配置清单

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第63页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Remarks 备注
1	CIP 酸碱罐	0.6m3,常压容器,立式,	316L	1	RiTai	保温，内部抛光Ra<0.5um
2	呼吸器	10 “ 0.22um	316L	1	PALL
3	喷淋球	DN25	316L	1	Alfa Laval	旋转式
4	隔膜阀	DN25	316L	1	GEMU
5	卡接头	DN25	316L	2	Alfa Laval	ISO 2037
6	卡环	DN25	304	2	Alfa Laval	ISO 2037
7	密封圈	DN25	PTFE	2	Alfa Laval	ISO 2037
	以上为CIP 酸碱罐配置清单

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第64页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

3.2.6. 焊点费

Welding Point Cost

Item 序号	Supply Scope 供货范围	Location 位置		Quantity 数量	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
1	配液系统		自动焊点	1312	150.00	196,800.00
2	CIP 系统		自动焊点	602	150.00	90,300.00
3	罐的安装			12		60,000.00
			总价			287,100.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第65页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

3.2.7. 系统所用辅材数量清单

Accessories List

		胶木支架（套包含连接件） Bakelite Bracket(set)			不锈钢底板（套） Stainless steel Plate (set)			穿墙套管（套） Ceiling Access Pipe(set)			固定用支架（个） V Bar carbon steel(Piece)			氩气费	钢平台	酸洗费
		数量	单价	合计	数量	单价	合计	数量	单价	合计	数量	单价	合计	价格	价格	价格
1	配料管道系统	85	45.00	3825.00	85	50.00	4250.00	14	120.00	1680.00	25	45.00	1125.00	18000.00	0.00	9000.00
2	CIP 管道系统	18	45.00	810.00	18	50.00	900.00	2	120.00	240.00	15	45.00	675.00	9000.00	180000.00	8000.00
		共计：Total		4635.00	共计：Total		5150.00	共计：Total		1920.00	共计：Total		1800.00	27000.00	180000.00	17000.00
								合计 Total：						237505.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第66页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

3.2.8. 验证服务报价

Quotation For Validation Activities

序号 No.	验证项目 Scope		报价 Quotation(RMB)
1	EPO 配制系统 EPO preparation system	DQ，TM,RA	20,000
2		FAT,SAT	15,000
3		IQ	15,000
4		OQ	25,000
6	TPO 配制系统 TPO preparation system	DQ，TM,RA	20,000
7		FAT,SAT	15,000
8		IQ	15,000
9		OQ	25,000
11	CIP 站 CIP system	DQ，TM,RA	20,000
12		FAT,SAT	15,000
13		IQ	15,000
14		OQ	25,000
11	控制系统 Automatic control system	控制系统验证Validation of control system	200,000
15	总价		425,000
	Remarks 备注：
	1) 包含本报价服务范围内的朗脉验证人员在客户现场的差旅食宿费用。 The cost of trips and living in client site are included in above price。
	2） 包含验证仪器费用。 The fee of validation instruments are included in above price.。
	3） 验证不包括系统中仪表和传感器的校准工作。 The calibration work for instruments and sensors in the systems is not validation work。
	4） 本报价有效期：3 个月内。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第67页/ 共67 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

第 2 部分

Part 2

公司介绍及资质文件

Company introduction and Certificate

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

上海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

T:021 54306717      F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

目 录

Index

1. 资质证明文件Certificate	3
1.1. 资质证书Certificate	3
1.1.1. 营业执照复印件Business license	3
1.1.2. 组织机构代码证Organization code certificate	4
1.1.3. 税务登记证Business Registration	5
1.1.4. 银行开户证明The opening of bank accounts permits	6
1.1.5. 代理证书Agency	7
1.1.6. 协会证书CAPE Certificate	13
1.2. 部分业绩Part reference	14
1.2.1. 部分竣工项目一览表 Part finished project List	14
1.2.2. 部分在建同类工程一览表 Part constructing project List	19
1.3. 2007 年财务报表Financial statement	20
2. 公司介绍Company Introduction	21
2.1. 公司概述Brief introduction	21
2.1.1. 公司实力Strength	21
2.1.2. 公司历史History	25
2.1.3. 公司文化Corporate cuture	26
2.1.4. 公司组织结构Organize chart	28
2.2. 朗脉的服务Service	29
2.2.1. 专业领域服务Professional service	29
2.2.2. 工程总承包Contractor	31
2.2.3. 植物提取工艺优化Process optimization	33
2.2.4. 自动化控制系统业务Automation Control system	34
2.2.5. 过程控制系统Process Flow	35
2.2.6. 空调自控系统HVAC automation system	36
2.2.7. 在线清洗系统Clean in place	38

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.3. 洁净管道系统业务Sanitary piping system business	40
2.3.1. 完善的工艺设计Perfect in process design	40
2.3.2. 材料选型及采购Material Selection and Procurement	41
2.3.3. 齐全的施工设备Construction facility	42
2.3.4. 现场管理及现场施工Project management and construction	44
2.3.5. 先进的检测设备Testing equipment	45
2.3.6. 系统调试和人员培训Training and system commission	45
2.3.7. 验证服务Validation service	47

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1. 资质证明文件Certificate

1.1. 资质证书Certificate

1.1.1. 营业执照复印件Business license

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第3页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.1.2. 组织机构代码证Organization code certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第4页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.1.3. 税务登记证Business Registration

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第5页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.1.4. 银行开户证明The opening of bank accounts permits

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第6页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.1.5. 代理证书Agency

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第7页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第8页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第9页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第10页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第11页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第12页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.1.6. 协会证书CAPE Certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第13页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.2. 部分业绩Part reference

1.2.1. 部分竣工项目一览表 Part finished project List

序号	客户名称	地点	项目概况	认证情况
1	北京凯因生物技术有限公司	北京	纯水/注射用水/纯蒸气分配系统/干扰素发酵物料管道转运系统和空调自控（工艺管道）
2	北京万泰制药有限公司	北京	纯水/注射用水/纯蒸汽/物料分配系统
3	北京三元基因工程有限公司	北京	纯水/注射用水/纯蒸汽/物料分配系统
4	常州四药有限公司	常州	注射用水/纯化水管道分配系统	依照FDA cGMP 规范，提供IQ/OQ 文件
5	河北恒利药业有限公司	河北	CIP 系统
6	成都普仕医塑公司	成都	纯水/注射用水/纯蒸汽及物料管道分配系统
7	扬子江药业集团广州海瑞药业有限公司	广州	纯蒸汽/纯水/注射用水/物料分配管道系统
8	齐鲁海南药业有限公司	海南	纯蒸汽/注射用水/纯水以及工艺管道系统
9	杭州天元生物制药有限公司	杭州	注射用水/纯蒸汽/纯化水/洁净压缩空气/氮气等工艺管道系统	依照FDA cGMP 规范，提供IQ/OQ 文件
10	杭州九源基因工程有限公司	杭州	纯蒸汽/注射用水/纯水以及工艺管道系统和空调自控	依照FDA cGMP 规范，提供IQ/OQ 文件

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第14页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

序号	客户名称	地点	项目概况	认证情况
11	上海博莱科信谊制药有限公司	上海	(蒸馏水生产装置MS304S，纯蒸汽生产装置PSG500DTS，纯水&蒸馏水&纯蒸汽分配系统)	依照FDA cGMP 规范，提供IQ/OQ 文件
12	齐鲁安替比奥制药有限公司	济南	纯水& 注射用水分配系统/ 发酵物料转运管道系统（二期）	无菌原料药已通过欧盟认证
13	齐鲁制药厂	济南	纯水/注射用水/纯蒸汽/物料分配系统
14	齐鲁安替比奥制药有限公司	济南	注射用水/纯化水/纯蒸汽管道分配系统
15	齐鲁天和惠世制药有限公司	济南	注射用水/纯化水/纯蒸汽管道分配系统
16	山东鲁抗辰欣药业有限公司	济宁	注射用水/纯化水/纯蒸汽管道分配系统和空调自控
17	山东鲁抗立科制药有限公司	济宁	注射用水/纯化水/纯蒸汽管道分配系统和空调自控
18	浙江耐斯康制药有限公司	金华	注射用水/纯蒸汽/纯化水分配系统改造项目	依照FDA cGMP 规范，提供IQ/OQ 文件
19	扬子江药业集团南京海陵药业有限公司	南京	纯蒸汽,注射用水分配系统工艺管道工程
20	宝利化（南京）制药有限公司	南京	注射用水/纯化水管道分配系统	无菌注射剂已通过TGA 认证
21	青岛生化制药有限公司	青岛	纯蒸汽/纯水/注射用水/压缩空气分配系统
22	GE Healthcare	上海	纯蒸汽/注射用水工艺管道工程	无菌注射剂已通过FDA 认证

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第15页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

序号	客户名称	地点	项目概况	认证情况
23	石药集团中润制药有限公司	石家庄	注射用水/纯化水/纯蒸汽及物料分配系统
24	上海天士力药业有限公司	上海	纯蒸汽/注射用水分配系统工艺管道工程
25	上海百特医疗用品有限公司	上海	纯水/注射用水/配液分配系统
26	上海惠生生物工程有限公司	上海	纯水/注射用水/纯蒸汽管道分配系统
27	上海迪赛诺制药有限公司	上海	注射用水/纯化水管道分配系统	符合WHO 规范
28	上海惠生生物工程有限公司	上海	抗体实验室纯化水分配系统（二期）
29	上海莱士血液制品股份有限公司	上海	注射用水分配系统过热水灭菌系统改造项目	依照FDA cGMP 规范，提供IQ/OQ 文件
30	深圳海王英特龙生物科技有限责任公司	深圳	纯蒸汽/注射用水/纯水系统工艺管道系统	依照FDA cGMP 规范，提供IQ/OQ 文件
31	华北制药奥奇德有限公司	石家庄	纯水/注射用水/纯蒸气分配系统/干扰素发酵物料管道转运系统
32	华北制药华胜有限公司	石家庄	纯蒸汽/注射用水/纯水系统及物料工艺管道分配系统
33	华北制药集团北元有限公司	石家庄	注射用水，纯化水，纯蒸汽分配系统改造项目	依照FDA cGMP 规范，
34	石家庄欧意制药有限公司	石家庄	纯化水分配系统改造项目	依照FDA cGMP 规范，

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第16页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

序号	客户名称	地点	项目概况	认证情况
35	无锡台裕制药有限公司	无锡	注射用水/纯化水/纯蒸汽系统及物料分配管道系统
36	厦门北大之路药业有限公司	厦门	注射用水/纯化水纯蒸汽系统及物料分配管道系统
37	苏州东瑞药业有限公司	苏州	纯蒸汽/注射用水/纯水系统及物料工艺管道分配系统	依照FDA cGMP 规范，提供IQ/OQ 文件
38	贝朗医疗（苏州）有限公司	苏州	纯水/注射用水/配液分配系统
39	苏州东瑞制药有限公司	苏州	104 车间物料系统改造	依照FDA cGMP 规范，提供IQ/OQ 文件
40	苏州东瑞制药有限公司	苏州	原料车间物料系统改造	依照FDA cGMP 规范，提供IQ/OQ 文件
41	贝朗医疗（苏州）有限公司	苏州	注射用水系统改造项目
42	扬子江药业集团有限公司	泰州	纯蒸汽,注射用水分配系统工艺管道工程
43	天津天士力药业有限公司	天津	纯蒸汽/纯水/蒸馏水/压缩空气分配系统
44	天津百特医疗用品有限公司	天津	纯蒸汽/注射用水分配系统工艺管道工程
45	天津天士力药业有限公司	天津	实验室纯水管道系统
46	通化东宝药业	通化	(蒸馏水生产装置MS3005S， 纯蒸汽生产装置PSG500DTS， 纯水&蒸馏水&纯蒸汽分配系统， 大输液配制系统)

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第17页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

序号	客户名称	地点	项目概况	认证情况
47	香港美达制药有限公司	香港	纯水分配系统
48	厦门科兴生物制品有限公司	厦门	(预处理，二级反渗透,蒸馏水生产装置MS504S， 纯蒸汽生产装置PSG500DTS ，纯水&蒸馏水&纯蒸汽分配系统)
49	劲牌有限公司	湖北	保健酒仪表、计量控制系统
50	贝朗医疗(苏州)有限公司	苏州	改造公用洁净设施工程

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第18页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.2.2. 部分在建同类工程一览表 Part constructing project List

序号	客户名称	地点	项目概况	认证情况
1	成都生物制品所	成都	洁净室配套公用工程系统	符合WHO 标准
2	株洲千金药业有限公司	湖南	煮提、浓缩自控总包项目
3	浙江普洛康裕药业有限公司	浙江	冻干粉针洁净管道和配料系统工程合同
4	赣州菊隆高科技食品有限公司	江西	萃取、提纯车间自控系统工程项目合同
5	山东先声麦得津生物制药有限公司	山东	工艺管道安装工程项目
6	成都生物制品所	成都	乙脑疫苗车间改造	符合WHO 标准
7	成都生物制品所	成都	病毒疫苗车间PW/WFI/PS 系统
8	杭州中美华东制药有限公司	杭州	冻干粉针201 车间洁净工艺管道系统工程
9	苏州东瑞制药有限公司	苏州	103 车间洁净管道系统改造
10	江苏正大丰海制药有限公司	江苏	输液车间注射水及物料洁净管道系统

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第19页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.3. 2007 年财务报表Financial statement

针对本招标文件，公司提供2007 年度财务审计报告复印件作为参考。

We provided the copy of 2007 financial statement as reference for the project bidding requirement.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第20页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2. 公司介绍Company Introduction

2.1. 公司概述Brief introduction

2.1.1. 公司实力Strength

公司上海朗脉科技有限公司由上海双赢洁净科技有限公司和上海朗和系统集成有限公司整合重组而成，公司注册资金一千万，现有员工一百多人。我们致力于成为中国最好的制药工程专业提供商。

Shanghai Macroprocess Co., Ltd. was founded by integrating Shanghai WinWin Process System Co., Ltd. and Shanghai Longhorn System Integration Co., Ltd. We have over one hundred employee with RMB 10 million pay up capital. We are committed to become a leading supplier for the total solution in pharmaceutical industry.

“朗脉”本着“以人为本、技术为核心”的原则，聘请多位国内外技术专家，经过长期发展，打造了一支经验丰富的设计、安装、调试及验证的专业队伍。我们为您的药厂建设提供专业的概念设计 、详细设计、工艺设备、洁净管道、暖通空调系统、洁净室系统、自动化系统、采购管理、施工管理、安装调试、验证等一体化服务。

Following the principle “ putting employee first, setting technology as core”, Macroprocess has accomplished an experienced professional team made up of experts on design , installation and validation by recuiting many technical experts both from home and abroad after a long-time development. We can provide your

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第21页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

pharmaceutical factory contruction with integrated services, including professional conceptual design, detailed design , process equipments , sanitary pipelines , HVAC system, cleanroom system, automation system , procurement management, construction management, installation with commissioning , validation and etc.

“朗脉”的客户涵盖了许多国内外知名的制药企业，其中已有多家客户通过FDA 、EME A、TGA 等国外认证，并建立了良好的长期合作关系。

Macroprocess has served many famous pharmaceutical enterprises both from home and abroad, of which many enterprises have passed foreign validation ( USA FDA, EU EMEA, Australian TGA and etc.) We are maintaining excellent cooperative relationship with our clients.

目前我们用户中已经通过国外验证的有some of our clients have gained International certification：

 ♦ GE Healthcare 通用医疗（上海）药业有限公司是美国GE 通用的独资企业，是目前为止国内唯一一家无菌小容量注射剂通过美国FDA 认证的制药企业；GE Healthcare Located in Shanghai City , Sterility injection was certified by USA FDA and also this is the only one which approvaled in China.

 ♦ 山东齐鲁安替比奥制药有限公司是意大利安替比奥公司与齐鲁制药有限公司的合资企业，是国内第一家无菌原料药（相当于注射剂）通过欧盟EMEA 认证的制药企业；Qilu Antibiotics Pharmaceutical Co., Ltd. is the joint venture company of Italy Antibiotics and Qilu

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第22页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

pharmceutical company, it is the first one of China which Sterile API was certified by EU EMEA.

 ♦ Polifarma 宝利化（南京）制药有限公司是意大利Polifarma 公司控股的企业，无菌制剂以及口服固体制剂于2007 年通过了澳大利亚TGA 认证。Polifarma (Nanjing) Co. Ltd. is a holding company of Italy Polifarma, Sterile injection was certified by TGA in 2007.

我公司在生物制药领域的部分客户有as the following there are some reference in bio pharmaceutical domain：

 ♦ 北京凯因生物技术有限公司作为病毒生物技术国家工程研究中心，是由中国疾病预防控制中心病毒所和大连国际合作（集团）股份有限公司共同投资建立，我公司多次承接其洁净管道系统安装工程；Kawin Technology's core R&D organization – National Engineering Research Center for Viral Bio-Technology (NERC) was established with the approval & support of National Development and Reform Commission. Beijing Kawin Technology Share-Holding Co., Ltd. (Kawin Technology) was invested by Beijing Kawin Bio-Tech Co., Ltd. We cooperation in piping system many times.

 ♦ 成都生物制品研究所作为我国西南六省、市、自治区计划免疫协作中心，是中国最大的生物制品研究、生产基地之一，我公司先后承接乙脑疫苗车间水系统、病毒性疫苗项目水系统、洁净室配套公用工程系统等多个符合GMP 标准的工程；  The Chengdu Institute of Biological Products (CDIBP), part of the China National Biotec Corporation,

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第23页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

is one of the largest research and manufacturing bases for biological products in China.And we are participated in some sanitary piping system with GMP standard.

 ♦ 浙江天元生物药业股份有限公司是中国国内规模最大的流感疫苗生产企业之一。所有的生产车间都通过国家药监局的GMP 认证。我公司先后承接其疫苗车间的洁净管道施工安装项目，按照WHO 的标准实施项目。Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. is one of China's largest private manufacturers of influenza vaccine. All manufacturing lines of Tianyuan have been granted with cGMP certificates from the State Food and Drug Administration (SFDA) of China. Our company carried on some sanitary piping system project in bacterin factory with WHO standard.

“朗脉”以“专业成就未来”为使命，打造中国真正意义上的制药领域的专业工程公司，不断增强公司的核心竞争力，推动更多的本土药厂走向世界。

With the mission that “expertise for future”, Macroprocess is committed to become a Chinese professional engineering company that can bring more and more local pharmaceutical companies to the world by continuously improving core competiton capability in pharmaceutical industry.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第24页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.1.2. 公司历史History

♦ 上海双赢洁净科技有限公司成立。Shanghai WinWin Process System Co., Ltd was founded

♦ 上海双赢洁净科技有限公司与意大利STILMAS 建立合作关系。Shanghai WinWin Process System Co., Ltd commenced business relationships with Italian STILMAS.

♦ 上海朗和系统集成有限公司成立，进入到中药现代化领域。Shanghai Longhorn System Integration Co., Ltd was founded with the entry into TCM modernization field.

♦ 上海双赢洁净科技有限公司将国际化的验证概念融入项目实施。WinWin brought the international validation concept into project execution.

♦ 聘请国外资深工艺及验证专家。International experienced process and validation experts were recruited.

♦ “朗脉”的多名技术成员成为国际制药工程协会(ISPE )会员。Several Macroprocess engineers are members of ISPE

♦ 融合工艺、管道、自控、HVAC 及洁净室系统、验证等各专业，成立技术中心。A technical center was operated with integration of process, piping, automation, HVAC and validation sections.

♦ 双赢与朗和整合，成立上海朗脉科技有限公司。WINWIN and LONGHORN were intergrated into MACROPROCESS.

♦ “朗脉”与国外公司合作开发了连续式真空带式干燥机。Macroprocess invented Vacuum belt dryer with cooperation with foreign enterprises.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第25页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.1.3. 公司文化Corporate cuture

· 朗脉的愿景The Vision of MACROPROCESS：

我们致力于成为中国最好的制药工程专业提供商。

We are committed to become a leading supplier for the total solution in pharmaceutical industry.

· 朗脉的使命Mission of Macroprocess：

专业成就未来！Experitise for future!

· 朗脉的核心价值观Core values of Macroprocess：

合作、创新、负责、分享 Collaboration, Innovation, Responsibility and Sharing.

· 朗脉的核心竞争力Core Competitiveness of Macroprocess：

ª 朗脉的专业能力将永远是我们引以为荣的核心竞争力Expertise of Macroprocess is always our core competitiveness；

ª 因为我们专业，完成了一个又一个的高标准项目Owing to our expertise, we have successfully completed a large

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第26页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

number of high-standard projects;

ª 因为我们专业，建立了与客户的长久合作关系Owing to our expertise, we have built long-term cooperation relationship with our clients;

ª 专业，成就朗脉的未来，也将成就朗脉伙伴的未来Our expertise is creating the future for both MACROPROCESS and our clients！

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第27页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.1.4. 公司组织结构Organize chart

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第28页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.2. 朗脉的服务Service

2.2.1. 专业领域服务Professional service

“朗脉”在引进吸收国际先进项目管理理念的基础上，经过多年积累，建立了完善的项目管理体系，对工程整个周期进行全方位的管理，最大限度提高项目的成功率，降低过程控制的成本，规避项目风险。

With the introduction of advanced international project management ideology and many years’ experiences, Macroprocess has established a perfect project management system to conduct all-round management to the entire cycle of project. This system can facilitate project success , cost reduction and risk avoidance.

“朗脉”真诚的为您提供以下各专业服务Macroprocess can offer the following professional service：

·洁净管道系统Sanitary piping system

ª 配料系统Formulation system：

· 小容量注射剂配料及输送系统 SVP formulation and distribution system

· 大输液配料及输送系统LVP formulation and distributionsystem

· 冻干制剂配料及输送系统Lyophilized product formulation and distribution system

· 生物工程、血液制品等配料及输送系统preparation and distribution system for bioengineering and blood products

· 无菌原料药生产工艺系统等Sterile raw material production

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第29页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

process system etc.

ª 工艺用水、汽系统Process used water and steam system：

· 纯化水系统、注射用水系统、纯蒸汽系统等Purified water system, water for injection system and pure steam system etc.

ª 洁净气体（空气、氮气等）输送系统Clean gas( air/nitrogen etc.) delivering system

ª CIP 在线清洗工作站及系统CIP（Clean In Place）work stations and systems

ª SIP 在线消毒工作站及系统SIP（Sterilization-in-Place）work stations and systems

·  自动化系统Automation control system

ª 工艺过程自动化控制系统Automation control system of process procedure

ª 洁净室空调自动化控制系统HVAC automation system

·  洁净厂房系统Clean room system

ª 洁净厂房系统的设计、安装、调试及验证（中国GMP、欧盟EMEA 及美国FDA 等） 。Professional design , installation, commissioning and validation (Chinese GMP, EMEA, FDA , etc.) of clean room system.

·  验证服务Validation services

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第30页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

“朗脉”专门的验证部门为您研究全球的认证规范，涉及FDA 、EMEA 、T GA、WHO 等。我们熟悉验证的重要性和复杂性，为顾客提供切实有效的验证服务，确保项目符合国内外GMP 法规要求。我们提供以下专业验证服务    Macroprocess Validation department can provide world class validation service, such as cGMP of SFDA, FDA, EMEA, TGA, WHO and etc. With great familiarity and complexity of validtion, we can provide pragmatic and effective validation services to ensure the uniformity of your project with GMP standards. We can provide the following professional validation services：

ª 编写验证主计划Writing of VMP (Validation Master Plan)

ª 设计cGMP 审核Design cGMP Review

编写URS Writing of URS

ª HVAC 系统和洁净室的验证Validation of HVAC system and Cleanroom

ª 水系统、纯蒸汽和压缩空气系统的验证Validation of Water system, Pure steam and compressed air system

ª 灭菌设备的性能确认PQ of Sterilization equipments

ª 关键工艺设备的验证指导Guiding of Critical Process Equipments Validation

ª 清洗验证的指导Guiding of Cleaning Validation

ª 工艺验证的指导Guiding of Process Validation

ª 计算机系统的验证Computer System Validation

ª 验证培训Validation Training

2.2.2. 工程总承包Contractor

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第31页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

对于任何一个项目，工程设计、安装调试、投资控制、工期控制和质量控制以及环保健康和安全管理等对于投资商的利益和发展都是至关重要。“朗脉”提供的专业化工程服务最大限度地避免了工程建设的风险，给投资方带来最大的经济效益。

For any project, the key to the benefit and development of investors are engineering design, installation and commissioning, investment control, project period control, quality control, environment protection, safety and security managemnt. Besides, GMP inspection consultation and validation services also play a special role in pharmaceutical factory project. Professional engineering services that offered by Macroprocess maximize the project risk avoidance and the benefit.

“朗脉”通过采用国际通用的工程总承包（EPC ）模式，将“朗脉”自身的各子专业服务整合及与国际知名的工程公司合作，为您的药厂建设提供符合国际cGMP 规范的概念设计 、详细设计、工艺设备、洁净管道、暖通空调系统、洁净室系统、自动化系统、采购管理、施工管理、安装调试、验证等一体化整体解决方案。

Through adoption of EPC formula, integration of different specialties and cooperation with international famous engineering companies, Macroprocess can provide integrated total solution ,including conceptual design, detailed design, process equipments, sanitary piping , HVAC, cleanroom system, automation system , procurement management, construction management, installation, commissioning and validation etc. which are in conformity with international cGMP for pharmaceutical factory construction .

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第32页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.2.3. 植物提取工艺优化Process optimization

“朗脉”致力于植物提取工艺的优化及中药现代化。

we are committed to process optimization of plant extraction and TCM modernization

● 植物提取工艺优化Optimization of Plant extraction 我们提供植物提取生产线的工艺设计优化、工艺成套设备、管道安装及自动化集成等专业服务。

We can provide process optimization for plant extraction production line, process equipment, piping installation and integration of automation control and etc.

● VBD 系列全自动连续式真空带式干燥机VBD series --fully automatic continuous vaccum band-type dryer

“朗脉”在引进消化国外先进技术基础上,研制开发的一种全新概念的高效节能、环保型干燥设备。彻底解决了其它干燥设备难以解决的高粘度、高脂、高糖、高热敏性等物料的干燥。

Based on the introduction of foreign advanced technology ,

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第33页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

Macroprocess has developed this kind of new drying machine of high efficiency and ecological characteristics which can thoroughly solve the problem of drying substances of high vicosity, high fat, high sugar content and heat sensitivity etc. that other drying machines cannot overcome.

2.2.4. 自动化控制系统业务Automation Control system

制药及相近行业自动化系统的设计、安装、调试及验证（中国GMP、欧盟EMEA 及美国FDA 的cGMP）的工程是上海朗脉科技有限公司主营业务之一。

Professional design, installation and validation (Chinese GMP,EU EMEA and USA FDA ) of automation systems for the pharmaceutical and relevant industry fields is one of Macroprocess Technology’s core business.

“朗脉科技”本着“以技术为核心”的原则，聘用多位国内外技术专家，经过长期发展，造就了一批经验丰富的设计、安装、调试及验证的专业团队。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第34页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

In line with the principle “take the technology as the core”, we recruits lots of domestic and foreign technical experts. After the extensive experience we have cultivated and accomplished a group of specialized experts in design, installation and validation for domestic and foreign projects.

2.2.5. 过程控制系统Process Flow

在工业生产中，各单元操作集合而成的生产流程，例如：提取、发酵、合成、萃取、过滤、配料、浓缩、精馏、沉淀、结晶、干燥等，实现生产过程的自动化，并且可以大大提高生产效率，减少人为差错，保证产品质量，降低生产成本，提高生产质量管理水品，为企业现代化和信息化管理搭建数据平台。

In pharmaceutical factory, the process flow integrated by each unit operation, i.e. extraction, fermentation, chemosynthesis, filtration, preparation, concentration, distillation, deposition, crystallization, drying and so on, and the process flow with automation could maximize production efficiency, reduce human error, ensure product quality, reduce production cost, advance the quality management level, set up the data platform for company modernization and informationization.

工艺状态的实时监控管理 Real time supervision of process situation 过程整定使控制过程更加完美 Optimizing control process 简单友好的操作界面，操作方便 Friendly interface, more convenient for operation

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第35页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

过程参数在线检测、实时显示并记录存档Process parameters can be measured online, displaying in real time, recorded and saved. 实时在线分析、在线解决问题和历史查询Easy for online analysis, trouble shooting and searching history. 加强生产数据管理，保证产品质量Enhancement for production data management to ensure product quality.

2.2.6. 空调自控系统HVAC automation system

上海朗脉科技有限公司拥有自己的洁净室项目实施管理团队，对制药厂房实 施项目实施。

Macroprocess has own team to manage clean room project, and to proceed the project for whole pharmaceutical facotory.

朗脉公司采用国际先进的板材保证洁净厂房的质量，采用先进的HVAC 系统，尤其对HVAC 系统进行自动化控制和门禁一卡通系统，实现EMS 管理和空气缓冲的互锁，符合FDA 的要求；对于空气质量要求高的厂房引入文丘里风阀系统保证压差。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第36页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

朗脉公司认为一个好的洁净室项目的实施，离不开好的集成化的设计，公 司各个富有施工经验的专业人员利用三维设计对项目进行预演。

 We believe that to proceed a HVAC Automation system project without a integrated design, and we will preview the system via 3D software.

空调运行需要用大量的能源，系统在满足生产要求的前提下，实现能耗最 小化、运行效率最高化，可以提高设备运行安全可靠性和使用寿命。

HVAC’s operation needs lot of energy. BA system could minimize consumption, maximize operation efficiency, enhancing the reliability of operation and working life and achieving the process requirements.

系统具有数据记录、查询、报警、打印及趋势曲线图功能，利于管理。

[可动态图形显示各参数值 新风、回风风阀的开度控制 过滤网脏堵报警 温湿度控制 风机变频控制 送风与排风风机联锁控制 Illustrating display of real-time parameters Regulation control of the valve for fresh air and return air Alarm for filter block Temperature control and humidity control Inverter control of fan Interlock control of inlet air fan and discharge fan

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第37页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

自动调整主机、冷却塔运行数量、达到最佳节能目的 旁路压差控制  故障时备用设备自动切换 冷机和泵的缺水保护 冷冻站设备的顺序启停控制 自动补水控制 Adjusting the quantity of air conditioning units and cooling towers automatically in operation to save energy Bypass pressure control Automatic shift of backup machine in case of machine failure Protection of chillers and pumps against lack of water. Sequence of on-off control for freezing station Automatic control of water feeding

BA System has the functions of data logging, search, alarm, printout and trend graph for easy operation.

2.2.7. 在线清洗系统Clean in place

全自动CIP 清洗是指设备（罐体、管道、泵等）及整个生产线在封闭的系 统中，无需人工拆卸便能进行有效的清洗和消毒。系统由酸、碱、热水、纯化 水、注射用水、酸碱配置罐和换热器组成，根据工艺特点设定酸碱浓度、清洗 流程、清洗液温度、清洗时间、保证产品质量，便于QA 工作的自动化和清洗 工作的规范化。

CIP means that the equipment and the whole production line could be efficiently cleaned and sanitized without disassembly in close system. A CIP system is composed by detergents, hot water, purified water, WFI, preparation tank and heat exchanger. Concentration of detergents, clean flow, water temperature and cleaning time can be set

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第38页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

according to process specification, which could ensure the product quality, automation of QA affairs and standardization of cleaning.

● 可分区同时清洗一个或者两个以上区域，大大缩短CIP 清洗时间，使生产 计划合理化，提高生产能力CIP system could clean one or more areas simultaneously. It can reduce time for cleaning, and enhance production capacity.

● 减少工艺用水量、节省清洗剂、减低生产成本CIP system conduces to reduce process water consumption, saving detergent and reducing production cost

● 对清洗过程进行自动检测、显示和控制CIP system conduces to automatic measurement, display and control in cleaning process.

● 形成电子记录，符合GAMP4 和FDA 21 CFR PART 11 的要求CIP system generates electronic record compliance with the requirement of GAMP4 and 21 CFR PART 11

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第39页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.3. 洁净管道系统业务Sanitary piping system business

2.3.1. 完善的工艺设计Perfect in process design

对于我们承接的每一个项目，我们的设计团队在公司具有丰富管理施工经验的项目经理的领导下，并充分结合客户的URS 进行详细的优化设计，为客户做出具精确的P&ID 图、平面布局图、乃至施工图。这种优化设计是重要的，也是必须的，精确了材料数量，节省了施工时间，是为客户争取最大利益的保证。

For each project in which we are participated, our project manager in construction; Our design team can provide fully integrated and optimized detailed design according to the URS of our clients, the precise P&ID chart, layout plans, as well as construction plans. This kind of optimized design is a must. The precise amount of material, the organization of time, guarantees to act in the best interests of customers.

对于复杂的工艺管道系统，根据客户的需要和现场实际情况，我们的设计团队可以制作模拟现场的3D 效果图，从而保证了整个系统的精确定位和合理布置。3D 效果图可以衍生出相应的平面图，单管图及材料清单便于控制投资成本及施工周期，大大提高了施工效率和质量，是为提供给客户良好工程的重要 保证。

Regarding complex piping systems, the needs of the customers and

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第40页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

the actual conditions, our design team can produce 3D simulation of the complete site, thus ensuring the accurate positioning and rational layout of the whole system. The corresponding plan can be developed from the 3D effect chart; singular pipeline plans can facilitate inventory control and materials costs and also the investment in the construction cycle, greatly increasing the efficiency and quality of construction.

2.3.2. 材料选型及采购Material Selection and Procurement

“质量和信誉是企业生存之本”，优质的材料供应商是高质量工程的基石。

Quality materials suppliers -- the cornerstone of high-quality works.

采购部门，根据技术部门的提供的参数和要求，为客户选择可靠的供应商及高性价比的产品。通过对供应商的评估、采购数据、所购产品的认证并结合客户的URS 为我们良好的工程提供重要的保证。Procurement departments, according to provided technical parameters and requirements, purchase products from reliable suppliers with high performance. Through vendor evaluation, procurement data, certificate of products and integration with URS provide an important guarantee for our work.

目前“朗脉科技”已经成为国内外许多知名公司的长期合作伙伴，如：After years of development, "Win Win" becomes the long-term partner of many well-known domestic and foreign enterprises:

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第41页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

瑞典：Alfa laval

德国：Gemu、Burker t、E+H、+GF+、Siemens

瑞士：Mettler-Toledo

丹麦：Grundfos

台湾：Kinglai

优质的材料供应商，加上“朗脉科技”先进的优化设计理念、科学的工程管 理、丰富的国内外验证经验，以及科学严谨地规范每一个工作流程；确保您的整个自控系统工程准时、高质量地完成。

Good cooperative relations with suppliers and ensuring their quality plans to ensure that the project completed on time and according to the specified quality of the Client.

2.3.3. 齐全的施工设备Construction facility

我们齐全的施工设备能够承担任何作业。Our organization is fully equipped with hardware to undertake any task.

洁净管道专业切割设备Import cutting machinery specially for pipelines:

●  切割端面平整Flat cutting surface

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第42页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

●切割端面无氧化Non-oxidized cutting surface

●切割端面无变形Non-deformed cutting surface

平口机完成专用切割机无法完成的其他任务，如特殊位置用的管件需要修整或对管道的端面进行平整等等。Tube square machine that can complete the mission that special cutting machine can not complete, e.g. special positions and surface in the pipeline which need trimming.

●全自动轨道焊接设备World-class automatic orbital welding machinery

●焊缝内外充氩气保护，无氧化Welding is argon-protected without being oxidized

●操作简单、方便Simple and convenient handling

●避免人为的焊接缺陷Manual welding defect can be avoided

所有的焊接点都是经过专业处理，设备与材料具有可追溯型，手动焊接由受过培训的具有职业资格证书的人员操作。All welding joints are professionally treated; all materials and equipments are certified and traceable; Manual welding is accomplished by trained personnel with appropriate qualifications and certification.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第43页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.3.4. 现场管理及现场施工Project management and construction

项目经理根据公司制定的良好工程规范组建项目组来进行质量管理、设计 变更控制、文件和数据的控制、采购控制、过程控制、检查和测试控制、检测 设备的控制、不合格品的控制、纠正和预防措施、安全防护控制、包装、运输、储存控制、培训以及验证等。

The project manager sets up the project team according to Clients Company for complete project quality management. Control in change of design, document and data control, procurement control, process control, inspection and control testing, testing of equipment control, control of defective products, corrective and preventive measures, security control, packaging, transport, storage control, training, testing and validation is also strictly monitored.

严谨规范的安装队伍是良好工程的保证。Installation team with stringent standards is our Guarantee for good work.

公司富有多年施工经验的施工人员将会按照公司制定的操作规范和客户要求进行施工操作。Our experienced construction staff are rich in experience and they will strictly follow the rules and regulations of operation, and customer requirements.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第44页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.3.5. 先进的检测设备Testing equipment

先进的检测设备确保高质量的完成工程安装，公司拥有完善的焊接质量检测系统。Advanced testing equipment ensure the quality of the completed work.and Welding quality examination system as the follow aim:

• 焊缝质量检测Welded joint quality test
• 焊缝质量评定Welded joint quality assessment
• 提供焊接质量检测报告表Provide welding quality inspection reports

为了确保每一个焊缝的焊接质量。公司结合科学的检测手段配备了先进的检测仪表，如X 光烫伤机、内窥镜、钝化检测仪等。To ensure the quality of welding, the company utilises the scientific detection means equipped with advanced instrumentation, such as the X-ray crack detection machine、Slope meter 、Passivation test and endoscope.

2.3.6. 系统调试和人员培训Training and system commission

根据包含的系统及其范围，我们将编制详细的调试计划。这个计划将包括范围内的每一个系统和设备的描述，包括自控系统；确定个系统进行调试顺利，

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第45页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

及相关前后工序；与项目施工进度结合在一起。

According to the scope and contents of the system, we will establish the detailed commissioning plan. This plan will include descriptions of the scope for each system and equipment, including automatic control system and ensure all systems are commissioned in the correct order, and in their correlation to working procedures.

我们确保所有人员的培训是有文件证明的。直到接受培训的人员能胜任他们各自的任务。

We ensure that all staff training is well documented with certification. Until those trained personnel are capable of performing their respective tasks.

所有人员的培训过程是必须可以被记录的。对于所有人员来说，都需要资格、经验和培训的记录。所有室内和室外的记录都将被保存。

All the training process must be documented for easy reference. For all the staffs they are required to acquire qualifications, experience and training records. All training records will be preserved.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第46页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.3.7. 验证服务Validation service

作为药品生产过程中的关键系统。洁净管道在设计施工中面对的是严格的规范要求和质量标准。朗脉聘用的是曾经在跨国制药及工程公司服务多年的技术专家，按照国际GMP 规范进行洁净管道系统的验证。

As one of the critical systems in pharmaceutical production facility, clean piping faces more and more stringent requirement on quality assurance and regulatory compliance. Macroprocess employs experts who have served at multinational pharmaceutical and engineering companies and provide qualification/validation services in accordance with international GMP guidelines.

我们在洁净管道系统方面的验证范围包括The scope of our qualification service include:

· 系统的风险分析System Risk Analysis

· 确认文件的准备 Preparation of IQ/OQ/PQ protocol

· 确认执行 Execution of IQ/OQ/PQ

· 验证报告的编制 Final Qualification Report

· 现有系统的差距分析及整改建议 Gap analysis on existing system and recommendations on retrofits

· 回顾性验证 Retrospective Validation

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第47页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第3部分公司介绍及资质文件 Techincal and control system proposal

第 3 部分

Part 3

技术及控制方案

Techincal and control system proposal

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

上海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

T:021 54306717      F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第3部分公司介绍及资质文件 Technical and control system

目 录

1. 技术方案Technical	2
1.1. 项目背景Project Background	2
1.2. 管道系统设计标准和规范Design Standards	4
1.3. 施工规范和法规Construction Regulations and Guidance	8
1.3.1. GMP 法规 GMP regulations	8
1.3.2. ISPE 指南	9
1.3.3. 工艺管道标准 Process pipe system standards	10
1.4. 生产工艺描述Process Description	10
1.4.1. 概要General	10
1.4.2. 工艺配料系统Process Formulation System	11
2. 控制方案Technical	15
2.1. 项目配置Project Configuration	15
2.1.1. 系统拓扑结构Topological Structure of System	15
2.1.2. 现场仪表层The Scene Instrument Layer	19
2.1.3. 过程控制层Process Control Layer	20
2.1.4. 数据监控层Datamonitor Layer	22
2.2. 技术方案Technical Solution	37
2.2.1. 配液控制系统Liquid preparation control System	37
2.2.2. CIP 在线清洗系统CIP control System	39

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/共44 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第3部分公司介绍及资质文件 Technical and control system

1. 技术方案Technical

1.1. 项目背景Project Background

沈阳三生制药有限责任公司是集生物药品的研发、生产和销售一体化的高新技术企业。公司的生产基地位于沈阳经济技术开发区，生产车间面积3000 平方米，通过了国家GMP 认证。公司计划建设新的厂房，提高生产能力，来满足日益增长的市场需求。

Shenyang Sunshine Pharmaceutical Company Limited (SUNSHINE) is an integrated biopharmaceutical company engaged in research/development, manufacture and marketing/sales of biopharmaceutical products in China. Its clinical and commercial manufacturing operations are based in Shenyang, China, where Chinese current Good Manufacturing Practice, or cGMP, certified, 3,000 square meters, and state-of-the-art facility resides. SUNSHINE plan to expand the plant in Shenyang to increase the manufacturing capacity and take further advantage of his favorable cost structure.

本次项目为沈阳三生制药有限责任公司的新建车间工艺配料系统的设计、材料、安装、检查和测试、调试、文件和交付。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2页/共44 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第3部分公司介绍及资质文件 Technical and control system

This project is invited tender for design, supply & install of distribution loops for new workshop of SUNSHINE Company. And it is process formulation system including CIP system . this is a turnkey project.

上海朗脉科技有限公司被邀请参加本次洁净管路项目的招标，我们的系统方案以及设计完全按照业主2009 年1 月发布的招标要求以及系统设计要求。

Macroprocess was invited to provide a quotation for the clean piping/utilities systems of this facility. Our proposal is based on SUNSHINE’s tendering specification distributed in January 2009.

本次方案我们提供以下各系统的施工图设计，交货，安装，测试，调试和确认：

Our Scope of Work consists of final detail design, delivery, installation, testing, commissioning and qualification of following packages:

● process formulation system 工艺配料系统

● CIP 在线清洗系统

● Related control system 相关的自控系统

● Other related Accessories   其他相关辅助材料系统

各循环系统根据客户的要求进行详细设计，具体详见相关技术描述和

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第3页/共44 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第3部分公司介绍及资质文件 Technical and control system

PID 图。我们按照GMP 的要求对贵公司的系统进行验证，此部分验证内容和报价可以参见报价清单说明。

All loop is designed to meet owner’s requirement and for details see technical description and PID.and we also provide the quotation on validtion to meet GMP requirement. And this part of validation scope and pricelist please refer to the related section.

公司聘认了国外专家专门从事FD A、WHO、欧盟、TGA 等法规的验证工作。“朗脉”的客户涵盖了许多国内外知名的制药企业，其中已有多家客户通过FDA 、EMEA 、TGA 等国外认证，并建立了良好的长期合作关系。

Macroprocess has accomplished an experienced professional team made up of experts on FDA ,WHO,EMEA,TGA validation by recuiting many technical experts both from home and abroad . Macroprocess has served many famous pharmaceutical enterprises both from home and abroad, of which many enterprises have passed foreign validation ( USA FDA, EU EMEA, Australian TGA and etc.) We are also maintaining excellent cooperative relationship with our clients.

1.2. 管道系统设计标准和规范Design Standards

· According to related national and local government pipeline construction standards and stipulations

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第4页/共44 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第3部分公司介绍及资质文件 Technical and control system

根据国家及当地政府管道施工的相关标准及规定

· WHO about Guidelines for Drinking-water Quality WHO 关于饮用水水质的指南

· WHO about water treatment guide & aqueous system Examination guide WHO 关于水处理指南和水系统检测指南

· Drugs production quality control in 1998 amended 药品生产质量管理规范1998 年修订

· ASE BPE 2002 Edition ASE BPE 2002 年版

· ICH Q7A GMP of Bulk Pharmaceutical Chemicals, November 2000 ICH Q7A 原料药的GMP， 2000 年11 月

· USP-29 2006 Edition USP-29 2006 年版

· FDA federation laws & regulations related stipulation FDA 联邦法规有关规定

· European pharmacopoeia 欧洲药典

· According to JBJ23- 96 edition (Code for Construction & acceptance of machinery and equipment installation) 根据JBJ23- 96 版《机械设备安装工程施工及验收规范》

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第5页/共44 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第3部分公司介绍及资质文件 Technical and control system

· According to HGJ203-83 edition (Code for Construction & acceptance of chemical machinery installation) 根据HGJ203-83 版 《化工机器安装工程施工及验收规范》

· According to GB50236-98 Edition (Code for Construction & acceptance of field equipment installation & industry pipeline welding) 根据GB50236-98 版《现场设备、工业管道焊接工程施工及验收规范》

· According to DL5017-93 Edition (Code for Construction, Manufacturing & acceptance of Pressure Piping) 根据DL5017-93 版 《压力管道制造安装及验收规范》

· According to (Pharmaceutical chemicals overall examination Guide) 根据《医药化学品总体检验指南》

· According to (Code for Drugs production & management) 根据《药品生产管理规范》

· According to (Code for Clean room construction and Acceptance) 根据《洁净室施工及验收规范》

· According to Planning & Design Ordinance of Macroprocess Technology 根据朗脉科技设计条例

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第6页/共44 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第3部分公司介绍及资质文件 Technical and control system

· According to PW piping system design & standards of Macroprocess Technology 根据朗脉科技高纯度管道系统的设计标准

· According to Construction requirements for Clean Room & High purified water pipeline system of Macroprocess Technology 根据朗脉科技高纯度管道工程洁净厂房施工守则

· According to guide to Construction safety of Macroprocess Technology 根据朗脉科技安全施工注意事项

· According to Construction procedure for High purified water piping system of Macroprocess Technology 根据朗脉科技高纯度管道系统的施工程序

· According to operational procedure for testing of Macroprocess Technology 根据朗脉科技高纯度管道系统的测试作业程序

· Code & requirements of China, the United States and the European in production of vaccine for Human 用于生产人用疫苗的中国、欧洲和美国的规范和要求

· Laws and regulations for Electric appliance & installation 电器设备和安装的法规

· Laws & regulations for safety standards

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第7页/共44 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第3部分公司介绍及资质文件 Technical and control system

安全标准、法典和规范

·  According to drawings and relevant requirements of products provided by owner. 根据业主提供的图纸及产品的相关要求

1.3. 施工规范和法规Construction Regulations and Guidance

本洁净管道系统项目，将按照以下法规和指南进行设计、施工、调试和验证：This project for sanitary piping system will be assured that its design, construction, commissioning and qualification will be in accordance with the following regulations and guidance:

1.3.1. GMP 法规 GMP regulations

a) (SFDA) 药品生产质量管理规范 1998 年修订版

Good Manufacturing Practice, revised in 1998

b) (SFDA) 药品生产质量管理规范附录 1998 年

Annex of GMP, in 1998

c) (FDA) 联邦法规第21 篇第210-211 部分，现行的成品药生产质量管理规范

21 CFR parts 210 and 211, Current Good Manufacturing Practice (cGMP) for finished pharmaceuticals.

d) (FDA) 联邦法规第21 篇第11 部分，电子记录和电子签名

21 CFR part 11, Electronic Records; Electronic Signatures

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第8页/共44 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第3部分公司介绍及资质文件 Technical and control system

e) (FDA) 无菌工艺生产的无菌产品的GMP 的行业指南， 2004 年9 月

Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing- Current Good Manufacturing Practice, September 2004

f) (FDA) 高纯水系统的检查指南，1993年7 月

Guide to Inspections of High Purity Water Systems, July 1993

g) (Europe) 欧盟最新的

GMP European Current GMP

1.3.2. ISPE 指南

a) ISPE 工程指南卷3：无菌生产厂房设施，2000年6 月 ISPE Baseline Guide Volume 3: Sterile Manufacturing Facilities, June 2000

b) ISPE 工程指南卷4：水和蒸汽系统，2000年12 月 ISPE Baseline Guide Volume 4: Water and Steam System, December 2000

c) ISPE 工程指南卷5：调试和确认，2000年6 月 ISPE Baseline Guide Volume 5: Commissioning and Qualification, June 2000

d) ISPE 工程指南卷6：生物制药，2003年1 月 ISPE Baseline Guide Volume 6: Biopharmaceuticals, January 2003

e) GAMP 5 : 制药生产中的自动化系统验证的良好规范 Good Automated Manufacturing Practice for Validation of Automated Systems in Pharmaceutical Manufacture

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第9页/共44 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第3部分公司介绍及资质文件 Technical and control system

1.3.3. 工艺管道标准 Process pipe system standards

a) GB50235-97 工业金属管道工程施工及验收规范 Code for construction and acceptance of industrial metallic piping.

b) ASME BPE-2005 生物工艺设备 Bioprocess equipment

1.4. 生产工艺描述Process Description

1.4.1. 概要General

以下技术描述基于UR S（用户需求规格）。我们提供各系统的详细设计包括设备，控制系统，以及各类仪表，并按照标准提供整个系统的设计、安装、交货、调试、验证、培训方案。我们的设计图纸（包括管路平面走向示意图、系统流程图和P&ID’s 等）将作为主要设计依据。另外，我们提供必要的条款，确保整个设计系统符合生产要求。

The following description is based on the URS. Upon award of the bid, we shall carry out detail design of the entire system including equipment, controls, and instrumentation, and use the approved design as guideline for the procurement, delivery, installation, commissioning and qualification of the system. Our design drawings, including Piping and Instrument Diagrams (P&ID's), piping layout drawing, piping isometric drawing and so on, will become the master documents to which and for which the Chengdu Institute’s documents will be modified. We shall provide necessary items to ensure that the overall system performs to meet the process requirements.

整个系统的符合中国、WHO、EU和FDA 的标准。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第10页/共44 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第3部分公司介绍及资质文件 Technical and control system

The sanitary aspects of the system will meet GMP requirements for China, WHO, EU and FDA.

1.4.2. 工艺配料系统Process Formulation System

●概述General

工艺配料系统：根据业主工艺流程要求，配合CIP/SIP 系统共同实现灭菌效果。CIP/SIP system will be designed as per client’s process requirements to sterilize Process Formulation System.

CIP 在位清洗站由注射水、纯水、碱液贮罐及动力罐、管道、分布器、出料泵、回流泵、气动控制阀、板式换热器、温度控制仪、电导率检测仪、称重模块、PLC 触摸屏及控制柜等部件组成。CIP system consists of storage tanks for WFI, PW and lye, power tank, piping, distributor, outfeed pump, return flow pump, pneumatic valves, plate exchanger, temperature controller, conductivity tester, weighing module, PLC touch screen and control cabinet.

贮罐用不锈钢316L 制作，具有保温层。出料泵入口与贮罐的底部放液口相连并用气动阀控制，其循环管道中设有板式换热器，清洗液经加热后送至各清洗点。回流泵入口与回流管道相连，其出口与贮罐上部的回流液入口相连，并用气动阀控制，每个贮液下部设有排污口，罐上设有温度计，顶部有孔盖，罐还设有呼吸器，以排放废气。阀门均由PLC 或PC 控制阀门的开关以实现各清洗程序。在管线上还设有各种在线检测元件以保证各项清洗参数。Storage tanks are made in AISI 316 stainless steel with heat insulation. The inlet of outfeed pump is connected with tank drains through pneumatic valves. Cleaning liquid will be heated by plate exchanger installed in the recirculation loop before reaching cleaning points. The inlet of return flow pump is connected with return flow

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第11页/共44 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第3部分公司介绍及资质文件 Technical and control system

piping and outlet is connected with return flow inlet on the top of storage tanks through pneumatic valves. Each storage tank is equipped with drain, thermometer, lid and breathing ventilator. All valves are controlled by PLC or PC. Adequate online instruments are installed to monitor process parameters.

CIP 出料泵和回流泵选择离心泵。碱液从外部由蠕动泵输送到循环管道中。经纯化水或注射用水稀释后，由输送泵输送到需清洗的配液罐，清洗后的污水由回流泵返回CIP 罐或排放。Centrifugal pumps are used as outfeed pump and return flow pumps. Lye is pumped into recirculation loop by a dosing pump. After being diluted by PW or WFI, lye will be pumped into formulation tanks to be cleaned. Sewage will be drained or pumped into CIP tank by return flow pump.

所有的选型设备将满足不少于12 小时/天， 84 小时/周的工作强度要求。All the equipment will be guaranteed for 24 hours/day X 7 days/week per year operation. The major equipment within this system scope includes:

主要设备及工艺Main equipment and technical

Ø 阀门、仪表

自动化控制部分均选用进口气动操作阀组；现场仪表需采用隔膜式。CIP 管路管阀连接均采用快卡连接，其阀门采用卫生级隔膜阀。Import pneumatic opration valves configuration can be used in automatic control section; on-site instruments possess the characteristic of diaphragm-style. CIP ducts and valves are interconnected . All valves are hygienic diaphragm valves.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第12页/共44 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第3部分公司介绍及资质文件 Technical and control system

Ø 管道工程Pipelines Engineering

管道安装坡度不小于0.5%， 可重力全部排空；公司提供固定支架或滑动支架以便于现场安装。穿墙采用的是不锈钢套管，穿墙板或顶板采用不锈钢套管硅胶密封。

Pipeline installation slope won’t be less than 0.5%, for the total loss of gravity. Our company will provide both fixed frame and sliding frame for the pipeline bracket of on-site installation . Stainless steel pipe is used to pierce into the wall. Special seal on the joint of the penetration tube and inner pipe.

Ø 技术描述Technical Description

工作时，根据设置程序（程序可调）由CIP 清洗系统自动配制清洗液，首先检查清洗液的浓度是否按比例配制，如果浓度不够，泵入浓碱，直到罐内的浓度比例达到要求为止。经气动控制阀与增出料泵、回流泵来完成清洗液的输送及回流循环清洗、排放、回收的整个清洗过程。通过电导率、温度控制仪、酸碱计量及PLC 触摸屏组成的控制系统达到自动在线清洗功能。可以对每一道清洗程序时间、流量、电导率进行检测与记录，可打印输出，同时能确保清洗液温度和浓度在相应清洗过程中自动恒定，系统清洗结果由电导率仪自动检测显示，准确无误。

By setting up program to control CIP system , cleaning liquid can be automatically formulated. CIP system will firstly check whether the

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第13页/共44 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第3部分公司介绍及资质文件 Technical and control system

density of cleaning liquid is formulated according to appropriate proportion or not. If not, alkali with high density will be pumped into the tank until the required density is achieved. The complete cleaning process ,including cleaning liquid transportation as well as the reflow liquid cleaning, discharging and recycling, is accomplished by pneumatic control valves , feeder pump and reflow pump. On-site cleaning function can be realized by utilizing electrical conductivity rate, temperature control meter , acid-alkali meter and PLC touch screen. Consequently, each cleaning program time ,flow and conductivity rate can be tested , recorded and printed out. Meanwhile, temperature and density can be assured consistently the same in different cleaning stages. System cleaning result can be automatically and precisely tested and displayed via conductivity rate meter.

循环泵根据瞬间用水量的大小实现自动变频控制，维持管道流速处于 0.6—1.5m/s 之间，以保证物料管道清洗效果。在系统循环泵出口设有在线隔膜式压力表，便于直观的看到泵的运行状况是否正常。所有水平管道均设计有1%的坡度，以便于排净管道中积水。Frequency of circulation pump would be automatically controlled as per instantaneous water current , so that water current velocity can be maintained between 0.6 to 1.5m/s. Thus a good cleaning result of the material pipelines can be assured. On-site diaphragm pressure meter beside the circulation pump exit can display the pump operation conditions. All pipelines are designed to own 1% slope , so that the water inside can be evacuated thoroughly.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第14页/共44 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第3部分公司介绍及资质文件 Technical and control system

主要清洗程序如下

注碱> > 碱循环> > 排空 > >碱回收 > > 纯化水冲洗碱 > >排空 > > 注射水清洗> > 排空> >压缩空气吹干

配碱程序：水循环 > >补碱> > 碱加热 > > 配碱 > > 冲水 Main Cleaning Procedures as below

Feeding Alkali> >Alkali circulation> > evacuation> >alkali recycling> >rinsing alkali with purified water> > evacuation> >rinsing with water for injection > >evacuation> >dying with compressed air

Alkali formulation procedure: water circulation> >feeding alkali> >heating alkali> >formulating alkali> >rinsing

2. 控制方案Technical

2.1. 项目配置Project Configuration

2.1.1. 系统拓扑结构Topological Structure of System

两套工艺配料系统分别用两套PLC 系统控制。基本类似，控制层分为三层 , 总体结构如下图描述：

第一层为现埸仪表、执行器，即数据采集层和执行层；第二层为PLC 控制器，即过程控制层，第三层为人机界面，通过彩色触摸屏的形式，实现对系统的监控，其中一线培养基配置罐1103/1109 设一台触摸屏，缓冲液配置罐1421设一台触摸屏，缓冲液暂存罐1301 设一台触摸屏；二线培养基配置罐2106/2109 设一台触摸屏，缓冲液配置罐2421 和缓冲液暂存罐2301 设一台触

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第15页/共44 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第3部分公司介绍及资质文件 Technical and control system

摸屏，合计5 台触摸屏；系统实时状态、联动、报警、相关参数可以实现控制和记录，通常，至少实现三级密码保护。另外配置一台上位机，通过以太网（PN） 与纯化水和注射用水系统共用，实现打印、记录和存档等工作。

Two process ingredient systems are controlled by two PLC systems,the control layer is divided into three layers. The following diagram describes the overall structure:

The first layer is local instruments and actuators,just Data acquisition layer and implementation layer，PLC is the second layer,just process control layer.the third is a HMI device in the on the control cabniet.Through the in’touch ,the system is real-time monitored. Touch screens are used to First-line medium preparation tank 1103/1109, buffer preparation tank 1421, buffer tank 1301 for temporary save, Second-line medium preparation tank 2106/2109, buffer preparation tank 2421 and buffer tank 2301 for temporary save.there are five touch sreens.The system’s real-time data and status,interlock,alarms,general parameters can be controlled and recorded.Usually,it’s needed three grade password at least.Moreover,the system configured a computer as Engnieer Station. It is share with others system through Ethernet( PN ),to achieve print,record and store.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第16页/共44 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第3部分公司介绍及资质文件 Technical and control system

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第17页/共44 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第3部分公司介绍及资质文件 Technical and control system

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第18页/共44 页

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2.1.2. 现场仪表层The Scene Instrument Layer

该层主要由电气执行设备和在线仪表组成，采集现场的参数信号，并执行PLC 下达的控制命令。

The layer is mainly constituted by electrial devices and online instruments.It recives the scene’s parameters signals and actuates commands,which PLC sends.

现场自动检测仪表对水处理和物料系统过程中的各个参数自动、连续地进行检测，通过变送器转换为4～20mA 标准信号，并将信号传送给PLC 控制站。

The online instruments in the scene auotomatical and continuous detect parameters in water process and material systems,which are very importment to process control.And then these signals are transformed to 4～20mA standard signals by transmitters. These 4～20mA standard signals are transmitted to PLC,the control center.

现场设备状态信号（如阀门的开关状态、泵的运行、故障状态）、报警信号直接传送到PLC 站，控制按钮、开关的动作信号等一般先经现场电控盘，以无源接点开关量信号的形式送至相应区域的PLC 站。

The scene device’s status(for example valve’s O/C status,pump’s status,fault status) and alarms’ signals  are tranmittered to PLC plant.The actuator signals of buttons and switchs are through the electrial control panels ,which are installed in the scene,to PLC plant

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第19页/共44 页

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with passive contact switch signal forms.

电气执行元件（如接触器、继电器、电磁阀线圈等）接收PLC 站开关量输出卡件送出的控制逻辑信号，用于改变现场设备的状态（如开关阀门、起停水泵）和信号屏指示灯的状态。

Electrial actuators(contactors),relays,solenoid valves) recives the logic signals which output cards send on PLC plant,so that changing the scene’s devices’status(open/close valves,run/stop pump) and signal lights’status.

执行系统一般具有现场手动/自动转换功能，功能便于设备的维护和调试，当某个设备切换到现场手动模式下，该设备就不受PLC 的控制，只接受现场的操作命令。

The actuator systems usually have manual/auto conversion function,so that these devices can be maintenanced and tested.When at manual mode,these devices are not controlled by PLC,instead of local operating commands.

2.1.3. 过程控制层Process Control Layer

● 主要功能Major Function

主要是完成控制联锁功能（PLC 控制站是本系统核心），系统的测控联锁功能主要是在这里完成的，包括：

This layer’s function is controlling the function of interlock(PLC

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第20页/共44 页

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plant is the center of this system ).System’s function of measure and interlock are mainly finished in this layer.including：

v 检测各设备的操作模式和状态Check up all devices' operating mode and status.

v 检测液位、压力、流量、ph 值等工艺参数；Check up parameters,for example level,pressure,flow,ph ,and so on.

v 根据工艺参数组态形成控制策略，并据此对处理系统的全过程实现自动控制和关键工序的PID 调节；According to these process parameters,this system's control program is formated.

● 操作方式Computed Mode

根据工艺要求，完成对阀门，仪表，电机等控制；阀门的开关，仪表数据的采集，电机的启停；通过在程序中设计功能块，完成对这些阀门，电机等的控制；通过在上位机或者触摸屏上发命令，开启或者关闭阀门，启动或者停止电机，现场的阀门，电机收到信号动作，再反馈信号给PLC， 程序中采集到这些信号后，得出是否启动，是否动作，或者是否没有反馈，如果有反馈，在触摸屏上会显示一个运行状态，以颜色来区分。如果报警，又会以另外一种颜色来显示，提醒现场操作人员及时发现问题，解决问题；仪表反馈回来的信号，关键点都有工艺设定值，而一些不是很重要的点，只是在触摸屏中作为显示；象一些温度，流量，电导率，PH，压力等关键点通过PID 功能块来实现特定的控制功能。

According to the technical requirements, completion of the valves, meters, motor control, etc.Valves’ O/C, Instruments data acquisition,

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第21页/共44 页

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motor start and stop. Through the process design function blocks to complete on these valves, electrical and machinery control. Through the PC or a touch screen, give an order to open/close the valve, start/stop the motor,then the scene of the valves,motors receive the electrical signals and act , and then feedback signals to PLC, PLC receives these signals ,and it is aware of status of these valves and motors, whether there is no feedback or not. If there is feedback ,on the touch screen,it will display a running status, to distinguish between colors. If alarm, with anothor color to show in the screen to remind the operator to detect and solve problems. Instrumentation feedback signal, the key point of both technology settings, and some not very important point, just display in a touch-screen.Such as temperature, flow, conductivity, PH, pressure , through the PID function blocks , achieve specific control functions.

2.1.4. 数据监控层Datamonitor Layer

控制系统采用西门子人机界面，完成数据的采集、设定参数、处理和储存记录数据、实时时钟控制、监视、通讯等功能。

Adopting PLC and touch screen control of Siemens as control system to gather, setup parameter，deal with and store data, to control real-time clock, to complete the display and communication etc.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第22页/共44 页

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● 显示功能Display Function

控制系统提供计算机图形化过程监控功能，操作人员可通过HMI 液晶屏观察生产线各自控设备单元的单元操作过程（例如生产品种、批号设备、所处的操作阶段，温度、压力、液位、时间等数据）。显示的画面种类如下：

The control system provides graphical process monitoring function. The operator can observe each unit control process of equipment of corrsponding production line (for example, the production of varieties, lot equipment, the operation phase, temperature, pressure, liquid level, time, etc. data)on computer screen. Displayed screen types as follows:

Ø 工艺流程图（Process Flow Diagram）

Ø 测量值显示（Measurement display）

Ø 趋势图显示（Trend display）

Ø 报警显示（Alarm display）

Ø 生产参数管理（Process parameters mangement）

不同产品在生产过程中，其工艺参数/控制参数可能各不相同，为了减轻工艺员烦琐的参数重复设定，减少参数输入出错率，保证系统非客观因素的正常运行，系统提供完善的生产参数管理功能；

Different products in the production process, the process parameters / control parameters may vary.In order to reduce cumbersome craft duplicate set of parameters, to reduce the error rate of

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第23页/共44 页

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input parameters, and to ensure the system’s normal running ofnon-objective factors , System provides comprehensive management capabilities of production parameters.

Ø 工艺参数输入存储，工艺参数以文件形式存储在上位机；Process parameters into storage, processing parameters in the form of a document stored in the HMI.

Ø 生产流程（含指令点）编辑；Production processes (including command points) Editor.

Ø 输入文件名即可打开相应参数；Enter the file name to open the corresponding parameters.

Ø 参数修改，输入新的参数值同配方名存储即可完成文件参数修改；Modify the parameters: Enter the new parameter values and the formula to complete to modify parameters.

Ø 下载功能，点击下载按钮将文件参数传进PLC， 系统将依据文件参数运行控制；Download function: click the button of download, the file parameters transfromed to PLC, the system will be controlled based on operational control file parameters.

Ø 上载功能，点击上载按钮将PLC 运行控制参数上传到上位机并显示，以此确定当前PLC 运行控制参数，防止因生产参数的不匹配

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第24页/共44 页

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影响生产；Upload function: click the upload button to let the PLC control parameters uploads to the host computer and display in order to determine the current PLC operational control parameters,to prevent production parameters does not match to impact the production.

Ø 生产程序（生产流程、工艺参数）存储、调用。The production process (the production process, process parameters) to store, call.

● 报警及报警查询Alarm and Alarm Query

控制系统提供即时报警和电子永久报警记录、查询功能，具体包括如下： Control system  provides real-time alarm and electronic permanent alarm records, the inquiry, including the following:

Ø 报警内容全面，编号、日期、持续时间、报警描述、报警设定值、单位、当前报警值、提示处理、状态确认和操作员姓名；Comprehensive of alarm report : number, date, duration, alarm description, alarm settings, units, the current alarm value, prompt treatment, state to confirm and the names of the operators.

Ø 报警出现、报警消失、报警确认显示不同颜色区分；Alarm occurred, alarm disappeared, alarm acknowledged that the

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第25页/共44 页

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distinction with different colors.

Ø 根据报警持续时间和确认时间可以判断出设备自动或操作员报警处理情况；According to the alarm duration time and the recognition time ,judge the equipments’statment or operator handle statement.

Ø 通过报警处理提示操作员可快速、准确的处理报警（不能自动解决情况下）；Prompted the adoption of the alarm ,the operator can quickly and accurately deal with the alarm(can not automatically resolve the case).

Ø 强大的报警存储容量，连续开机记录五年报警信息，当报警存储空间满时系统自动导出存储于用户指定的硬盘上；Powerful alarm storage capacity, boot record consecutive five-year report of alarm information, when the alarm storage space is full,it will automatically export storage to a user-specified hard drive.

Ø 报警信息永久记录不随断电而消失，不可更改，并提供方便而快速的查询，完全符合FDA 要求，做到责任明确化。Permanent record of alarm messages, do not disappear with no power, can not be changed, and provide convenient and speedy inquiry, in full compliance with FDA requirements, and let the

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第26页/共44 页

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responsibility clearly.

● 工艺控制和手动操作process control and manual operation

操作人员可通过操作触摸屏编辑生产工艺，进行联动或单机启动/停止生产线的任一单元设备的单元操作过程和两个单元间的料液传输过程，还可暂停这些操作，进行人工干预。干预结束恢复正常控制，也可对各个控制环节和整个控制系统实施强制结束操作；

Operators can modify production process in in' touch sceen, so that carry out joint or signle start / stop any unit equipment ,unit operation process of production line and operate liquid transfer process  between  the two units, but also to suspend these operations, carry out human intervention. After interfere, the restoration of normal control, and also end each link or the entire control system in a mandtory operation.

● 泵、阀等执行器的点动操作Pump,valve etc.acutor step operation

在授权允许的情况下，可通过操作触摸屏控制生产线的任何自控阀门开关、泵启停和电机启停、流量计清零操作，每次手动操作都会出现相应提示确认操作对话框，防止人为误操作。点动操作同样能够完成生产。

Authorization permission, through the operation of touch screen to control any self-control valve O/C, pump motor start or stop, flowmeter Clear operation of production line,.Each manual

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第27页/共44 页

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operation,it will be prompted to confirm the operation with corresponding dialogue box, to prevent man-made misoperation.JOG operation can also complete the production.

● 计算机批量生产数据管理及报表打印data management of mass production and print statements

计算机批量生产数据管理及报表功能如下Data management of mass production and print statements,function as follows：

Ø 自动采集各批次产品在各工艺阶段的生产过程数据，存储于数据库； Automatic acquisition production process data of the batch process at all stages, store in a database.

Ø 按要求自动生成各批次产品在整个生产报表；According to request, automatically generate the batch statements throughout the production.

Ø 生产报表不可更改、永久电子储存； The production of statements can not be changed, permanent electronic storage.

Ø 生产数据提供多种查询；Production data provide a wide range of inquiries.

Ø 可按要求提供多种方式打印。It can be requested to print in a variety of ways.

● 操作记录Operator records

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系统完善的操作记录及查询显示：

Perfect System operation records and inquiries show：

Ø 记录阀门操作、泵电机操作、参数操作、工艺编辑等； Record valve operation, pump motor operation, parameters operation, process modification.

Ø 记录操作内容、操作时间和操作者； Record on operational content, operation time and the operator.

Ø 电子永久记录不随断电而消失，不可更改，并提供方便而快速的查询，完全符合FDA 要求，做到责任明确化。 Permanent record of alarm messages, do not disappear with no power, can not be changed, and provide convenient and speedy inquiry, in full compliance with FDA requirements, and let the responsibility clearly.

● 报警管理Alarm mangement

完善报警管理是系统安全操作控制保障。根据实践经验固化的报警管理系统已不再适应配液系统安全操作控制，报警管理控制系统提供全面的报警后台管理功能具体如下：

Perfect alarm management ensures the safe operation of system control. In accordance with practical experience in curing the alarm

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第29页/共44 页

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management system,which is no longer equipped to adapt to the safe operation of hydraulic control systems.Alarm management control systems provide comprehensive background alarm management functions ,as follows:

Ø 报警值设定；Alarm set value

Ø 报警有效/失效设定；Alarm valid / invalid setting

Ø 报警延迟时间设定；Alarm delay time settings

Ø 报警等级设定，通过蜂鸣器与指示灯组合操作员不在控制室的情况下即可判断出报警内容。Alarm level settings.Through the combination of buzzer and light,  operator can judge the alarm contents in the case of operator not in control room.

● 系统安全性Security of System

为了满足GAMP5 等规范的要求，本系统同时具有安全性及电子权限的设定、电子签名和电子记录功能。

In order to satisfy requirement of GMP5 etc, the System have security and electronic access settings, electronic signatures and electronic records functions.

系统采用封闭的系统管理，建立、修改、维保、或传送电子记录能够保持记录真实性、完整性和适当的机密性。电子签名和电子记录具有真实性，完整性，不可抵赖性，和不可篡改性。这样的程序和控制应包括如下:

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The system uses a closed system management, to establish, modify, Maintenance, or send electronic records to maintain records of authenticity, integrity and appropriate confidentiality. Electronic signatures and electronic records have the functions of authenticity, integrity, non-repudiation, and not tamper with nature.

● 安全策略Security Policy

Ø 系统的验证保证准确、可靠、稳定地预期性能,有能力识别无效的和被改变的记录；Verification of system ensures accuration, reliable and stable performance which are expected,.It can identify invalid and changed records.

Ø 确保产生人们易读的电子形式的正确的、完整的记录副本，记录的保护以使记录能够在整个的保护期内是准确的易于检索的；It is to ensure to generate Correct, completed copy of record with the form of electronic document ,which people can read easily. The protection of records ,so that records can be accurate, easy retrieval in the whole protected period.

Ø 通过授权个人用户以限制系统的登录。使用安全的、计算机产生的、时间印记的审核跟踪以便独立的记录操作者登陆和建立、修改、或删除电子记录的行为的日期和时间。记录的改变不能使先前的记录信息被覆盖。使用验证检查以保证只有被授权用户才可以使用系统，以电子方式署名

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第31页/共44 页

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记录，使用和操作计算机系统的输入输出设备，改变记录或手动执行操作；It is to limit the system registry by empowering individual users. The use of safe, computer-generated, the time of the audit trail ,so that the records of independent operators establish, land, modify, or delete the conduct of electronic records of the date and time. The previous record of information Changed Records can not be covered by the changed records. Using verification check is to ensure that only authorized users can use the system , electronically sign records, use and operation input and output devices of computer systems, change the record or manually operate.

Ø 电子签名的显示：电子签名记录应能包含清晰显示如下所有与签名相关的信息：Electronic signature display: Electronic signatures should be able to contain all below relevant informations with the signatures recordclearly：

Ø 用印刷体写出签名者的名字Write the name of the signer with printing font.

Ø 签名生效的日期和时间，和签名相关的含义（例如：批准，职责，或备注等）Sign of the date and time, and signature-related meaning (for example: approval, duties, or notes, etc.)

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Ø 电子签名的唯一性The uniqueness of electronic signatures.

Ø 每一个电子签名应是唯一对应单独一个人的并且不能再使用、或再分配给其他任何人；Each electronic signature should be the only corresponding to a single person and can no longer be used by another, or the redistribution to any other person.

Ø 在一个组织建立，分配，证明或者批准一个人的电子签名或者其他的任何这样的电子签名的要素之前，组织将校验个人身份；Before establishment of an organization, distribution, certification or approval of a person's electronic signature, or any other such elements of electronic signatures, the organization will check their personal capacitis.

● 电子签名成分及管理 Composition and management of electronic signatures

Ø 使用至少两种截然不同的证明成分，例如识别码和密码；It must be used with two distinct proof components, such as ID and password.

Ø 当一个人在一个独立的持续受控的系统登陆期间内签署一系列的签名，签署的第一个签名将使用所有的电子签名成分。后续签署的签名应使用至少一种的电子签名的成分。该成分只能由个人签署，并且设计只能由个人来使用；When a person signs a series of signatures in an period of independent ,controlled, landing sustained system' s

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time, the sign of the first signature will use all of the electronic signature components. Follow-up signature should be used at least one component of electronic signatures. The ingredients can only be signed by individuals, and designed to be only used by the individual.

Ø 管理和签署以保证任何除其真正所有使用者外的其他尝试使用该电子签名时需要第二个或更多的人的协作；Management and signature are to ensure that another except for real user try to use the electronic signature,which is required a second or more people collaboration.

● 识别代码和密码的管理

Identification code and password management.

使用基于识别码和密码混合的电子签名应使用管理以保证他们的安全和完整，这种管理包括：

Using a mixture of electronic signatures based on ID and password ,people should study to manage it ,in order to ensure their safety and integrity, this management should include:

Ø 保持每一个的识别码和密码发布能定期被检查、收回或是修订； To ensure that each of the ID and password can be issued to regular inspection, to recover or to amend.

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Ø 按照损失管理过程对丢失、被盗、找不到的用户和密码进行电子失效；

In accordance with loss management process ,these ID and password,such as thefting,losing and not finded should be conducted of electronic failure.

● 实施措施Implementing Measures

系统安全性由工艺的合理性、系统硬件、组态软件、二次开发软件操作安全性四部分组成，这里系统安全性是指二次开发软件操作安全性，为此本系统安全性由以下三部分组成：

System security is composed by the rationality of technology, system hardware, software configuration, the security of secondary development of software. System security here refers to the secondary development of software security, for it , the security of the system is composed by the following three parts:

Ø 报警管理及报警处理Alarm management and alarm deal

Ø 电子权限管理Electronic Permissions management

Ø 根据操作类型、管理层次、安全等级系统实施多权分配According to the type of operation, management-level, multi-level of security, the system is distributed.

Ø 根据安全管理和操作权限，分为四个级别：一级：初级操作员（可以进行任何设备的开启或者关闭）。二级：高级操作员（进行系统监督和改

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变系统参数）。三级：维护工程师（校正和修改工艺仪表参数）。四级：系统管理员（分配和确认每个人的权限和密码和系统管理）;权限间互不包含, 系统中任何操作都有相应权限配置，只有经过登录并具有相匹配权限才能对其操作；权限用户的建立统一由车间管理员在管理室建立，操作室只具有操作登录功能不具备权限管理功能，操作员在第一次使用车间配置的用户时系统强制要求操作员对自己操作密码更改，该方式保证了多级权限安全和规范性。According to security management and operation of authority, it is divided into four levels: level1: junior operators (operate all devices to open or close). level2: Senior Operator (monitor system and change the system parameters). level3: maintenance engineer (instrument calibration and modification process parameters). level4: System Administrator (distribution , acknowledge each person's permission and password and system management).

Permission does not include inter-interoperability 。Any operation in the system has corresponding permission, only to log on and have the permissions to match their operation,and then operate it.

Permission of users to establish is  unified by the workshop manager in the management room. It has the

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function to operate the registry and hasn’t the competence management capabilities in the operation room.When operators first use the user of workshop,operators are asked to mandatorily change their own passwords, so that it ensures a multi-level security and regulatory authority.

2.2. 技术方案Technical Solution

2.2.1. 配液控制系统Liquid preparation control System

配液控制系统功能描述如下（一、二线基本相同）：

It’s the Function to Liquid preparation control System Description:

（The same of Line 1 ＆ Line 2）

Ø 根据配液管路流程以及客户要求配置该控制系统；

The Monitor and Control System will be configured and constructed according to liquid preparation process requirement and URS.

Ø 控制系统用于配液系统的信号检测和过程控制；

This Monitor and Control System will be used for liquid preparation signal monitoring and process control

Ø 现场安装控制柜，并附带警报报警装置；

Control cabinet will be installed on site, It will be provide with

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Alarms.

Ø 现场控制系统带有密码权限功能，不同级别操作人员设不同操作权限 Different levels pass word are availably on control system, each operator will be assigned with different levels of access.

Ø 系统可以设定手动和自动操作，并可以设定管路中各类仪表的参数； Manual and automatic operation modes are availably, It is possible to set parameters for instruments.

Ø 在配液过程中，系统自动记录并保存过程中的温度、压力、流量、PH 参数以及每次操作人员资料，供以后查询追溯；

During the liquid preparation, system will automatically record and store such important data like: Temperature, Pressure, Flow Rate, PH during the process and Operator’s Information for easy tracking in feature.

Ø 系统可以记录并保存生产过程中的流量变化曲线； During production process, Flow Cycle will be recorded and stored on the system.

Ø 现场控制系统的各类数据信号，可以上传至总厂监控系统。

All data on site system can be uploaded to the control system of factory central monitor office.

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2.2.2. CIP 在线清洗系统CIP control System

● CIP 的重要性（Importance of CIP）

GMP(Good Manufacturing Pra ctice)即药品良好的制作实施规范，目的是严格控制药品的制作过程，以保证药品的质量。在GMP 规范中，对于引起药品品种之间、药品批次之间的交叉污染要求严加排除，并实施在线的动态验证，以确保药品生产的万无一失。

GMP(Good Manufacturing Practice), the implementation norms of drugs production, in order to strictly control the drug production process to ensure the quality of medicines. In the GMP norms, Cross-contamination between drugs and batches is required strict exclusion. And implement a dynamic online verification, to ensure the safety of pharmaceutical production.

GMP 对制药设备有严格要求，设备除了要防止外界的微生物（杂菌）及其他杂菌混入反应物料之中外，还应具备原位清洗（Clean in place，简称 CIP） 的功能。在位清洗是指无需移动或拆卸设备即可进行有效清洗，以防止一批物料或其他杂质积存而影响后续批次的生产。

GMP for pharmaceutical equipment, there are strict requirements. Equipment has function of preventing micro-organisms (bacteria) and other bacteria of the outside world

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into reaction of materials, but also has clean in place (Clean in place, referred to as CIP) function.CIP. Reign cleansing refers that it is not the need to move or demolition equipment to carry out effective cleaning to prevent a number of materials or other impurities affecting the accumulation of follow-up batches of production.

● CIP 系统的组成(CIP System Composition)

在位清洗技术（Clean-in-place）是一种包括设备、管道、操作规程、自动控制和监控要求的一整套技术系统，能在不拆卸、不挪动设备、管线的情况下，利用清洗液的循环流动洗净污垢和滋生物。

Technology of CIP(Clean-in-place) is a kind of system which includes equipment, pipes, operation, automatic control and monitoring requirements technology.It can not be demolished, not to move equipment, and pipes, using of cleaning fluid circulation to wash dirt and Huizi biological.

● CIP 的控制(Control of CIP)

a. CIP清洗程序(CIP Program)

v 碱洗（Alkaline clean）

v 酸洗（Acid clean）

v 饮用水洗（Drinking water to clean）

v 纯化水洗（Purification clean）

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v 回水清洗（Return water clean）

v 压缩空气气吹（Compressed air blow）

b. 控制变量(Control variable)

v 时间(Time)

通过PLC 中的程序设定控制各工艺段的时间,根据验证设定时间。 The times of all procedures are controlled in accordance with settings in program of PLC.According verify,the time is setted.

v 温度(Temperture)

对于清洗是否成功CIP 温度是非常重要的，可以根据清洗对象和物料的清洗难度和粘度、生物度进行温度控制。在CIP 车间，温度传感器被装在不同的地方，每个CIP 罐上的传感器只是用来监测罐体的温度，在稳定性的监测中每条线都有一温度传感器 蒸汽的热度也有传感器。

在CIP 回路中的温度传感器监测回流介质温度，以确保设备清洗区域有足够高的温度。

The temperature of CIP is very important to sucessful CIP. In accordance with the cleaning objects ,cleaning difficulty ,viscosity,and bio-degree of materials,it can control temperature. In CIP workshop, temperature sensors are installed in different places.The temperature in each CIP tank is

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used to monitor the temperature of the tank. In order to monitor the stability of each line,the pipe has also a temperature sensor. There is temperature sensor in steam pipe to monitor the Steam temperature.

In the CIP circuit pipe,temperature sensor is used to monitor the return of medium temperature to ensure that the temperature is enough to meet the seetings in cleaning devices.

v 压力，液位(Pressure,Level) 为保证稳定性而控制和监测压力值，可在每条线上给定不同的CIP 清洗液的量和压力，这在所有的区域都是必须的。

In order to ensure stability，it must control and monitor the pressure values.Giving different CIP cleaning fluid volume and pressure in each pipe is necessary in all regions .

v 电导(Conductivity)

v 流量，流量开关(Flow,Flow Switch)

c. PL C程序 (PLC Program)

本系统的自动化控制，可实现自动清洗处理车间的各系统设备，从开始至最后的清洗工作，都由预先设定的清洗程序自动完成，操作人员只需要对所需清洗的设备选择和清洗过程的启停操作，即可快速、简单的洗净所有设

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备。

The automatic control system can achieve self-cleaning the various workshop equipments. from the beginning to the final cleaning work, it is finished by the pre-set automatic washing program. Operators only need to choose the necessary cleaning equipment and start and stop of cleaning process,and all equipment are washed fast,simply.

v CIP 各清洗罐自动液位检测和超限防护Automatical detecting the level of tank in CIP procedure and protection transfinite.

v 清水罐的自动补水（Automatic replenishment of water tank）

v 酸碱液的自动补加（Acid and lye solution automatically addtion）

v 温度的PID 控制（PID control of temperature）

v 阀门开关和泵的启停控制（Valve O/C and pump starting and stopping control）

v 运转状况实时显示（Real-time display of running status）

v 故障自动暂停及警示（Suspension and warning result of fault）

v 历史数据的记录和查询（Passed data records and inquirion）

v 在线电导率仪监测（Detection of online conductivity）

v 回水压力检测、判断是否断流（Detection pressure of return

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water ,judging Devascularization）

v 自动回水判断、连续清洗工艺控制（Detection reutrn water, and continuous cleaning process control）

d. 具体控制流程 (Specific Control flow)

v 准备阶段（Preparation phase）

v 清洗液配置（Cleaning fluid configuration）

v 需清洗的设备设置（Cleaning equipment configuration）

v 自动清洗（Automatical cleaning）

v 清洁水或纯化水冲洗（Cleaning water or Purified water wash）

v 回水冲洗（Return water wash）

v 压缩空气反吹，压力检测，判断反吹是否完毕（Compressed air blowback,pressure detection,judging if the blowback finished or not）

v 清洗结束（CIP finish）

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第 4 部分

Part 4

验证方案

Validation

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

上海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

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目 录

Index

1. 介绍Introduction	3
2. 验证范围Work scope of validation	3
3. 验证方法Validation approach	4
3.1. 总要求General Requirement	4
3.2. 风险评估Risk Assessment	6
3.3. 追溯矩阵表Traceability Matrix	7
3.4. 设计确认Design Qualification	7
3.5. 工厂验收测试 Factory Acceptance Test	10
3.6. 现场验收测试 Site Acceptance Test	12
3.7. 校准Calibration	13
3.8. 安装确认Installation Qualification	15
3.9. 运行确认Operation Qualification	18
3.10. 控制系统的验证 Validation of Automatic Control System	19
3.11. 性能确认Performance Qualification	20
4. 质量项目计划Quality and Project Plan	21

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验证服务范围

Work Scope of Validation Service

配料系统和CIP 站

Formulation system and CIP system

提供方：上海朗脉科技有限公司

Provided by: Shanghai Macroprocess Co., Ltd.

January 2009

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1. 介绍Introduction

沈阳三生制药有限责任公司（“沈阳三生”） 将新建一个生物制药车间，现对工艺配料系统和CIP 站系统的详细设计、施工、调试和确认（验证）的工程服务项目进行招标。

Shenyang Sunshine Pharmaceutical Co., Ltd. (3SBIO) will build one new biopharmaceutical plant, and now invite the bidding for the project of detailed design, construction, commissioning and qualification (validation) of preparation system and CIP system. 上海朗脉受邀参与投标，本文件将为本次的项目中验证范围进行做出说明，并给出最优的报价。

Shanghai Macroprocess is invited to bid for this project. This document will define the work scope of validation activities and give a best quotation.

2. 验证范围Work scope of validation

我们提供的验证服务范围，见以下验证矩阵表。

We provide the validation services shown in Validation Matrix.

表T able 1-验证矩阵表Validation Matrix

系统System	RA	TM	DQ	FAT	SAT	IQ	OQ	PQ*
培养基配制系统 Media preparation system	√	√	√	√	√	√	√	-

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缓冲液配制系统 Buffer solution preparation system	√	√	√	√	√	√	√	-
CIP 站 CIP system	√	√	√	√	√	√	√	-

备注Remark：

1） RA- 风险评估Risk Assessment ; TM- 追溯矩阵表Traceability Matrix; DQ- 设计确认Design Qualification; FAT -工厂验收测试Factory Acceptance Test; SAT- 现场验收测试Site Acceptance Test; IQ-安装确认Installation Qualification; OQ- 运行确认Operational Qualification; PQ- 性能确认 Performance Qualification

2） PQ 方案和实施由客户负责。

PQ protocols are prepared and executed by client.

详细的验证要求描述见后面章节。

Detailed validation requirement description will be found in the following section.

3. 验证方法Validation approach

3.1. 总要求General Requirement

我们将按照以下V 模型对关键系统开展验证工作。

We will conduct the validation/qualification activities according to

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	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

the following V-Model.

在设计开始之时，验证工作也将同时开展。在详细设计完成的后期，进行设计确认，并对系统进行风险评估，编写追溯矩阵表。在采购和施工过程中，任何的关键性变更(影响产品质量或安全的变更) ， 需要提交给验证人员进行审核。

Validation activities should begin with design. In the end of detailed design stage, Design Qualification and Risk assessment will be conducted, and also Traceability matrix will be prepared. During purchase and construction, any significant change(impact product quality or safety) should be submitted to validation person for review. 系统施工结束后，进行调试，在合适的时候组织客户相关人员，进行FAT 或

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	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

SA T。然后，进行安装确认和运行确认。性能确认，由客户自己负责实施。 When the finish of construction and commissioning, we will invite related persons from client to conduct FAT or SAT. Then Installation and Operational qualification will be done by us with witness by client. Performance qualification will be done by client own.

3.2. 风险评估Risk Assessment 风险评估的基本步骤Basic Steps of Risk Assessment:

- 了解系统或设备，以及工艺流程 Identification of System/Equipment, Process

- 识别可能出现风险、产生的原因、带来的影响 Identification of the risk event, cause and effects

- 评估该风险出现的可能性 Evaluation of the probability that the event occurs

- 评估该风险带来的影响的严重程度 Evaluation of the Impact of the Risk

- 评估该风险被发现的可能性 Evaluation of the probability of detection of the event

- 建议采取的措施

Suggested actions

报告Reporting：

风险评估的结果将报告下列内容：

The results of the risk assessment will be reported with the following typical contents:

- 目的

Objective

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	工艺配料系统 Process Formulation System
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- 风险评估的参与者

Participants in the risk analysis

- 工艺参数、功能、关键组件 Process parameters, Function and Components

- 潜在的风险

Potential risk

- GMP 关键性的判断

Identification if it is GMP critical

- 风险的原因和后果

Cause and consequences of risk

- 风险评估（出现的可能性、影响的程度、被发现的可能性） Risk Assessment (probability of occur, Impact, probability of detection)

- 处理的措施（如测试要求、特别措施等） Measures(e.g. Test requirement, specific measures etc.)

3.3.  追溯矩阵表Traceability Matrix

追溯矩阵表对验证项目的质量关键及基本要求自用户需求标准到功能标准直至测试方案进行追溯。

Traceability Matrix traces the quality critical and essential requirements from the User Requirements Specification (URS) to the functional specifications and onto the test protocols for this validation project.

3.4.  设计确认 Design Qualification

DQ 是对系统的设计进行审核，以确认它们符合预定功能及运行要求，并符合GMP 要求。

DQ is the review for the design of system which ensures that these are according to advanced function and operation requirement as

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	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

well as GMP requirement.

DQ 是贯穿于项目设计阶段的一个持续的过程，它保证与特定设备和系统相关的所有的设计文件符合现行GMP 的要求。我们将积极采取行动，保证项目的设计符合国际GMP 及客户的内控标准。

DQ is a continuous progress throughout project design stage. DQ ensure the design documents related to specific equipment and system according to current GMP requirement. We will act for it and ensure the project design meet the international GMP and internal standard of Client.

DQ 的关键工作是对系统的设计进行GMP 审查。该审查由朗脉验证专家主持，双方人员均参加。此审查将提供一个正式文件，证明设计按照GMP 各方面要求。会议的记录，完整的文件检查清单及变更清单将是DQ 的质量记录，被妥善保存。

The critical work of DQ is GMP review to system design. This review is conducted by specialist from Macroprocess, both sides would join it. This review will provide an official document to prove the design meet the GMP requirement of each aspect. Meeting memo, complete document check list and change list will be quality record of DQ and will be preserved appropriately.

设计确认（DQ ）并非法规的恶强制要求。然而，从正式性和加强的设计审

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	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

核角度，我们推荐执行DQ。

Design Qualification (DQ) is not a mandatory requirement of the regulations. However, in this formal format or through enhanced design reviews, it is recommended that it be carried out.

DQ 通过对系统进行有组织的设计审查来进行。这种审查将在严格要求下进行，因为它在IQ、OQ之前能够更好地发现设计问题或不符合要求的方面，否则将对项目的工期和费用造成巨大影响。

The DQ will be executed by applying a structured review of the design of the systems. The review should be rigorous as it is better to discover any design problems or non-conformance issues before reaching IQ or OQ, where remedial work may have a significant impact on the project schedule and cost.

方案将用采用书面格式。详细的检查清单将确保设计和文件的所有方面均被涉及。方案被各方正式签署后执行。

A protocol will be prepared with a written description of the format and approach for the reviews. Detailed checklists will be prepared to enable all aspects of the design and documentation to be interrogated. The requirements of the risk assessment and cGMP reviews will also be reviewed to ensure that their requirements are incorporated. The protocol will be formally signed off as approved

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	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

prior to execution and post execution by all parties.

DQ 文件的通常标准包括：

Typical criteria, which would be used to generate the DQ protocol are:

- 设计确保满足GMP 的要求 Design satisfies GMPs and regulatory requirements

- 设计符合性能标准

Design meets performance criteria

- 材料材质

Materials of construction

- 清洗要求

Cleaning requirements

- 操作的可靠性和有效性 Reliability and Efficiency of operation

- 设备安装

Equipment Installation

- 系统调试

System commissioning

- 关键仪表的参数，量程和精度是否满足工艺要求和控制要求 parameters of critical instruments, verify if the measuring range and accuracy satisfy the process and control requirement

- 关键组件的结构

Structure of critical components

- 文件要求

Documentation requirements

3.5. 工厂验收测试 Factory Acceptance Test

工厂验收测试应该关注设备关键的方面，包括进行测试活动。这些测试将在设备起运之前进行，以保证该设备已按照设计标准进行制造，并提供所需要 的文件。因此，FAT 可帮助避免可能影响现场测试的问题的产生。

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	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

Factory acceptance test could be applied to any critical aspect and includes test activity, that will be carried out before the shipment, to get assurance that a new critical equipment/ package has been built following the design specifications and it is provided with the required documentation; moreover the FAT will help to avoid problems that could affect the on site activities progress.

FAT 可适用于所有关键的设备或设备包。

FAT could be applied to any critical equipment or components.

FAT 将包括IQ OQ 所包含的一些测试内容。任何不受运输或安装所影响的测试内容，如果其得到合适的执行、复核和记录，在以后的确认中，可以不需重复进行。下面是一些被认为可以作为确认目的的测试内容，但不仅限于此：

FAT will already include some tests foreseen by the IQ and OQ; any test, which reliability will not be affected by the shipment and the installation could not be repeated for qualification purpose, if properly executed, witnessed and documented. Test activity that typically could be considered validated for qualification purpose, but not limited, are the following:

- 文件确认

Documents verification

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	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

- 图纸的确认（P&ID、布置图、电子和气路图） Drawings verification (P&ID, Lay Out, electrical and pneumatic scheme)

- 材料和表面抛光的检查 Materials and surfaces finishing verification

- 控制系统图形界面的检查 Control system graphical pages check

- 报警和联锁

Alarms and interlocks

FAT 将要求进行记录；相关的测试报告或方案，将被提交给客户审核和批准。

FAT 将在客户批准后进行。

FAT will be documented; the relevant test report or protocol, will be submitted to client for review, comments and approval; FAT execution will begin after client approval.

本项目仅要求对储罐进行FA T。

It is required to conduct FAT only for Tank.

3.6. 现场验收测试 Site Acceptance Test 此工作适用于关键的系统或设备。 SAT 包含动态的和静态的测试活动，测试活动在现场由供应商在移交系统给客户之前进行。每一项SAT 工作将被文件记录下来。我们将提交测试文件（定义为SAT 报告或方案）给客户，以审核和批准。

Activity Applicable to critical system or equipment; SAT consists of

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	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

Dynamic and static testing activities performed on site by the vendor before hand over the system to the client. Each SAT activity will be documented. Macroprocess will submit the test document (defined as SAT report or protocol) to Client (for comments and approval).

那些不会因为系统/设备的改变而影响可靠性的测试，如果已得到正确的执行、证明和文件记录，那么在验证过程中不必重复进行。

All tests which reliability will not be affected by the system/equipment modification could not be repeated for qualification purpose, if properly executed (in conformity with Qualification Protocols), witnessed and documented.

3.7. 校准Calibration 因为是新的安装， 所有的仪器仪表和变送器应被校准并产生校准证书。 Since this is a new installation all transmitter instruments will be calibrated, and calibration certificate will be produced. 所有不受安装影响的仪器仪表将经过校准后送到现场，并提供校准证书（溯源为NIST 或中国国家计量基准）。其它的仪器仪表将在现场使用计量标准进行校准。在任何情况下，应提供参考仪器的校准证书和校准程序。  

All instruments not affected by the installation will be bench calibrated and then, supplied to the field, provided with NIST or

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Chinese National measurement standards  traceable calibration certificate; the others will be calibrated in field using traceable standards references. In a case copy of the reference instrument calibration certificate and approved procedures will be provided.

下列是对不同等级仪器仪表的处理方法。

On the following different dedicated approach for class of instruments.

不受安装影响的仪表

Instruments not affected by the installation:

温度和压力变送器，需要校准证书（溯源为NIST 或中国国家计量基准）。确认工作，仅为确认安装情况（是否有合适的配置、范围、计量单位、信号）和带有相关显示器或相关监督和控制站的信号定位。

Temperature and pressure transmitters; for which will be required (to the vendor) a bench calibration certificate (NIST or Chinese National measurement standards traceable) and during the qualification will only be verified the set up (if smart the relevant configuration, range, engineering unit, signals) and the signal alignment with the relevant indicator or the eventual supervision and control station.

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会受安装影响的仪表

Instruments affected by the installation:

流量和液位变送器，不需要实验室校准。校准将在现场使用可溯源为NIST 或中国国家计量标准的仪器进行校准。

Flow rate and level transmitters; for which will not be required a bench calibration. The calibration will be performed after the installation in field using NIST or Chinese National measurement standards traceable reference instruments.

电导仪和PH 计将在现场通过使用相关的指示器与标准溶液进行确认/校准。

conductivity and pH probe will be verified/calibrated in field reading the measurement using the relevant indicator in comparison with a reference standard solution.

仪表的校准工作不属于验证工作。本项目的仪表校准工作由哪方负责，将由合同进行约定。

Calibration is not included into Validation work. The responsible party for calibration work will be according to the contract.

3.8. 安装确认Installation Qualification

安装确认将检查每一个设备/系统的安装是否符合设计和相应的GMP 规范。IQ 将确认所有的需要用于设备/系统的管理和操作的文件的可用性。

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	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

The Installation Qualification will determine that each equipment/system has been installed in accordance with the design (if new or renovated) and the applicable current good manufacturing practice (either if new or existing). IQ will confirm the availability of all the required documentation useful to manage and operate with the equipment/system itself.

在执行IQ 之前，系统的机械安装工作已完成。

Prior to the IQ, systems will have to be mechanically completed.

IQ 方案编写 IQ Protocols Preparation:

在所有对产品质量有影响的系统上都要进行IQ。每个IQ 方案都是针对特定系统的，但是所有方案都基本包含以下内容：

For all of the system that affect product quality must undergo IQ. Each IQ protocol are targeted at specific system, but all protocols usually contain the following elements:

- 方案批准页Protocol Review and Approval Sheet

- 目的Purpose

- 验证范围 Scope of Validation

- 职责Responsibility

- 参考文件Reference documents

- 系统描述 System description

- 文件检查 Document verification

- 系统图和布局图检查 P&ID and Layout verification

- 设备确认 Equipment verification

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- 仪表确认 Instrument verification

- 材质和表面抛光的检查 Materials and Surface finishes verification

- 组件结构的检查Components construction verification

- 死角的确认Deadleg verification

- 安装情况的检查 Installation verification

- 公用设施的检查Utilitites verification

- 人员的确认 Personnel identification

- 偏差报告Deivation report

- 实施结果批准 Execution review and approval

 IQ 接受标准 IQ Acceptance Criteria:

- 所有的参与IQ 执行的人员在实施前须经相关培训。 All personnel participation in IQ execution must pass through the correlation pre-job training.

- 所有文件（如操作手册，维修手册，焊点图，焊接记录，焊接检查，坡度确认，压力测试文件，内窥镜检查测试记录等）将被检查，文档位置将被记录。 All documents (such as operating manuals, maintenance manuals, solder joint plans, records of welding, welding inspection, slope confirmation, pressure test document, endoscopies test records, etc.) will be examined, file location will be recorded.

- 所有的图纸（如管道和仪表流程图，管道轴测图，电气图，气动图等）和材质证明等将被检查，文档位置将被记录。 All drawings (For example pipeline and measuringappliance flow chart, three dimensional pipelineschematic drawing, electrical chart, pneumatic operated chart and so on) and with the material quality proved and inspection file location will be recorded.

- 特定系统的备件清单须完备 The detailed list of spare parts for specific system must be completed

- 所有的设备，仪表和配套将被检查并须符合预设标准 All equipment, instrument and accessory will be inspected and they are required to meet the pre-set standards

- 仪表的校正已经成功完成 Instrument calibration has been successfully completed

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	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

3.9. 运行确认Operation Qualification 运行确认是按照预设的操作范围和机械性能进行，通过记录的文件，证明系统和设备能正确运行。 OQ could be executed and operated according to the pre-set operation arrange and mechanism performance through the recorded documentations prove that the system and equipment have been proper operated.

OQ 方案编写 OQ Protocols Preparation:

在所有对产品质量有影响的系统上都要进行OQ。我们会为每一个系统写一份OQ 方案。每个OQ 方案都是针对特定系统的，但是所有方案都包含以下内容：

All systems which influence the product quality are needed to execute OQ. We will write a OQ protocol for each system. Each OQ protocol aims at specific system separately, but all protocols are including:

- 方案批准页Protocol Review and Approval Sheet

- 目的Purpose

- 验证范围 Scope of Validation

- 职责Responsibility

- 参考文件Reference documents

- 系统描述 System description

- 验证仪器的检查 Validation Instruments verification

- 功能检查 Function Verification

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	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

- 报警和联锁的检查Alarms and interlocks verification

- 人员的确认 Personnel identification

- 偏差报告Deivation report

- 实施结果批准 Execution review and approval

OQ 接受标准 OQ Acceptance Criteria:

- 所有的参与IQ 执行的人员在实施前须经相关培训。 All personnel participation in IQ execution must pass through the correlation pre-job training.

- 所有的OQ 工作将按照已批准的方案执行 All OQ activities should be conducted according to approved protocols.

- OQ 测试仪器应被校准过的， 相关的证书应可溯源NIST 或中国国家计量基准， 并附在相应的方案中OQ Test instruments should be calibrated; the relevant certificate should be NIST or Chinese National measurement standards traceable to the National Institute of Standard Technology and attached to the relevant protocol.

- 系统报警和联锁的情况应符合设计标准 The system’s alarms and interlocks should operate in accordance with the design specification.

- 系统功能运行应符合设计标准 The system’s function should operate in accordance with the design specification.

- 系统所用的公用设施应当在规定范围以内（ 温度、压力、流量） Utilities, used by the system, should be available at the battery limit within the specified range (temperature, pressure, flow-rate).

3.10. 控制系统的验证 Validation of Automatic Control System

所有的跟产品生产、质量控制和分销有关的自控系统及其他数据采集，存储和处理系统都属于验证的范围。自控/计算机系统的验证将依据美国FDA （包括21CFR 第11 部分有关电子记录和电子签名的规定）、欧盟的GMP 指南和良好自控生产规范（GAMP）进行。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第19页/共21 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

All automatic control system and other data collection, storage and treatment system related to production, quality control and distribution are involved in the scope of validation. The validation of automatic system would be held according to the US FDA (21 CFR Part 11), GMP guideline of EU and GAMP.

3.11. 性能确认Performance Qualification OQ 的成功完成之后，将进行PQ 工作。PQ 将整合考虑规程、人员、物料、设备和工艺。 Upon successful completion of the OQ, Performance Qualification will be carried out. The PQ will integrate procedures, personnel, material, equipment, and process. 测试、规程和接受标准将在系统的挑战性实验之前确立，并在执行完PQ 之后进行审核。 Tests, procedures and acceptance criteria will be defined before challenging the systems and review after PQ execution. PQ 将证明设备、工艺步骤和参数、公用设施、原料、中间体和标准操作程序可以生产出预先所建立的生产和质量要求。 PQ will demonstrate that equipment, process phases and parameters, utilities, raw materials, intermediates and standard operating procedures allow to reach the pre-established manufacturing and

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第20页/共21 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

quality requirements.

测试可能包括化学的、物理的、微生物的分析。

Testing may include analysis for chemical, physical, microbiological constituents.

任何显著变化的情况将被要求进行审核和调查，以最终决定适当的纠偏措施。

Any outstanding condition will be identified for review and investigated to eventually determine the appropriate corrective action.

4. 质量项目计划Quality and Project Plan

参见附件See attachment.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第21页/共21 页

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Quality and Project Plan

质量项目计划

Preparation system and CIP system

配料系统和CIP 站

User 用户：	Shenyang Sunshine Pharmaceutical Co., Ltd.  沈阳三生制药有限责任公司
Department 部门：
Location 位置：
Document No. 文件编号：	3SBIO-03-QPP
Revision 版本：	00

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Review and Approval

审核和批准

	Name 名字	Company 公司	Function 职能	Signature 签名	Date 日期 (yyyy.mm.dd)
Prepared by		Macroprocess	Project Manager
编写		朗脉	项目经理
Reviewed by		Macroprocess	Validation Director
审核		朗脉	验证总监
Reviewed by		3SBIO	Production Manager
审核		三生	生产经理
Reviewed by		3SBIO	Engineering Manager
审核		三生	工程部经理
Reviewed by		3SBIO	Validation Manager
审核		三生	验证经理
Approved by		3SBIO	QA Manager
批准		三生	QA 经理

Revision History

版本历史

Revision	Date	Name of Author(s)	Description of Changes
版本	日期	编写人	变更描述
00	2009-01-12		Draft 草案

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INDEX 目录

1. Introduction 介绍	4
2. Overview 概况	4
3. Quality Plan 质量计划	4
3.1. User Quality Requirements 用户质量要求	4
3.2. Quality System 质量体系	5
3.2.1. References 参考文件	5
3.2.2. Work Flow 工作流程	6
3.2.3. Kick off meeting 项目启动	7
3.2.4. Design Review and Design Qualification 设计审核和设计确认	7
3.2.5. Receiving Inspection 收货检查	7
3.2.6. Construction Control 施工控制	7
3.2.6.1. Welding Documentation and Inspection 焊接文件和检查......	7
3.2.6.2. Slope Inspection 坡度检查	9
3.2.6.3. Hydraulic Testing 水压测试	9
3.2.6.4. Cleaning and Passivation 清洗和钝化	10
3.2.7. Acceptance Test 验收测试	11
3.2.7.1. Factory Acceptance Test 工厂验收测试	11
3.2.7.2. Site Acceptance Test 现场验收测试	12
3.2.8. Installation Qualification 安装确认	12
3.2.9. Documentation Management 文件管理	14
3.2.10. Change Control 变更控制	15
3.2.11. Deviation Handling 偏差处理	15
4. Project Plan 项目计划	16
4.1. Project Organization 项目组织	16
4.2. Deliverable Items 移交清单	17
4.3. Project Schedule 项目进度表	18
5. Glossary 词汇	19
6. Attachment 附件	19
6.1. Attach.1- Project Organization Chart 项目组织结构图	19
6.2. Attach.2- Project Schedule 项目进度表	19

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1. Introduction

介绍

This Quality and Project Plan (QPP) is used for project management and quality control of new plant of Shenyang Sunshine pharmaceutical company limited. This document is written by Shanghai Macroprocess and is reviewed and approved by 3Sbio.

本质量项目计划是为了沈阳三生制药有限责任公司的新建车间的项目管理和质量控制而制定。本文件由上海朗脉科技有限公司编写完成，经三生审核和批准。

2. Overview

概况

This project include the design, construction, commissioning and qualification for the following systems:

本项目包括了以下系统的设计、施工、调试和确认：

- Media preparation system

培养基配制系统

- Buffer solution preparation system

缓冲液配制系统

- CIP system

CIP 系统

3. Quality Plan

质量计划

3.1. User Quality Requirements

用户质量要求

These systems of the project should be in accordance with Chinese GMP (1998) and FDA cGMP requirements.

本项目建设的系统，应该符合中国GMP（1998 年修订版）要求和美国cGMP 要求。

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3.2. QualitySystem

质量体系

3.2.1.References

参考文件

The project will conduct the design, construction, commissioning and qualification according to the following regulations and guidance.

本项目将按照以下标准和法规进行设计、施工、调试和确认：

No.  序号	Document Name 名称	Document Number  编号	Revision/date  版本/日期
1	User requirement specification (tender technical part) 用户需求说明（URS）（招标文件技 术部分）	NA	2008.12.31
2	Chinese GMP 2005 中国GMP（1998 年修订版）	NA	1998 revised
3	US cGMP 美国cGMP	21 CFR part 210-211	Current 现行
4	Eu GMP 欧盟GMP	NA	2008
5	ISPE Baseline Volume 4: water and steam system ISPE 指南第4 卷：水和蒸汽系统	NA	First edition/January, 2001
6	GAMP 5	NA	2008 年

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3.2.2. Work Flow

工作流程

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3.2.3.  Kick off meeting

项目启动会

After the contract is signed and effective, our project manager will arrange the Kick-off meeting in order to confirm the project schedule, persons resource, detailed design and procurement etc.

合同签订生效之后，项目经理将召开项目启动会，进行技术交底，并讨论和确定项目进度、人员安排、详细设计和采购事项等等。

3.2.4.  Design Review and Design Qualification

设计审核和设计确认

In the end of detailed design phase, the project manager will arrange our project team persons including validation person to do design review in order to the design is in accordance with user requirements and cGMP requirements. Finally, the reviewed design documents will be submitted to client for review and approval.

详细设计完成之后，项目经理将组织项目各专业人员，包括验证人员，对详细设计图纸进行设计审核，以确保设计能够符合用户需求和GMP 要求。最后，审核后的详细设计文件将提交给客户进行批准。

If the contract require that a formal DQ document should be provided, our validation engineer will write the DQ document and submit to client for review and approval.

如果合同规定要提供正式的DQ 文件，那么我们的验证人员将编写一份DQ 文件，并提交给客户审核和批准。

3.2.5.  Receiving Inspection

收货检查

When the material arrival at construction site, the receiving inspection will be done by our project engineer and a “material receiving inspection sheet” will be filled in.

材料到达现场时，项目人员将对材料进行检查，并填写“材料检查记录”。

As a minimum, the inspection items should at least include the following”

检查的项目，至少包括以下几项内容：

- packaging inspection 外观检查，是否完好

- check if the name, model and quantity of goods conform with purchase orders 与供货单进行对照，检查物品、型号规格、数量是否一致

- documentation, such as material certificate 文件资料是否完整，如材质证明。如没有随货一起，那么另外进行收集和检查

3.2.6. Construction Control

施工控制

3.2.6.1.  Welding Documentation and Inspection

焊接文件和检查

Prior to welding ,sample welds will be made to ensure highest quality of welding:

在正式焊接之前，要进行焊样焊接，以检查焊样是否合格。以下情况要进行焊样焊接和检查：

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- Daily at at the beginning and finishing of each work shift| 每班开始和结束

- when changing welding machine, pipe size or pipe lot. 当更换焊机、管子规格或管子批号时

Each sample weld shall be given a subsequent number and welding parameters shall be noted on the “welding report of sample welds”. If contract requires that the report should be signed and approved by client representative, then the report shall be submitted to client for approval.

每个焊样都有一个独自的焊点编号，并编写“焊样焊接报告”。如果合同规定，焊样焊接报告由客户项目负责人或代表进行签字确认，则将此报告提交给客户签字。

Once the samples found satisfactory, the welding on the piping can begin.

焊样合格之后，才能进行正式焊接。

Welding type includes orbital welding and manual welding. After each welding, the visual inspection should be done for welding appearance, and fill result in the “welding report”, such as material, diameter, welding type, welding number, welder and welding date etc. Each weld will be consecutively numbered and marked on the isometric drawing.

焊接类型分为自动轨道氩弧焊和手工氩弧焊。每次焊接之后，要对焊点的外观进行检查，并填写“焊接报告”，包括焊接的物料、管径、焊接类型、焊点编号、焊接人和焊接日期等。每个焊接都有独自的焊点编号，并在管道轴测图上标注。

Generally, inspection for welding will be performed:

对焊点的检查，通常包括了以下项目：

- Visual inspection of external surface on 100% of the welds

100%的焊点需进行外表面的外观检查

- Borescopic Inspections of internal surface on 20% of the welds

20%的自动焊点需进行内表面的内窥镜检查

- Borescopic Inspections of internal surface on 100% of the welds

100%的手工焊点需进行内表面的内窥镜检查

Borescopic inspection result is recorded on photograph or video.

内窥镜检查的结果以照片或录像的形式记录下来，并保存。

If contract requires that X-ray inspection should be done, X-ray inspection will be done after complete of pipe installation. Generally, the following inspection will be performed: (final sample quantity is according to contract)

如果合同规定需进行焊点的X 光探伤检查，则安排进行X 光探伤检查，一般可对以下项目进行X光探伤检查（最终的取样量以合同约定为准）：

- 100% of sample welds

100%的焊样

- 100% of manual welds

100%的手工焊点

X-ray inspection result is recorded on radiograph.

X 光探伤检查的结果以X 光片的形式记录下来，并保存。

Welding documents include:

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焊接文件包括了以下：

- Isometric drawing with welds marked and numbered 带焊点的管道轴测图

- Welding report for sample welds 焊样的焊接报告

- Welding report 焊接报告

- Welding machine print-out 机器打印报告

- Borescopic inspection report and photograph or video 内窥镜检查报告和照片或录像

- X-ray inspection report and radiograph (if applicable)  X 光探伤检查报告和X 光片（如果需要）

- Welder’s certificates 焊工资质文件

3.2.6.2. Slope Inspection

坡度检查

In order to assure the complete drainability, it is required 0.5-1.0% of slope for horizontal line.

为了使洁净管道系统能够实现完全排放，对于水平管道，要求有至少为0.5%-1%的坡度，以使管道残留水能够顺着管道排出。

During installation of pipe, the slope inspection will be done and recorded in the “slope inspection report”, if non-conformity, modification should be done.

在管道安装时，须对管道的坡度进行检查，并填写“坡度检查报告”， 如不符合要求，须进行调整。

Membrane valves on horizontal pipe should have a slope according to valve supplier and Diameter in order to completely drain.

水平管道上的隔膜阀的安装，须有一定的倾斜角度，以使管道的水能够完全排放。

3.2.6.3. Hydraulic Testing

水压测试

Prior to hydraulic testing, the preliminary pneumatic testing shall be carried out with compressed air or nitrogen in order to check the networks tightness and no leakage.

在进行水压测试之前，先用压缩空气或氮气进行气压测试，以确保系统无泄漏。

Hydraulic Testing procedure and criteria: DI water or Purified water is used. The hydraulic test pressure is equal to 1.5 times the design pressure and not less than 0.6 MPa. The test time is not less than 2 hours. As criteria, there should be no leakage and pressure loss is not more than 0.03MPa.

水压测试程序和标准：用去离子水或纯化水充满整个系统，用水压测试泵加压至设计压力的1.5 倍，且至少0.6 MPa 压力，保压至少2 小时，系统无泄漏，压力降低不大于0.03MPa。

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3.2.6.4. Cleaning and Passivation

清洗和钝化

The purpose of cleaning and passivation is to remove the grease, oxidation layer of welding and free iron etc. in the internal pipe and form a chromium oxide film.

清洗和钝化目的是为了去除管道系统内表面油脂、焊接氧化皮、游离铁离子等污物，并在管道内部形成一层铬保护膜。

The solution of cleaning and passivation should not contain chlorine. DI water (de-ionized water, purified water or more quality water should be used. In the document, DI water is in lieu of all others.

清洗钝化过程使用不含氯的溶液，使用的水为去离子水,纯化水或更高水质的水，以下以去离子水统称。

Cleaning and passivation of sanitary pipe usually include the following stages:

洁净管道的清洗和钝化，大致分为以下步骤：

1） Degreasing and cleaning 脱脂清洗

2） DI water rinse 去离子水冲洗

3） Passivation 钝化处理

4） DI water rinse 去离子水冲洗

For loop system, such as purified water and WFI loops, the below procedure will be followed:

对于循环管路系统，如纯化水和注射用水分配系统，清洗和钝化程序如下：

Degreasing and cleaing 脱脂清洗

Chemical 化学品	NaOH
Cleaning Solution	2% NaOH
清洗溶液	98% DI water
Procedure 程序	Recirculate at 0.1-0.3 MPa 泵压循环 0.1-0.3 MPa
Temperature 温度	Ambient 室温
Time 时间	45 min

Passivation 钝化

Chemical 化学品	HNO3, HF
Passivation solution 钝化溶液	20% HNO3  3% HF  77% DI water
Procedure 程序	Recirculate at 0.1-0.3 MPa  泵压循环 0.1-0.3 MPa
Temperature 温度	Ambient 室温
Time 时间	30 min

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For one way pipe system, such as pure steam distribution, the below procedure will be followed:

对于单路管路系统，如纯蒸汽分配系统，清洗和钝化程序如下：

Degreasing and cleaning 脱脂清洗

Chemical 化学品	NaOH
Cleaning Solution	2% NaOH
清洗溶液	98% DI water
Procedure 程序	Completely filled 浸泡
Temperature 温度	Ambient 室温
Time 时间	60 min

Passivation 钝化

Chemical 化学品	HNO3, HF
Cleaning Solution 清洗溶液	20% HNO3  3% HF  77% DI water
Procedure 程序	Completely filled 浸泡
Temperature 温度	Ambient 室温
Time 时间	45 min

After passivation, rinse with DI water until neutral pH is reached for each use point.

钝化之后，进行去离子水冲洗，直至所有区域，包括每个使用点，用pH 试纸测试为中性为止。

For non-water pipe system such as compressed air, nitrogen, only cleaning is required and passivation is not required.

对于压缩空气、氮气等非水介质的管道系统，只需进行脱脂清洗，无需进行钝化。

3.2.7. Acceptance Test

验收测试

3.2.7.1. Factory Acceptance Test

工厂验收测试

Factory acceptance test could be applied to any critical aspect and includes test activity, that will be carried out before the shipment, to get assurance that a new critical equipment/ package has been built following the design specifications and it is provided with the required documentation; moreover the FAT will help to avoid problems that could affect the on site activities progress.

工厂验收测试应该关注设备关键的方面，包括进行测试活动。这些测试将在设备起运之前进行，以保证该设备已按照设计标准进行制造，并提供所需要的文件。因此，FAT 可帮助避免可能影响现场测试的问题的产生。

FAT will be documented; the relevant test report or protocol, will be submitted to client for

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review, comments and approval; FAT execution will begin after client approval.

FAT 将要求进行记录；相关的测试报告或方案，将被提交给客户审核和批准。FAT 将在客户批准后进行。

It is required to conduct FAT only for Tank.

本项目仅要求对水系统储罐进行FAT 。

3.2.7.2. Site Acceptance Test

现场验收测试

Activity Applicable to critical system or equipment; SAT consists of Dynamic and static testing activities performed on site by the vendor before hand over the system to the client. Each SAT activity will be documented. Macroprocess will submit the test document (defined as SAT report or protocol) to Client (for comments and approval).

此工作适用于关键的系统或设备。 SAT 包含动态的和静态的测试活动，测试活动在现场由供应商在移交系统给客户之前进行。每一项SAT 工作将被文件记录下来。我们将提交测试文件（定义为SAT 报告或方案）给客户，以审核和批准。

All tests which reliability will not be affected by the system/equipment modification could not be repeated for qualification purpose, if properly executed (in conformity with Qualification Protocols), witnessed and documented.

那些不会因为系统/设备的改变而影响可靠性的测试，如果已得到正确的执行、证明和文件记录，那么在验证过程中不必重复进行。

3.2.8. Installation Qualification

安装确认

After SAT is finished, IQ and OQ will be conducted. In some case, IQOQ will be concurrent conducted with SAT .

在进行SAT 之后，进行安装确认（IQ）和运行确认（OQ）。有时，IQOQ 可与SAT 同时进行。

The Installation Qualification will determine that each equipment/system has been installed in accordance with the design (if new or renovated) and the applicable current good manufacturing practice (either if new or existing). IQ will confirm the availability of all the required documentation useful to manage and operate with the equipment/system itself.

安装确认将检查每一个设备/系统的安装是否符合设计和相应的GMP 规范。IQ 将确认所有的需要用于设备/系统的管理和操作的文件的可用性。

Prior to the IQ, systems will have to be mechanically completed.

在执行IQ 之前，系统的机械安装工作已完成。

IQ Acceptance Criteria IQ 接受标准:

-  All personnel participation in IQ execution must pass through the correlation pre-job training. 所有的参与IQ 执行的人员在实施前须经相关培训。

-  All documents (such as operating manuals, maintenance manuals, solder joint plans, records of welding, welding inspection, slope confirmation, pressure test document, endoscopies test records, etc.) will be examined, file location will be recorded.

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所有文件（如操作手册，维修手册，焊点图，焊接记录，焊接检查，坡度确认，压力测试文件，内窥镜检查测试记录等）将被检查，文档位置将被记录。

- All drawings (For example pipeline and measuring appliance flow chart, three dimensional pipeline schematic drawing, electrical chart, pneumatic operated chart and so on) and with the material quality proved and inspection file location will be recorded.

所有的图纸（如管道和仪表流程图，管道轴测图，电气图，气动图等）和材质证明等将被检查，文档位置将被记录。

- All equipment, instrument and accessory will be inspected and they are required to meet the pre-set standards

所有的设备，仪表和配套将被检查并须符合预设标准

- Instrument calibration has been successfully completed 仪表的校正已经成功完成

OQ could be executed and operated according to the pre-set operation arrange and mechanism performance through the recorded documentations prove that the system and equipment have been proper operated.

运行确认是按照预设的操作范围和机械性能进行，通过记录的文件，证明系统和设备能正确运行。

OQ Acceptance Criteria:OQ 接受标准

- All personnel participation in IQ execution must pass through the correlation pre-job training. 所有的参与IQ 执行的人员在实施前须经相关培训。

- All OQ activities should be conducted according to approved protocols. 所有的OQ 工作将按照已批准的方案执行

- OQ Test instruments should be calibrated; the relevant certificate should be NIST or Chinese National measurement standards traceable to the National Institute of Standard Technology and attached to the relevant protocol. OQ 测试仪器应被校准过的，相关的证书应可溯源NIST 或中国国家计量基准，并附在相应的方案中

- The system’s alarms and interlocks should operate in accordance with the design specification. 系统报警和联锁的情况应符合设计标准

- The system’s function should operate in accordance with the design specification. 系统功能运行应符合设计标准

- Utilities, used by the system, should be available at the battery limit within the specified range (temperature, pressure, flow-rate). 系统所用的公用设施应当在规定范围以内（温度、压力、流量）

For some simple system, such as pure steam distribution, because OQ tests are not much, usually IQ and OQ will be combined into one document.

对于简单的系统，如纯蒸汽分配系统，因为OQ 测试项目较少，可将IQOQ 文件合二为一。

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3.2.9. Documentation Management

文件管理

The effective control of all documentation is vital to the Project Management System. This control is important to the technical documents that form the primary elements for the Project.

对所有文件的有效控制对项目管理是十分重要的。特别对于技术类文件的有效控制，是项目中的基本要素。

Documents controlled under this system include:

受控的文件，包括以下：

-  Design documents设计文件

-  Project management documents项目管理文件

-  Contract documents合同文件

-  All other documents that affect or control the quality of the Project 其它与本项目的质量相关的文件

Document Control 文件控制

Design Specifications and Test Specifications will be reviewed and approved by Macroprocess and client. Documents within Design, Tests and Inspections are controlled as minimum by revision and document history, date, author’s initials and project information.

对于设计、测试和检查等的文件，应进行控制，起草之后，经过客户方授权的人审核和批准，并有版本、变更历史、日期和签名。

Modification of approved documents should be reviewed and approved by Macroprocess and Client and upgraded to next version.

批准后的文件的修改，需要经过朗脉和客户双方的审核和批准，版本进行更新。

Documentation and associated information should be stored safely and securely, They should be protected against accidental and malicious damage, and should be retrievable throughout the defined retention period.

文件档案应妥善保管，保证安全，避免遗失和损坏。

Document number and version 文件编号和版本

Every document should have a Document Number and Version. Document Number has the following structure:

每份文件应该有文件编号和版本。文件编号由以下几个部分组成：

- Abbreviation for the project 项目缩写词

- Abbreviation for system/equipment, if applicable 系统或设备的缩写词（如果适用）

- Abbreviation for different project phase 项目活动缩写词

- Serial Number (three digitals), if applicable三位数字的顺序号（如果适用）

Documents should be under version control and in draft form prior to formal issue. Their version number should clearly distinguish between draft and approved versions. Version numbers are assigned to each project document, ranging from 00, 01, 02, until 99. The project document has to be distributed as a new version, when any changes are made. If a new draft document is issued, the author assigns the version number 00 to it and distributes this under the “draft”

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status to the review team.

文件应进行版本控制，正式发布之前为草案。每个项目文件的版本号，从00、01、02 到99 进行一次编号。当文件有变更时，版本也进行更新。起草一份新的文件时，版本为00，意为“草案”， 经过审核和批准后，正式首次发布的版本为01。

3.2.10.  Change Control

变更控制

All system changes that affect already approved documents and GMP Compliance have to be managed according to a change control procedure. All these changes are demonstrably planned, evaluated, approved, and GMP-conform executed and documented.

所有影响已经批准的文件和GMP 有关的变更，需要按照变更程序进行管理。所有这些变更需要进行书面提出，经过合适的评估和批准，然后实施，并进行记录。

3.2.11.  Deviation Handling

偏差处理

A Deviation report will be generated during execution of tests. If a test result is not accepted according to the given acceptance criteria the report will be filled in. The deviation should be evaluated and documented and the action measures also should be evaluated, reviewed and approval before execution. Finally, follow-up should be done to check the action result.

如果在测试过程中，出现不符合要求的项目，需编写偏差报告。偏差情况需进行书面的评估、提出偏差处理意见，并经书面审核和批准，然后实施。而且，跟踪实施情况，记录实施的结果。

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4. Project Plan

项目计划

4.1.  Project Organization

项目组织

For good management and control of whole project, one project team should be founded which include persons from Macroprocess and client. The project organization chart please see attachment 1. List of main project members is following:

为了对整个项目进行良好的管理和控制，成立一个项目组织团队，包括了朗脉的项目人员和客户的项目人员，项目组织结构图请见附件1。以下是主要项目人员的清单：

Title 职务	Name 姓名	Contact 联系方式
Macroprocess
上海朗脉
Project manager
项目经理
Site manager
现场经理
Design engineer
设计
Procurement engineer 采购
Automatic engineer 自控
Electrical engineer 电气
Validation 验证
3SBIO 三生
Project manger
项目负责人
Project coordinator
项目协调员
Production manager
生产部经理
Engineering manager
工程部经理
QA manager
QA 经理

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4.2.  Deliverable Items

移交清单

No. 序号	Document Number 文件编号	Document Name 文件名称	Macroprocess 朗脉	3SBIO 三生
	General 通用部分
1	3SBIO-03-QPP	Quality and Project Plan 质量项目计划	W	A
	标准和说明
2	3SBIO-MPS-FS	Functional Specification of Media preparation system 培养基配制系统的功能说明	W	A
3	3SBIO-BPS-FS	Functional Specification of Buffer solution preparation system 缓存液配制系统的功能说明	W	A
4	3SBIO-CIP-FS	Functional Specification of CIP system CIP 站的功能说明	W	A
	Design 设计-Mechanical Part 机械部分
5	3SBIO-MPS-PID-01	P&ID of Media preparation system 培养基配制系统的管道仪表流程图	W	A
6	3SBIO-BPS-PID-01	P&ID of Buffer solution preparation system 缓存液配制系统的管道仪表流程图	W	A
7	3SBIO-CIP-PID-01	P&ID of CIP system CIP 站的管道仪表流程图	W	A
	Construction Documents 施工文件
8	QMS-SOP-SP-03-F01	Welding Report of sample welds 焊样的焊接报告	W	A
9	QMS-SOP-SP-03-F02	Welding Report 焊接报告	W	A
10	QMS-SOP-SP-03-F03	Borescopic Inspection Report 内窥镜检查报告	W	A
11	QMS-SOP-SP-03-F04	X-Ray Inspection Report X 光探伤检查报告	W	A
12	QMS-SOP-SP-04-F01	Slope Test Report 坡度测试报告	W	A
13	QMS-SOP-SP-05-F01	Hydraulic Test Report 水压测试报告	W	A
14	QMS-SOP-SP-06-F01	Cleaning and Passivation Report 清洗和钝化报告	W	A
	Qualification Documents 确认文件
15	3SBIO-MPS-DQ	DQ of Media preparation system 培养基配制系统的DQ	W, E	A

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No. 序号	Document Number 文件编号	Document Name 文件名称	Macroprocess 朗脉	3SBIO 三生
16	3SBIO-BPS-DQ	DQ of Buffer solution preparation system 缓存液配制系统的DQ	W, E	A
17	3SBIO-CIP-DQ	DQ of CIP system CIP 站的DQ	W, E	A
18	3SBIO-MPS-RA	RA of Media preparation system 培养基配制系统的RA	W, E	A
19	3SBIO-BPS-RA	RA of Buffer solution preparation system 缓存液配制系统的RA	W, E	A
20	3SBIO-CIP-RA	RA of CIP system CIP 站的RA	W, E	A
21	3SBIO-MPS-TM	TM of Media preparation system 培养基配制系统的TM	W, E	A
22	3SBIO-BPS-TM	TM of Buffer solution preparation system 缓存液配制系统的TM	W, E	A
23	3SBIO-CIP-TM	TM of CIP system CIP 站的TM	W, E	A
24	3SBIO-MPS-IQOQ	IQOQ of Media preparation system 培养基配制系统的IQOQ	W, E	A
25	3SBIO-BPS-IQOQ	IQOQ of Buffer solution preparation system 缓存液配制系统的IQOQ	W, E	A
26	3SBIO-CIP-IQOQ	IQOQ of CIP system CIP 站的IQOQ	W, E	A
27	3SBIO-MPS-PQ	PQ of Media preparation system 培养基配制系统的PQ	/	W ,E, A
28	3SBIO-BPS-PQ	PQ of Buffer solution preparation system 缓存液配制系统的PQ	/	W ,E, A
29	3SBIO-CIP-PQ	PQ of CIP system CIP 站的PQ	/	W ,E, A

Note 备注:

W-Writing 编写, R-Review 审核, A-Approval 批准, E-Execution 实施

4.3.         Project Schedule

项目进度表

The project will include the following activities:

本项目包括了以下活动：

- Detailed design 二次设计

- Design review 设计评审

- Procurement 采购

- Construction 现场施工

- Commissioning 调试

- Qualification 确认

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The detailed Project Schedule is shown in attachment 2. (see bidding document)

详细的项目进度表，请见附件2 (见标书其它部分)。

5. Glossary

词汇

CFR	Code of Federal Regulations 美国联邦法规
FAT	Factory Acceptance Test 工厂验收测试
FS	Functional Specification 功能说明
GAMP	Good Automated Manufacturing Practice 良好的控制系统生产规范
GMP	Good Manufacturing Practice 药品生产质量管理规范
HDS	Hardware Design Specification 硬件设计说明
IQ	Installation Qualification 安装确认
OQ	Operational Qualification 运行确认
PQ	Performance Qualification 性能确认
QP	Qualification Protocol 确认方案
QPP	Quality and Project Plan 质量和项目计划
QR	Qualification Report 确认报告
RA	Risk Assessment 风险评估
SAT	Site Acceptance Test 现场验收测试
SDS	Software Design Specification 软件设计说明
SOP	Standard Operating Procedure 标准操作规程
TM	Traceability Matrix 追溯矩阵表
URS	User Requirement Specification 用户需求说明
VP	Validation Plan 验证计划
VR	Validation Report 验证报告

6.  Attachment

附件

6.1. Attach.1- Project Organization Chart 项目组织结构图

(见标书 see bidding document)

6.2. Attach.2- Project Schedule 项目进度表

(见标书see bidding document)

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第5 部分验证方案 Construction Scheme

第 5 部分

Part 5

施工组织

Construction Scheme

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

上海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

T:021 54306717      F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第5 部分验证方案 Construction Scheme

目 录

Index

1.工程施工人员组织设计 Staff organization	2
1.1. 人员组成结构图 Organization Chart	2
1.2. 项目组成人员角色及职责 team and responsibility	2
1.3. 验证经理资质 Validation manager qualification	5
1.4. 施工人员组织 Construction organize	10
1.5. 项目经理负责人资质 project manager qualification	10
1.6. 质量控制组织图 Quality control	15
2.施工设备材料投入计划 Tools list	16

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第1页/共18 页

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	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第5 部分验证方案 Construction Scheme

1. 工程施工人员组织设计Staff organization

1.1. 人员组成结构图Organization Chart

目前拟定结构如下：At present,we study out the staff organization chart as the following:

1.2. 项目组成人员角色及职责team and responsibility

项目经理Project manager

项目负责人；协调和负责整个项目执行，确保项目执行达到各节点要求；安全第一负责人；是业主用户和上海朗脉科技有限公司的联系人；确认来往资料及传真，负责所有项目资料的归档。

Take charge of the whole project , ensure the project proceed to the right requirement and conduct the construction staff. As the window between the owner and Macroprocess; clarify the letter

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第2页/共18 页

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	工艺配料系统 Process Formulation System
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and fax and all document of the project.

项目组project team

负责监督完成系统的工艺设计、自动化控制系统设计、CAD 图纸制作等的设计，出图、资料准备、组态及实施监控，完成整个项目设计工作。

Work together to take charge of all design, drawings of technical and control system. Also prepare the document, configration and inspection to achieve the design task.

施工经理 construction manager

负责项目系统的现场调度、实施、安装、检测和系统正常运行等现场技术支持服务，同时负责协调工程培训事宜，包括培训日程、地点、人员安排等。该职位作为项目实施过程中朗脉公司人员直接与业主沟通。

Take charge of technical support for implement 、installation 、test and operation of whole project, and also response to training including the place、schedule。This position is used to communicate with owner directly.

品质管理和质量 quality manager

负责协调和监督工程实施过程中项目质量符合系统设计要求，满足客户需求，同时监控项目实施中的安全操作，确保人力物力的安全。

Ensure the quality meet the owner’s requirement and comply with sepecification, and also control the operation in the construction work, ensure the safty of human resource and material resources.

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第3页/共18 页

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采购经理 purchase manager

具体负责系统设备的预算、采购、物流等管理和支持工作，是项目正常实施的物流枢纽。

Take charge of project’s budget, purchase, logistic and other support. As a hinge of all project.

验证经理Validation manager

评估项目质量要求和提供项目实施验证方案确保符合顾客要求，验证与行业规范相符合。

Evaluate the whole project quality requirement and provide the validation proposal to meet the client regulation requirement.

用户项目经理 owner project manager

为了使双方的共同渠道畅通，顾客需任命一名项目经理，该项目经理要保证用户的招标承诺实现。并且确认上海朗脉科技有限公司的项目经理定期与用户沟通。用户项目经理是用户与上海朗脉科技有限公司的交流窗口。

In order to push the project smothly,client need to appoint one project manager to ensure promises of whole work. And also need to communicate with Macroprocess stablely.this postion is also a window between owner and client.

用户工程组 user team

用户工程组为上海朗脉科技有限公司提供实施项目质量保证的支持工作。作为设计、质量、验证、工程、安全卫生环保的沟通机构。

This team shall provide support to Macroprocess to ensure

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第4页/共18 页

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	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第5 部分验证方案 Construction Scheme

quality.

用户工程师代表 Engineer representation

工程的成功需要用户工程组的努力及配合，参与设计方案的准备有助于他们理解系统，而系统最终要由他们来维护。参与设计及以后的培训使他们能够更加彻底的了解系统。

Engineer representation of client need join with Macroprocess to understand the whole design and the proposal, and they will maintain the system by themselves. That to take part in the design is good for them to familiar with whole project.

1.3. 验证经理资质Validation manager qualification

验证是项目不可或缺的组成部分，验证的过程将直接确保项目的实施是否符合国际法规的要求，确认是否满足验证指定要求。上海朗脉科技有限公司的验证部门派出质量总监全权与其验证团队监督项目的执行。

Validation is one important part of the whole project, Macroprocess will delegate quality director with his team to monitor the project. And his qualification as the following:

他的履历情况如下：

验证经理 Validtion manager 陈国笋 Chen Guosun

学历教育Education and Qualification： 浙江大学药学院 药学专业本科 执业药师 Bachelor in Pharmacy,

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第5页/共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第5 部分验证方案 Construction Scheme

Pharmacy College of Zhejiang University

Licensed Pharmacist

专业技能 Professional Competence：

有8 年多的制药行业经验，尤其在验证和质量管理方面。Has over 8 years of professional experience in Pharmaceutical Industry, especially in Validation and Quality Management.

ü  熟悉中国、美国和欧盟GMP 法规和指南。Be familiar with Chinese, USA and EU GMP Regulations and Guidance.

ü  有GMP 培训和验证的经验，如HVAC 系统的确认、水系统的确认、设备确认、清洗验证和工艺验证等。Experience in GMP training and validation (i.e. HVAC system qualification, water system qualification, equipment qualification, cleaning validation, process validation etc.).

ü  有在制药公司进行生产和质量管理的经验。Experience in Production and Quality Management in Pharmaceutical Company.

主要项目Key Projects：

石家庄欧意药业  口服固体制剂 Shijiazhuang Ouyi Pharma.   Oral Solid Dosage Forms

验证经理。负责按照中国GMP 和FDA cGMP 的要求领导验证工作。对HVAC 系统和纯化水系统进行设计审核。编写HVAC 系统、洁净室和纯化水系统的IQOQ 方案，并实施。

Validation Manager

Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, FDA cGMP.

Design review of HVAC system and purified water system.

IQOQ Protocols writing and execution of HVAC system, Clean room and purified water system. IQOQ protocols

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第6页/共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第5 部分验证方案 Construction Scheme

writing and execution of HVAC computerized system.

杭州九源基因     原料药 Hangzhou Jiuyuan Bio-Gene.     API

验证经理。负责按照中国GMP 和FDA cGMP 的要求领导验证工作。

纯化水和注射用水系统的设计审核。纯化水和注射用水系统的IQOQ 方案的审核。

Validation Manager

Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, FDA cGMP.

Design review of Purified water, WFI systems.

Review of IQOQ protocols of purified water, WFI systems.

齐鲁安替制药     无菌原料药 Qilu Antibiotics Pharma      Sterile API

验证经理。负责按照中国GMP 和FDA cGMP 的要求领导验证工作。

纯化水、注射用水和纯蒸汽系统的设计审核。

Validation Manager

Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, FDA cGMP.

Design review of Purified water, WFI system and pure steam system.

成都生物研究所      疫苗 Chengdu Institute of biological product      Vccine

验证经理。负责按照中国GMP 和WHO GMP 的要求领导验证工作。 纯化水、注射用水、纯蒸汽和压缩空气的设计确认。

Validation Manager

Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, WHO GMP.

DQ of Purified water, WFI, Pure steam, compressed air.

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第7页/共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第5 部分验证方案 Construction Scheme

浙江华海药业      口服固体制剂

Zhejiang Huahai Pharma.      Oral Solid Dosage Forms 

GMP 咨询师。按照中国GMP、FDA cGMP 和欧盟GMP 对概念设计进行GMP 审核。(已于2007 年通过FDA GMP 检查)

GMP Consultant

GMP review of conceptual design in accordance with the requirement of Chinese GMP, FDA cGMP and EU GMP. (Already passed FDA GMP Inspection in 2007)

大连美罗制药厂      滴眼剂

Dalian Merro Pharma.      Eye Drops

验证经理。负责按照中国GMP 和欧盟GMP 的要求领导验证工作。

负责验证主计划的编写。编写HVAC 系统、洁净室、纯化水、注射用水系统的IQOQ 方案，并实施。

Validation manager

Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, EU GMP.

Responsible for VMP writing.

IQOQ protocols writing and execution of HVAC system, Clean room, PW/WFI system.

北京四环生物      疫苗

Beijing Four ring Bio-pharma      Vaccine

验证经理。负责按照中国GMP 和欧盟GMP 的要求领导验证工作。

编写HVAC 系统、洁净室的IQOQ 方案，并实施。

Validation manager

Responsible for Design GMP review and VMP writing in accordance with the requirement of Chinese GMP, EU GMP.

IQOQ protocols writing and execution of HVAC system

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第8页/共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第5 部分验证方案 Construction Scheme

and Clean room.

石家庄恩必普药业      软胶囊

Shijiazhuang NBP Pharma.      Soft capsule

验证经理。负责按照中国GMP 和FDA cGMP 的要求领导验证工作。

负责验证主计划的编写。编写HVAC 系统、洁净室、纯化水系统的IQOQ 方案，并实施。工艺验证、清洗验证和分析方法验证的培训。

工艺设备的计算机系统验证。

Validation manager Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, FDA GMP. Responsible for VMP writing. IQOQ protocols writing and execution of HVAC system, Clean room, PW system. Training of process validation, cleaning validation and analytical method validation. Computer validation of process equipments.

北京费森尤斯卡比医药 片剂

Beijing Fresenius Kabi Pharma.     Tablet

验证工程师。HVAC 系统和洁净室的DQ/IQ/OQ 方案编写和实施。

(已于2005 年通过EMEA 的GMP 检查)

Validation engineer

DQ/IQ/OQ protocols writing and execution of HVAC system and Clean room.

(Already passed EMEA GMP Inspection in 2005)

上海莱士 血制品

Shanghai RAAS Blood Products

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第9页/共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第5 部分验证方案 Construction Scheme

验证工程师。HVAC 系统、纯化水和注射用水系统的DQ/IQ/OQ 方案编写和实施。

Validation engineer

DQ/IQ/OQ protocols writing and execution of HVAC system, Purified water and WFI systems.

1.4. 施工人员组织 Construction organize

为保质，按时完成贵公司的管道系统的施工，特组织人员如下：In order to guarantee the quality, & to complete the distribution loop on time, we especially organize our personnel as follows:

1.5. 项目经理负责人资质 project manager qualification

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第10页/共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第5 部分验证方案 Construction Scheme

针对本次项目的情况，目前暂时确定选择经验丰富的程千振经理作为项目经理人负责整个项目的实施。他的履历情况如下：

Evaluating this project,we choose professional manager named Chen Qianzhen as project manager to take charge the technical of whole peoject. And the folloing is the qualification:

Cheng Qianzhen

程千振

Education and Qualifications 学历教育

• Bachelor of Science，Mechanic Design (1992-1996) 理学学士，机械设计(1992-1996) Shandong University 山东大学

Professional Experience 专业经验

Mr. Cheng has over 10 years of professional experience in project co-ordination, procurement and planning, facility design, generation of facility design drawings, commissioning in pharmaceutical engineering field.

程千振先生在制药工程领域内已有10 年以上专业的项目统筹经验，其中包括采购计划，设施设计，生产设备的设计图，设备调试等。

Key Projects 重点工程

MACROPROCESS TECHNOLOGY CO., LTD.

上海朗脉科技有限公司

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第11页/共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第5 部分验证方案 Construction Scheme

Feb 2005 – 2005 年2 月至今 CHENGDU INSTITUTE OF BIOLOGICAL PRODUCTS 成都生物制品研究所 Project Manager, responsible for engineering design, construction, commissioning and validation execution for clean utilities system which complies to WHO GMP 项目经理，负责疫苗工厂按照WHO 的GMP 进行水系统设计，安装和验证执行。

NCPC NORTHBEST

华北制药集团北元有限公司

Project Manager, responsible for complete a retrofitted Clean Piping system and validation execution which complies to FDA. Water for Injection distribution system, Purified Water distribution system, Pure Steam piping system and Clean Compressed air piping system are included.

项目经理，制药厂按照美国FDA 的GMP 标准进行水系统的改造和验证执行。水系统包括注射用水分配系统，纯化水分配系统，纯蒸汽管道系统，洁净压缩空气管道系统等。

B.BRAUN MEDICAL (SUZHOU) CO., LTD.

贝朗医疗（苏州）有限公司

Project Manager, responsible for complete a retrofitted material preparation system and validation execution which complies to EMEA.

项目经理，制药厂按照欧盟的GMP 标准进行对大输液配料系统进行改造和验证执行。

SHANGHAI WISON BIOENGINEERING CO., LTD.

上海惠生生物工程有限公司

Project Manager, responsible for complete a new clean piping system for a new vaccine plant and an antibody laboratory. Including WFI and PW distribution system.

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第12页/共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第5 部分验证方案 Construction Scheme

项目经理，负责完成一个新的疫苗工厂和抗体实验室的洁净管道系统。包括注射用水系统和纯化水分配系统。

HANGZHOU TIANYUAN BIOPHARMA

杭州天元生物药业

Project Manager, responsible for engineering design, construction, commissioning and validation execution for clean utilities system which complies to WHO GMP

项目经理，负责疫苗工厂按照WHO 的GMP 进行水系统设计，安装和验证执行。

POLIFARMA (NANJING) CO., LTD.

南京宝利化制药有限公司

Project Manager, responsible for complete a retrofitted Clean Piping system and validation execution which complies to TGA. Water for Injection distribution system, Purified Water distribution system are included.

项目经理，制药厂按照澳大利亚TGA 的GMP 标准进行水系统的改造和验证执行。水系统包括注射用水分配系统，纯化水分配系统等。

GE HEALTHCARE (SHANGHAI) CO., LTD.

通用电气（上海）药业有限公司

Project Manager, responsible for complete a retrofitted WFI piping and PS piping system which complies to FDA. This company has been certificated by FDA

项目经理，制药厂按照美国FDA 的标准进行注射用水系统和纯蒸汽系统的改造。该厂的无菌大容量注射剂已通过美国FDA 的认证。

Project Manager, responsible for complete the clean piping system for their extension project which complies to FDA. WFI distribution system, PW distribution system, PS system and CA system.

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第13页/共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第5 部分验证方案 Construction Scheme

项目经理，扩建项目按照美国FDA 的标准进行洁净管道系统的建设。包括注射用水分配系统，纯化水分配系统，纯蒸汽系统以及压缩空气系统。

SUZHOU DOWNRAYS

苏州东瑞制药有限公司

Project Manager, responsible for process design, construction and commissioning for a clean piping for sterile API production.

项目经理， 负责无菌原料药生产，洁净管道的工艺设计，安装和调试。

BAXTER HEALTHCARE (SHANGHAI) CO., LTD.

百特医疗用品（上海）有限公司

Project Manager, responsible for complete a retrofitted material preparation system and validation execution which complies to EMEA.

项目经理，制药厂按照欧盟的GMP 标准进行对大输液配料系统进行改造和验证执行。

QILU ANTIBIOTICOS PHARMACEUTICAL CO., LTD.

齐鲁安替比奥制药有限公司

1996 – 2005 Project Engineer. Mr. Cheng, who has gotten rich engineering experience in this ten years, through organize and participate all the pharmaceutical project constructed by QILU Group. Such as sterile API project, sterile small volume injection dosage, lyo-product project and so on. And the sterile API project of Qilu Antibioticos has passed the qualification of EU GMP. Mr. Cheng organized and participate the whole duration. 项目工程师，十年内，通过组织并参与了所有齐鲁集团建设的制药项目，有无菌原料药，无菌小容量液体制剂，冻干产品等

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第14页/共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第5 部分验证方案 Construction Scheme

一系列项目，他获得了丰富的工程经验。其中齐鲁安替比奥制药有限公司的无菌原料药通过了欧盟 GMP 的检查。他参与了全过程。

1.6. 质量控制组织图Quality control

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第15页/共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第5 部分验证方案 Construction Scheme

2. 施工设备材料投入计划Tools list

齐全的施工设备准备是一个项目能够顺利执行的前提条件，朗脉公司已经准备了设备随时按需入场，按照项目施工要求，公司拟定安排以下主要施工机械设备投入计划，清单参照如下（最终设备材料计划以项目经理实际安排为最终确认实施清单）：

Our construction equipment is ready to undertake any task. And acoording to the requirement,we draw a draft plan to launch into project. The list as the following: (the finally plan is refer to project manager’s arrangement)

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第16页/共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第5 部分验证方案 Construction Scheme

 

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第17页/共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第5 部分验证方案 Construction Scheme

 

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第18页/共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

第 6 部分

Part 6

施工工艺

Construction Technics

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

上海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

T:021 54306717      F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

目  录 Index

1 主要施工工艺Construction Technics	2
1.1. 施工准备Construction preparations	2
1.2. 施工步骤Construction Flow	4
1.3. 配管质量检查流程 Pipline Quality Testing flow chart	6
1.4. 安全施工管理规范Safety and Good Engineering Plan	6
1.4.1. 安全目标safety target	6
1.4.2. 安全管理机构management organization chart	6
1.4.3. 安全管理规范health and safety guidance	7
1.4.4. 安全管理措施safety management measures	11
1.5. 施工质量管理Construction quality management	15
1.5.1. 质量保证体系quality assurance system	15
1.5.2. 质量保证措施quality assurance measures	17
1.6. 施工进度管理schedule manage	26
1.6.1. 进度管理及程序progress management and procedure	26
1.6.2. 全面资源保障Strategy for Deploying All Resources	26
1.6.3. 应急预案emergency preparation	27
1.6.4. 排除施工干扰之政策Strategy to Expel Interference	29

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第1页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

1 主要施工工艺Construction Technics

1.1. 施工准备Construction preparations

施工准备按以下几个过程：Construction preparations refer to the following procedure:

直观检查 Visual inspection

抽样检查，确认无损伤并符合要求，检查是否有塑料帽密封10%  random checks, confirmed no damage and meet requirements, check whether there are any sealed plastic caps 10%

检查型号，数量及证书Check model No., quantities & Certificates

核对定货单 Verification with materials order form

加工现场的准备 Preparations for field fabrication

验收及接收由负责人完成确认 Acceptance and receipt of completion to be recognize by the person in charge

材料储存在指定区域内并根据型号，尺寸，洁净级别分类保存 Materials stored in the designated areas under the model, size and sanitary class for preservation & identification

材料运输不可弯曲，撞击，挤压等 When transport materials do not bending, impact and have other extrusion.

材料取用需有详细记录 Material shall be released from storage with detailed records

现场测量，相关设备的检查 Field survey and inspection of Related Equipment

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第2页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

样本制作 Samples production

材料预制：管道切割，面处理，弯曲及预制焊接。Prefabricated materials: Pipeline Cutting, surface treatment. Bending and prefabricated welding

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第3页/共30 页

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	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第4页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
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	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

Field welding include 现场焊接包括：

管道定位，现场焊接，质量检查。为保证每一焊缝内表面无氧化变色。必须使用高纯度保护气体，保证冲气时间不小于30 分钟。Pipeline positioning; field welding; quality inspection. To ensure that no surface oxidation color on inner weld surfaces; protection must use high-purity gases, air time is guaranteed– not less than 30 minutes.

  非焊接连接：配件、设备连接 Non-Welding connection: accessories, equipment connection

施工后处理：管道检查。气密性测试。Procedure after Construction: pipeline inspection, gas tightness test.

文件移交：样本记录，施工记录及测试报告 Documents submission: samples records, test reports and construction records

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第5页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

1.3. 配管质量检查流程 Pipline Quality Testing flow chart

1.4. 安全施工管理规范 Safety and Good Engineering Plan

1.4.1. 安全目标 safety target

本项目的安全目标是“零事故”。

The safety target for this project is Zero Accident.

1.4.2. 安全管理机构 management organization chart

项目经理 Project Manager：

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第6页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
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	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

项目经理是健康安全环保工作的第一责任人,对健康安全环保工作负全面的责任。 Project manager is the first responsible person for safety works. He is fully responsible for the safety work.

安全员 Safety Officer: 协助项目经理管理和执行健康安全环保计划,为健康安全环保工作的具体负责人。 Assist the project manager to manage and execute safety plan. He is the specific person in charge for the safety work.

1.4.3. 安全管理规范health and safety guidance

施工现场应有专职安全员，每天应定期、不定期巡查，发现安全隐患可责令相关人员停工整顿。In the constructing site, there should have full time safety inspectors who go on a tour of inspection periodically or aperiodically. If any hidden problem is found, order relative personnel shutdown and make amendment.

进入施工现场应戴好安全帽，系紧帽扣，穿好工作服，工作鞋，并佩带工作牌。When entering the constructing site, wear safety helmet, tie the helmet buckle tightly, wear working clothes and shoes and carry working tablet.

严禁穿拖鞋、高跟鞋、泡沫底鞋在工地行走、作业；特别是高空作业（高空作业是指操作点高度在离地面或楼面 1.5m 以上的施工作业）。Strictly forbidden walking and working on the constructing site with slipper and high-heel shoe on, especially high altitude working (high altitude working indicates working at a position more than 1.5mhigh from the ground or floor).

在现场作业人员严禁与其它施工队发生纠打等现象。Forbidden in site working personnel fighting with other construction team.

施工现场人员在工作期间严禁赌博、喝酒。No gambling and drinking is allowed during working time for the in site construction

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第7页/共30 页

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	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

personnel.

施工机械（设备）进场前，应检查设备的完好状态；重要的工具在每次使用前，应检查其是否完好。Check the construction mechanism before entering the construction place. Important tools should be checked each time before usage.

施工现场应规范用电，严禁私拉乱接，所有接线应由电工进行；电箱内应有漏电保护开关，保险丝。每一个用电回路均应由单一的断路器（或刀闸） 控制。Regulate electricity usage in the construction site. No private electricity connection is allowed. All the wire connection should be carried out by electrician. The electricity box should be equipped with leakage protection switch and fuse. Each electric loop should be controlled by signal switch (or brake).

所有电气工具操作人员应穿绝缘鞋或带绝缘手套。All electric facility operators should wear insulating gloves or shoes.

电焊机、手工氩弧焊机、自动轨迹焊机均应有可靠接地，接线端子有防护罩，在雷雨天气应暂停焊接作业。 Electric weld machine, manual argon arc weld machine and automatic orbit weld machine should all reliably connected to the earth. The connection should have protective cover. Stop welding in thunder storm situation.

高速旋转的电动工具（如型材切割机、砂轮机、台钻）在操作时严禁带纱质手套。工件的夹持应牢固，不得松动，防止随转动轴旋转或飞出。Wearing gauze gloves when operating the electric equipments with high revolving (such as cutting machine, grinding wheel machine) is forbidden. Hold the tools tightly to prevent their revolving or flying out along the revolving of axis.

各种气品在存放使用时，要距离明火 10 米以上，并且避免在阳光下爆晒，钢瓶在搬动过程中应轻拿轻放，严禁在地面上滚动或拖拉，严禁抛掷。All kinds of gases shall be over 10 meters away from open flame and avoid being insolated in the sun when they are stored or used. Slightly lift and put sown the steel tank. No rolling,

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第8页/共30 页

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	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

dragging and throwing is allowed.

登高作业时（高度超过 1. 5 米），应有专人配合，配合人员负责工具，材料的接送，并负责看护；作业人员应佩带安全带，安全带的搭扣应系在操作点的上方的牢固构件上。 Climbing work should be assisted by special person who is in charge of delivering materials and tools and watching. Working person should wear safety belt with its agraffe tied to substantial component on top of the operating point.

撑梯的张角应合适（一般为 60-70°为宜），梯子在摆放前应先清理地面，梯子严禁接长使用。Folding ladder should have a suitable open angle (60-70°preferred). Make up the ground before placing the ladder. Prolonging the ladder for usage is forbidden.

严禁病时酒后作业，严禁有恐高症、高血压等疾病的人员进行高空作业。Do not work when in sickness or after drinking alcohol. High altitude working is forbidden if operated by people with acrophobia, high blood pressure, etc.

在施工现场动火，应得到业主、工地安全员的书面批准，并在火源处摆放手提式灭火器。Making fire in the construction site should be approved by written permission given by the owner or safety personnel in construction place and a portable fire extinguisher should be put on the fire place.

动火前应先清理操作点附近的易燃易爆品，并由专业人员进行。Remove the flammable and explosive material around the fire place. This should be operated by professionals.

所有操作人员应按规定在进入施工现场施工时，签定安全施工责任书，实行安全奖惩制度。 All the operation personnel should sign safe construction duty sheet before entering construction site. Put the safety rewards and punishments regulation into use.

在彩钢板上施工时。应先检查彩钢板是否已安装完成，（特别是彩钢板加强吊筋是否已安装。人员在行走时应尽量在隔墙、隔断、吊筋处或附近，

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第9页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
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	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

重物应摆放在隔墙、隔断处。Before constructing on the colored steel sheet, first inspect if it has been completely installed (especially whether the reinforced hanger has been installed). People should walk on or near the partition, obstruct and hanger. Heavy things should be put at the place of partition and obstruct.

严禁在彩钢板开口处（如风口、灯孔等）行走、作业。 Walking and working at the colored steel sheet opening (e.g. air pot, lamp hole) are forbidden.

在容器和狭小管道内焊接时，应加强通风，严格执行双人监护制，监护人必须坚守岗位，发现问题要及时采取措施。When welding in containers or small-spaced pipes, ventilation shall be reinforced. Strictly execute the double-guardian system. The guardians shall stick to their post and take necessary measures once finding problems.

受压容器、密封容器、各种油桶、管道沾有可燃气体和溶液的工作进行时，必须先进行检查，并经过冲洗除掉有害、易燃、易爆物质并解除容器管道压力，清除容器 (包括密封空心、工件、管子 )的密封状态 (敞开口旋开盖)再进行工作，禁止在已做油漆或喷漆塑料的容器内焊接。When performing operations involving combustible gas and solution on the pressurized tanks, sealed tanks, various oil tanks and pipes, you should check them first, remove the harmful, combustive, and explosive material by flushing them, release the pressure of tanks and pipes, and remove the seals of the tanks (including the sealed cavity, work pieces, and pipes) before any work is done. To weld in the painted tanks is forbidden.

在做酸洗时，先试压，保压后用碱液试纸擦抹每一个焊缝，观察有无泄漏，严格执行双人坚督制、签字确认制，应穿带好防酸手套及防毒面具防酸胶鞋等防护用品。有关硝酸、盐酸、硫酸的化学用品使用中应注意：配比稀释时应逐渐地缓慢地小剂量的混合，切忌大剂量强制溶合,防止爆溅伤人。When performing pickling, have a pressure test first. Then

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第10页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
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	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

keep the pressure and erase each weld seam with alkali test paper to check if there is any leakage. Strictly execute the double-guardian system and signature-conforming system. Protective articles should be worn, such as acidproof gloves, gas mask, and acidproof rubber shoes. When using chemicals such as nitric acid, hydrochloric acid, and sulfuric acid, take care: When carrying out dilution practices, gradually and slowly mix with small volume. Do not mix with large volume, or it will cause explosion, spattering and damage.

废料、废水应妥善处理、不应污染工作环境Waste material and waste water should be treated properly without polluting the working environment.

进入甲方施工现场，应遵守甲方的一切安全规章制度。Obey party A‘s all safety regulations while entering party A’s construction site.

未尽事宜，应按国家有关规定的标准执行。Unmentioned matters are carried out in accordance with relative national criteria.

1.4.4. 安全管理措施 safety management measures

健康安全管理措施 health and safety management measures 总的原则是执行业主的健康安全计划，执行我公司安全管理的制度及政府的有关法规。The general principle is to execute the owner’s safety plan, our company’s safety management system and relative official regulations.

安全教育 safety education

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第11页/共30 页

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	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

安全教育的目的是提高职工的安全意识和自我保护的能力，避免各类事故的发生。 The safety education aims to improve employee’s safety awareness and self-protection ability and avoid accidents.

安全教育的形式 forms of safety education

进场安全教育*（*表示教育后需进行考试）Safety education on field entrance * (*indicates tests will be held after education）

方案技术交底教育 Technical notification on design proposal

星期一安全例会的教育 Regular safety meeting on Mondays

班前安全教育 Safety education before work

每一次教育都必须记录 ,记录教育的时间、地点、参加人员名单、教育的内容，进行考试的还应保存好考试成绩及试卷。 Each time the education should have a record to note the education time, location, person list and contents. Keep the test scores and test papers if test is taken.

安全作业单元与安全许可证safety operation unit and safety license

安全作业单 ,施工任务的布置通过安全作业单的方式下达 , 以保证安全工作与施工过程”五同时 ”(即计划、布置、检查、总结、评比五同时) Safety operation sheet. The construction tasks are assigned by safety operation sheets, which ensure the “five simultaneous” (simultaneous plan, assign, inspect, summarize, compare) of safety work and construction procedures

安全许可证，以下特殊作业必须有安全许可证：Safety license. The following special operations require safety licenses:

n 进入设备作业许可证 Equipment entry operation license

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第12页/共30 页

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	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

	■	电工作业许可证 Electrician operation license
	■	有毒有害作业许可证 Poisonous and deleterious operation license

安全检查safety inspection

安全检查是做好健康安装工作的重要手段之一,能及时发现事故隐患,及时制止“三违”(违章作业、违章指挥、违反劳动纪律)的行为发生，保证各项安全管理规章制度落到实处，从而杜绝事故的发生。Safety inspection is one of the key measures in safe installation. It can timely find the potential accident, prevent the “three breaches” activities (regulation-breaching operation, regulation-breaching direction, breach labor laws), and ensure all the safety regulations can be executed, so as to prevent the possibility of accidents.

安全检查的内容是：查领导、查制度、查机械设备、查安全设施、查教育培训、查操作行为、查劳保用品使用、查事故处理等。Contents of safety inspection: inspect the leaders, inspect the system, inspect the equipment, inspect the safety devices, inspect the education and training, inspect the operation, inspection the labor protection appliance, inspect the accident reasons, etc.

季节性安全检查。冬季应以防雪、解冻、跑漏、防临时建筑物倒塌为重点，秋季以防火防爆为重点。Seasonal safety inspection. In winters focus on snowproof, defreezing, and preventing the building collapse. In autumns focus on fireprotection and blameproof.

所有检查均必须按安全检查表进行，并做好记录。 All the inspections should be taken as per safety inspection sheet with relative records done.

基层检查均必须按安全检查表进行，并做好记录。Grass roots inspection should accord with safety inspection sheet with

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第13页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
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	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

relative records done.

代表性的安全检查种类 Typical Safety Inspection Category

领导检查中发现的隐患应下达书面的《事故隐患整改通知单》限期整改。If any hidden trouble is found during leader inspection, send out a Modification Notification on Hidden Trouble and ask them to modify it within a certain time.

隐患整改 hidden trouble modification

接《事故隐患整改通知单》后，责任人应立即组织整改，做到“三定”（定具体整改人员、定整改措施、定整改完成时间）； After receiving the Modification Notification on Hidden Trouble, the person in charge should arrange modification immediately, accomplishing “three establishes” (establish the persons involved in modification, establish the modification measures, and establish the finish time)

隐患整改完毕及时将整改结果书面反馈给通知单发出人。After finishing modifying the hidden troubles, timely feedback the modification results in paper to the person who sends out the modification notification.

通知发出人收到反馈情况后，要复验整改结果。The notification sender should re-inspect the modification results after having received the feedback.

应急计划 emergency

目的正确、及时处理意外情况，防止事故扩大，将事故损失控制在最小范围内。 The plan aims to correctly and timely treat the accidental conditions, prevent the accident from extending, and control the damages to a smallest limit.

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第14页/共30 页

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1.5. 施工质量管理Construction quality management

1.5.1. 质量保证体系quality assurance system

1.5.1.1. 公司质量方针guidance on quality

质量是永恒的追求，提供满足业主要求的工程和服务。

Quality is the goals to meet the requirement of owner on project and service.

1.5.1.2. 本项目质量目标target quality for this project

目标：保证我公司所提供的工程和服务，一次性通过相关认证。

Target: Ensure our engineering and services can pass relative certification only one time

1.5.1.3. 基本质量要求basic quality requirements

恰当的控制各项工程步骤；连续的保持各项质量的有效性。Control all the construction procedures correctly. Maintain all the quality indexes effective continuously.

要具有及时预防和及时纠偏的能力。Have the ability to timely prevent and correct the errors.

具有可追溯性，能正确方便的追溯到各项质量、生产状况、检验情况，能追溯到事和人，便于分析改进不断完善体系和提高工程质量。Traceability. We can trace back to quality, manufacturing, and checking status as well as matters and persons for the convenience of analyse and improving system and project quality.

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第15页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
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确保整个工程能顺利通过国家 GMP 验证，并达到美国 FDA 中要求的相应水平。 Ensure the whole project can pass the national GMP validation and FDA standards.

1.5.1.4. 现场质量保证体系construction field quality assurance system

项目质量实行公司经理负责制，对现场项目质量负有全面监督和保证职责。The project quality is ensured by manager responsibility system, which will monitor the on-site project quality.

现场项目经理对现场质量负有组织、全面管理的职责。 The field project manager is responsible to organize and manage the field construction quality.

建立以自检、互检和专职检查相结合的检验体系，把检验工作贯穿于预制、安装的全过程。对各个质量控制点，一定要按有关规范要求进行严格的检查、验收，验收不合格的工序坚决不允许转入下道工序。Establish a checking system combining self-check, cross check, and special check. The checking operation should be implemented through the prefabrication and installation. The quality control points should be checked and accepted by all relative regulations. Do not turn to the next procedure of the process if the previous procedure is unqualified.

质量员负责现场项目施工中的质量的检查监督、检验和试验、质量记录和不合格品的控制，以及推动、监督现场质量保证体系的正常运行。Quality officer is in charge of the quality supervision, inspection, experiment, quality record, and unqualified product control during field project construction, so as to promote and monitor the normal operation of on-site quality assurance system.

材料员负责自行采购和业主提供设备、材料的质量控制。The material officer is in charge of on-site purchasing and the

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第16页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
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	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

quality control of the equipment and materials provided by the owner.

现场作业层的各专业、施工单位，统一在现场质量保证机构领导和控制下进行质量活动。All the construction companies will carry out activities involving quality under the united supervision and control of on-site quality assurance organization.

恰当的控制各项工程步骤；连续的保持各项质量的有效性。Correctly control all the engineering steps. Maintain all the quality index continuously effective.

具有及时预防和及时纠偏的能力。This system has the capacity to timely prevent and correct errors.

具有可追溯性，能正确方便的追溯到各项质量、生产状况、检验情况，能追溯到事和人，便于分析改进不断完善体系和提高工程质量。This system is traceable. We can trace back to quality, manufacturing, and checking status as well as matters and persons for the convenience of analyse and improving system and project quality.

确保整个工程能顺利通过国家 GMP 验证，并达到美国 FDA 中要求的相应水平。Ensure the whole project can pass the national GMP validation and FDA standards

1.5.2. 质量保证措施quality assurance measures

严格按公司质量体系要求进行，特别注意人员培训，资质审核，材料检验，焊接工艺评定，工机具、量器具检验，各质量控制点等方面严格把关。

Strictly operate according to the quality system. Pay special attentions to personnel training, qualification verification, material checking, welding verification, tools and instruments checking. Check all the quality control points.

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第17页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

1.5.2.1. 图纸资料管理drawings management

对下发到各部门的图纸、方案、技术规范联络笺、材料代用单等必须指定专人统一管理，并登记收发，各技术员应做好施工原始资料，交工资料的整理工作，并协助施工班组填写各种施工记录表、卡，施工技术员每天必须记录施工日记。

All the drawings, proposals, technical standards, contact list, material sheet should be unitedly managed by a special person and have a registration record. The technicians should compile and pack all the original construction data and project handing over data, and assist the construction group to fill in all kinds of construction records and cards. The technicians should write the construction log daily.

1.5.2.2. 材料管理material management

材料方面的资料由材料员管理，如产品合格证、材质说明书、收发料单等。根据专业技术负责人审核过单线图，材料表和预算并填写限额领料单到仓库领料时，对材质、规格、数量进行核实和验收。并且有合格证件（或复印件）确认无误，并在计算机上进行消料处理。收货人签字。领回后入库时应规格、型号、材质、分类挂牌存放并计入帐卡，按上述程序材料员向班组发料，每天将领、发料单装订成册备查，领回后不入库直接运到现场的材料，也应计入帐卡，交接清楚，按指定地方堆放整齐。     The data concerning material, such as product certificates, material specification, material accepting and delivery sheet, are administered by material officer. Check the material, specification, and quality when receive material in the warehouse after fill in a material receiving sheet according to the drawings, material list, and budget. Check whether the certificates (or their copies) are valid and input it into the computer. The person who receives

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第18页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

the material should sign on the receiving sheet. After accepting the material, put it into the inventory. Separate and store them according to the specifications, models, materials and category. Distribute the material to the construction teams according to the above procedures. Compile a material receiving and distribution booklet each day. If a certain material is moved to the construction field instead of being put into the warehouse after being received, it should also be registered with clear notes to identify its location.

对所有材料特别是不锈钢，在切割后必须进行材质标识移置。The material marks should be moved after welding for all the materials, especially stainless steel.

1.5.2.3. 焊接管理 welding management

项目部设置焊接专业工程师、焊接组长及系统验证专职人员，具体负责焊接工作，包括在单线图上标注焊口号、焊工代号、无损检验部位，填写无损检验委托单，联系与配合试验室无损检验。焊缝预热和热处理记录，透视报告的保管，焊接及热处理施工记录，管理焊条的烘烤、存放和保管记录等验证文件都由专职人员进行处理。Project department possesses the welding technician, welding team leader, and system validation personnel. They are in charge of welding, including note welding port number, welder code, non-destruction inspection parts on the single line diagram, fill in the non-destruction inspection sheet, contact and coordination with the lab non-destruction inspection, welding seam preheating and heat treatment record, perspective report maintenance, welding and heat treatment record, welding rot roasting, and record storage and maintenance. These works will be done by special personnel.

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第19页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

每个焊工均有一个固定的代号。公司焊接试验室应把经考试合格的焊工姓名、代号及合格项目表及时发给焊工所在的施工队及检验部门备查。焊后在其所焊的焊缝旁用记号笔写上代号，并要标注在单线图上。 Each welder has his own stable code. Our company will hand over the welder’s name, code, and qualified project sheet to the construction team and inspection department for reference in time. The welder will mark his code close to the weld seam and note on the single line diagram after welding.

焊好的管线经自检、互检合格后按规定的 X 射线透视比例由施工队委托试验进行透视，X光底片以区域为单位，以管线号为依据，建立流水号。同一焊口在透视委托单、底片、透视记录、检验报告以及在单线图上的标注必须一致，使抽查任何一张底片就可知道焊接位置。透视一定要及时，未经透视或抽透不足及需要重新返修的管线一般不要去安装，以减少高空作业，对透视不合格的焊口应立即在管线上作出明显标志，并及时组织返修，直至合格为止。返修次数不锈钢管不超过两次，并作好返修记录。 Self-check and cross check the pipelines after welding. If it is qualified, the construction team shall carry out perspective operation according to the specified X-ray perspective ratio. The X-ray negative film is divided by units of area. Set up a numerical order according to the pipeline number. The marks should be unified for the same weld port on perspective sheet, negative file, perspective record, inspection record, and single line diagram for the convenience of knowing the welding position just by checking only one negative film. The perspective should be taken in time. The pipeline without perspective or with less insufficient perspective or repair needed should not be installed so as to reduce aloft work. Make obvious marks on the pipelines that have welding ports with unqualified perspective. Arrange repairs timely, until it is qualified. The

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第20页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

repair times should not be more than twice for stainless steel pipes. Do not forget to make repair records.

对所有预制完并经检验合格的管段，暂不安装的，管口应予以封闭。To all the pipes that have being prefabricated and qualified, but will not be installed immediately, seal the pipe ends.

对不锈钢管道，在预制和安装时不得与其它管道接触。 To the stainless steel pipes, do not contact them with other pipes when under prefabracation and installation.

1.5.2.4. 检验管理 checking management

  建立以自检、互检和专职检查相结合的检验体系，把检验工作贯穿于预制、安装的全过程。对各个质量控制点，一定要按有关规范要求进行严格的检查、 验收，验收不合格的工序坚决不允许转入下道工序。Establish a checking system combining self-check, cross check, and special check. The checking operation should be implemented through the prefabrication and installation. The quality control points should be checked and accepted by all relative regulations. Do not turn to the next procedure of the process if the previous procedure is unqualified.

1.5.2.5. 质量控制

项目质量控制重点参照业主工艺的要求，结合本公司在类似工程的施工经历，初步明确下列质量控制重点： according to the owner’s requirements and our similar construction experiences in the past, we’ve established the following key quality control points:

设备、材料的选择与采购 The selection and purchasing of equipment and material

焊接工程 Welding

电气、仪表 Electricity and instruments

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第21页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

清洁清扫Cleaning

资料管理 Documentation management

质量控制的原则the principles for quality control

预防为主、检验把关； Focus on prevention and inspection

以 FDA、SFDA 的标准作为项目施工和验收的依据；Set FDA and SFDA criteria as the standards for project construction and acceptance

设备、材料的选择和采购必须经过技术部检验合格后方可使用；The equipment and material can be used only after being verified by the technique department

工序质量否决制：即上一道工序不合格，坚决不允许进入下一道工序；Process quality veto system: Namely no entrance to the next procedure if the previous one is unqualified.

施工记录、质量记录与施工同步，确保施工过程得到有效控制；Construction record and quality record should be simultaneous with the construction, ensuing the construction procedure can be effectively controlled.

所有施工机具、检验、检测、计量设备符合项目施工技术、施工质量要求；All the construction devices and checking, measuring, and accounting instruments accord with the technical and quality requirements

参加和参与施工的人员必须符合施工技术的要求，主要工种须持证上岗，所有人员须经技术、安全培训合格。People who are involved in the construction should meet the technical requirements for construction. Person at important job position shall have certificate. All the staff must pass technical and safety training.

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第22页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

1.5.2.6. 针对性质量保证措施Pertinent quality assurance measures

焊接质量保证措施Welding quality assurance measures

焊接质量是施工质量中关键的组成部分。本工程为制药项目，有洁净度要求，为保证管道焊接质量，我们采取以下措施：Welding quality is the key in construction quality. This is a pharmaceutical project, which have high requirement on sanitation. To ensure the pipe welding quality, we will take the following measures:

不锈钢管道采用全自动氩气保护焊接；The stainless steel pipes are auto welded with argon gas protection

设置专门的不锈钢材料堆放场所；Set up special stainless steel storage place

成立专门的不锈钢管道施工队；Establish a special stainless steel pipe engineering team

每个焊工均有一个固定的代号。公司焊接试验室应把经考试合格的焊工姓名、代号及合格项目表及时发给焊工所在的施工队及检验部门备查。焊后在其所焊的焊缝旁用记号笔写上代号，并要标注在单线图上；Each welder has his own code. Our company will hand over the welder’s name, code, and qualified project sheet to the construction team and inspection department for reference in time. The welder will mark his code close to the weld seam and note on the single line diagram after welding.

对所有预制完并经检验合格的管段，暂不安装的，管口应予以封闭。To all the pipes that have being prefabricated and qualified, but will not be installed immediately, seal the pipe ends.

对不锈钢管道，在预制和安装时不得与其它管道接触。To the stainless steel pipes, do not contact them with other pipes when under prefabracation and

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第23页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

installation.

试压时使用的水源必须为纯化水，必须有效控制游离氯和氯离子的含量. The source water for pressure test should be purified water, which can effectively control the free chlorine and chlorine ion.

保温工程质量保证措施 Quality assurance measures for heat preservation

管道保温须进行错缝连接；Breaking joints for pipe heat preservation

保温层的包扎应严密不漏，符合规范的要求。The bandage for heat insulating layer should be tight and accords with the specification 。

清洁文明保证措施 Assurance measures for cleaning

施工现场保持清洁文明，特别是有洁净要求的厂房，每个工种完成工作后，清理干净工作区域；Keep the construction field clean. Especially in the plant building that have special requirements on sanitation, clean the working area each time after finish operation.

进入洁净厂房施工前，工具、设备、材料、防护用品都必须进行清洁，经检查后方可进入洁净厂房施工；Before entering the sanitary plant for construction, the tools, equipment, materials, and protective articles should be cleaned and inspected.

洁净厂房管道施工内外壁清理干净，焊口内外清除干净，并及时封闭，室内所有缝隙、电仪管口、接线盒必须清扫干净。Clean the inner and outer pipe walls. Clean the weld ports and timely seal them. Clean all the seams, electric instrument pipe ports, and connection box

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第24页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

1.5.2.7. 资料管理

对下发到各部门的图纸、方案、技术规范联络笺、材料代用单等必须指定专人统一管理，并登记收发，各技术员应做好施工原始资料，交工资料的整理工作，并协助施工班组填写各种施工记录表、卡，施工技术员每天必须记录施工日记。All the drawings, proposals, technical standards, contact list, material sheet should be unitedly managed by a special person and have a registration record. The technicians should compile and pack all the original construction data and project handing over data, and assist the construction group to fill in all kinds of construction records and cards. The technicians should write the construction log daily.

项目部设立专职验证员和资料员，专门负责相关文件的填写、交接、整理、归档等管理工作，使在施工过程中的每一道工序、每一个变更、每一次变更等都有相应的记录，具有可追溯性。施工过程中材料的质量证明文件，材料的自查、委托检查记录；施工方案的确定；施工人员的安排、施工机械的调配以及所有施工资源的分配全部有案可查。施工过程中与建设单位，其他施工单位的协调也相应作详尽的记录。最终目标使工程顺利通过建设单位、国家职能部门等检查，验证。The project department has verification officer and data officer to be specially in charge of document filling handing over, management and filing. Each procedure or each change should have relative record and is traceable.We have the history documents for material quality certificates, material self-check and cross check record, construction proposal determination, construction personnel arrangement, construction mechanics arrangement, and construction resources deployment. The detailed record of coordination with the constructed company and other construction

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第25页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

companies should also be available.

安装现场临时库房--分类存放

1.6. 施工进度管理schedule manage

1.6.1. 进度管理及程序progress management and procedure

向业主及工程总包递交的进度文件清单：The Progress list supplied to the owner:

进度周报、进度月报、进度计划（总体计划、季度计划、月度计划）、纠偏计划 Progress Weekly, Progress Monthly, Progress Plan (whole plan, quarterly plan, monthly plan), Correction Plan

进度管理职责表：Progress Management Responsibility Sheet

进度管理程序图 Progress Management Process Chart

1.6.2. 全面资源保障 Strategy for Deploying All Resources

充分调动公司内部的资源 Sufficiently Deploy Resources in Our

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第26页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

Company

我们充分认识到此项目的重要性，公司总部将从各个方面对此项目进行支持政策的倾斜 We fully understand the importance of this project. Our headquarter will offer privileged support on this project

项目经理长驻现场。Project manager will stay at the construction field for a long time.

向此项目选择经验的项目经理，优秀的工程师，有丰富经验的工人和完好的施工设备。We will select experienced project manager, excellent engineers, skillful workers, and whole package of engineering equipment

我们已做好劳动力的充分保障。We have sufficient labor insurance

充分调动当地资源 Sufficiently Deploy Local Resources

充分与兄弟施工单位加强联系，利用当地在水、电、气、材料供应，人力资源，加工能力，运输能力等优势。Sufficiently contact with other construction companies and make advantages of local water, electricity, gas, material, labor, and machining ability

1.6.3. 应急预案emergency preparation

冬季施工工期保证措施Assuring Measures for Construction in Winter

因工程主要施工时间在主体厂房施工完成之后，且装修、装饰基本施工完成之后，所以在冬季施工的寒冷气候对工程施工的影响并不是特别大。Our construction will start after the main part of the plant building is finished and its decoration is done, therefore the cold weather won’t have big influences to our construction

尽量避免室外施工，应全面检查防冻保暖工作，充分做好防寒、防冻、防滑、防火和防止一氧化碳中毒的措施。Try to

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第27页/共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

avoid outdoor construction. Fully check the antifreeze and heat protection measures. Take measures for anti-cold, anti-freeze, skid proof, fire proof, and carbon monoxide poisoning proof.

尽量避免冬季登高作业。Try to avoid ascending work

遇暴风雪应停止室外工作，严禁在冰冻的湿地上施工。Stop working at snowstorm. Do not work on cold and moist field.

夏季施工工期保证措施Assuring Measures in Summer

首先调整作息时间，使施工的主要时间集中在早晚比较凉爽的时间进行。 Adjust the work and rest time at first to focus the engineering time on morning and evening, when it is cold.

要配备必要的防暑降温设施、器材、药品和茶水饮料。Prepare necessary heatstroke preventative devices, equipment, drugs, and waters.

高温作业场所，应加强通风和降温措施。Reinforce ventilation and cooling measures for

通风机和排风扇等设备应由防护网罩。The ventilator and exhaust fan should have protection shield

要加强食堂的清洁卫生工作，严格执行检查消毒制度，防止职工食物中毒。Strengthen the sanitary conditions in dining room. Strictly execute the disinfection system. Avoid food poisoning.

雨季施工工期保证措施Assuring Measures in Rain Season

暴雨前后，要检查工地临时设施，脚手架、机电设备、临时用电线路等，发现倾斜、变形、下沉、漏雨、漏电等现象应及时修理加固，有严重危险的应立即排除；After rainstorm, check the temporary equipment, scaffold, electric devices, temporary electric loop, etc. Repair it if any

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第28页/共30 页

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incline, deformation, sinking, rain leakage, and electricity leakage is found. Remove it if it is severely dangerous.

雷雨时，严禁管道焊接工作。Pipe welding is strictly forbidden at thunder storm.

1.6.4. 排除施工干扰之政策Strategy to Expel Interference

当设备材料、设计图纸因特殊原因不能正点到位时，立即调整施工计划，制定补救工期的对策。一旦到位，立即施工，将失去的工期补回来。If the equipment, material, or design drawings can not arrive in place in time, adjust the construction plan immediately and set up countermeasure. Once they arrive, carry out construction immediately to offset the time limit.

自供的材料合理安排采购计划，确保不影响施工进度计划，对于因施工计划改变可能需紧急采购的材料，应在施工前做工供应商的评估。 For the materials that are supposed to be purchased by ourselves, reasonably arrange the purchasing plan. Verify the supplier before construction if urgent purchasing is necessary because of construction plan changes.

与生产运行有交叉的，在施工开始前做好防护隔离措施，保证施工与生产的安全顺利进行。 Take protective measures before construction if production operation is involved, so as to ensure the successful operation of construction and manufacturing.

坚持逐月检查，警惕和预防传染病的袭击，发现病员，立即隔离。Carry out checking month by month. Look out and guard against the attack of infection. If any patients are found, separate them from others.

管线及其它设施的加固措施 Solidifying Measures for Pipes and Other Devices

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管道在安装过程中，严格执行工艺作业规程，一般现做支架固定，并手工点焊固定，并在短期内施焊完成。During installation procedures, strictly implement the process working specifications. Normally use a bracket for the sake of solidifying and weld it in short time.

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第 7 部分

Part 7

管道系统施工规范

Construction Regulation for

Piping System

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

上海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

T:021 54306717      F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
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	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation

目 录

1. 管道系统施工规范 Construction Regulation	3
1.1. 焊接总则 General	3
1.2. 焊接规范 Welding regulation	3
1.2.1. 总体要求 General requirements	3
1.2.2. 材料 Material	3
1.2.3. 焊接准备 Weld joint preparation and fit-up	3
1.2.4. 预热温度 Preheating temperature	3
1.2.5. 供电 Electrical characteristics	3
1.2.6. 焊接程序 Welding procedure	3
1.2.7. 焊接修补 Weld repair	3
1.2.8. 自动焊接程序Automatic welding program	3
1.2.9. 文档 Documentation	3
1.2.10. 非破坏性检查 Non destructive examination	3
1.2.11. 每日焊接样品 Weld daily samples	3
1.3. 装配和安装 Fabrication and erection	3
1.3.1. 范围 Scope	3
1.3.2. 管件材料接收储存 Tubing materials receipt storage	3
1.3.3. 分类 Identification	3
1.3.4. 装配 Fabrication	3
1.3.5. 布管，切割和装备 Lay-out, cutting and fitting up	3
1.3.6. 焊接程序和资格 Welding procedure and qualifications	3
1.3.7. 安装 Erection	3
1.3.8. 焊接接口 Welded joints	3
1.3.9. 法兰接口 Flanged joints	3
1.3.10. 快装接口 Clamped joints	3

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1.3.11. 支撑和穿管Support of tubing and penetrations	3
1.4. 检查Inspection	3
1.4.1. 范围Scope	3
1.4.2. 配件和焊接编号Component & weld identification	3
1.4.3. 焊接准备Weld preparation	3
1.4.4. 焊接检验Weld inspection	3
1.4.5. 预装配件的保护Protection of prefabricated spools	3
1.4.6. 验收Acceptance	3
1.4.7. 其它要求Other requirements	3
1.5. 水压测试与清洁water pressure test and cleaning	3
1.5.1. 压力测试Pressure testing	3
1.5.2. 测试报告Test reports	3
1.5.3. 水压压力测试Hydrostatic test pressure	3
1.5.4. 系统清洁和清洗System cleaning and flushing	3
1.6. 管道系统脱脂、酸洗和钝化Chemical treatment	3
1.6.1. 安全Safty	3
1.6.2. 处理方法Method Treatment	3
1.6.3. 纯水和分配系统的化学处理treatment for PW and WFI	3
1.6.4. 蒸汽管道的化学处理solution for pure steam distribution loop	3
1.7. 水压、酸洗以及焊接报告Report	3
1.7.1. 水压测试报告表Certificate hydraulic test	3
1.7.2. 管道系统脱脂、酸洗、钝化报告表 Report	3
1.7.3. 焊接报告表Welding inspection sheet	3

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1. 管道系统施工规范Construction Regulation

1.1. 焊接总则 General

本规范适用于卫生管道的焊接、装配和安装。The specification applies for welding, fabrication and erection of sanitary piping.

本规范特别用于不锈钢 316L 管件间之圆周对接焊头之连接 In particular such specification is to be used for circumferential butt joints between sanitary piping components made of stainless steel type AISI 316 L.。

在项目中与本规范有冲突的其它规格必须与朗脉公司讨论，以便澄清和定义。Existing discrepancies between this specification and others applicable for the project, must be discussed with MACROPROCESS for clarification and definition

本规范中的焊接连接将需要符合 FDA 的验收标准和 3A 标准。Welded joints in the scope of this specification shall require the acceptance by FDA and shall comply with Sanitary Standard 3A.

本规范中术语装配者是指朗脉公司，她负责管道的装配和安装。In the scope of this specification the term FABRICATOR is referred to MACROPROCESS, who is encharged for fabrication and erection of piping.

“业主” 是指用户或其代表。the term OWNER is referred to CUSTOMER or his representative.

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焊接检查员”是指业主或用户代表，他将负责检查管道承建商的焊接操作。the term WELDING INSPECTOR is referred to the Owner or Customer representative who is en charged to inspect the welding operation and examination performed by piping construction Contractor.

1.2. 焊接规范 Welding regulation

本规范覆盖用自动轨迹焊接机或手动TIG 设备的气体钨电弧不锈钢焊接设备。

This specification covers the gas tungsten arc welding of austenitic stainless steel using automatic orbital tube welding machines or manual TIG equipments.

“管道”应包括所有需要焊接元件。

The term TUBING shall include all components of the welding.

1.2.1. 总体要求 General requirements

采用这些程序的手动 TIG 焊接工，将用实际工作材料作焊接试样测试以确认合格。这些焊接试样和自动焊接试样进行同样的独立检验。Manual Tungsten Inert Gas (TIG) welders using these procedure shall be qualified by making coupon test welds using actual job material. These coupons shall be subject to the same Independent examination as the automatic welds.

自动焊接机的操作人员将用样品材料做焊接测试以确认其资格。焊接测试应该选用项目常用的管材尺寸材料。Automatic welding machine operators shall be qualified by making acceptable test welds on sample materials. The welds shall be made on the prevalent job size tube material.

组件的定位点焊必须避免对完全焊接的不良影响。Tack welding of

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the components must avoid deleterious effect on the complete weld.

定位点焊应该尽可能的轻，以降低过热而导致材料的内部结构变化。Tack should be as light as possible to reduce over heat that might cause structural changes to the granular composition of the material.

定位点焊不应焊透内表面。Tacks should not penetrate the inner surfaces.

定位点焊完成后，需要检查线定位焊接的对准性和缝隙。After the tack welding completion it’s necessary to check the alignment and gap

1.2.2. 材料 Material

用于焊接的材料须符合甲方的技术规格。The material to be welded shall comply with the owner specification, .

所有管道和配件须完全焊透。All tubing and fittings shall have complete weld penetration.

采用的焊接电极为2%涂钍平头钨焊电极。Welding electrode to be used shall be a pointed 2% thoriated tungsten electrode with a flat tip.

焊接电极如有污染须更换。The electrode shall be replaced if contaminated.。

焊接管道内、外部保护氩气的最低纯度为 99.99%。Welding grade argon gas shall be use inside the pipe for back-up purge and

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shall be 99.99% minimum purity.

焊接过程中必须要通入氩气进行保护，以防止焊接的内表面被氧化。在开始焊接前，吹走焊接区域的所有氧气。Argon gas back-up has to be provided to prevent oxidative attack of the inner weld surface.Before starting the welding all oxygen is purged from the welding area.

1.2.3. 焊接准备 Weld joint preparation and fit-up

当焊接表面潮湿时，不得进行任何焊接。除非有适当的保护措施，在严酷气候或风速高或不良大气条件下不得进行室外焊接。No weld is carried out when surfaces to be welded are wet. No outside welding is carried cut during inclement weather or during periods of high wind or negative atmospheric agent unless the work is properly protected.

焊接接头两端面的清洁，圆整和平直是重要的。It is essential that the two surfaces of the joint are clean, circular and squared.

金属加工方法应确保焊接端表面光滑，无划痕或其它有害的不规则形状。The machining method of base metal preparation shall leave the weld end with smooth surfaces, free from notches or other harmful irregularities.

建议采用G+F 或同类设备来处理切割和最终处理。It is recommended to carry out the cut-off and final preparation using a G+F equipment or equivalent.

切割必须平直和不会造成管件变形或损坏。砂轮切割的管件端面必须清洁以除去磨屑。Cut-off must be squared and not cause any distortion or damage to the tubing. The pipe cut-off by an

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abrasive wheel must be cleaned to remove the abrasive dust.

碳钢切割工具在任何情况下都不得使用。Carbon steel cutting tools are not admitted in any circumstance,

用于焊接端面的处理、装配和安装工具，在使用前须检查是否是没有生锈的认可合金钢，清洁无油脂，和无其它污染残留物。Tools used for weld joint and preparation, fabrication and installation, shall be stainless of approved alloy steel, cleaned free of oil, grease and other contamination residuals before they are used.

不得使用硫基切割油，除非在焊接前管件的内外表面都被彻底清除所有残留油渍。Non sulphur based cutting oil may be used, provided all traces of such oil are completely removed from both the interior and exterior surfaces on the tubing prior to welding.

需与焊接检查员一起设定焊接设备。The welding equipment shall be set up together with WELDING INSPECTOR.

此检查员将检查所有设置是否符合主程序。他将签署焊接日志和注明日期。The inspector will check that all settings comply with the master program. He shall sign and date the welding log to that effect.

每天的开始时，每个操作人员要作焊接测试。这些焊样将编号，并呈交给焊接检查员。每台自动焊接机都需做测试。At the start of each day, each operator shall make acceptable test welds on plain tubing, These pieces shall be identified and made available to the welding inspector. Test shall be made for each

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automatic welding machine.

1.2.4. 预热温度 Preheating temperature

在焊接材料的温度不得低于 10 ºC。一般来说，不需要预热。The minimum base material temperature shall not be less than 10 0 C prior to welding. In general, no preheating shall be required.

1.2.5. 供电 Electrical characteristics

电流应与注明在相应的焊接表相符。Current shall be as specified on the applicable welding schedule.

1.2.6. 焊接程序 Welding procedure

焊接工艺，如焊接次序，焊接程序设置，焊极位置等，都将与相应的焊接表相符。The welding technique, such as weld sequence, welding program settings, electrode positioning etc., shall be as shown in the applicable welding schedule。

1.2.7. 焊接修补 Weld repair

经检查，如发现不符合标准的缺陷并且此缺陷是可修复的，有必要进行修复焊接。最可能的修复是在已有的焊接上进行再焊接；A weld repair is required when, through inspection, it is determined that an unacceptable defect exists and that the defect is correctable . The first repair may be a re-weld over one existing.

可做修补的缺陷包括不佳的准备，不良线性，过量或不适当的焊接穿透，多孔性和沙眼；The allowable defects which may be repaired include poor fit up, misalignment, excessive or inadequate weld penetration, porosity and pin holes.

所有有裂纹的焊接将被视为不合格，并须与受热区一起去除。All welds with cracks shall be rejected and removed together with the heat affected zone.

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1.2.8. 自动焊接程序 Automatic welding program

所有主程序都规定了不同尺寸管件焊接的一组参数；Calibration of the automated tube welding system shall be in accordance with the procedures to be defined by the welding operator together with the inspector.

自动管道焊接系统的焊接程序都须符合焊接操作员与检查员一起制定的程序； Any master program defined a set of parameters for different size of tubing to be welded.

正式和测试焊接需采用已认可的焊接程序；Production and test welds shall be made only using approved welding programs.

焊接样品必须按顺序编号(如 T1，T2 等)。焊接样品，具备完全的可追朔性，将备独立机构检验；Welding samples must be numbered in sequence ( ex.: T1, T2, etc.). Welding samples, with complete traceability, are subject to independent laboratory examination.

在整个施工阶段，所有每天的现场样品将留予业主；All daily samples will be available in site to the owner, during all the construction period.

自动管道焊接系统的校正都须符合焊接操作员与检查员一起制定的程序。Welding programs of the automated tube welding system shall be in accordance with the procedures to be defined by the welding operator together with the inspector.

1.2.9. 文档 Documentation

朗脉将提供此系统所有焊接记录报告。此焊接记录报告表格，必须

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完全填写，最少包含：MACROPROCESS will provide a written log on all welds carried out on the system. The weld log forms, that must be fully filled, will minimally contain :

系统名称 system name

焊接号 weld number

焊接工姓名 welder name

设备编号 machine identification

焊接日期 welding date

焊接程序编号 welding program number

焊接操作工(如有，还加上检查员)签名 welding operator ( and in addition inspector, if any ) signature

设备将打印相应自动焊接的报告。在此焊接报告中要有焊接编号。In addition the machine will print out an automatic log that will refer to the weld carried. This weld number shall be then identified on the welding log.

透视简图 (标示相应的坡度，尺寸和长度，所有焊点编号)将在整个施工期间使用并且更新，在工程完成生成竣工图。Each weld shall be numbered in progressive way. All welds will be shown on isometric sketches and on the related Welding Report ( FORMAT 5, already mentioned ).

每个焊点以累进方式编号。所有焊点标示在透视简图和焊接报告中。Isometrics sketches (showing installed elevations for proper sloping, dimensions and lengths, all weld numbers) will be available during site activity and will be updated (“as-built” issue ) at the end of job.

1.2.10. 非破坏性检查Non destructive examination

当相应的条例或合同规格要求时，非破坏性检查将在符合条例或合

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同规格下进行。须考虑到因此而造成的时间延误。Non destructive examination, when required by the applicable by the applicable code or contract specification, shall be performed in accordance with the code rules of contract specification. The time delay due to these controls must be considered.

1.2.11. 每日焊接样品 Weld daily samples

每日焊接样品应采用设备焊接程序。这些样品必须按顺序编号(如P1，P2 等)。所有这些焊接样品将在整个施工期间提供给业主；Weld daily samples shall be made using the machine welding programs. These samples must be numbered in sequence ( ex.: P1, P2, etc.). All of those will be available to the owner in site during all the construction period.

每日样品结果必须收集在完全填写的自动焊接设备测试报告中。The daily samples results must be collected in the Automatic Welding Machine Test Report that must be fully f illed。

1.3. 装配和安装 Fabrication and erection

1.3.1. 范围 Scope

本节和引用的图纸标准以及条例将适合所有管道现场装配和安装。This section and drawings standard and codes referenced shall apply to the field fabrication and erection of all tubing.

本规格中的内容不得用于解释使供应商从完全符合引用条例的责任中解脱。Nothing in this specification shall be interpreted as in any way relieving SUPPLIER from the responsibility for complete compliance with the referenced codes wherever they apply.

1.3.2. 管件材料接收储存 Tubing materials receipt storage

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管件材料接收储存和现场处理如下：Tubing materials receipt storage and handling at site：

管件材料需由其他人确认和检验；Tubing materials shall be identified and inspected by others.

管材和预装配件的存放应注意不会被油脂，潮湿或其它物质污染；管材和预装配件应处理得当，以避免变形，刮伤或任何有形损伤；It shall be taken care to keep all tubing materials and prefabricated assemblies free from contamination by grease, moisture or other matter does not occur, Tubing materials and prefabricated assemblies must be handed in order to avoid any denting, scraping or any other physical damage.

所有不锈钢材料应与其它施工材料分开检查和储存。储存区必须在建筑物内，并且有防护任何腐蚀性环境和温度变化的措施；All stainless steel materials should be checked and stocked separately from other construction materials. The storage area must be located inside a building and protected from any corrosive atmosphere and temperature changes.

通道应严格限制以确保材料不会受损伤和丢失。只有在施工需要时才能从储存区提取材料。Access shall be strictly limited in order to guarantee a protection against physical damage and losses. Material shall be released from storage only when needed for construction purposes.

1.3.3. 分类 Identification

所有材料将按规格进行分类，并且适当储存和处理以便于辨认。All materials will be identified in accordance with the applicable specification and shall be stored and handled in order to

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第12页/共35 页

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allow their proper identification.

1.3.4. 装配 Fabrication

装配应按照此规格的要求和如有的详细安装要求(图纸或其它)进行。Fabrication shall be in accordance with the requirements of this specification and with installation specific details ( drawings or others ), if any.

1.3.5. 布管，切割和装备 Lay-out, cutting and fitting up

管件应按图纸上的尺寸精确切割以适应现场情况。Tubing shall be cut accurately to measurements shown on drawing to suit field conditions.

所有待焊接的管件端面需清理毛刺，并且切割面应平直，边角无切割园弧。管件边缘的端面处理和清理毛刺应使用终端处理工具，并且其公差与配件一致以确保适当的焊接线性。All tube ends to be welded shall be deburred and have square cut edges, free of shear radii at the corner. Tube edge facing and deburring shall be done with an end prep tool and be of equal tolerance as the fittings to assure proper alignment for welding.

检查切割管件终端，以确保其平直。The end of the cutted pipe shall be checked to insure its squareness.

清除毛刺应避免破坏内外径，或损伤管件的内抛光。Burs shall be removed in such a manner as not to level I.D. or O.D. or damage polished interior of the tubing.

在管件端口积聚的磨屑必须擦拭干净。Abrasive dust accumulated near the end of the tube must be wiped clean.

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所有安装在管线上的管件不应受过分弹力和受力下装配。All tubing shall be worked in place without excessive springing or forcing.

不允许通过管件加热和弯曲以达到线性整齐。Heating and bending tubing to achieve alignment is not allowed.

1.3.6. 焊接程序和资格 Welding procedure and qualifications

所有焊工应具备6 个月现场工作经验经过工厂培训 All welders shall be qualified either by 6 months field experience or by factory training.；

在开始焊接前，焊接程序应提交给焊接检查员核准 Welding procedures shall be submitted to welding inspector for approval before starting the welding activities.

1.3.7. 安装 Erection

所有组装管件应在不受过分弹力和受力下装配。不允许有切割或弱化的支撑物作管道安装；All assembled tubing shall be installed without excessive springing of forcing . Cutting or other weakening of structural members to facilitate tubing installation will be not permitted.

所有管件安装应可以自由膨胀和收缩，而不至于损坏连接和支撑；All tubing shall be installed to permit free expansion and contraction without damage to joints or supports.

所有管道必须有适当的坡度(0.3% 最大0.5% )以确保完全排水。All lines must guarantee the complete drainage with proper

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slope (0.3% max. 0.5%).

1.3.8. 焊接接口 Welded joints

所有焊接应按照本规格所述的要求进行准备和装配。All welded joints shall be prepared and made in accordance with described of this specification.

1.3.9. 法兰接口 Flanged joints

所有法兰接口，应用全新的密封圈和螺栓。在拧紧螺栓前应确保所有密封圈定位准确。应注意防止将螺栓拧的过紧。所有被拧得过紧的螺栓螺帽都应更换；All flanged joints, if any, shall be made with gaskets and bolting materials brand new. It shall be taken care to assure that all gaskets are properly positioned prior to bolts tightening. It shall be taken care to avoid overtorquing any bolts. All bolts and nuts which are overtorqued shall be replaced.

法兰螺栓孔应跨骑于管道中心线，除非图纸上另有说明。 Flange bolt holes shall straddle pipe center lines except when noted otherwise on drawings.

1.3.10. 快装接口Clamped joints

不得使用螺纹接口。Threated joints shall not be used.

1.3.11. 支撑和穿管 Support of tubing and penetrations

管件的支撑应按管件支撑图纸上的参数和细节设计、装配和安装。Support to tubing shall be designed, fabricated and installed in accordance with the details and parameters of the pipe support drawings.

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第15页/共35 页

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不锈钢管件的安装按制造商的建议进行。Stainless steel tubing is to be installed in accordance with manufacturers recommendations.

吊架和支撑的安装应尽量的经济，并符合支撑图纸或规格上的描述。Hangers and/or support should be installed as economically possible and be in accordance with the charts and notes on the pipe support drawings or specifications.

管道的支撑应符合管道图纸上要求的坡度。Tubing shall be supported in such a way to comply with the slope required on piping drawings.

所有装配的管道应最少符合检查，检验和测试要求规格。All fabricated tubing shall as a minimum meet the examination, inspection and testing requirements specifications.

1.4. 检查 Inspection

1.4.1. 范围 Scope

本技术规格适用于不锈钢管件自动焊接检查，该焊接检查按照技术规格中的焊接要求；This specification covers the inspection of automatic welding stainless steel tube and fittings, in accordance with the welding specification.

焊接日志检查清单将用于查核主要信息，准备和质量要求；The weld log inspection check list shall be used to verify the principal information, preparation and quality requirements.

焊接检查员按照焊接要求，检视分包商的焊接记录、检查和设置、非破坏性测试，以及目检。在双方同意并理解相应的时间延误下，

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此工作须在任何时间进行；The welding inspector shall witness the required subcontractor records, checks and setups, non-destructive tests, and visually inspect the welds, as specified herein and in accordance with the welding specification. This activity must be carried out at any time with the agreement of both parties involved and knowing the related time delay.

焊接检查员或其指定代表应目检所有焊接。The welding inspector or his appointed representative shall visually examine all welds.

1.4.2. 配件和焊接编号 Component & weld identification

每个焊接应在其立体图中编号；Each weld shall be numbered on his isometrics.

检查员应保留焊接检查清单，而且实际的焊点以此编号辨别；The inspector shall maintain a weld inspection check list and the actual weld shall be identified primarily by this number.

每个焊点的记录应包括所有相关的条目。The record for each weld which shall include all items listed

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1.4.3. 焊接准备Weld preparation

焊接检查员决定是否进行下列检查/确认。

The following inspection/verification could be made at the welding inspector option.

管道截面确认 Tube section verification

管道的长度按要求在管道图纸中标示；The length of tube is as required to give dimensions as shown on the piping drawings.

要去掉管道端口切割产生的任何可能之污物；Tube ends are removed any possible contamination from the cut off.

工具不得被碳钢所污染；No tool has been contaminated by contact with carbon steel.

确认管道圆度公差。Verify tube roundness to tolerance.

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清洁确认 Cleaning verification

用认可的溶剂清洁配件。Components are cleaned with approved solvent.

在焊接前，已清洁和准备好的端口不得接触皮肤。The cleaned and prepared ends should not come into contact with the skin prior to welding.

在部件的端口不得有可目见的异物，此包括清洁布的纤维。No visible foreign material is acceptable at the weld ends of the components. This includes lint from cleaning cloths.

钨焊极必须清洁和无污染。Tungsten electrode must be clean and uncontaminated.

接口准备 Joint fit-up

焊接组件端口间隙用厚度塞尺测量，不得超过 0.25 mm。The gap between ends of welding components shall not exceed 0.25 mm as checked by thickness gauge.

钨焊极应置于焊点中央。The tungsten electrode shall be centered on the join t。

焊机设置 Weld machine settings

参数的设置应按焊接程序中相应的焊接表进行。Parameters shall be set in accordance with appropriate welding schedule as shown in the welding procedure.

确认气源就位。Verify that purge bladder is in place.

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1.4.4. 焊接检验 Weld inspection

每个焊接样品和所有装配焊都要目检管道内侧。如焊接有可修复的缺陷，

在焊接部件拆离焊机前进行第二次焊接以修复缺陷。如果重新焊接未修复缺陷，则此焊接视为不合格并不得装配。

Every sample weld and all production welds shall be visually inspected on the interior, If the weld has correctable defects, a second weld pass may be made to try to correct them before the spool is removed from the welding machine . If the rewelding does not remove the defect, the weld shall be rejected and not mounted.

所有自动焊接按如下控制：

All automatic welds will be controlled as follows：

对每日样品，用选定的焊接程序完成一个焊接，进行X 射线检验 For each daily sample a weld carried out with the same welding program will be chosen. The check will be done with Rx will be carried out.

对于所有完成的自动焊接，含有焊接参数的焊机打印报告 For all executed automatic welds, a welding machine print out with welding parameters will be annexed.

10%的自动焊接，进行X 射线检验 10% of executed automaticwelds, Rx will be carried out.

所有手工焊接要进行X 射线检验。All the manual weldings will be Rx inspected.

如有表面缺陷，则本规格条目适用。For surface defects, the headlines of this specification are valid.

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表1：Table 1

A		B
须进行重新焊接的缺陷 Defects for which rewelding may be attempted		不合格的缺陷：须与受热区(棕色)一起切除： Defects to be rejected : Cut out required together with its heat affected zone ( brown color ):
1.	未焊透 incomplete penetration	1.	裂纹 cracks
2.	多孔 porosity	2.	过烧 burn out
3.	沙眼 pin hole	3.	解块 sugaring
4.	冷隔 cold lap	4.	冷隔 cold lap
5.	过度穿透( <0.4 mm ) excessive penetration	5.	过度穿透(>0.4 mm ) excessive penetration
6.	未对准( <0.55 mm) misalignment	6.	未对准(> 0.55 mm) misalignment

点焊如有破裂、完全焊透、过烧、组件未对准，则视为不合格。Tack welds shall be rejected if : cracked, full penetrated, burned, components misalignment.

焊件移离焊机后，对焊接外观进行目检。The outside of the weld is visually inspected after the spool is removed from the welding machine.

1.4.5. 预装配件的保护 Protection of prefabricated spools

所有开口应有适当的保护，保持密封；All openings shall be kept sealed at all times with proper protection.

快装接口和法兰端面应有保护措施以防止损坏；Clamp ends and flange face shall be protected from damage in handling by approved protective devices.

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除了在工作台上，在处理和存放期间，预装配件应置于保护区内的木支架上。 During handling and storage other than on work tables, spools shall be on wooden skids of racks in a protected area.

1.4.6. 验收 Acceptance

焊接检查员应完成焊接检查清单并须在完成的清单上共同签署和注明日期。如在任何地方有不合格焊接，则不合格原因应被记录。焊接检查员应在焊接完成时签署清单。The welding inspector shall complete the weld inspection check-list. When it has been completed.  It shall be jointly signed and dated. If at any place the weld is rejected, the reason for rejection shall be recorded. The welding supervisor shall sign each list at the time the weld is made.

1.4.7. 其它要求 Other requirements

检查员应确认吹刷气体和后备气体流量计处于准确工作状态。The inspector shall insure that the flow gauges on the purge gas and back up gas be in accurate working condition, where applicable.

如任何工具或组件被怀疑有污染，应按ASTM 标准程序进行清洁和测试。If any tool or component is suspected of having contamination, it shall be cleaned and tested in accordance with ASTM standard procedures.

1.5. 水压测试与清洁 water pressure test and cleaning

本规程包含在管道系统完成后，为测试系统性能和特性而进行的所有工作。This specification covers the activities to be carried out after the system

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pipe construction, to test and improve his capability to perform the required characteristics.

1.5.1. 压力测试 Pressure testing

所有压力测试应当同检查员一起进行；All pressure tests shall be complete system tests carried out together with the inspector.

所有测试进行时应对操作人员的安全作好预防，要进行水压测试的系统应该带有合适的表和压力安全泻载装置；Every test shall be carried out with all the precaution needed to insure the safety of the operator, Systems to be hydraulically tested will be provided with appropriate gauges and pressure relieving devices.

所有连接点，包含焊缝应该去除绝热保温以便在测试过程中观察；All joints, including welds, are to be left un-insulated and exposed for examination during testing.

不需要进行压力测试的设备，在测试过程中应该与系统断开或使用其他合适的方式与测试系统隔离开；Equipment which is not to be subjected to the pressure test shall be either disconnected from the tubing or isolated by proper means during the test.

可以安装测试过程需要的阀门；Valves may be used provided that they are suitable for the proposed test procedure.

在管线上的压力计不应在超过量程的压力下测试。没有表明测试压力的部件和设备应排除在测试内容之外；In line pressure gauges shall not be subjected to pressure in excess of their scale range. All pieces of equipment which do not have their test

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pressures indicated or declared or not proper shall be excluded from these tests.

在进行所有测试之前，需目测管线系统以保障没有可见的缺陷且所有连接紧密；Before every test the tubing systems shall have visually inspected to assure that there are no visual defects and that all connections are tightened.

控制阀门只要不是正在被测试，应该打在全开的位置；Control valves, unless being tested, shall be set and maintained in the wide open position.

只要有可能应将所有在管线上的设备，表玻璃，流量计，漂浮液位计和所有其他受压部分包含在测试之内；All in-line instruments, gauge glasses, flow meters, liquid level float gauges and all other pressure parts of instruments shall be included in these test, where feasible.

水压测试的压力应由测试压力在其量程一半处的计量表测量；Hydrostatic test pressure must be measured by gauges having the test pressure value approximately in its mid-range.

有缺陷的连接点应该被移除并重新测试；Joints found to be defective shall be removed and retested.

在修复后重新进行测试后测试压力需和原来指定测试压力相同。Retesting of lines after repair shall be done at pressures originally specified for the test

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1.5.2. 测试报告 Test reports 承包商应为每个测试做相应记录，记录包含‘水压测试证书’和测试编号。The subcontractor shall make a record of the test as per specimen included “Hydraulic Test Certificate “, Certification Code “ CER-003 ”

测试编号 test number；

测试日期 date of test

系统名称 system name；

测试媒介，压力和相应压力下维持的时间 test media, pressureapplied and length of time at test pressure 。

1.5.3. 水压压力测试 Hydrostatic test pressure

水压测试压力需根据项目技术要求进行，不需进行压力测试的容器和组件应被隔离。The hydrostatic test pressure shall be calculated in accordance with the project specifications: vessels or components which are not designed for the testing pressure shall be isolated.

所有水压测试系统应在设计压力的1.5 倍和至少3.5 巴的压力下进行测试。在进行连接点目测前测试压力需维持至少15 分钟。All hydrostatically tested systems shall be tested to a one-half ( 1 1/2 ) times the design pressure or to a minimum pressure for3.5 bar whichever is greater.  All test pressures shall be maintained a minimum of 15 minutes before visual examination of joints beings.

在待测试的管线系统和测试的媒介达到热平衡之后再进行水压测试。Hydrostatic test pressure shall not be applies until the tubing system and the testing medium reached thermal equilibrium.

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第25页/共35 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation

在测试过程中需对所有连接点进行目测。All joints shall be visually examinated for leakage during the test.

水压测试压力至少需维持两个小时。Hydrostatic test pressure will be maintained for at least two hours.

在含有水的管线部分不能做任何修复焊接。No repairs welding shall be done on any section of tubing that contains water.

所有不锈钢管线在水压测试结束后需立即排空。All stainless steel lines shall be emptied immediately after hydrostatic tests completion.

1.5.4. 系统清洁和清洗System cleaning and flushing

清洗和清洁全部安装好的管线，应按照供应商要求：不锈钢清洗，酸洗和钝化规程执行。Washing and cleaning of the whole piping installed will be carried out according to Supplier document requirement :

STAINLEES STEEL WASHING, PICKLING AND PASSIVATION”.

1.6. 管道系统脱脂、酸洗和钝化 Chemical treatment

本技术文件说明的是纯水，纯蒸汽，分配系统的化学处理操作。用于该分配系统的管道和管件是机械或电抛光的AISI316 L 不锈钢材料。This scope of this document is to describe the procedure for chemical conditioning of PW (purified water), PS (pure steam), WFI (water for injection) distribution loops. The pipes and fittings used for loops are in stainless steel (AISI 316L) and could be mechanically polished or electro polished.

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第26页/共35 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation

系统的化学处理包括以下步骤：The chemical conditioning consists of the following steps:

脱脂 DEGREASING

酸洗 PICKLING

钝化 PASSIVATION

脱脂是除去表面的油，油脂和微粒。

Degreasing removes from surfaces oil, grease and powders.

酸洗是除去焊接过程中产生的氧化物和机械抛光产生的沉淀层。

Pickling removes the oxides formed during welding and eventual deposits coming from mechanical polishing.

钝化是重新在表面镀上在机械和化学处理中除去的氧化防腐层。

Passivation restores on the surfaces the corrosion resistance layer of Cromo Oxides, that has been removed from previous mechanical and chemical operation

1.6.1. 安全 Safty

在化学处理中的安全防护措施 During the treatment observe the safetyprecautions listed here below:

操作者需配戴透明面或眼镜 The operators shall wear a transparent face mask or suitable glasses.。

操作者需配戴手套和围裙 The operators shall also wear gloves and apron or track resistant to the chemicals。

在加入和溶解化学品时必须连续搅拌 All chemical must be stirred continuously during addition and dissolution of the

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第27页/共35 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation

chemicals。

准备几袋石灰或碳酸氢钠，防备在有滴漏的地方中和溶液 Some bags of lime or sodium bicarbonate must be available to neutralize the acid solution in c ase leakage。

参照化学品的安全说明。

Safety instructions for chemicals used are annexed.

1.6.2. 处理方法Method Treatment 根据参数用泵循环溶液处理管线。 Pipelines shall be treated by pumping and circulation solutionaccording to parameter indicated in sectio

1.6.3. 纯水和分配系统的化学处理treatment for PW and WFI

脱脂 degtreasing

化学品	无水酒精
Necessary chemical components	- Absolute alcohol
溶液	去离子水 + 10% 酒精
Solution :	- Demi water + 10% of alcohol
程序	泵压循环2-3bar
Procedure :	- Recycle by a pump at 2/3 bar
温度	环境温度
Temperature :	- Ambient
时间	30 分钟
Time :	- 30 minutes
排放并用去离子水冲洗
discharge and wash by demi water.

酸洗

   化学品 硝酸+ 氢氟酸

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第28页/共35 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation

Necessary chemical components :	- Nitric acid (HNO3) and Fluoridric acid (HF)
溶液	75% （重量）的硝酸和25%（重量）的氢氟酸组成的溶液，用50%体积的去离子水稀释
Solution	- Prepare a solution composed of 75% in weight of HNO3 and 25% in weight of HF. Dilute the prepared volume at 50% with demi water
程序	泵压循环2-3bar
Procedure :	- Recycle by a pump at 2/3 bar
温度	环境温度
Temperature :	- Ambient
时间	1 小时
Time :	- I hour
排放并用去离子水冲洗
discharge and wash by demi water

钝化 passivation

化学品 Necessary chemical components :	硝酸 - Nitric acid (HNO3)
溶液	20% 的硝酸和80%的去离子水
Solution	- Prepare a solution with 20% of HNO3 and 80% of demi water
程序	泵压循环2-3bar
Procedure :	- Recycle by a pump at 2/3 bar
温度	环境温度
Temperature :	- Ambient
时间	2 小时
Time :	- 2 hour
排放并用去离子水冲洗直到PH 中性
discharge and wash by demi water until neutral ph is reached

1.6.4. 蒸汽管道的化学处理 solution for pure steam distribution loop

脱脂

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第29页/共35 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation

化学品	无水酒精
Necessary chemical components :	- Absolute alcohol
溶液	去离子水 + 10% 酒精
Solution :	- Demi water + 10% of alcohol
程序	灌满整个系统静态保压
Procedure :	- Static method. The whole distribution collector must be kept completely filled
温度	环境温度
Temperature :	- Ambient
时间	2 小时
Time :	-2  hours
排放并用去离子水冲洗
Discharge and wash by demi water

备注：钝化检测仪

钝化 passivation

化学品	双氧水
Necessary chemical components :	-Hydrogen peroxide (H2O2)
溶液	25% 的双氧水和75%的去离子水
Solution	- Prepare a solution with25% of H2O2 and 75% of demi water
程序	灌满整个系统静态保压
Procedure :	Static method. The whole distribution collector must be kept completely filled
温度	环境温度
Temperature :	-Ambient
时间	最少4 小时，最长72 小时
Time :	-Min. 4 hours, Max. 72 hours
排放并用去离子水冲洗直到PH 中性。
Discharge and wash by demi water until neutral ph is reached

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第30页/共35 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation

1.7. 水压、酸洗以及焊接报告 Report

1.7.1. 水压测试报告表 Certificate hydraulic test

CERTIFICATE HYDRAULIC TEST 水 压 测 试
CUSTOMER : 用户 :	PROJECT : 项目 :
SYSTEM : 系统 :	SERIAL NUMBER : 系列号 :
DATE : 日期 :	DRAWING NUMBER : 图号 :
CERTIFICATION CODE : Cer-001	Page 1 of 3

THE PIPING LINE HAS BEEN HYDRAULICALLY TESTED UNDER THE CONDITIONS SPECIFIED BELOW.

该管线已经在下列状况下进行水压测试。

PRESSURE 压力 TIME 时间 MANOMETER 压力表读数 RESULT 结果 OPERATOR 操作者

备注REMARKS :

PLACE :	DATE :
地点	日期
OPERATOR :	INSPECTOR :
操作者	检查者
MACROPROCESS SIGNATURE :	CLIENT SIGNATURE:
朗脉代表签字	客户代表签字

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第31页/共35 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation

1.7.2. 管道系统脱脂、酸洗、钝化报告表 Report

CERTIFICATE LOOP DEGREASING, PICKLING & PASSIVATION 管道系统脱脂、酸洗、钝化报告表
CUSTOMER : 用户               :	PROJECT : 项目          :
SYSTEM : 系统	DATE : 日期    :
CERTIFICATION CODE :	Page    of

THE DISTRIBUTION LOOP HAS BEEN DEGREASED, PICKLED AND PASSIVATED UNDER THE CONDITIONS SPECIFIED IN THE ATTACHED PROCEDURE 该管道分配系统已经在下列状况下进行脱脂、酸洗、钝化程序。

1. 脱脂: 10%无水酒精用90%的纯化水稀释,用泵在2-3bar 压力下常温循环30 分钟后排放,并用纯化水冲洗干净。

2. 酸洗: 75% 硝酸和25% (重量)氢氟酸混合液用50%体积的纯化水稀释,用泵在2-3 bar 压力下常温循环,1小时后排放,并用纯化水冲洗至中性。

3. 钝化: 20%的硝酸用80%体积的纯化水稀释,用泵在2-3 bar 压力下常温循环2 小时后排放,并用纯化水冲洗至中性。

PLACE :	DATE :
地点     :	日期    :
OPERATOR :	INSPECTOR :
操作者          :	检查者           :
MACROPROCESS SIGNATURE :	CLIENT SIGNATURE:
朗脉代表签字                                 :	客户代表签字

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第32页/共35 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation

1.7.3. 焊接报告表Welding inspection sheet

FORMAT 1 表1 WELDING INSPCETION DATA SHEET 焊接检查单
用户 CUSTOMER :	项目 PROJECT :
系统 SYSTEM :	日期 DATE :
CERTIFICATION CODE :	Page   of

焊接程序说明
焊接程序号	#
焊接方式	自动
管道	ISO  2037
材质	AISI 316L
连接方式	管/管
直径	mm
壁厚	mm
焊机型号	COBRATIG 150
制造商	美国MK
焊头型号	5002
管道切割设备	G+F 切割机
端面清洁	乙醇
焊接时间	SEC
焊头氩气	lt/min
收弧氩气	lt/min
管内氩气	lt/min
电极缝隙	1.0 mm

地点PLACE :	日期 DATE :
OPERATOR :	INSPECTOR :
操作者 :	检查者 :
MACROPROCESS SIGNATURE :	CLIENT SIGNATURE:
朗脉代表签字 :	客户代表签字

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第33页/共35 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation

FORMAT 2 表2
WELDING REPORT
焊接报告
CUSTOMER :	PROJECT :
用户 :	项目 :
SYSTEM :	DATE :
系统 :	日期 :
CERTIFICATION CODE :	Page 1 of 3

焊接报告单

焊接打印单粘贴处

结果：接受□                          拒绝□

PLACE :	DATE :
地点:	日期:
OPERATOR :	INSPECTOR :
操作者:	检查者:
MACROPROCESS SIGNATURE :	CLIENT SIGNATURE:
朗脉代表签字:	客户代表签字：

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第34页/共35 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation

FORMAT 3 表3
WELDING REPORT
焊接报告
CUSTOMER :	PROJECT :
用户 :	项目 :
SYSTEM :	DATE :
系统 :	日期 :
CERTIFICATION CODE :	Page  of

焊 接 报 告

日期 焊接编号 直径 焊接类型 焊接程序 焊样编号 结果 签名

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第35页/共35 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第8 部分售后服务和技术承诺 Technical Promise and after-sale Service

第 8 部分

Part 8

售后服务和技术承诺

Technical Promise and

After-sale Service

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

上海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

T:021 54306717      F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第8 部分售后服务和技术承诺 Technical Promise and after-sale Service

目 录

1.售后服务和承诺Technical Promise and after-sale Service	2
1.1. 技术承诺Technical Promise	2
1.2. 售后服务After-sale Service	2

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第1页/共3 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第8 部分售后服务和技术承诺 Technical Promise and after-sale Service

1.售后服务和承诺Technical Promise and after-sale Service

1.1. 技术承诺Technical Promise

上海朗脉科技有限公司，拥有先进的焊接设备和质量检测设备，以及完全符合中国GMP 标准，FDA 认证以及其他国家标准的文件系统。工程中将使用验证过的全自动轨迹焊机进行焊接。所有的焊工都具有相关的上岗资格，至少要有2 年的实际工作经验或者经过工厂培训。上海朗脉科技有限公司承诺，我们承接的工程将完全按照GMP 标准进行施工。

工程质量保证期为1 年。

Macroprocess Technologies Co., Ltd. has advanced welding machine, quality-checking equipment and integrated files system according with Chinese GMP standard, FDA GMP standard and other country’s standards. Qualified automatic orbital welding machines will be used in our projects. All welders are qualified either by 2 year field experience or by factory training. The seller promises that the project we will do is completely according to GMP.

The Quality Guarantee Period of project will be 1 year.

1.2. 售后服务After-sale Service

售后服务联络：买方可直接与卖方联系，并将派自己的维修人员到买方工厂进行售后服务。After-sale service contact: The Buyer can contact the Seller directly. The seller will dispatch its’ own technicians to provide after-sale service on the Buyer’s site.

售后服务的响应时间：接到买方报修传真后2 天内 (公共假日除外)。Responding time: within two day from the receipt of written report from the Buyer (public holidays are excluded).

售后服务的质量要求：卖方应派遣有实际工作经验的工程技术人员来买方工厂进行维修。卖方技术人员需在接到通知后48 小时内到达

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第2页/共3 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第8 部分售后服务和技术承诺 Technical Promise and after-sale Service

买方现场 (公共假日除外)。Requirement of service quality: The seller shall dispatch engineers with good experience to the Buyer’s premise. The seller should arrive the buyer’s site within 48 hours after receipt of notice (public holidays are excluded).

售后服务的费用：质保期内免费维修，维修人员的差旅费、人工费、食宿费等由卖方承担 (因买方操作不当、未采用合同文件中规定的主材和操作环境条件、合同供货范围以外的工作除外)。质保期外的维修费由买方承担，收费标准由双方友好协商。Expense for after-sale service: The seller is responsible to provide free technical service within the Quality Guarantee Period. All the travel and accommodation expenses as well as the labor costs of the service engineer are to be born by the seller (exclusive of situations that problems are brought by incorrect operation and works beyond the scope of supply). The Buyer should be responsible for the service expenses after the guarantee period and the price is determined through friendly discussion.

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第3页/共3 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第9 部分偏离和图纸 Deviation and Drawings

第 9 部分

Part 9

偏离及图纸

Deviation and Drawings

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

上海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

T:021 54306717      F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第9 部分偏离和图纸 Deviation and Drawings

目 录

9. 偏离及图纸 Deviation and Drawings	2
9.1. 商务偏离表 Deviation Form for Commercial Terms	2
9.2. 技术偏离表 Deviation Form for Technical Specifications	3
9.3. 图纸 Drawings	4

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第1页/共4 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第9 部分偏离和图纸 Deviation and Drawings

9. 偏离及图纸 Deviation and Drawings

9.1. 商务偏离表 Deviation Form for Commercial Terms

商务偏离表

Deviation Form for Commercial Terms

项目名称	工艺配料系统 Process Formulation System
数 量	1 套	规格型号
标 书要求		投标参数及其它
付款方式： 合同签订后10 日内，甲方支付合同总额10%给乙方，同时乙方向甲方提供相同金额的发票； 乙方根据甲方提供的设计资料完成工程的二次设计，并经甲方书面确认后10 日内，甲方支付合同总额20%给乙方，同时乙方向甲方提供相同金额的发票；全部设备和材料运输到施工现场指定位置，甲乙双方开箱验收完毕，10 日内甲方支付合同总额30%给乙方， 同时乙方向甲方提供相同金额的发票。安装、调试、验收、验证合格并交付甲方使用后，10日内甲方再支付合同总价30%，同时乙方向甲方提供相同金额的发票；余合同总价10%的作为质量保证金，质量保证期1 年， 质保期满，无质量问题，10 日内甲方付清全部余款，同时乙方向甲方提供相同金额的发票。		付款方式： 合同签订后，10日内甲方支付合同总额30%预付款；全部设备和材料运输到施工现场指定位置前，甲方支付合同总额40%； 安装、调试、验收合格并交付甲方使用后，10 日内甲方再支付合同总额25%， 余合同总价5%作为质量保证金，质量保证期1 年， 质保期满，无质量问题，10日内甲方付清全部余款。

投标人(公章)：上海朗脉科技有限公司

授权代表人（签字或盖章）：

日期：

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第2页/共4 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第9 部分偏离和图纸 Deviation and Drawings

9.2. 技术偏离表 Deviation Form for Technical Specifications

技术偏离表

Deviation Form for Technical Specifications

项目名称	工艺配料系统 Process Formulation System
数 量	1 套	规格型号
标 书要求		投标参数及其它
管件的外部抛光度Ra<0.8um，内部为R a<0.5um。 CIP 回水管道BPE 抛光		管件外部Ra<1.0um 内部Ra<0.5um CIP 回水管道ISO2037

投标人(公章)： 上海朗脉科技有限公司

授权代表人（签字或盖章）：

日期：

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第3页/共4 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	工艺配料系统 Process Formulation System
	投标文件 Bidding Documents	第9 部分偏离和图纸 Deviation and Drawings

9.3. 图纸 Drawings

● PID 流程图 PID 

●    项目进度表 Schedule

 上海市闵行区罗阳路168 号A 座101 室    201100  1F, building A, No.168 LuoYang Rd, Shanghai, China 201100  T:021 54306717    F: 021 54306718 第4页/共4 页

EX-4.7.10

Exhibit 4.7.10 - Appendix 5 - Bidding Document 2

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第1 部分投标书 Part 1 Tender

第 1 部分

Part 1

投 标 书

Tender

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

T:021 54306717      F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第1 部分投标书 Tender

目 录

1. 报价书	2
1.1. 法定代表人资格证明书	2
1.2. 法人授权委托书	3
1.3. 授权代表人身份证复印件	4
1.4. 投标书	5
1.5. 报价一览表	6
2.分项报价清单	8
2.1. 压缩空气系统材料清单及报价	8
2.2. 氮气管道系统材料清单及报价	11
2.3. 氧气管道系统材料清单及报价	13
2.4. 二氧化碳气体管道系统材料清单及报价	15
2.5. 焊点费	17
2.6. 系统所用辅材数量清单	18
2.7. 验证服务报价	19

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/ 共19 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第1 部分投标书 Tender

1. 报价书

1.1. 法定代表人资格证明书

法定代表人资格证明书

单位名称：上海朗脉科技有限公司

单位地址：上海市闵行区罗阳路168 号A 座1 层

经营期限：2007年7 月26 日到2017 年7 月25 日

姓名：王伟

性    别： 男

年    龄： 36

职务：法人代表

王伟先生系上海朗脉科技有限公司 的法定代表人,签署本招标项目的投标文件,进行合同谈判,签署合同和处理与之有关的一切事务。

特此证明。

投标单位（盖章）： 上海朗脉科技有限公司

日期：2009-1-15

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2页/ 共19 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第1 部分投标书 Tender

1.2. 法人授权委托书

法人授权委托书

沈阳三生制药有限责任公司:

本授权委托书声明：我王伟先生系上海市闵行区罗阳路168号A 座101室的上海朗脉科技有限公司的法定代表人，现代表公司授权委托下面签字的上海朗脉科技有限公司的销售经理张松为本公司的合法代理人，代表本公司参加沈阳三生制药有限责任公司组织的压缩空气及工艺气体系统项目的投标活动。代理人在本次投标中所签署的一切文件和处理与之相关的一切事务，我均予以承认。

代理人无转委权

本授权于2009 年1 月15 日签字生效，特此声明。

代理人：张松性别：男 年龄：35

单位：上海朗脉科技有限公司 职务：销售经理

地址：上海市闵行区罗阳路168 号A 座101 室

投标人:（公章）上海朗脉科技有限公司

法定代表人:（印鉴）

2009 年1 月15 日

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第3页/ 共19 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第1 部分投标书 Tender

1.3. 授权代表人身份证复印件

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第4页/ 共19 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第1 部分投标书 Tender

1.4. 投标书

投标书

致沈阳三生制药有限责任公司：

我们收到贵方压缩空气及工艺气体系统 招标文件，经详细研究，我们决定参加该项目投标。并授权 张松销售经理 ， 全权代表我投标方提交下述文件正本一份，副本叁份。并同时宣布愿意遵守下列条款：

1、承认和愿意按照招标文件中的各项规定和要求，提供压缩空气及工艺气体系统的供货、安装、调试及维保等。

2、投标总报价 1,322,028.71 元，供货周期承诺 50 日历天，安装周期承诺 60 日历天，安装质量承诺 符合GMP 要求。

3、愿意按照《合同法》和《中华人民共和国招标投标法》履行自己的责任和义务。

4、如果我们投标函被接受，我们将履行招标文件中规定的每一项要求，按期、按质、按量完成任务。

5、我们愿意提供招标方在招标文件中要求的所有资料。

6、我们理解，最低报价不是中标的唯一条件。

7、我们同意按招标文件规定，交纳投标保证金，遵守有关招标的各项规定。

8、我方的投标书在开标后60 天内有效。

9、与本投标有关的一切往来通讯请寄：

地址： 上海市闵行区罗阳路168 号A 座101 室邮编：201100

电话： 021-54306717/ 13901375676 传真： 021-54306718

投标方(公章)： 上海朗脉科技有限公司

授权代表人（签字或盖章）：  

日期： 

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第5页/ 共19 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第1 部分投标书 Tender

1.5. 报价一览表

Item 序号	Scope of Supply 供货范围	Price (RMB) 价格
1	Price Breakdown for  CA Distribution System 压缩空气系统材料清单及报价	248,861.78
2	Price Breakdown for N2 Distribution System 氮气系统材料清单及报价	64,492.78
3	Price Breakdown for O2 Distribution System 氧气系统材料清单及报价	54,806.58
4	Price Breakdown for CO2 Distribution System 二氧化碳系统材料清单及报价	54,806.58
5	Piping surport 辅助材料，洁净区用不锈钢支架，非洁净区用镀锌角铁	143,065.00
	Subtotal 1 for Material 材料费用	566,032.72
6	Welding Point Cost 焊点费用	259,890.00
7	Cost of Welding Point marking (100% of total welding point ) 20RMB /point 焊点刻码费用,100%自动焊点刻码,20 元/焊点	31,660.00
8	Endoscopic Check ( 20% of total welding point ) 120 RMB /point             内窥镜检测，自动焊点的20% 取样，120 元/焊点	37,992.00
9	X-ray Check ( 100% of total hand-welding point,all welded samples ) 180 RMB /point X-光检测，（100% 手工焊点,所有焊样），180 元/焊点,	32,400.00
10	Insurance and Transportation 保险和运输	10,000.00
	Subtotal 2 for Piping fabrication 管道装配	371,942.00
11	Detail Design, Shop Drawings and As-built Drawings       详细设计，施工图纸和竣工文件	30,000.00
12	Quotation For Validation Activities 验证服务报价	160,000.00
13	COMPANY Management & Supervision 公司管理&监督	100,000.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第6页/ 共19 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第1 部分投标书 Tender

14	Project Management & Supervision 项目管理&监督	50,000.00
	Subtotal 3 for Project Service 项目服务	340,000.00
	Subtotal 1, 2, 3, 合计	1,277,974.72
	Tax 税金(主材部分开增值税，其他开工程发票）	44,053.99
	Total Price 总价（元）	1,322,028.71

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第7页/ 共19 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第1 部分投标书 Tender

2.分项报价清单

2.1. 压缩空气系统材料清单及报价

Price Breakdown for CA Distribution System

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第8页/ 共19 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第1 部分投标书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
14	卡环	DN19	304	92	Alfa Laval	ISO 2037,Ra≤0.8	95.79	8,812.52
15	密封圈	DN63.5	PTFE	1	Alfa Laval	ISO 2037,Ra≤0.8	53.38	53.38
16	密封圈	DN51	PTFE	74	Alfa Laval	ISO 2037,Ra≤0.8	46.51	3,441.44
17	密封圈	DN25	PTFE	44	Alfa Laval	ISO 2037,Ra≤0.8	46.51	2,046.26
18	密封圈	DN19	PTFE	92	Alfa Laval	ISO 2037,Ra≤0.8	37.12	3,414.82
19	变径三通（WCW)	DN63.5/51	316L	1	Alfa Laval	ISO 2037,Ra≤0.8	264.15	264.15
20	变径三通	DN63.5/38	316L	1	Alfa Laval	ISO 2037,Ra≤0.8	102.27	102.27
21	变径三通	DN63.5/19	316L	1	Alfa Laval	ISO 2037,Ra≤0.8	147.81	147.81
22	变径三通	DN51/38	316L	2	Alfa Laval	ISO 2037,Ra≤0.8	68.18	136.35
23	变径三通	DN51/25	316L	2	Alfa Laval	ISO 2037,Ra≤0.8	129.53	259.06
24	变径三通	DN51/19	316L	1	Alfa Laval	ISO 2037,Ra≤0.8	127.65	127.65
25	变径三通	DN38/25	316L	10	Alfa Laval	ISO 2037,Ra≤0.8	100.27	1,002.71
26	变径三通	DN38/19	316L	4	Alfa Laval	ISO 2037,Ra≤0.8	99.69	398.78
27	三通	DN25/25	316L	5	Alfa Laval	ISO 2037,Ra≤0.8	65.08	325.41
28	变径三通	DN25/19	316L	30	Alfa Laval	ISO 2037,Ra≤0.8	81.60	2,448.00
29	三通	DN19	316L	2	Alfa Laval	ISO 2037,Ra≤0.8	262.44	524.87

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第9页/ 共19 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第1 部分投标书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
30	大小头	DN63.5/51	316L	1	Alfa Laval	ISO 2037,Ra≤0.8	163.62	163.62
31	大小头	DN51/25	316L	1	Alfa Laval	ISO 2037,Ra≤0.8	136.71	136.71
32	大小头	DN38/25	316L	3	Alfa Laval	ISO 2037,Ra≤0.8	77.21	231.64
33	大小头	DN25/19	316L	7	Alfa Laval	ISO 2037,Ra≤0.8	83.72	586.02
34	弯头	DN63.5	316L	12	Alfa Laval	ISO 2037,Ra≤0.8	56.49	677.93
35	弯头	DN51	316L	10	Alfa Laval	ISO 2037,Ra≤0.8	39.61	396.12
36	弯头	DN38	316L	18	Alfa Laval	ISO 2037,Ra≤0.8	34.26	616.66
37	弯头	DN25	316L	54	Alfa Laval	ISO 2037,Ra≤0.8	26.95	1,455.46
38	弯头	DN19	316L	110	Alfa Laval	ISO 2037,Ra≤0.8	220.33	24,236.24
39	管道	DN63.5	304	18	Alfa Laval	ISO 2037,Ra≤0.8	234.93	4,228.73
40	管道	DN51	304	48	Alfa Laval	ISO 2037,Ra≤0.8	149.74	7,187.58
41	管道	DN38	304	84	Alfa Laval	ISO 2037,Ra≤0.8	115.67	9,716.33
42	管道	DN25	304	246	Alfa Laval	ISO 2037,Ra≤0.8	85.19	20,956.31
43	管道	DN19	316L	114	Alfa Laval	ISO 2037,Ra≤0.8	102.22	11,653.48
	以上为压缩空气管道系统管材，管件配置清单及报价							248,861.78

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第10页/ 共19 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第1 部分投标书 Tender

2.2. 氮气管道系统材料清单及报价

Price Breakdown for N2 Distribution System

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
1	压力表	0-6kgf/cm2, 1”	316L	1	CHINA		500.00	500.00
2	球阀	DN25	316L	1	King Lai		293.74	293.74
3	球阀	DN15	316L	21	King Lai		230.77	4,846.20
4	过滤器	5“ 0.22um		3	PALL		4,700.00	14,100.00
5	卡接头	DN25	316L	10	Alfa Laval	ISO 2037,Ra≤0.8	48.04	480.35
6	卡接头	DN19	316L	45	Alfa Laval	ISO 2037,Ra≤0.8	47.40	2,133.00
7	卡环	DN25	304	10	Alfa Laval	ISO 2037,Ra≤0.8	49.56	495.65
8	卡环	DN19	304	45	Alfa Laval	ISO 2037,Ra≤0.8	95.79	4,310.47
9	密封圈	DN25	PTFE	10	Alfa Laval	ISO 2037,Ra≤0.8	46.51	465.06
10	密封圈	DN19	PTFE	45	Alfa Laval	ISO 2037,Ra≤0.8	37.12	1,670.29
11	三通	DN25/25	316L	3	Alfa Laval	ISO 2037,Ra≤0.8	65.08	195.25
12	变径三通	DN25/19	316L	18	Alfa Laval	ISO 2037,Ra≤0.8	81.60	1,468.80
13	大小头	DN25/19	316L	5	Alfa Laval	ISO 2037,Ra≤0.8	83.72	418.59
14	弯头	DN25	316L	15	Alfa Laval	ISO 2037,Ra≤0.8	26.95	404.29

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第11页/ 共19 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第1 部分投标书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
15	弯头	DN19	316L	45	Alfa Laval	ISO 2037,Ra≤0.8	220.33	9,914.82
16	管道	DN25	304L	210	Alfa Laval	ISO 2037,Ra≤0.8	85.19	17,889.53
17	管道	DN19	316L	48	Alfa Laval	ISO 2037,Ra≤0.8	102.22	4,906.73
	以上为氮气管道系统管材，管件配置清单及报价							64,492.78

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第12页/ 共19 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第1 部分投标书 Tender

2.3. 氧气管道系统材料清单及报价

Price Breakdown for O2 Distribution System

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
1	压力表	0-6kgf/cm2, 1”	316L	1	CHINA		500.00	500.00
2	球阀	DN25	316L	1	King Lai		293.74	293.74
3	球阀	DN15	316L	20	King Lai		230.77	4,615.43
4	过滤器	5“ 0.22um		2	PALL		4,700.00	9,400.00
5	卡接头	DN25	316L	8	Alfa Laval	ISO 2037,Ra≤0.8	48.04	384.28
6	卡接头	DN19	316L	42	Alfa Laval	ISO 2037,Ra≤0.8	47.40	1,990.80
7	卡环	DN25	304	8	Alfa Laval	ISO 2037,Ra≤0.8	49.56	396.52
8	卡环	DN19	304	42	Alfa Laval	ISO 2037,Ra≤0.8	95.79	4,023.11
9	密封圈	DN25	PTFE	8	Alfa Laval	ISO 2037,Ra≤0.8	46.51	372.05
10	密封圈	DN19	PTFE	42	Alfa Laval	ISO 2037,Ra≤0.8	37.12	1,558.94
11	三通	DN25/25	316L	3	Alfa Laval	ISO 2037,Ra≤0.8	65.08	195.25
12	变径三通	DN25/19	316L	17	Alfa Laval	ISO 2037,Ra≤0.8	81.60	1,387.20
13	大小头	DN25/19	316L	4	Alfa Laval	ISO 2037,Ra≤0.8	83.72	334.87

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第13页/ 共19 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第1 部分投标书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
14	弯头	DN25	316L	12	Alfa Laval	ISO 2037,Ra≤0.8	26.95	323.44
15	弯头	DN19	316L	45	Alfa Laval	ISO 2037,Ra≤0.8	220.33	9,914.82
16	管道	DN25	304L	174	Alfa Laval	ISO 2037,Ra≤0.8	85.19	14,822.75
17	管道	DN19	316L	42	Alfa Laval	ISO 2037,Ra≤0.8	102.22	4,293.39
	以上为氧气管道系统管材，管件配置清单及报价							54,806.58

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第14页/ 共19 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第1 部分投标书 Tender

2.4. 二氧化碳气体管道系统材料清单及报价

Price Breakdown for CO2 Distribution System

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
1	压力表	0-6kgf/cm2, 1”	316L	1	CHINA		500.00	500.00
2	球阀	DN25	316L	1	King Lai		293.74	293.74
3	球阀	DN15	316L	20	King Lai		230.77	4,615.43
4	过滤器	5“ 0.22um		2	PALL		4,700.00	9,400.00
5	卡接头	DN25	316L	8	Alfa Laval	ISO 2037,Ra≤0.8	48.04	384.28
6	卡接头	DN19	316L	42	Alfa Laval	ISO 2037,Ra≤0.8	47.40	1,990.80
7	卡环	DN25	304	8	Alfa Laval	ISO 2037,Ra≤0.8	49.56	396.52
8	卡环	DN19	304	42	Alfa Laval	ISO 2037,Ra≤0.8	95.79	4,023.11
9	密封圈	DN25	PTFE	8	Alfa Laval	ISO 2037,Ra≤0.8	46.51	372.05
10	密封圈	DN19	PTFE	42	Alfa Laval	ISO 2037,Ra≤0.8	37.12	1,558.94
11	变径三通	DN25/25	316L	3	Alfa Laval	ISO 2037,Ra≤0.8	65.08	195.25
12	变径三通	DN25/19	316L	17	Alfa Laval	ISO 2037,Ra≤0.8	81.60	1,387.20
13	大小头	DN25/19	316L	4	Alfa Laval	ISO 2037,Ra≤0.8	83.72	334.87

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第15页/ 共19 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第1 部分投标书 Tender

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第16页/ 共19 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第1 部分投标书 Tender

2.5. 焊点费

Welding Point Cost

Item 序号	Supply Scope 供货范围	Location 位置		Quantity 数量	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
1	压缩空气系统		自动焊点	835	150.00	125,250.00
2	氮气系统		自动焊点	262	180.00	47,160.00
3	氧气系统		自动焊点	243	180.00	43,740.00
4	二氧化碳系统		自动焊点	243	180.00	43,740.00
	总价（元）					259,890.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第17页/ 共19 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第1 部分投标书 Tender

2.6. 系统所用辅材数量清单

Accessories List

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第18页/ 共19 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第1 部分投标书 Tender

2.7. 验证服务报价

Quotation For Validation Activities

序号 No.	验证项目 Scope		报价 Quotation(RMB)
1	压缩空气分配系统 Compressed air distribution system	DQ，TM,RA	10,000
2		SAT	5,000
3		IQ,OQ	20,000
4		PQ 方案 PQ protocol	5,000
6	氮气分配系统 Nitrogen distribution system	DQ，TM,RA	10,000
7		SAT	5,000
8		IQ,OQ	20,000
9		PQ 方案 PQ protocol	5,000
11	氧气分配系统 Carbon dioxide distribution system	DQ，TM,RA	10,000
12		SAT	5,000
13		IQ,OQ	20,000
14		PQ 方案 PQ protocol	5,000
11	二氧化碳分配系统 Carbon dioxide distribution system	DQ，TM,RA	10,000
12		SAT	5,000
13		IQ,OQ	20,000
14		PQ 方案 PQ protocol	5,000
15	总价		160,000
Remarks 备注：
1) 包含本报价服务范围内的朗脉验证人员在客户现场的差旅食宿费用。 The cost of trips and living in client site are included in above price。
2） 包含验证仪器费用。 The fee of validation instruments are included in above price.。
3） 验证不包括系统中仪表和传感器的校准工作。 The calibration work for instruments and sensors in the systems is not validation work.。
4） 本报价有效期：3 个月内。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第19页/ 共19 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

第 2 部分

Part 2

公司介绍及资质文件

Company introduction and Certificate

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

T:021 54306717      F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

目录Index

1. 资质证明文件Certificate	3
1.1. 资质证书Certificate	3
1.1.1. 营业执照复印件Business license	3
1.1.2. 组织机构代码证Organization code certificate	4
1.1.3. 税务登记证Business Registration	5
1.1.4. 银行开户证明The opening of bank accounts permits	6
1.1.5. 代理证书Agency	7
1.1.6. 协会证书CAPE Certificate	13
1.2. 部分业绩Part reference	14
1.2.1. 部分竣工项目一览表 Part finished project List	14
1.2.2. 部分在建同类工程一览表 Part constructing project List	15
1.3. 2007 年财务报表Financial statement	15
2. 公司介绍Company Introduction	15
2.1. 公司概述Brief introduction	15
2.1.1. 公司实力Strength	15
2.1.2. 公司历史History	15
2.1.3. 公司文化Corporate cuture	15
2.1.4. 公司组织结构Organize chart	15
2.2. 朗脉的服务Service	15
2.2.1. 专业领域服务Professional service	15
2.2.2. 工程总承包Contractor	15
2.2.3. 植物提取工艺优化Process optimization	15
2.2.4. 自动化控制系统业务Automation Control system	15
2.2.5. 过程控制系统Process Flow	15
2.2.6. 空调自控系统HVAC automation system	15
2.2.7. 在线清洗系统Clean in place	15

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.3. 洁净管道系统业务Sanitary piping system business	15
2.3.1. 完善的工艺设计Perfect in process design	15
2.3.2. 材料选型及采购Material Selection and Procurement	15
2.3.3. 齐全的施工设备Construction facility	15
2.3.4. 现场管理及现场施工Project management and construction	15
2.3.5. 先进的检测设备Testing equipment	15
2.3.6. 系统调试和人员培训Training and system commission	15
2.3.7. 验证服务Validation service	15

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1. 资质证明文件Certificate

1.1. 资质证书Certificate

1.1.1. 营业执照复印件Business license

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第3页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.1.2. 组织机构代码证Organization code certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第4页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.1.3. 税务登记证Business Registration

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第5页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.1.4. 银行开户证明The opening of bank accounts permits

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第6页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.1.5. 代理证书Agency

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第7页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第8页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第9页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第10页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第11页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第12页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.1.6. 协会证书CAPE Certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第13页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.2. 部分业绩Part reference

1.2.1. 部分竣工项目一览表 Part finished project List

序号	客户名称	地点	项目概况	认证情况
1	北京凯因生物技术有限公司	北京	纯水/注射用水/纯蒸气分配系统/干扰素发酵物料管道转运系统和空 调自控（工艺管道）
2	北京万泰制药有限公司	北京	纯水/注射用水/纯蒸汽/物料分配系统
3	北京三元基因工程有限公司	北京	纯水/注射用水/纯蒸汽/物料分配系统
4	常州四药有限公司	常州	注射用水/纯化水管道分配系统	依照FDA cGMP 规范，提供IQ/OQ 文件
5	河北恒利药业有限公司	河北	CIP 系统
6	成都普仕医塑公司	成都	纯水/注射用水/纯蒸汽及物料管道分配系统
7	扬子江药业集团广州海瑞药业有限公司	广州	纯蒸汽/纯水/注射用水/物料分配管道系统
8	齐鲁海南药业有限公司	海南	纯蒸汽/注射用水/纯水以及工艺管道系统
9	杭州天元生物制药有限公司	杭州	注射用水/纯蒸汽/纯化水/洁净压缩空气/氮气等工艺管道系统	依照FDA cGMP 规范，提供IQ/OQ 文件
10	杭州九源基因工程有限公司	杭州	纯蒸汽/注射用水/纯水以及工艺管道系统和空调自控	依照FDA cGMP 规范，提供IQ/OQ 文件

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第14页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

序号	客户名称	地点	项目概况	认证情况
11	上海博莱科信谊制药有限公司	上海	(蒸馏水生产装置MS304S，纯蒸汽生产装置PSG500DTS，纯水& 蒸馏水&纯蒸汽分配系统)	依照FDA cGMP 规范，提供IQ/OQ 文件
12	齐鲁安替比奥制药有限公司	济南	纯水& 注射用水分配系统/ 发酵物料转运管道系统（二期）	无菌原料药已通过欧盟认证
13	齐鲁制药厂	济南	纯水/注射用水/纯蒸汽/物料分配系统
14	齐鲁安替比奥制药有限公司	济南	注射用水/纯化水/纯蒸汽管道分配系统
15	齐鲁天和惠世制药有限公司	济南	注射用水/纯化水/纯蒸汽管道分配系统
16	山东鲁抗辰欣药业有限公司	济宁	注射用水/纯化水/纯蒸汽管道分配系统和空调自控
17	山东鲁抗立科制药有限公司	济宁	注射用水/纯化水/纯蒸汽管道分配系统和空调自控
18	浙江耐斯康制药有限公司	金华	注射用水/纯蒸汽/纯化水分配系统改造项目	依照FDA cGMP 规范，提供IQ/OQ 文件
19	扬子江药业集团南京海陵药业有限公司	南京	纯蒸汽,注射用水分配系统工艺管道工程
20	宝利化（南京）制药有限公司	南京	注射用水/纯化水管道分配系统	无菌注射剂已通过TGA 认证
21	青岛生化制药有限公司	青岛	纯蒸汽/纯水/注射用水/压缩空气分配系统
22	GE Healthcare	上海	纯蒸汽/注射用水工艺管道工程	无菌注射剂已通过FDA 认证

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第15页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

序号	客户名称	地点	项目概况	认证情况
23	石药集团中润制药有限公司	石家庄	注射用水/纯化水/纯蒸汽及物料分配系统
24	上海天士力药业有限公司	上海	纯蒸汽/注射用水分配系统工艺管道工程
25	上海百特医疗用品有限公司	上海	纯水/注射用水/配液分配系统
26	上海惠生生物工程有限公司	上海	纯水/注射用水/纯蒸汽管道分配系统
27	上海迪赛诺制药有限公司	上海	注射用水/纯化水管道分配系统	符合WHO 规范
28	上海惠生生物工程有限公司	上海	抗体实验室纯化水分配系统（二期）
29	上海莱士血液制品股份有限公司	上海	注射用水分配系统过热水灭菌系统改造项目	依照FDA cGMP 规范，提供IQ/OQ 文件
30	深圳海王英特龙生物科技有限责任公司	深圳	纯蒸汽/注射用水/纯水系统工艺管道系统	依照FDA cGMP 规范，提供IQ/OQ 文件
31	华北制药奥奇德有限公司	石家庄	纯水/注射用水/纯蒸气分配系统/干扰素发酵物料管道转运系统
32	华北制药华胜有限公司	石家庄	纯蒸汽/注射用水/纯水系统及物料工艺管道分配系统
33	华北制药集团北元有限公司	石家庄	注射用水，纯化水，纯蒸汽分配系统改造项目	依照FDA cGMP 规范，
34	石家庄欧意制药有限公司	石家庄	纯化水分配系统改造项目	依照FDA cGMP 规范，

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第16页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

序号	客户名称	地点	项目概况	认证情况
35	无锡台裕制药有限公司	无锡	注射用水/纯化水/纯蒸汽系统及物料分配管道系统
36	厦门北大之路药业有限公司	厦门	注射用水/纯化水纯蒸汽系统及物料分配管道系统
37	苏州东瑞药业有限公司	苏州	纯蒸汽/注射用水/纯水系统及物料工艺管道分配系统	依照FDA cGMP 规范，提供IQ/OQ 文件
38	贝朗医疗（苏州）有限公司	苏州	纯水/注射用水/配液分配系统
39	苏州东瑞制药有限公司	苏州	104 车间物料系统改造	依照FDA cGMP 规范，提供IQ/OQ 文件
40	苏州东瑞制药有限公司	苏州	原料车间物料系统改造	依照FDA cGMP 规范，提供IQ/OQ 文件
41	贝朗医疗（苏州）有限公司	苏州	注射用水系统改造项目
42	扬子江药业集团有限公司	泰州	纯蒸汽,注射用水分配系统工艺管道工程
43	天津天士力药业有限公司	天津	纯蒸汽/纯水/蒸馏水/压缩空气分配系统
44	天津百特医疗用品有限公司	天津	纯蒸汽/注射用水分配系统工艺管道工程
45	天津天士力药业有限公司	天津	实验室纯水管道系统
46	通化东宝药业	通化	(蒸馏水生产装置MS3005S， 纯蒸汽生产装置PSG500DTS， 纯水& 蒸馏水&纯蒸汽分配系统， 大输液配制系统)

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第17页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

序号	客户名称	地点	项目概况	认证情况
47	香港美达制药有限公司	香港	纯水分配系统
48	厦门科兴生物制品有限公司	厦门	(预处理，二级反渗透,蒸馏水生产装置MS504S， 纯蒸汽生产装置PSG500DTS ，纯水&蒸馏水&纯蒸汽分配系统)
49	劲牌有限公司	湖北	保健酒仪表、计量控制系统
50	贝朗医疗(苏州)有限公司	苏州	改造公用洁净设施工程

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第18页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.2.2. 部分在建同类工程一览表 Part constructing project List

序号	客户名称	地点	项目概况	认证情况
1	成都生物制品所	成都	洁净室配套公用工程系统	符合WHO 标准
2	株洲千金药业有限公司	湖南	煮提、浓缩自控总包项目
3	浙江普洛康裕药业有限公司	浙江	冻干粉针洁净管道和配料系统工程合同
4	赣州菊隆高科技食品有限公司	江西	萃取、提纯车间自控系统工程项目合同
5	山东先声麦得津生物制药有限公司	山东	工艺管道安装工程项目
6	成都生物制品所	成都	乙脑疫苗车间改造	符合WHO 标准
7	成都生物制品所	成都	病毒疫苗车间PW/WFI/PS 系统
8	杭州中美华东制药有限公司	杭州	冻干粉针201 车间洁净工艺管道系统工程
9	苏州东瑞制药有限公司	苏州	103 车间洁净管道系统改造
10	江苏正大丰海制药有限公司	江苏	输液车间注射水及物料洁净管道系统

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第19页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.3. 2007 年财务报表Financial statement

针对本招标文件，公司提供2007 年度财务审计报告复印件作为参考。

We provided the copy of 2007 financial statement as reference for the project bidding requirement.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第20页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2. 公司介绍Company Introduction

2.1. 公司概述Brief introduction

2.1.1. 公司实力Strength

公司上海朗脉科技有限公司由上海双赢洁净科技有限公司和上海朗和系统集成有限公司整合重组而成，公司注册资金一千万，现有员工一百多人。我们致力于成为中国最好的制药工程专业提供商。

Shanghai Macroprocess Co., Ltd. was founded by integrating Shanghai WinWin Process System Co., Ltd. and Shanghai Longhorn System Integration Co., Ltd. We have over one hundred employee with RMB 10 million pay up capital. We are committed to become a leading supplier for the total solution in pharmaceutical industry.

“朗脉”本着“以人为本、技术为核心”的原则，聘请多位国内外技术专家，经过长期发展，打造了一支经验丰富的设计、安装、调试及验证的专业队伍。我们为您的药厂建设提供专业的概念设计 、详细设计、工艺设备、洁净管道、暖通空调系统、洁净室系统、自动化系统、采购管理、施工管理、安装调试、验证等一体化服务。

Following the principle “ putting employee first, setting technology as core”, Macroprocess has accomplished an experienced professional team made up of experts on design , installation and validation by recuiting many technical experts both from home and abroad after a long-time development. We can provide your

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第21页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

pharmaceutical factory contruction with integrated services, including professional conceptual design, detailed design , process equipments , sanitary pipelines , HVAC system, cleanroom system, automation system , procurement management, construction management, installation with commissioning , validation and etc.

“朗脉”的客户涵盖了许多国内外知名的制药企业，其中已有多家客户通过FDA 、EME A、TGA 等国外认证，并建立了良好的长期合作关系。

Macroprocess has served many famous pharmaceutical enterprises both from home and abroad, of which many enterprises have passed foreign validation ( USA FDA, EU EMEA, Australian TGA and etc.) We are maintaining excellent cooperative relationship with our clients.

目前我们用户中已经通过国外验证的有some of our clients have gained International certification：

u GE Healthcare 通用医疗（上海）药业有限公司是美国GE 通用的独资企业，是目前为止国内唯一一家无菌小容量注射剂通过美国FDA 认证的制药企业；GE Healthcare Located in Shanghai City , Sterility injection was certified by USA FDA and also this is the only one which approvaled in China.

u 山东齐鲁安替比奥制药有限公司是意大利安替比奥公司与齐鲁制药有限公司的合资企业，是国内第一家无菌原料药（相当于注射剂）通过欧盟EMEA 认证的制药企业；Qilu Antibiotics Pharmaceutical Co., Ltd. is the joint venture company of Italy Antibiotics and Qilu

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第22页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

pharmceutical company, it is the first one of China which Sterile API was certified by EU EMEA.

u Polifarma 宝利化（南京）制药有限公司是意大利Polifarma 公司控股的企业，无菌制剂以及口服固体制剂于2007 年通过了澳大利亚TGA 认证。Polifarma (Nanjing) Co. Ltd. is a holding company of Italy Polifarma, Sterile injection was certified by TGA in 2007.

我公司在生物制药领域的部分客户有as the following there are some reference in bio pharmaceutical domain：

u 北京凯因生物技术有限公司作为病毒生物技术国家工程研究中心，是由中国疾病预防控制中心病毒所和大连国际合作（集团）股份有限公司共同投资建立，我公司多次承接其洁净管道系统安装工程；Kawin Technology's core R&D organization – National Engineering Research Center for Viral Bio-Technology (NERC) was established with the approval & support of National Development and Reform Commission. Beijing Kawin Technology Share-Holding Co., Ltd. (Kawin Technology) was invested by Beijing Kawin Bio-Tech Co., Ltd. We cooperation in piping system many times.

u 成都生物制品研究所作为我国西南六省、市、自治区计划免疫协作中心，是中国最大的生物制品研究、生产基地之一，我公司先后承接乙脑疫苗车间水系统、病毒性疫苗项目水系统、洁净室配套公用工程系统等多个符合GMP 标准的工程；  The Chengdu Institute of Biological Products (CDIBP), part of the China National Biotec Corporation,

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第23页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

is one of the largest research and manufacturing bases for biological products in China.And we are participated in some sanitary piping system with GMP standard.

u 浙江天元生物药业股份有限公司是中国国内规模最大的流感疫苗生产企业之一。所有的生产车间都通过国家药监局的GMP 认证。我公司先后承接其疫苗车间的洁净管道施工安装项目，按照WHO 的标准实施项目。Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. is one of China's largest private manufacturers of influenza vaccine. All manufacturing lines of Tianyuan have been granted with cGMP certificates from the State Food and Drug Administration (SFDA) of China. Our company carried on some sanitary piping system project in bacterin factory with WHO standard.

"朗脉" 以 "专业成就未来" 为使命，打造中国真正意义上的制药领域的专业工程公司，不断增强公司的核心竞争力，推动更多的本土药厂走向世界。

With the mission that  "expertise for future", Macroprocess is committed to become a Chinese professional engineering company that can bring more and more local pharmaceutical companies to the world by continuously improving core competiton capability in pharmaceutical industry.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第24页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.1.2. 公司历史History

u 上海双赢洁净科技有限公司成立。Shanghai WinWin Process System Co., Ltd was founded

u 上海双赢洁净科技有限公司与意大利STILMAS 建立合作关系。Shanghai WinWin Process System Co., Ltd commenced business relationships with Italian STILMAS.

u 上海朗和系统集成有限公司成立，进入到中药现代化领域。Shanghai Longhorn System Integration Co., Ltd was founded with the entry into TCM modernization field.

u 上海双赢洁净科技有限公司将国际化的验证概念融入项目实施。WinWin brought the international validation concept into project execution.

u 聘请国外资深工艺及验证专家。International experienced process and validation experts were recruited.

u "朗脉" 的多名技术成员成为国际制药工程协会(ISPE )会员。Several Macroprocess engineers are members of ISPE

u 融合工艺、管道、自控、HVAC 及洁净室系统、验证等各专业，成立技术中心。A technical center was operated with integration of process, piping, automation, HVAC and validation sections.

u 双赢与朗和整合，成立上海朗脉科技有限公司。WINWIN and LONGHORN were intergrated into MACROPROCESS.

u "朗脉" 与国外公司合作开发了连续式真空带式干燥机。Macroprocess invented Vacuum belt dryer with cooperation with foreign enterprises.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第25页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.1.3. 公司文化Corporate cuture

朗脉的愿景The Vision of MACROPROCESS：

我们致力于成为中国最好的制药工程专业提供商。

We are committed to become a leading supplier for the total solution in pharmaceutical industry.

朗脉的使命Mission of Macroprocess：

专业成就未来！Experitise for future!

朗脉的核心价值观Core values of Macroprocess：

合作、创新、负责、分享

Collaboration, Innovation, Responsibility and Sharing.

朗脉的核心竞争力Core Competitiveness of Macroprocess：

♦ 朗脉的专业能力将永远是我们引以为荣的核心竞争力Expertise of Macroprocess is always our core competitiveness；

♦ 因为我们专业，完成了一个又一个的高标准项目Owing to our expertise, we have successfully completed a large

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第26页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

number of high-standard projects；

♦ 因为我们专业，建立了与客户的长久合作关系Owing to our expertise, we have built long-term cooperation relationship with our clients;

♦ 专业，成就朗脉的未来，也将成就朗脉伙伴的未来Our expertise is creating the future for both MACROPROCESS and our clients！

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第27页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.1.4. 公司组织结构Organize chart

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第28页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.2. 朗脉的服务Service

2.2.1. 专业领域服务Professional service

“朗脉”在引进吸收国际先进项目管理理念的基础上，经过多年积累，建立了完善的项目管理体系，对工程整个周期进行全方位的管理，最大限度提高项目的成功率，降低过程控制的成本，规避项目风险。

With the introduction of advanced international project management ideology and many years’ experiences, Macroprocess has established a perfect project management system to conduct all-round management to the entire cycle of project. This system can facilitate project success , cost reduction and risk avoidance.

“朗脉”真诚的为您提供以下各专业服务Macroprocess can offer the following professional service：

洁净管道系统Sanitary piping system

♦ 配料系统Formulation system：

● 小容量注射剂配料及输送系统SVP formulation and distribution system

● 大输液配料及输送系统LVP formulation and distribution system

● 冻干制剂配料及输送系统Lyophilized product formulation and distribution system

● 生物工程、血液制品等配料及输送系统preparation and distribution system for bioengineering and blood products

● 无菌原料药生产工艺系统等Sterile raw material production

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第29页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

process system etc.

♦ 工艺用水、汽系统Process used water and steam system：

● 纯化水系统、注射用水系统、纯蒸汽系统等Purified water system, water for injection system and pure steam system etc.

♦ 洁净气体（空气、氮气等）输送系统Clean gas( air/nitrogen etc.) delivering system

♦ CIP 在线清洗工作站及系统CIP（Clean In Place）work stations and systems

♦ SIP 在线消毒工作站及系统SIP（Sterilization-in-Place）work stations and systems

自动化系统Automation control system

♦ 工艺过程自动化控制系统Automation control system of process procedure

♦ 洁净室空调自动化控制系统HVAC automation system

洁净厂房系统Clean room system

♦ 洁净厂房系统的设计、安装、调试及验证（中国GMP、欧盟EMEA 及美国FDA 等） 。Professional design , installation, commissioning and validation (Chinese GMP, EMEA, FDA , etc.) of clean room system.

验证服务Validation services

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第30页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

“朗脉”专门的验证部门为您研究全球的认证规范，涉及FDA 、EMEA 、TGA、WHO 等。我们熟悉验证的重要性和复杂性，为顾客提供切实有效的验证服务，确保项目符合国内外GMP 法规要求。我们提供以下专业验证服务    Macroprocess Validation department can provide world class validation service, such as cGMP of SFDA, FDA, EMEA, TGA, WHO and etc. With great familiarity and complexity of validtion, we can provide pragmatic and effective validation services to ensure the uniformity of your project with GMP standards. We can provide the following professional validation services：

♦ 编写验证主计划Writing of VMP (Validation Master Plan)

♦ 设计cGMP 审核Design cGMP Review

♦ 编写URS Writing of URS

♦ HVAC 系统和洁净室的验证Validation of HVAC system and Cleanroom

♦ 水系统、纯蒸汽和压缩空气系统的验证Validation of Water system, Pure steam and compressed air system

♦ 灭菌设备的性能确认PQ of Sterilization equipments

♦ 关键工艺设备的验证指导Guiding of Critical Process Equipments Validation

♦ 清洗验证的指导Guiding of Cleaning Validation

♦ 工艺验证的指导Guiding of Process Validation

♦ 计算机系统的验证Computer System Validation

♦ 验证培训Validation Training

2.2.2. 工程总承包Contractor

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第31页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

对于任何一个项目，工程设计、安装调试、投资控制、工期控制和质量控制以及环保健康和安全管理等对于投资商的利益和发展都是至关重要。“朗脉”提供的专业化工程服务最大限度地避免了工程建设的风险，给投资方带来最大的经济效益。

For any project, the key to the benefit and development of investors are engineering design, installation and commissioning, investment control, project period control, quality control, environment protection, safety and security managemnt. Besides, GMP inspection consultation and validation services also play a special role in pharmaceutical factory project. Professional engineering services that offered by Macroprocess maximize the project risk avoidance and the benefit.

“朗脉”通过采用国际通用的工程总承包（EPC ）模式，将“朗脉”自身的各子专业服务整合及与国际知名的工程公司合作，为您的药厂建设提供符合国际cGMP 规范的概念设计 、详细设计、工艺设备、洁净管道、暖通空调系统、洁净室系统、自动化系统、采购管理、施工管理、安装调试、验证等一体化整体解决方案。

Through adoption of EPC formula, integration of different specialties and cooperation with international famous engineering companies, Macroprocess can provide integrated total solution ,including conceptual design, detailed design, process equipments, sanitary piping , HVAC, cleanroom system, automation system , procurement management, construction management, installation, commissioning and validation etc. which are in conformity with international cGMP for pharmaceutical factory construction .

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第32页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.2.3. 植物提取工艺优化Process optimization “朗脉”致力于植物提取工艺的优化及中药现代化。

we are committed to process optimization of plant extraction and TCM modernization

植物提取工艺优化Optimization of Plant extraction

我们提供植物提取生产线的工艺设计优化、工艺成套设备、管道安装及自动化集成等专业服务。

We can provide process optimization for plant extraction production line, process equipment, piping installation and integration of automation control and etc.

VBD 系列全自动连续式真空带式干燥机VBD series --fully automatic continuous vaccum band-type dryer

“朗脉”在引进消化国外先进技术基础上,研制开发的一种全新概念的高效节能、环保型干燥设备。彻底解决了其它干燥设备难以解决的高粘度、高脂、高糖、高热敏性等物料的干燥。

Based on the introduction of foreign advanced technology ,

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第33页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

Macroprocess has developed this kind of new drying machine of high efficiency and ecological characteristics which can thoroughly solve the problem of drying substances of high vicosity, high fat, high sugar content and heat sensitivity etc. that other drying machines cannot overcome.

2.2.4. 自动化控制系统业务Automation Control system

制药及相近行业自动化系统的设计、安装、调试及验证（中国GMP、欧盟EMEA 及美国FDA 的cGMP）的工程是上海朗脉科技有限公司主营业务之一。

Professional design, installation and validation (Chinese GMP,EU EMEA and USA FDA ) of automation systems for the pharmaceutical and relevant industry fields is one of Macroprocess Technology’s core business.

“朗脉科技”本着“以技术为核心”的原则，聘用多位国内外技术专家，经过长期发展，造就了一批经验丰富的设计、安装、调试及验证的专业团队。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第34页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

In line with the principle “take the technology as the core”, we recruits lots of domestic and foreign technical experts. After the extensive experience we have cultivated and accomplished a group of specialized experts in design, installation and validation for domestic and foreign projects.

2.2.5. 过程控制系统Process Flow

在工业生产中，各单元操作集合而成的生产流程，例如：提取、发酵、合成、萃取、过滤、配料、浓缩、精馏、沉淀、结晶、干燥等，实现生产过程的自动化，并且可以大大提高生产效率，减少人为差错，保证产品质量，降低生产成本，提高生产质量管理水品，为企业现代化和信息化管理搭建数据平台。

In pharmaceutical factory，the process flow integrated by each unit operation, i.e. extraction, fermentation, chemosynthesis, filtration, preparation, concentration, distillation, deposition, crystallization, drying and so on, and the process flow with automation could maximize production efficiency, reduce human error, ensure product quality, reduce production cost, advance the quality management level, set up the data platform for company modernization and informationization.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第35页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.2.6. 空调自控系统HVAC automation system

上海朗脉科技有限公司拥有自己的洁净室项目实施管理团队，对制药厂房实施项目实施。

Macroprocess has own team to manage clean room project, and to proceed the project for whole pharmaceutical facotory.

朗脉公司采用国际先进的板材保证洁净厂房的质量，采用先进的HVAC 系统，尤其对HVAC 系统进行自动化控制和门禁一卡通系统，实现EMS 管理和空气缓冲的互锁，符合FDA 的要求；对于空气质量要求高的厂房引入文丘里风阀系统保证压差。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第36页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

朗脉公司认为一个好的洁净室项目的实施，离不开好的集成化的设计，公司各个富有施工经验的专业人员利用三维设计对项目进行预演。

We believe that to proceed a HVAC Automation system project without a integrated design, and we will preview the system via 3D software.

空调运行需要用大量的能源，系统在满足生产要求的前提下，实现能耗最小化、运行效率最高化，可以提高设备运行安全可靠性和使用寿命。

HVAC’s operation needs lot of energy. BA system could minimize consumption, maximize operation efficiency, enhancing the reliability of operation and working life and achieving the process requirements.

系统具有数据记录、查询、报警、打印及趋势曲线图功能，利于管理。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第37页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

BA System has the functions of data logging, search, alarm, printout and trend graph for easy operation.

2.2.7. 在线清洗系统Clean in place

全自动CIP 清洗是指设备（罐体、管道、泵等）及整个生产线在封闭的系 统中，无需人工拆卸便能进行有效的清洗和消毒。系统由酸、碱、热水、纯化水、注射用水、酸碱配置罐和换热器组成，根据工艺特点设定酸碱浓度、清洗流程、清洗液温度、清洗时间、保证产品质量，便于QA 工作的自动化和清洗工作的规范化。

CIP means that the equipment and the whole production line could be efficiently cleaned and sanitized without disassembly in close system. A CIP system is composed by detergents, hot water, purified water, WFI, preparation tank and heat exchanger. Concentration of detergents, clean flow, water temperature and cleaning time can be set

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第38页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

according to process specification, which could ensure the product quality, automation of QA affairs and standardization of cleaning.

● 可分区同时清洗一个或者两个以上区域，大大缩短CIP 清洗时间，使生产

● 减少工艺用水量、节省清洗剂、减低生产成本CIP system conduces to reduce process water consumption, saving detergent and reducing production cost

● 对清洗过程进行自动检测、显示和控制CIP system conduces to automatic measurement, display and control in cleaning process.

● 形成电子记录，符合GAMP4 和FDA 21 CFR PART 11 的要求CIP system generates electronic record compliance with the requirement of GAMP4 and 21 CFR PART 11

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第39页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.3. 洁净管道系统业务Sanitary piping system business

2.3.1. 完善的工艺设计Perfect in process design

对于我们承接的每一个项目，我们的设计团队在公司具有丰富管理施工经验的项目经理的领导下，并充分结合客户的URS 进行详细的优化设计，为客户做出具精确的P&ID 图、平面布局图、乃至施工图。这种优化设计是重要的，也是必须的，精确了材料数量，节省了施工时间，是为客户争取最大利益的保证。

For each project in which we are participated, our project manager in construction; Our design team can provide fully integrated and optimized detailed design according to the URS of our clients, the precise P&ID chart, layout plans, as well as construction plans. This kind of optimized design is a must. The precise amount of material, the organization of time, guarantees to act in the best interests of customers.

对于复杂的工艺管道系统，根据客户的需要和现场实际情况，我们的设计团队可以制作模拟现场的3D 效果图，从而保证了整个系统的精确定位和合理布置。3D 效果图可以衍生出相应的平面图，单管图及材料清单便于控制投资成本及施工周期，大大提高了施工效率和质量，是为提供给客户良好工程的重要保证。

Regarding complex piping systems, the needs of the customers and

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第40页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

the actual conditions, our design team can produce 3D simulation of the complete site, thus ensuring the accurate positioning and rational layout of the whole system. The corresponding plan can be developed from the 3D effect chart; singular pipeline plans can facilitate inventory control and materials costs and also the investment in the construction cycle, greatly increasing the efficiency and quality of construction.

2.3.2. 材料选型及采购Material Selection and Procurement

“质量和信誉是企业生存之本”，优质的材料供应商是高质量工程的基石。

Quality materials suppliers -- the cornerstone of high-quality works.

采购部门，根据技术部门的提供的参数和要求，为客户选择可靠的供应商及高性价比的产品。通过对供应商的评估、采购数据、所购产品的认证并结合客户的URS 为我们良好的工程提供重要的保证。Procurement departments, according to provided technical parameters and requirements, purchase products from reliable suppliers with high performance. Through vendor evaluation, procurement data, certificate of products and integration with URS provide an important guarantee for our work.

目前“朗脉科技”已经成为国内外许多知名公司的长期合作伙伴，如：After years of development, "Win Win" becomes the long-term partner of many well-known domestic and foreign enterprises:

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第41页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

瑞典：Alfa laval

德国：Gemu、Burker t、E+H、+GF+、Siemens

瑞士：Mettler-Toledo

丹麦：Grundfos

台湾：Kinglai

优质的材料供应商，加上“朗脉科技”先进的优化设计理念、科学的工程管理、丰富的国内外验证经验，以及科学严谨地规范每一个工作流程；确保您的整个自控系统工程准时、高质量地完成。

Good cooperative relations with suppliers and ensuring their quality plans to ensure that the project completed on time and according to the specified quality of the Client.

2.3.3. 齐全的施工设备Construction facility

我们齐全的施工设备能够承担任何作业。Our organization is fully equipped with hardware to undertake any task.

洁净管道专业切割设备Import cutting machinery specially for pipelines: 

● 切割端面平整Flat cutting surface

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第42页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

● 切割端面无氧化Non-oxidized cutting surface

● 切割端面无变形Non-deformed cutting surface 平口机完成专用切割机无法完成的其他任务，如特殊位置用的管件需要修整或对管道的端面进行平整等等。Tube square machine that can complete the mission that special cutting machine can not complete, e.g. special positions and surface in the pipeline which need trimming.

● 全自动轨道焊接设备World-class automatic orbital welding machinery

● 焊缝内外充氩气保护，无氧化Welding is argon-protected without being oxidized

● 操作简单、方便Simple and convenient handling

● 避免人为的焊接缺陷Manual welding defect can be avoided

所有的焊接点都是经过专业处理，设备与材料具有可追溯型，手动焊接由受过培训的具有职业资格证书的人员操作。All welding joints are professionally treated; all materials and equipments are certified and traceable; Manual welding is accomplished by trained personnel with appropriate qualifications and certification.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第43页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.3.4. 现场管理及现场施工Project management and construction

项目经理根据公司制定的良好工程规范组建项目组来进行质量管理、设计 变更控制、文件和数据的控制、采购控制、过程控制、检查和测试控制、检测 设备的控制、不合格品的控制、纠正和预防措施、安全防护制、包装、运输、储存控制、培训以及验证等。

The project manager sets up the project team according to Clients Company for complete project quality management. Control in change of design, document and data control, procurement control, process control, inspection and control testing, testing of equipment control, control of defective products, corrective and preventive measures, security control, packaging, transport, storage control, training, testing and validation is also strictly monitored

严谨规范的安装队伍是良好工程的保证。Installation team with stringent standards is our Guarantee for good work.

公司富有多年施工经验的施工人员将会按照公司制定的操作规范和客户要求进行施工操作。Our experienced construction staff are rich in experience and they will strictly follow the rules and regulations of operation, and customer requirements.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第44页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.3.5. 先进的检测设备Testing equipment

先进的检测设备确保高质量的完成工程安装，公司拥有完善的焊接质量检测系统。Advanced testing equipment ensure the quality of the completed work.and Welding quality examination system as the follow aim:

● 焊缝质量检测Welded joint quality test

● 焊缝质量评定Welded joint quality assessment

● 提供焊接质量检测报告表Provide welding quality inspection reports

为了确保每一个焊缝的焊接质量。公司结合科学的检测手段配备了先进的检测仪表，如X 光烫伤机、内窥镜、钝化检测仪等。To ensure the quality of welding, the company utilises the scientific detection means equipped with advanced instrumentation, such as the X-ray crack detection machine、Slope meter 、Passivation test and endoscope.

2.3.6. 系统调试和人员培训Training and system commission

根据包含的系统及其范围，我们将编制详细的调试计划。这个计划将包括范围内的每一个系统和设备的描述，包括自控系统；确定个系统进行调试顺利，

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第45页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

及相关前后工序；与项目施工进度结合在一起。

According to the scope and contents of the system, we will establish the detailed commissioning plan. This plan will include descriptions of the scope for each system and equipment, including automatic control system and ensure all systems are commissioned in the correct order, and in their correlation to working procedures.

我们确保所有人员的培训是有文件证明的。直到接受培训的人员能胜任他们各自的任务。

We ensure that all staff training is well documented with certification. Until those trained personnel are capable of performing their respective tasks.

所有人员的培训过程是必须可以被记录的。对于所有人员来说，都需要资格、经验和培训的记录。所有室内和室外的记录都将被保存。

All the training process must be documented for easy reference. For all the staffs they are required to acquire qualifications, experience and training records. All training records will be preserved.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第46页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.3.7. 验证服务Validation service

作为药品生产过程中的关键系统。洁净管道在设计施工中面对的是严格的规范要求和质量标准。朗脉聘用的是曾经在跨国制药及工程公司服务多年的技术专家，按照国际GMP 规范进行洁净管道系统的验证。

As one of the critical systems in pharmaceutical production facility, clean piping faces more and more stringent requirement on quality assurance and regulatory compliance. Macroprocess employs experts who have served at multinational pharmaceutical and engineering companies and provide qualification/validation services in accordance with international GMP guidelines.

我们在洁净管道系统方面的验证范围包括The scope of our qualification service include:

● 系统的风险分析 System Risk Analysis

● 确认文件的准备 Preparation of IQ/OQ/PQ protocol

● 确认执行 Execution of IQ/OQ/PQ

● 验证报告的编制 Final Qualification Report

● 现有系统的差距分析及整改建议 Gap analysis on existing system and recommendations on retrofits

● 回顾性验证 Retrospective Validation

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第47页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

第 3 部分

Part 3

技术及控制方案

Technical and control system proposal

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

T:021 54306717      F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

目 录

1. 技术方案Technical	2
1.1. 项目背景Project Background	2
1.2. 管道系统设计标准和规范Design Standards	4
1.3. 施工规范和法规Construction Regulations and Guidance ..	8
1.3.1. GMP 法规 GMP regulations	8
1.3.2. ISPE 指南	9
1.3.3. 工艺管道标准 Process pipe system standards	10
1.4. 生产工艺描述Process Description	10
1.4.1. 概要General	10
1.4.2. 洁净压缩空气系统Compressed Air (CDA) Distribution ....	11
1.4.3. 氮气系统Nitrogen Distribution	11
1.4.4. 氧气系统Oxygen Distribution	12

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/ 共12 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

1. 技术方案 Technical

1.1. 项目背景Project Background

沈阳三生制药有限责任公司是集生物药品的研发、生产和销售一体化的高新技术企业。公司的生产基地位于沈阳经济技术开发区，生产车间面积3000 平方米，通过了国家GMP 认证。公司计划建设新的厂房，提高生产能力，来满足日益增长的市场需求。

Shenyang Sunshine Pharmaceutical Company Limited (SUNSHINE) is an integrated biopharmaceutical company engaged in research/development, manufacture and marketing/sales of biopharmaceutical products in China. Its clinical and commercial manufacturing operations are based in Shenyang, China, where Chinese current Good Manufacturing Practice, or cGMP, certified, 3,000 square meters, and state-of-the-art facility resides. SUNSHINE plan to expand the plant in Shenyang to increase the manufacturing capacity and take further advantage of his favorable cost structure.

本次项目为沈阳三生制药有限责任公司的新建车间压缩空气和工艺气体系统的设计、材料、安装、检查和测试、调试、文件和交付。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2页/ 共12 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

This project is invited tender for design, supply & install of distribution loops for new workshop of SUNSHINE Company. And it is Compressed Air and Process Gas System . this is a turnkey project.

上海朗脉科技有限公司被邀请参加本次洁净管路项目的招标，我们的系统方案以及设计完全按照业主2009 年1 月发布的招标要求以及系统设计要求。

Macroprocess was invited to provide a quotation for the clean piping/utilities systems of this facility. Our proposal is based on SUNSHINE’s tendering specification distributed in January 2009.

本次方案我们提供以下各系统的施工图设计，交货，安装，测试，调试和确认：

Our Scope of Work consists of final detail design, delivery, installation, testing, commissioning and qualification of following packages:

·  Compressed Air and Process Gas System 压缩空气和工艺气体系统

·  Related control system 相关的自控系统

·  Other related Accessories   其他相关辅助材料系统

各循环系统根据客户的要求进行详细设计，具体详见相关技术描述和PID 图。我们按照GMP 的要求对贵公司的系统进行验证，此部分验证内容

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第3页/ 共12 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

和报价可以参见报价清单说明。

All loop is designed to meet owner’s requirement and for details see technical description and PID.and we also provide the quotation on validtion to meet GMP requirement. And this part of validation scope and pricelist please refer to the related section.

公司聘认了国外专家专门从事FD A、WHO、欧盟、TGA 等法规的验证工作。“朗脉”的客户涵盖了许多国内外知名的制药企业，其中已有多家客户通过FDA 、EMEA 、TGA 等国外认证，并建立了良好的长期合作关系。

Macroprocess has accomplished an experienced professional team made up of experts on FDA ,WHO,EMEA,TGA validation by recuiting many technical experts both from home and abroad . Macroprocess has served many famous pharmaceutical enterprises both from home and abroad, of which many enterprises have passed foreign validation ( USA FDA, EU EMEA, Australian TGA and etc.) We are also maintaining excellent cooperative relationship with our clients.

1.2. 管道系统设计标准和规范Design Standards

·   According to related national and local government pipeline construction standards and stipulations 根据国家及当地政府管道施工的相关标准及规定

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第4页/ 共12 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

·   WHO about Guidelines for Drinking-water Quality WHO 关于饮用水水质的指南

·   WHO about water treatment guide & aqueous system Examination guide WHO 关于水处理指南和水系统检测指南

·   Drugs production quality control in 1998 amended 药品生产质量管理规范1998 年修订

·   ASE BPE 2002 Edition ASE BPE 2002 年版

·   ICH Q7A GMP of Bulk Pharmaceutical Chemicals, November 2000 ICH Q7A 原料药的GMP, 2000 年11 月

·   USP-29 2006 Edition USP-29 2006 年版

·   FDA federation laws & regulations related stipulation FDA 联邦法规有关规定

·   European pharmacopoeia 欧洲药典

·   According to JBJ23- 96 edition (Code for Construction & acceptance of machinery and equipment installation) 根据JBJ23- 96 版《机械设备安装工程施工及验收规范》

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第5页/ 共12 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

·   According to HGJ203-83 edition (Code for Construction & acceptance of chemical machinery installation) 根据HGJ203-83 版 《化工机器安装工程施工及验收规范》

·   According to GB50236-98 Edition (Code for Construction & acceptance of field equipment installation & industry pipeline welding) 根据GB50236-98 版《现场设备、工业管道焊接工程施工及验收规范》

·   According to DL5017-93 Edition (Code for Construction, Manufacturing & acceptance of Pressure Piping) 根据DL5017-93 版 《压力管道制造安装及验收规范》

·   According to (Pharmaceutical chemicals overall examination Guide) 根据《医药化学品总体检验指南》

·   According to (Code for Drugs production & management) 根据《药品生产管理规范》

·   According to (Code for Clean room construction and Acceptance) 根据《洁净室施工及验收规范》

·   According to Planning & Design Ordinance of Macroprocess Technology 根据朗脉科技设计条例

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第6页/ 共12 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

·   According to PW piping system design & standards of Macroprocess Technology 根据朗脉科技高纯度管道系统的设计标准

·   According to Construction requirements for Clean Room & High purified water pipeline system of Macroprocess Technology 根据朗脉科技高纯度管道工程洁净厂房施工守则

·   According to guide to Construction safety of Macroprocess Technology 根据朗脉科技安全施工注意事项

·   According to Construction procedure for High purified water piping system of Macroprocess Technology 根据朗脉科技高纯度管道系统的施工程序

·  According to operational procedure for testing of Macroprocess Technology 根据朗脉科技高纯度管道系统的测试作业程序

·   Code & requirements of China, the United States and the European in production of vaccine for Human 用于生产人用疫苗的中国、欧洲和美国的规范和要求

·   Laws and regulations for Electric appliance & installation 电器设备和安装的法规

·   Laws & regulations for safety standards

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第7页/ 共12 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

安全标准、法典和规范

·   According to drawings and relevant requirements of products provided by owner. 根据业主提供的图纸及产品的相关要求

1.3. 施工规范和法规Construction Regulations and Guidance

本洁净管道系统项目，将按照以下法规和指南进行设计、施工、调试和验证：This project for sanitary piping system will be assured that its design, construction, commissioning and qualification will be in accordance with the following regulations and guidance:

1.3.1. GMP 法规 GMP regulations

a) (SFDA) 药品生产质量管理规范 1998 年修订版

Good Manufacturing Practice, revised in 1998

b) (SFDA) 药品生产质量管理规范附录 1998 年

Annex of GMP, in 1998

c) (FDA) 联邦法规第21 篇第210-211 部分，现行的成品药生产质量管理规范 21 CFR parts 210 and 211, Current Good Manufacturing Practice (cGMP) for finished pharmaceuticals.

d) (FDA) 联邦法规第21 篇第11 部分，电子记录和电子签名

21 CFR part 11, Electronic Records; Electronic Signatures

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第8页/ 共12 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control

e) (FDA) 无菌工艺生产的无菌产品的GMP 的行业指南， 2004 年9 月 Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing- Current Good Manufacturing Practice, September 2004

f) (FDA) 高纯水系统的检查指南，1993年7 月 Guide to Inspections of High Purity Water Systems, July 1993

g) (Europe) 欧盟最新的GMP European Current GMP

1.3.2. ISPE 指南

a) ISPE 工程指南卷3：无菌生产厂房设施，2000年6 月 ISPE Baseline Guide Volume 3: Sterile Manufacturing Facilities, June 2000

b) ISPE 工程指南卷4：水和蒸汽系统，2000年12 月 ISPE Baseline Guide Volume 4: Water and Steam System, December 2000

c) ISPE 工程指南卷5：调试和确认，2000年6 月 ISPE Baseline Guide Volume 5: Commissioning and Qualification, June 2000

d) ISPE 工程指南卷6：生物制药，2003年1 月 ISPE Baseline Guide Volume 6: Biopharmaceuticals, January 2003

e) GAMP 5 : 制药生产中的自动化系统验证的良好规范 Good Automated Manufacturing Practice for Validation of Automated Systems in Pharmaceutical Manufacture

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第9页/ 共12 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

1.3.3. 工艺管道标准 Process pipe system standards

a) GB50235-97 工业金属管道工程施工及验收规范   Code for construction and acceptance of industrial metallic piping.

b) ASME BPE-2005 生物工艺设备   Bioprocess equipment

1.4. 生产工艺描述Process Description

1.4.1. 概要General

以下技术描述基于UR S（用户需求规格）。我们提供各系统的详细设计包括设备，控制系统，以及各类仪表，并按照标准提供整个系统的设计、安装、交货、调试、验证、培训方案。我们的设计图纸（包括管路平面走向示意图、系统流程图和P&ID’s 等）将作为主要设计依据。另外，我们提供必要的条款，确保整个设计系统符合生产要求。

The following description is based on the URS. Upon award of the bid, we shall carry out detail design of the entire system including equipment, controls, and instrumentation, and use the approved design as guideline for the procurement, delivery, installation, commissioning and qualification of the system. Our design drawings, including Piping and Instrument Diagrams (P&ID's), piping layout drawing, piping isometric drawing and so on, will become the master documents to which and for which the Chengdu Institute’s documents will be modified. We shall provide necessary items to ensure that the overall system performs to meet the process requirements.

整个系统的符合中国、WHO、EU和FDA 的标准。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第10页/ 共12 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

The sanitary aspects of the system will meet GMP requirements for China, WHO, EU and FDA.

1.4.2. 洁净压缩空气系统Compressed Air (CDA) Distribution

通过洁净压缩空气管路，压缩空气分配给各个使用点。使用点采用球阀，管子及阀门全部为316L 不锈钢材质，为了防止污染的压缩空气回流，管路中应设置止回阀。

Piping will connect CDA to all use points from air compressor. Interface point with the general CDA pipe will be ball valves. Pipe material for general CDA system is 316L Stainless Steel. To prevent back-flow contamination to general CDA system, check valves shall be installed after the connected valves

1.4.3. 氮气系统Nitrogen Distribution

通过氮气管路，氮气分配给各个使用点。使用点采用球阀，管子及阀门全部为304 不锈钢材质，为了防止污染的氮气回流，管路中应设置止回阀。

Piping will connect nitrogen to all use points from nitrogen generation plant. Interface point with the general nitrogen pipe will be ball valves. Pipe material for general nitrogen system is 304 Stainless Steel. To prevent back-flow contamination to general nitrogen system, check valves shall be installed after the connected valves.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第11页/ 共12 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

1.4.4. 氧气系统Oxygen Distribution

通过氧气管路，氧气分配给各个使用点。使用点采用球阀，管子及阀门全部为304 不锈钢材质，为了防止污染的氧气回流，管路中应设置止回阀。

Piping will connect Oxygen to all use points from Oxygen generation plant. Interface point with the general Oxygen pipe will be ball valves. Pipe material for general Oxygen system is 304 Stainless Steel. To prevent back-flow contamination to general Oxygen system, check valves shall be installed after the connected valves.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第12页/ 共12 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

第 4 部分

Part 4

验证方案

Validation

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

T:021 54306717      F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

目 录

Index

1. 介绍Introduction	3
2. 验证范围Work scope of validation	3
3. 验证方法Validation approach	5
3.1. 总要求General Requirement	5
3.2. 风险评估Risk Assessment	6
3.3. 追溯矩阵表Traceability Matrix	8
3.4. 设计确认Design Qualification	9
3.5. 工厂验收测试 Factory Acceptance Test	12
3.6. 现场验收测试 Site Acceptance Test	14
3.7. 校准Calibration	14
3.8. 安装确认Installation Qualification	17
3.9. 运行确认Operation Qualification	19
3.10. 控制系统的验证 Validation of Automatic Control System	21
3.11. 性能确认Performance Qualification	21
4. 质量项目计划Quality and Project Plan	22

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/ 共22 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

验证服务范围

Work Scope of Validation Service

压缩空气、氮气、氧气和二氧化碳分配系统

Distribution System of Compressed air,

Nitrogen, Oxygen and Carbon Dioxide

提供方：上海朗脉科技有限公司

Provided by: Shanghai Macroprocess Co., Ltd.

January 2009

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2页/ 共22 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

1. 介绍Introduction

沈阳三生制药有限责任公司（“沈阳三生”） 将新建一个生物制药车间，现对压缩空气、氮气、氧气和二氧化碳分配系统的详细设计、施工、调试和确认（验证）的工程服务项目进行招标。

Shenyang Sunshine Pharmaceutical Co., Ltd. (3SBIO) will build one new biopharmaceutical plant, and now invite the bidding for the project of detailed design, construction, commissioning and qualification (validation) of distribution system of compressed air, Nitrogen, Oxygen and Carbon dioxide.

上海朗脉受邀参与投标，本文件将为本次的项目中验证范围进行做出说明，并给出最优的报价。

Shanghai Macroprocess is invited to bid for this project. This document will define the work scope of validation activities and give a best quotation.

2. 验证范围Work scope of validation

我们提供的验证服务范围，见以下验证矩阵表。

We provide the validation services shown in Validation Matrix.

表Table 1-验证矩阵表Validation Matrix

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	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

系统System	RA	TM	DQ	FAT	SAT	IQ	OQ	PQ*
压缩空气分配系统 compressed air distribution system	√	√	√	-	√	√	√	√
氮气分配系统 Nitrogen distribution system	√	√	√	-	√	√	√	√
氧气分配系统 Oxygen distribution system	√	√	√	-	√	√	√	√
二氧化碳分配系统 Carbon dioxide distribution system	√	√	√	-	√	√	√	√

备注Remark：

1） RA- 风险评估Risk Assessment ; TM- 追溯矩阵表Traceability Matrix; DQ- 设计确认Design Qualification; FAT -工厂验收测试Factory Acceptance Test; SAT- 现场验收测试Site Acceptance Test; IQ-安装确认Installation Qualification; OQ- 运行确认Operational Qualification; PQ- 性能确认 Performance Qualification

2） PQ 方案由朗脉提供，实施由客户负责。 PQ protocols are prepared by Macroprocess, but the execution will be done by client.

详细的验证要求描述见后面章节。

Detailed validation requirement description will be found in the following section.

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	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

3. 验证方法Validation approach

3.1. 总要求General Requirement

我们将按照以下V 模型对关键系统开展验证工作。

We will conduct the validation/qualification activities according to the following V-Model.

Figure 1- V-model

在设计开始之时，验证工作也将同时开展。在详细设计完成的后期，进行设计确认，并对系统进行风险评估，编写追溯矩阵表。在采购和施工过程中，任何的关键性变更(影响产品质量或安全的变更) ， 需要提交给验证人员进行审核。

Validation activities should begin with design. In the end of detailed design stage, Design Qualification and Risk assessment will be

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第5页/ 共22 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

conducted, and also Traceability matrix will be prepared. During purchase and construction, any significant change(impact product quality or safety) should be submitted to validation person for review. 系统施工结束后，进行调试，在合适的时候组织客户相关人员，进行FAT 或SA T。然后，进行安装确认和运行确认。性能确认，由客户自己负责实施。 When the finish of construction and commissioning, we will invite related persons from client to conduct FAT or SAT. Then Installation and Operational qualification will be done by us with witness by client. Performance qualification will be done by client own.

3.2. 风险评估 Risk Assessment

风险评估将决定哪些系统/部件需在GEP 基础上还须进行确认，哪些仅仅需要按照GEP 规范进行安装和调试。 Risk assessment is the process of determining which systems/components should be subject to qualification practice in addition to Good Engineering Practices (GEP) and which systems/components should be commissioned in accordance with GEP.

评估通过衡量某一系统对产品质量的影响进行。在系统完成评估之后，系统的部件也将被评估，来确定它们是否对保证和维持产品质量有关键影响。 有直接影响的系统和部件将进行确认，而有间接影响的仅按照GEP 进行设计，

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第6页/ 共22 页

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	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

安装和调试。

The assessment is made by evaluating the impact that a system has on the quality of the product. After the system assessment, the components of the system are evaluated to determine if they are critical to establish or maintain the quality of the product. The appropriate qualification practices are then applied to the ‘direct impact’ systems and components, while the ‘indirect impact’ systems and their components shall be designed, installed and commissioned according to GEP.

根据这种方式，工作的重点集中在对产品质量有关的系统和部件上。评估的完成途径多种多样，由每个公司最终确定。

Following this approach, the appropriate effort and focus can be maintained on the quality impacting systems and components. The assessment process can be done in a variety of ways, which will be ultimately defined by each individual operation company.

风险评估的基本步骤Basic Steps of Risk Assessment:

- 了解系统或设备，以及工艺流程 Identification of System/Equipment, Process

- 识别可能出现风险、产生的原因、带来的影响 Identification of the risk event, cause and effects

- 评估该风险出现的可能性 Evaluation of the probability that the event occurs

- 评估该风险带来的影响的严重程度 Evaluation of the Impact of the Risk

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	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

- 评估该风险被发现的可能性 Evaluation of the probability of detection of the event

- 建议采取的措施

Suggested actions

报告Reporting：

风险评估的结果将报告下列内容：

The results of the risk assessment will be reported with the following typical contents:

- 目的

Objective

- 风险评估的参与者

Participants in the risk analysis

- 工艺参数、功能、关键组件 Process parameters, Function and Components

- 潜在的风险

Potential risk

- GMP 关键性的判断

Identification if it is GMP critical

- 风险的原因和后果

Cause and consequences of risk

- 风险评估（出现的可能性、影响的程度、被发现的可能性） Risk Assessment (probability of occur, Impact, probability of detection)

- 处理的措施（如测试要求、特别措施等） Measures(e.g. Test requirement, specific measures etc.)

3.3. 追溯矩阵表Traceability Matrix

追溯矩阵表对验证项目的质量关键及基本要求自用户需求标准到功能标准直至测试方案进行追溯。

Traceability Matrix traces the quality critical and essential

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	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

requirements from the User Requirements Specification (URS) to the functional specifications and onto the test protocols for this validation project.

3.4. 设计确认 Design Qualification

DQ 是对系统的设计进行审核，以确认它们符合预定功能及运行要求，并符合GMP 要求。

DQ is the review for the design of system which ensures that these are according to advanced function and operation requirement as well as GMP requirement.

DQ是贯穿于项目设计阶段的一个持续的过程，它保证与特定设备和系统相关的所有的设计文件符合现行GMP的要求。我们将积极采取行动，保证项目的设计符合国际GMP 及客户的内控标准。

DQ is a continuous progress throughout project design stage. DQ ensure the design documents related to specific equipment and system according to current GMP requirement. We will act for it and ensure the project design meet the international GMP and internal standard of Client.

DQ 的关键工作是对系统的设计进行GMP 审查。该审查由朗脉验证专家主持，双方人员均参加。此审查将提供一个正式文件，证明设计按照GMP 各

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第9页/ 共22 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

方面要求。会议的记录，完整的文件检查清单及变更清单将是DQ 的质量记录，被妥善保存。

The critical work of DQ is GMP review to system design. This review is conducted by specialist from Macroprocess, both sides would join it. This review will provide an official document to prove the design meet the GMP requirement of each aspect. Meeting memo, complete document check list and change list will be quality record of DQ and will be preserved appropriately.

设计确认（DQ ）并非法规的恶强制要求。然而，从正式性和加强的设计审核角度，我们推荐执行DQ。

Design Qualification (DQ) is not a mandatory requirement of the regulations. However, in this formal format or through enhanced design reviews, it is recommended that it be carried out.

DQ 通过对系统进行有组织的设计审查来进行。这种审查将在严格要求下进行，因为它在IQ、OQ之前能够更好地发现设计问题或不符合要求的方面，否则将对项目的工期和费用造成巨大影响。

The DQ will be executed by applying a structured review of the design of the systems. The review should be rigorous as it is better to discover any design problems or non-conformance issues before reaching IQ or OQ, where remedial work may have a significant

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	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

impact on the project schedule and cost.

方案将用采用书面格式。详细的检查清单将确保设计和文件的所有方面均被涉及。方案被各方正式签署后执行。

A protocol will be prepared with a written description of the format and approach for the reviews. Detailed checklists will be prepared to enable all aspects of the design and documentation to be interrogated. The requirements of the risk assessment and cGMP reviews will also be reviewed to ensure that their requirements are incorporated. The protocol will be formally signed off as approved prior to execution and post execution by all parties.

DQ 文件的通常标准包括： Typical criteria, which would be used to generate the DQ protocol are:

- 设计确保满足GMP 的要求 Design satisfies GMPs and regulatory requirements

- 设计符合性能标准 Design meets performance criteria

- 材料材质 Materials of construction

- 清洗要求 Cleaning requirements

- 操作的可靠性和有效性 Reliability and Efficiency of operation

- 设备安装 Equipment Installation

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	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

- 系统调试 System commissioning

- 关键仪表的参数，量程和精度是否满足工艺要求和控制要求 parameters of critical instruments, verify if the measuring range and accuracy satisfy the process and control requirement

- 关键组件的结构 Structure of critical components

- 文件要求 Documentation requirements

3.5. 工厂验收测试 Factory Acceptance Test

工厂验收测试应该关注设备关键的方面，包括进行测试活动。这些测试将在设备起运之前进行，以保证该设备已按照设计标准进行制造，并提供所需要的文件。因此，FAT 可帮助避免可能影响现场测试的问题的产生。

Factory acceptance test could be applied to any critical aspect and includes test activity, that will be carried out before the shipment, to get assurance that a new critical equipment/ package has been built following the design specifications and it is provided with the required documentation; moreover the FAT will help to avoid problems that could affect the on site activities progress.

FAT 可适用于所有关键的设备或设备包。

FAT could be applied to any critical equipment or components.

FAT 将包括IQ OQ 所包含的一些测试内容。任何不受运输或安装所影响的测试内容，如果其得到合适的执行、复核和记录，在以后的确认中，可以不需重复进行。下面是一些被认为可以作为确认目的的测试内容，但不仅限于

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	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

此：

FAT will already include some tests foreseen by the IQ and OQ; any test, which reliability will not be affected by the shipment and the installation could not be repeated for qualification purpose, if properly executed, witnessed and documented. Test activity that typically could be considered validated for qualification purpose, but not limited, are the following:

- 文件确认 Documents verification

- 图纸的确认（P&ID、布置图、电子和气路图） Drawings verification (P&ID, Lay Out, electrical and pneumatic scheme)

- 材料和表面抛光的检查 Materials and surfaces finishing verification

- 控制系统图形界面的检查 Control system graphical pages check

- 报警和联锁 Alarms and interlocks

FAT 将要求进行记录；相关的测试报告或方案，将被提交给客户审核和批准。

FAT 将在客户批准后进行。

FAT will be documented; the relevant test report or protocol, will be submitted to client for review, comments and approval; FAT execution will begin after client approval.

本项目不需要进行FAT。

It doesn’t need to conduct FAT for this project.

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	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

3.6. 现场验收测试 Site Acceptance Test

此工作适用于关键的系统或设备。 SAT 包含动态的和静态的测试活动，测试活动在现场由供应商在移交系统给客户之前进行。每一项SAT 工作将被文件记录下来。我们将提交测试文件（定义为SAT 报告或方案）给客户，以审核和批准。

Activity Applicable to critical system or equipment; SAT consists of Dynamic and static testing activities performed on site by the vendor before hand over the system to the client. Each SAT activity will be documented. Macroprocess will submit the test document (defined as SAT report or protocol) to Client (for comments and approval).

那些不会因为系统/设备的改变而影响可靠性的测试，如果已得到正确的执行、证明和文件记录，那么在验证过程中不必重复进行。

All tests which reliability will not be affected by the system/equipment modification could not be repeated for qualification purpose, if properly executed (in conformity with Qualification Protocols), witnessed and documented.

3.7. 校准 Calibration

因为是新的安装， 所有的仪器仪表和变送器应被校准并产生校准证书。

Since this is a new installation all transmitter instruments will be calibrated, and calibration certificate will be produced.

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	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

所有不受安装影响的仪器仪表将经过校准后送到现场，并提供校准证书（溯源为NIST 或中国国家计量基准）。其它的仪器仪表将在现场使用计量标准进行校准。在任何情况下，应提供参考仪器的校准证书和校准程序。

All instruments not affected by the installation will be bench calibrated and then, supplied to the field, provided with NIST or Chinese National measurement standards  traceable calibration certificate; the others will be calibrated in field using traceable standards references. In a case copy of the reference instrument calibration certificate and approved procedures will be provided.

下列是对不同等级仪器仪表的处理方法。

On the following different dedicated approach for class of instruments.

不受安装影响的仪表

Instruments not affected by the installation:

温度和压力变送器，需要校准证书（溯源为NIST 或中国国家计量基准）。确认工作，仅为确认安装情况（是否有合适的配置、范围、计量单位、信号）和带有相关显示器或相关监督和控制站的信号定位。

Temperature and pressure transmitters; for which will be required (to

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	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

the vendor) a bench calibration certificate (NIST or Chinese National measurement standards traceable) and during the qualification will only be verified the set up (if smart the relevant configuration, range, engineering unit, signals) and the signal alignment with the relevant indicator or the eventual supervision and control station

会受安装影响的仪表

Instruments affected by the installation:

流量和液位变送器，不需要实验室校准。校准将在现场使用可溯源为NIST 或中国国家计量标准的仪器进行校准。

Flow rate and level transmitters; for which will not be required a bench calibration. The calibration will be performed after the installation in field using NIST or Chinese National measurement standards traceable reference instruments.

电导仪和PH 计将在现场通过使用相关的指示器与标准溶液进行确认/校准。conductivity and pH probe will be verified/calibrated in field reading the measurement using the relevant indicator in comparison with a reference standard solution.

仪表的校准工作不属于验证工作。本项目的仪表校准工作由哪方负责，将由合同进行约定。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第16页/ 共22 页

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	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

Calibration is not included into Validation work. The responsible party for calibration work will be according to the contract.

3.8. 安装确认Installation Qualification

安装确认将检查每一个设备/系统的安装是否符合设计和相应的GMP 规范。IQ 将确认所有的需要用于设备/系统的管理和操作的文件的可用性。

The Installation Qualification will determine that each equipment/system has been installed in accordance with the design (if new or renovated) and the applicable current good manufacturing practice (either if new or existing). IQ will confirm the availability of all the required documentation useful to manage and operate with the equipment/system itself.

在执行IQ 之前，系统的机械安装工作已完成。

Prior to the IQ, systems will have to be mechanically completed.

IQ 方案编写 IQ Protocols Preparation:

在所有对产品质量有影响的系统上都要进行IQ。每个IQ 方案都是针对特定系统的，但是所有方案都基本包含以下内容：

For all of the system that affect product quality must undergo IQ. Each IQ protocol is targeted at specific system, but all protocols usually contain the following elements:

- 方案批准页Protocol Review and Approval Sheet

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	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

- 目的 Purpose

- 验证范围 Scope of Validation

- 职责 Responsibility

- 参考文件Reference documents

- 系统描述 System description

- 文件检查 Document verification

- 系统图和布局图检查 P&ID and Layout verification

- 设备确认 Equipment verification

- 仪表确认 Instrument verification

- 材质和表面抛光的检查 Materials and Surface finishes verification

- 组件结构的检查 Components construction verification

- 死角的确认 Deadleg verification

- 安装情况的检查 Installation verification

- 公用设施的检查 Utilitites verification

- 人员的确认 Personnel identification

- 偏差报告 Deivation report

- 实施结果批准 Execution review and approval

IQ 接受标准 IQ Acceptance Criteria:

- 所有的参与IQ 执行的人员在实施前须经相关培训。 All personnel participation in IQ execution must pass through the correlation pre-job training.

- 所有文件（如操作手册，维修手册，焊点图，焊接记录，焊接检查，坡度确认，压力测试文件，内窥镜检查测试记录等）将被检查，文档位置将被记录。 All documents (such as operating manuals, maintenance manuals, solder joint plans, records of welding, welding inspection, slope confirmation, pressure test document, endoscopies test records, etc.) will be examined, file location will be recorded.

- 所有的图纸（如管道和仪表流程图，管道轴测图，电气图，气动图等）和材质证明等将被检查，文档位置将被记录。 All drawings (For example pipeline and measuringappliance flow chart, three dimensional pipelineschematic drawing, electrical chart, pneumatic operated

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	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

chart and so on) and with the material quality proved and inspection file location will be recorded.

- 特定系统的备件清单须完备 The detailed list of spare parts for specific system must be completed

- 所有的设备，仪表和配套将被检查并须符合预设标准 All equipment, instrument and accessory will be inspected and they are required to meet the pre-set standards

- 仪表的校正已经成功完成 Instrument calibration has been successfully completed

3.9. 运行确认Operation Qualification

运行确认是按照预设的操作范围和机械性能进行，通过记录的文件，证明系统和设备能正确运行。

OQ could be executed and operated according to the pre-set operation arrange and mechanism performance through the recorded documentations prove that the system and equipment have been proper operated.

OQ 方案编写 OQ Protocols Preparation:

在所有对产品质量有影响的系统上都要进行OQ。我们会为每一个系统写一份OQ 方案。每个OQ 方案都是针对特定系统的，但是所有方案都包含以下内容：

All systems which influence the product quality are needed to execute OQ. We will write a OQ protocol for each system. Each OQ protocol aims at specific system separately, but all protocols are including:

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	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

- 方案批准页 Protocol Review and Approval Sheet

- 目的 Purpose

- 验证范围 Scope of Validation

- 职责 Responsibility

- 参考文件 Reference documents

- 系统描述 System description

- 验证仪器的检查 Validation Instruments verification

- 功能检查 Function Verification

- 报警和联锁的检查 Alarms and interlocks verification

- 人员的确认 Personnel identification

- 偏差报告 Deivation report

- 实施结果批准 Execution review and approval

OQ 接受标准 OQ Acceptance Criteria:

- 所有的参与IQ 执行的人员在实施前须经相关培训。 All personnel participation in IQ execution must pass through the correlation pre-job training.

- 所有的OQ 工作将按照已批准的方案执行 All OQ activities should be conducted according to approved protocols.

- OQ 测试仪器应被校准过的， 相关的证书应可溯源NIST 或中国国家计量基准， 并附在相应的方案中 OQ Test instruments should be calibrated; the relevant certificate should be NIST or Chinese National measurement standards traceable to the National Institute of Standard Technology and attached to the relevant protocol.

- 系统报警和联锁的情况应符合设计标准 The system’s alarms and interlocks should operate in accordance with the design specification.

- 系统功能运行应符合设计标准 The system’s function should operate in accordance with the design specification.

- 系统所用的公用设施应当在规定范围以内（ 温度、压力、流量） Utilities, used by the system, should be available at the battery limit within the specified range (temperature, pressure, flow-rate).

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3.10. 控制系统的验证 Validation of Automatic Control System

所有的跟产品生产、质量控制和分销有关的自控系统及其他数据采集，存储和处理系统都属于验证的范围。自控/计算机系统的验证将依据美国FDA （包括21CFR 第11 部分有关电子记录和电子签名的规定）、欧盟的GMP 指南和良好自控生产规范（GAMP）进行。

All automatic control system and other data collection, storage and treatment system related to production, quality control and distribution are involved in the scope of validation. The validation of automatic system would be held according to the US FDA (21 CFR Part 11), GMP guideline of EU and GAMP.

3.11. 性能确认 Performance Qualification

OQ 的成功完成之后，将进行PQ 工作。PQ 将整合考虑规程、人员、物料、设备和工艺。

Upon successful completion of the OQ, Performance Qualification will be carried out. The PQ will integrate procedures, personnel, material, equipment, and process.

测试、规程和接受标准将在系统的挑战性实验之前确立，并在执行完PQ 之后进行审核。

Tests, procedures and acceptance criteria will be defined before challenging the systems and review after PQ execution.

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	投标文件 Bidding Documents	第4 部分验证方案 Validation Service

PQ 将证明设备、工艺步骤和参数、公用设施、原料、中间体和标准操作程序可以生产出预先所建立的生产和质量要求。

PQ will demonstrate that equipment, process phases and parameters, utilities, raw materials, intermediates and standard operating procedures allow to reach the pre-established manufacturing and quality requirements.

测试可能包括化学的、物理的、微生物的分析。

Testing may include analysis for chemical, physical, microbiological constituents.

任何显著变化的情况将被要求进行审核和调查，以最终决定适当的纠偏措施。

Any outstanding condition will be identified for review and investigated to eventually determine the appropriate corrective action.

4. 质量项目计划Quality and Project Plan

参见附件See attachment.

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	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

第 5 部分

Part 5

施工组织

Construction Scheme

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

T:021 54306717      F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

目 录

Index

1.工程施工人员组织设计Staff organization	2
1.1. 人员组成结构图Organization Chart	2
1.2. 项目组成人员角色及职责team and responsibility	2
1.3. 验证经理资质Validation manager qualification	5
1.4. 施工人员组织Construction organize	10
1.5. 项目经理负责人资质project manager qualification	10
1.6. 质量控制组织图Quality control	15
2.施工设备材料投入计划Tools list	16

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/ 共18 页

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	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

1.工程施工人员组织设计Staff organization

1.1. 人员组成结构图 Organization Chart

目前拟定结构如下：At present,we study out the staff organization chart as the following:

1.2. 项目组成人员角色及职责team and responsibility

  项目经理 Project manager

项目负责人；协调和负责整个项目执行，确保项目执行达到各节点要求；安全第一负责人；是业主用户和上海朗脉科技有限公司的联系人；确认来往资料及传真，负责所有项目资料的归档。

Take charge of the whole project , ensure the project proceed to the right requirement and conduct the construction staff. As the window between the owner and Macroprocess; clarify the letter

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2页/ 共18 页

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	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

and fax and all document of the project.

  项目组 project team

负责监督完成系统的工艺设计、自动化控制系统设计、CAD 图纸制作等的设计，出图、资料准备、组态及实施监控，完成整个项目设计工作。

Work together to take charge of all design 、drawings of technical and control system. Also prepare the document 、configration and inspection to achieve the design task.

  施工经理 construction manager

负责项目系统的现场调度、实施、安装、检测和系统正常运行等现场技术支持服务，同时负责协调工程培训事宜，包括培训日程、地点、人员安排等。该职位作为项目实施过程中朗脉公司人员直接与业主沟通。

Take charge of technical support for implement 、installation 、test and operation of whole project, and also response to training including the p lace、schedul e。This position is used to communicate with owner directly.

  品质管理和质量 quality manager

负责协调和监督工程实施过程中项目质量符合系统设计要求，满足客户需求，同时监控项目实施中的安全操作，确保人力物力的安全。

Ensure the quality meet the owner’s requirement and comply with sepecification, and also control the operation in the construction work, ensure the safty of human resource and material resources.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第3页/ 共18 页

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  采购经理 purchase manager

具体负责系统设备的预算、采购、物流等管理和支持工作，是项目正常实施的物流枢纽。

Take charge of project’s budget 、purchase 、logistic and other support. As a hinge of all project.

  验证经理 Validation manager

评估项目质量要求和提供项目实施验证方案确保符合顾客要求，验证与行业规范相符合。

Evaluate the whole project quality requirement and provide the validation proposal to meet the client regulation requirement.

  用户项目经理 owner project manager

为了使双方的共同渠道畅通，顾客需任命一名项目经理，该项目经理要保证用户的招标承诺实现。并且确认上海朗脉科技有限公司的项目经理定期与用户沟通。用户项目经理是用户与上海朗脉科技有限公司的交流窗口。

In order to push the project smothly,client need to appoint one project manager to ensure promises of whole work. And also need to communicate with Macroprocess stablely.this postion is also a window between owner and client.

  用户工程组 user team

用户工程组为上海朗脉科技有限公司提供实施项目质量保证的支持工作。作为设计、质量、验证、工程、安全卫生环保的沟通机构。

This team shall provide support to Macroprocess to ensure

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quality.

  用户工程师代表 Engineer representation

工程的成功需要用户工程组的努力及配合，参与设计方案的准备有助于他们理解系统，而系统最终要由他们来维护。参与设计及以后的培训使他们能够更加彻底的了解系统。

Engineer representation of client need join with Macroprocess to understand the whole design and the proposal, and they will maintain the system by themselves. That to take part in the design is good for them to familiar with whole project.

1.3. 验证经理资质Validation manager qualification

验证是项目不可或缺的组成部分，验证的过程将直接确保项目的实施是否符合国际法规的要求，确认是否满足验证指定要求。上海朗脉科技有限公司的验证部门派出质量总监全权与其验证团队监督项目的执行。

Validation is one important part of the whole project, Macroprocess will delegate quality director with his team to monitor the project. And his qualification as the following:

他的履历情况如下：

验证经理 Validtion manager                陈国笋 Chen Guosun

  学历教育 Education and Qualification：

浙江大学药学院 药学专业本科 执业药师

Bachelor in Pharmacy,

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Pharmacy College of Zhejiang University

Licensed Pharmacist

  专业技能Professional Competence：

有8 年多的制药行业经验，尤其在验证和质量管理方面。Has over 8 years of professional experience in Pharmaceutical Industry, especially in Validation and Quality Management.

ü  熟悉中国、美国和欧盟GMP 法规和指南。Be familiar with Chinese, USA and EU GMP Regulations and Guidance.

ü  有GMP 培训和验证的经验，如HVAC 系统的确认、水系统的确认、设备确认、清洗验证和工艺验证等。Experience in GMP training and validation (i.e. HVAC system qualification, water system qualification, equipment qualification, cleaning validation, process validation etc.).

ü  有在制药公司进行生产和质量管理的经验。Experience in Production and Quality Management in Pharmaceutical Company.

  主要项目Key Projects：

  石家庄欧意药业     口服固体制剂 Shijiazhuang Ouyi Pharma.      Oral Solid Dosage Forms

验证经理。负责按照中国GMP 和FDA cGMP 的要求领导验证工作。对HVAC 系统和纯化水系统进行设计审核。编写HVAC 系统、洁净室和纯化水系统的IQOQ 方案，并实施。

Validation Manager
Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, FDA cGMP.

Design review of HVAC system and purified water system.

IQOQ Protocols writing and execution of HVAC system, Clean room and purified water system. IQOQ protocols

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writing and execution of HVAC computerized system.

  杭州九源基因      原料药 Hangzhou Jiuyuan Bio-Gene. API

验证经理。负责按照中国GMP 和FDA cGMP 的要求领导验证工作。

纯化水和注射用水系统的设计审核。纯化水和注射用水系统的IQOQ 方案的审核。

Validation Manager

Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, FDA cGMP.

Design review of Purified water, WFI systems. Review of IQOQ protocols of purified water, WFI systems.

  齐鲁安替制药     无菌原料药 Qilu Antibiotics Pharma      Sterile API

验证经理。负责按照中国GMP 和FDA cGMP 的要求领导验证工作。

纯化水、注射用水和纯蒸汽系统的设计审核。

Validation Manager

Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, FDA cGMP.

Design review of Purified water, WFI system and pure steam system.

  成都生物研究所      疫苗

Chengdu Institute of biological product      Vccine

验证经理。负责按照中国GMP 和WHO GMP 的要求领导验证工作。

纯化水、注射用水、纯蒸汽和压缩空气的设计确认。

Validation Manager

Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, WHO GMP.

DQ of Purified water, WFI, Pure steam, compressed air.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第7页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

  浙江华海药业     口服固体制剂

Zhejiang Huahai Pharma.     Oral Solid Dosage Forms

GMP 咨询师。按照中国GMP、FDA cGMP 和欧盟GMP 对概念设计进行GMP 审核。(已于2007 年通过FDA GMP 检查)

GMP Consultant

GMP review of conceptual design in accordance with the requirement of Chinese GMP, FDA cGMP and EU GMP. (Already passed FDA GMP Inspection in 2007)

  大连美罗制药厂      滴眼剂

Dalian Merro Pharma.      Eye Drops

验证经理。负责按照中国GMP 和欧盟GMP 的要求领导验证工作。

负责验证主计划的编写。编写HVAC 系统、洁净室、纯化水、注射用水系统的IQOQ 方案，并实施。

Validation manager

Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, EU GMP. Responsible for VMP writing.

IQOQ protocols writing and execution of HVAC system, Clean room, PW/WFI system.

  北京四环生物      疫苗

Beijing Four ring Bio-pharma      Vaccine

验证经理。负责按照中国GMP 和欧盟GMP 的要求领导验证工作。

编写HVAC 系统、洁净室的IQOQ 方案，并实施。

Validation manager

Responsible for Design GMP review and VMP writing in accordance with the requirement of Chinese GMP, EU GMP.

IQOQ protocols writing and execution of HVAC system

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第8页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

and Clean room.

  石家庄恩必普药业      软胶囊

Shijiazhuang NBP Pharma.      Soft capsule

验证经理。负责按照中国GMP 和FDA cGMP 的要求领导验证工作。

负责验证主计划的编写。编写HVAC 系统、洁净室、纯化水系统的IQOQ 方案，并实施。

工艺验证、清洗验证和分析方法验证的培训。

工艺设备的计算机系统验证。

Validation manager

Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, FDA GMP. Responsible for VMP writing.

IQOQ protocols writing and execution of HVAC system, Clean room, PW system.

Training of process validation, cleaning validation and analytical method validation.

Computer validation of process equipments.

  北京费森尤斯卡比医药      片剂

Beijing Fresenius Kabi Pharma.      Tablet

验证工程师。HVAC 系统和洁净室的DQ/IQ/OQ 方案编写和实施。

(已于2005 年通过EMEA 的GMP 检查)

Validation engineer

DQ/IQ/OQ protocols writing and execution of HVAC system and Clean room.

(Already passed EMEA GMP Inspection in 2005)

  上海莱士      血制品

Shanghai RAAS      Blood Products

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第9页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

验证工程师。HVAC 系统、纯化水和注射用水系统的DQ/IQ/OQ 方案编写和实施。

Validation engineer

DQ/IQ/OQ protocols writing and execution of HVAC system, Purified water and WFI systems.

1.4. 施工人员组织 Construction organize

为保质，按时完成贵公司的管道系统的施工，特组织人员如下：In order to guarantee the quality, & to complete the distribution loop on time, we especially organize our personnel as follows:

1.5. 项目经理人负责人资质 project manager qualification

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第10页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

针对本次项目的情况，目前暂时确定选择经验丰富的程千振经理作为项目经理人负责整个项目的实施。他的履历情况如下：

Evaluating this project,we choose professional manager named Chen Qianzhen as project manager to take charge the technical of whole peoject. And the folloing is the qualification:

Cheng Qianzhen

程千振

Education and Qualifications 学历教育

• Bachelor of Science，Mechanic Design (1992-1996) 理学学士，机械设计(1992-1996) Shandong University 山东大学

Professional Experience 专业经验

Mr. Cheng has over 10 years of professional experience in project co-ordination, procurement and planning, facility design, generation of facility design drawings, commissioning in pharmaceutical engineering field.

程千振先生在制药工程领域内已有10 年以上专业的项目统筹经验，其中包括采购计划，设施设计，生产设备的设计图，设备调试等。

Key Projects 重点工程

MACROPROCESS TECHNOLOGY CO., LTD.

上海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第11页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

Feb 2005 – 2005 年2 月至今 CHENGDU INSTITUTE OF BIOLOGICAL PRODUCTS 成都生物制品研究所 Project Manager, responsible for engineering design, construction, commissioning and validation execution for clean utilities system which complies to WHO GMP 项目经理，负责疫苗工厂按照WHO 的GMP 进行水系统设计，安装和验证执行。 NCPC NORTHBEST 华北制药集团北元有限公司 Project Manager, responsible for complete a retrofitted Clean Piping system and validation execution which complies to FDA. Water for Injection distribution system, Purified Water distribution system, Pure Steam piping system and Clean Compressed air piping system are included. 项目经理，制药厂按照美国FDA 的GMP 标准进行水系统的改造和验证执行。水系统包括注射用水分配系统，纯化水分配系统，纯蒸汽管道系统，洁净压缩空气管道系统等。 B.BRAUN MEDICAL (SUZHOU) CO., LTD. 贝朗医疗（苏州）有限公司 Project Manager, responsible for complete a retrofitted material preparation system and validation execution which complies to EMEA. 项目经理，制药厂按照欧盟的GMP 标准进行对大输液配料系统进行改造和验证执行。 SHANGHAI WISON BIOENGINEERING CO., LTD. 上海惠生生物工程有限公司 Project Manager, responsible for complete a new clean piping system for a new vaccine plant and an antibody laboratory. Including WFI and PW distribution system.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第12页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

项目经理，负责完成一个新的疫苗工厂和抗体实验室的洁净管道系统。包括注射用水系统和纯化水分配系统。

HANGZHOU TIANYUAN BIOPHARMA

杭州天元生物药业

Project Manager, responsible for engineering design, construction, commissioning and validation execution for clean utilities system which complies to WHO GMP

项目经理，负责疫苗工厂按照WHO 的GMP 进行水系统设计，安装和验证执行。

POLIFARMA (NANJING) CO., LTD.

南京宝利化制药有限公司

Project Manager, responsible for complete a retrofitted Clean Piping system and validation execution which complies to TGA. Water for Injection distribution system, Purified Water distribution system are included.

项目经理，制药厂按照澳大利亚TGA 的GMP 标准进行水系统的改造和验证执行。水系统包括注射用水分配系统，纯化水分配系统等。

GE HEALTHCARE (SHANGHAI) CO., LTD.

通用电气（上海）药业有限公司

Project Manager, responsible for complete a retrofitted WFI piping and PS piping system which complies to FDA. This company has been certificated by FDA

项目经理，制药厂按照美国FDA 的标准进行注射用水系统和纯蒸汽系统的改造。该厂的无菌大容量注射剂已通过美国FDA 的认证。

Project Manager, responsible for complete the clean piping system for their extension project which complies to FDA. WFI distribution system, PW distribution system, PS system and CA system.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第13页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

项目经理，扩建项目按照美国FDA 的标准进行洁净管道系统的建设。包括注射用水分配系统，纯化水分配系统，纯蒸汽系统以及压缩空气系统。

SUZHOU DOWNRAYS

苏州东瑞制药有限公司

Project Manager, responsible for process design, construction and commissioning for a clean piping for sterile API production.

项目经理， 负责无菌原料药生产，洁净管道的工艺设计，安装和调试。

BAXTER HEALTHCARE (SHANGHAI) CO., LTD.

百特医疗用品（上海）有限公司

Project Manager, responsible for complete a retrofitted material preparation system and validation execution which complies to EMEA.

项目经理，制药厂按照欧盟的GMP 标准进行对大输液配料系统进行改造和验证执行。

QILU ANTIBIOTICOS PHARMACEUTICAL CO., LTD.

齐鲁安替比奥制药有限公司

1996 – 2005

Project Engineer. Mr. Cheng, who has gotten rich engineering experience in this ten years, through organize and participate all the pharmaceutical project constructed by QILU Group. Such as sterile API project, sterile small volume injection dosage, lyo-product project and so on.

And the sterile API project of Qilu Antibioticos has passed the qualification of EU GMP. Mr. Cheng organized and participate the whole duration.

项目工程师，十年内，通过组织并参与了所有齐鲁集团建设的制药项目，有无菌原料药，无菌小容量液体制剂，冻干产品等

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第14页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

一系列项目，他获得了丰富的工程经验。其中齐鲁安替比奥制药有限公司的无菌原料药通过了欧盟GMP 的检查。他参与了全过程。

1.6. 质量控制组织图 Quality control

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第15页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

2. 施工设备材料投入计划Tools list

齐全的施工设备准备是一个项目能够顺利执行的前提条件，朗脉公司已经准备了设备随时按需入场，按照项目施工要求，公司拟定安排以下主要施工机械设备投入计划，清单参照如下（最终设备材料计划以项目经理实际安排为最终确认实施清单）：

Our construction equipment is ready to undertake any task. And acoording to the requirement,we draw a draft plan to launch into project. The list as the following: (the finally plan is refer to project manager’s arrangement)

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第16页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第17页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第18页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

第 6 部分

Part 6

施工工艺

Construction Technics

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

T:021 54306717      F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

目  录Index

1 主要施工工艺Construction Technics	2
1.1. 施工准备Construction preparations	2
1.2. 施工步骤Construction Flow	4
1.3. 配管质量检查流程 Pipline Quality Testing flow chart	6
1.4. 安全施工管理规范Safety and Good Engineering Plan	6
1.4.1. 安全目标safety target	6
1.4.2. 安全管理机构management organization chart	6
1.4.3. 安全管理规范health and safety guidance	7
1.4.4. 安全管理措施safety management measures	11
1.5. 施工质量管理Construction quality management	15
1.5.1. 质量保证体系quality assurance system	15
1.5.2. 质量保证措施quality assurance measures	17
1.6. 施工进度管理schedule manage	26
1.6.1. 进度管理及程序progress management and procedure	26
1.6.2. 全面资源保障Strategy for Deploying All Resources	26
1.6.3. 应急预案emergency preparation	27
1.6.4. 排除施工干扰之政策Strategy to Expel Interference	29

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

1 主要施工工艺Construction Technics

1.1. 施工准备Construction preparations

施工准备按以下几个过程：Construction preparations refer to the following procedure:

  直观检查Visual inspection

  抽样检查，确认无损伤并符合要求，检查是否有塑料帽密封10% random checks, confirmed no damage and meet requirements, check whether there are any sealed plastic caps 10%

  检查型号，数量及证书Check model No., quantities & Certificates

  核对定货单Verification with materials order form

  加工现场的准备Preparations for field fabrication

  验收及接收由负责人完成确认Acceptance and receipt of completion to be recognize by the person in charge

  材料储存在指定区域内并根据型号，尺寸，洁净级别分类保存Materials stored in the designated areas under the model, size and sanitary class for preservation & identification

  材料运输不可弯曲，撞击，挤压等When transport materials do not bending, impact and have other extrusion.

  材料取用需有详细记录Material shall be released from storage with detailed records

  现场测量，相关设备的检查Field survey and inspection of Related Equipment

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

  样本制作Samples production

  材料预制：管道切割，面处理，弯曲及预制焊接。Prefabricated materials: Pipeline Cutting, surface treatment. Bending and prefabricated welding

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第3页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第4页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

Field welding include 现场焊接包括：

  管道定位，现场焊接，质量检查。为保证每一焊缝内表面无氧化变色。必须使用高纯度保护气体，保证冲气时间不小于30 分钟。Pipeline positioning; field welding; quality inspection. To ensure that no surface oxidation color on inner weld surfaces; protection must use high-purity gases, air time is guaranteed – not less than 30 minutes.

  非焊接连接：配件、设备连接Non-Welding connection: accessories, equipment connection

  施工后处理：管道检查。气密性测试。Procedure after Construction: pipeline inspection, gas tightness test.

  文件移交：样本记录，施工记录及测试报告Documents submission: samples records, test reports and construction records

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第5页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

1.3. 配管质量检查流程 Pipline Quality Testing flow chart

1.4. 安全施工管理规范Safety and Good Engineering Plan

1.4.1. 安全目标safety target 本项目的安全目标是“零事故”。 The safety target for this project is Zero Accident.

1.4.2. 安全管理机构management organization chart

  项目经理Project Manager：

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第6页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

项目经理是健康安全环保工作的第一责任人,对健康安全环保工作负全面的责任。 Project manager is the first responsible person for safety works. He is fully responsible for the safety work.

  安全员Safety Officer: 协助项目经理管理和执行健康安全环保计划,为健康安全环保工作的具体负责人。Assist the project manager to manage and execute safety plan. He is the specific person in charge for the safety work.

1.4.3. 安全管理规范health and safety guidance

  施工现场应有专职安全员，每天应定期、不定期巡查，发现安全隐患可责令相关人员停工整顿。In the constructing site, there should have full time safety inspectors who go on a tour of inspection periodically or aperiodically. If any hidden problem is found, order relative personnel shutdown and make amendment.

  进入施工现场应戴好安全帽，系紧帽扣，穿好工作服，工作鞋，并佩带工作牌。When entering the constructing site, wear safety helmet, tie the helmet buckle tightly, wear working clothes and shoes and carry working tablet.

  严禁穿拖鞋、高跟鞋、泡沫底鞋在工地行走、作业；特别是高空作业（高空作业是指操作点高度在离地面或楼面 1.5m 以上的施工作业）。Strictly forbidden walking and working on the constructing site with slipper and high-heel shoe on, especially high altitude working (high altitude working indicates working at a position more than 1.5mhigh from the ground or floor).

  在现场作业人员严禁与其它施工队发生纠打等现象。Forbidden in site working personnel fighting with other construction team.

  施工现场人员在工作期间严禁赌博、喝酒。No gambling and drinking is allowed during working time for the in site construction

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第7页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

personnel.

  施工机械（设备）进场前，应检查设备的完好状态；重要的工具在每次使用前，应检查其是否完好。Check the construction mechanism before entering the construction place. Important tools should be checked each time before usage.

  施工现场应规范用电，严禁私拉乱接，所有接线应由电工进行；电箱内应有漏电保护开关，保险丝。每一个用电回路均应由单一的断路器（或刀闸） 控制。Regulate electricity usage in the construction site. No private electricity connection is allowed. All the wire connection should be carried out by electrician. The electricity box should be equipped with leakage protection switch and fuse. Each electric loop should be controlled by signal switch (or brake).

  所有电气工具操作人员应穿绝缘鞋或带绝缘手套。All electric facility operators should wear insulating gloves or shoes.

  电焊机、手工氩弧焊机、自动轨迹焊机均应有可靠接地，接线端子有防护罩，在雷雨天气应暂停焊接作业。 Electric weld machine, manual argon arc weld machine and automatic orbit weld machine should all reliably connected to the earth. The connection should have protective cover. Stop welding in thunder storm situation.

  高速旋转的电动工具（如型材切割机、砂轮机、台钻）在操作时严禁带纱质手套。工件的夹持应牢固，不得松动，防止随转动轴旋转或飞出。Wearing gauze gloves when operating the electric equipments with high revolving (such as cutting machine, grinding wheel machine) is forbidden. Hold the tools tightly to prevent their revolving or flying out along the revolving of axis.

  各种气品在存放使用时，要距离明火 10 米以上，并且避免在阳光下爆晒，钢瓶在搬动过程中应轻拿轻放，严禁在地面上滚动或拖拉，严禁抛掷。All kinds of gases shall be over 10 meters away from open flame and avoid being insolated in the sun when they are stored or used. Slightly lift and put sown the steel tank. No rolling,

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第8页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

dragging and throwing is allowed.

  登高作业时（高度超过 1. 5 米），应有专人配合，配合人员负责工具，材料的接送，并负责看护；作业人员应佩带安全带，安全带的搭扣应系在操作点的上方的牢固构件上。 Climbing work should be assisted by special person who is in charge of delivering materials and tools and watching. Working person should wear safety belt with its agraffe tied to substantial component on top of the operating point.

  撑梯的张角应合适（一般为 60-70°为宜），梯子在摆放前应先清理地面，梯子严禁接长使用。Folding ladder should have a suitable open angle (60-70°preferred). Make up the ground before placing the ladder. Prolonging the ladder for usage is forbidden.

  严禁病时酒后作业，严禁有恐高症、高血压等疾病的人员进行高空作业。Do not work when in sickness or after drinking alcohol. High altitude working is forbidden if operated by people with acrophobia, high blood pressure, etc.

  在施工现场动火，应得到业主、工地安全员的书面批准，并在火源处摆放手提式灭火器。Making fire in the construction site should be approved by written permission given by the owner or safety personnel in construction place and a portable fire extinguisher should be put on the fire place.

  动火前应先清理操作点附近的易燃易爆品，并由专业人员进行。Remove the flammable and explosive material around the fire place. This should be operated by professionals.

  所有操作人员应按规定在进入施工现场施工时，签定安全施工责任书，实行安全奖惩制度。 All the operation personnel should sign safe construction duty sheet before entering construction site. Put the safety rewards and punishments regulation into use.

  在彩钢板上施工时。应先检查彩钢板是否已安装完成，（特别是彩钢板加强吊筋是否已安装。人员在行走时应尽量在隔墙、隔断、吊筋处或附近，

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第9页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

重物应摆放在隔墙、隔断处。Before constructing on the colored steel sheet, first inspect if it has been completely installed (especially whether the reinforced hanger has been installed). People should walk on or near the partition, obstruct and hanger. Heavy things should be put at the place of partition and obstruct.

  严禁在彩钢板开口处（如风口、灯孔等）行走、作业。 Walking and working at the colored steel sheet opening (e.g. air pot, lamp hole) are forbidden.

  在容器和狭小管道内焊接时，应加强通风，严格执行双人监护制，监护人必须坚守岗位，发现问题要及时采取措施。When welding in containers or small-spaced pipes, ventilation shall be reinforced. Strictly execute the double-guardian system. The guardians shall stick to their post and take necessary measures once finding problems.

  受压容器、密封容器、各种油桶、管道沾有可燃气体和溶液的工作进行时，必须先进行检查，并经过冲洗除掉有害、易燃、易爆物质并解除容器管道压力，清除容器 (包括密封空心、工件、管子 )的密封状态 (敞开口旋开盖)再进行工作，禁止在已做油漆或喷漆塑料的容器内焊接。When performing operations involving combustible gas and solution on the pressurized tanks, sealed tanks, various oil tanks and pipes, you should check them first, remove the harmful, combustive, and explosive material by flushing them, release the pressure of tanks and pipes, and remove the seals of the tanks (including the sealed cavity, work pieces, and pipes) before any work is done. To weld in the painted tanks is forbidden.

  在做酸洗时，先试压，保压后用碱液试纸擦抹每一个焊缝，观察有无泄漏，严格执行双人坚督制、签字确认制，应穿带好防酸手套及防毒面具防酸胶鞋等防护用品。有关硝酸、盐酸、硫酸的化学用品使用中应注意：配比稀释时应逐渐地缓慢地小剂量的混合，切忌大剂量强制溶合,防止爆溅伤人。When performing pickling, have a pressure test first. Then

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第10页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

keep the pressure and erase each weld seam with alkali test paper to check if there is any leakage. Strictly execute the double-guardian system and signature-conforming system. Protective articles should be worn, such as acidproof gloves, gas mask, and acidproof rubber shoes. When using chemicals such as nitric acid, hydrochloric acid, and sulfuric acid, take care: When carrying out dilution practices, gradually and slowly mix with small volume. Do not mix with large volume, or it will cause explosion, spattering and damage.

  废料、废水应妥善处理、不应污染工作环境Waste material and waste water should be treated properly without polluting the working environment.

  进入甲方施工现场，应遵守甲方的一切安全规章制度。Obey party A‘s all safety regulations while entering party A’s construction site.  

  未尽事宜，应按国家有关规定的标准执行。Unmentioned matters are carried out in accordance with relative national criteria.

1.4.4. 安全管理措施safety management measures

  健康安全管理措施health and safety management measures 总的原则是执行业主的健康安全计划，执行我公司安全管理的制度及政府的有关法规。The general principle is to execute the owner’s safety plan, our company’s safety management system and relative official regulations.

  安全教育safety education

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第11页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

安全教育的目的是提高职工的安全意识和自我保护的能力，避免各类事故的发生。 The safety education aims to improve employee’s safety awareness and self-protection ability and avoid accidents.

  安全教育safety education

   进场安全教育*（*表示教育后需进行考试） Safety education on field entrance * (*indicates tests will be held after education)

方案技术交底教育 Technical notification on design proposal

星期一安全例会的教育 Regular safety meeting on Mondays

班前安全教育 Safety education before work

每一次教育都必须记录 ,记录教育的时间、地点、参加人员名单、教育的内容，进行考试的还应保存好考试成绩及试卷。 Each time the education should have a record to note the education time, location, person list and contents. Keep the test scores and test papers if test is taken.

  安全作业单元与安全许可证safety operation unit and safety license

安全作业单 ,施工任务的布置通过安全作业单的方式下达 , 以保证安全工作与施工过程 ”五同时 ”(即计划、布置、检查、总结、评比五同时)Safety operation sheet. The construction tasks are assigned by safety operation sheets, which ensure the “five simultaneous” (simultaneous plan, assign, inspect, summarize, compare) of safety work and construction procedures

安全许可证，以下特殊作业必须有安全许可证：Safety license. The following special operations require safety licenses:

■ 进入设备作业许可证Equipment entry operation license

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第12页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

	■	电工作业许可证 Electrician operation license
	■	有毒有害作业许可证 Poisonous and deleterious operation license

  安全检查safety inspection

安全检查是做好健康安装工作的重要手段之一,能及时发现事故隐患,及时制止“三违”(违章作业、违章指挥、违反劳动纪律)的行为发生，保证各项安全管理规章制度落到实处，从而杜绝事故的发生。Safety inspection is one of the key measures in safe installation. It can timely find the potential accident, prevent the “three breaches” activities (regulation-breaching operation, regulation-breaching direction, breach labor laws), and ensure all the safety regulations can be executed, so as to prevent the possibility of accidents.

安全检查的内容是：查领导、查制度、查机械设备、查安全设施、查教育培训、查操作行为、查劳保用品使用、查事故处理等。Contents of safety inspection: inspect the leaders, inspect the system, inspect the equipment, inspect the safety devices, inspect the education and training, inspect the operation, inspection the labor protection appliance, inspect the accident reasons, etc.

季节性安全检查。冬季应以防雪、解冻、跑漏、防临时建筑物倒塌为重点，秋季以防火防爆为重点。Seasonal safety inspection. In winters focus on snowproof, defreezing, and preventing the building collapse. In autumns focus on fireprotection and blameproof.

所有检查均必须按安全检查表进行，并做好记录。 All the inspections should be taken as per safety inspection sheet with relative records done.

基层检查均必须按安全检查表进行，并做好记录。Grass roots inspection should accord with safety inspection sheet with

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第13页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

relative records done.

代表性的安全检查种类 Typical Safety Inspection Category

领导检查中发现的隐患应下达书面的《事故隐患整改通知单》限期整改。If any hidden trouble is found during leader inspection, send out a Modification Notification on Hidden Trouble and ask them to modify it within a certain time.

  隐患整改hidden trouble modification

 

接《事故隐患整改通知单》后，责任人应立即组织整改，做到“三定”（定具体整改人员、定整改措施、定整改完成时间）； After receiving the Modification Notification on Hidden Trouble, the person in charge should arrange modification immediately, accomplishing “three establishes” (establish the persons involved in modification, establish the modification measures, and establish the finish time)

隐患整改完毕及时将整改结果书面反馈给通知单发出人。After finishing modifying the hidden troubles, timely feedback the modification results in paper to the person who sends out the modification notification.

通知发出人收到反馈情况后，要复验整改结果。The notification sender should re-inspect the modification results after having received the feedback.

  应急计划 emergency

 

目的正确、及时处理意外情况，防止事故扩大，将事故损失控制在最小范围内。 The plan aims to correctly and timely treat the accidental conditions, prevent the accident from extending, and control the damages to a smallest limit.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第14页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

1.5. 施工质量管理Construction quality management

1.5.1. 质量保证体系quality assurance system

1.5.1.1. 公司质量方针guidance on quality

质量是永恒的追求，提供满足业主要求的工程和服务。

Quality is the goals to meet the requirement of owner on project and service.

1.5.1.2. 本项目质量目标target quality for this project

目标：保证我公司所提供的工程和服务，一次性通过相关认证。

Target: Ensure our engineering and services can pass relative certification only one time

1.5.1.3. 基本质量要求basic quality requirements

  恰当的控制各项工程步骤；连续的保持各项质量的有效性。Control all the construction procedures correctly. Maintain all the quality indexes effective continuously.

  要具有及时预防和及时纠偏的能力。Have the ability to timely prevent and correct the errors.

  具有可追溯性，能正确方便的追溯到各项质量、生产状况、检验情况，能追溯到事和人，便于分析改进不断完善体系和提高工程质量。Traceability. We can trace back to quality, manufacturing, and checking status as well as matters and persons for the convenience of analyse and improving system and project quality.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第15页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

  确保整个工程能顺利通过国家 GMP 验证，并达到美国 FDA 中要求的相应水平。 Ensure the whole project can pass the national GMP validation and FDA standards.

1.5.1.4. 现场质量保证体系construction field quality assurance system

 

  项目质量实行公司经理负责制，对现场项目质量负有全面监督和保证职责。The project quality is ensured by manager responsibility system, which will monitor the on-site project quality.

  现场项目经理对现场质量负有组织、全面管理的职责。 The field project manager is responsible to organize and manage the field construction quality.

  建立以自检、互检和专职检查相结合的检验体系，把检验工作贯穿于预制、安装的全过程。对各个质量控制点，一定要按有关规范要求进行严格的检查、验收，验收不合格的工序坚决不允许转入下道工序。Establish a checking system combining self-check, cross check, and special check. The checking operation should be implemented through the prefabrication and installation. The quality control points should be checked and accepted by all relative regulations. Do not turn to the next procedure of the process if the previous procedure is unqualified.

  质量员负责现场项目施工中的质量的检查监督、检验和试验、质量记录和不合格品的控制，以及推动、监督现场质量保证体系的正常运行。Quality officer is in charge of the quality supervision, inspection, experiment, quality record, and unqualified product control during field project construction, so as to promote and monitor the normal operation of on-site quality assurance system.

  材料员负责自行采购和业主提供设备、材料的质量控制。The material officer is in charge of on-site purchasing and the

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第16页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

quality control of the equipment and materials provided by the owner

  现场作业层的各专业、施工单位，统一在现场质量保证机构领导和控制下进行质量活动。All the construction companies will carry out activities involving quality under the united supervision and control of on-site quality assurance organization.

  恰当的控制各项工程步骤；连续的保持各项质量的有效性。Correctly control all the engineering steps. Maintain all the quality index continuously effective. 

  具有及时预防和及时纠偏的能力。This system has the capacity to timely prevent and correct errors.

  具有可追溯性，能正确方便的追溯到各项质量、生产状况、检验情况，能追溯到事和人，便于分析改进不断完善体系和提高工程质量。This system is traceable. We can trace back to quality, manufacturing, and checking status as well as matters and persons for the convenience of analyse and improving system and project quality. 

  确保整个工程能顺利通过国家 GMP 验证，并达到美国 FDA 中要求的相应水平。Ensure the whole project can pass the national GMP validation and FDA standards

1.5.2. 质量保证措施quality assurance measures 

严格按公司质量体系要求进行，特别注意人员培训，资质审核，材料检验，焊接工艺评定，工机具、量器具检验，各质量控制点等方面严格把关。

Strictly operate according to the quality system. Pay special attentions to personnel training, qualification verification, material checking, welding verification, tools and instruments checking. Check all the quality control points.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第17页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

1.5.2.1. 图纸资料管理drawings management

对下发到各部门的图纸、方案、技术规范联络笺、材料代用单等必须指定专人统一管理，并登记收发，各技术员应做好施工原始资料，交工资料的整理工作，并协助施工班组填写各种施工记录表、卡，施工技术员每天必须记录施工日记。

All the drawings, proposals, technical standards, contact list, material sheet should be unitedly managed by a special person and have a registration record. The technicians should compile and pack all the original construction data and project handing over data, and assist the construction group to fill in all kinds of construction records and cards. The technicians should write the construction log daily.

1.5.2.2. 材料管理material management

 

  材料方面的资料由材料员管理，如产品合格证、材质说明书、收发料单等。根据专业技术负责人审核过单线图，材料表和预算并填写限额领料单到仓库领料时，对材质、规格、数量进行核实和验收。并且有合格证件（或复印件）确认无误，并在计算机上进行消料处理。收货人签字。领回后入库时应规格、型号、材质、分类挂牌存放并计入帐卡，按上述程序材料员向班组发料，每天将领、发料单装订成册备查，领回后不入库直接运到现场的材料，也应计入帐卡，交接清楚，按指定地方堆放整齐。The data concerning material, such as product certificates, material specification, material accepting and delivery sheet, are administered by material officer. Check the material, specification, and quality when receive material in the warehouse after fill in a material receiving sheet according to the drawings, material list, and budget. Check whether the certificates (or their copies) are valid and input it into the computer. The person who receives

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第18页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

the material should sign on the receiving sheet. After accepting the material, put it into the inventory. Separate and store them according to the specifications, models, materials and category. Distribute the material to the construction teams according to the above procedures. Compile a material receiving and distribution booklet each day. If a certain material is moved to the construction field instead of being put into the warehouse after being received, it should also be registered with clear notes to identify its location.

  对所有材料特别是不锈钢，在切割后必须进行材质标识移置。The material marks should be moved after welding for all the materials, especially stainless steel.

1.5.2.3. 焊接管理welding management

  项目部设置焊接专业工程师、焊接组长及系统验证专职人员，具体负责焊接工作，包括在单线图上标注焊口号、焊工代号、无损检验部位，填写无损检验委托单，联系与配合试验室无损检验。焊缝预热和热处理记录，透视报告的保管，焊接及热处理施工记录，管理焊条的烘烤、存放和保管记录等验证文件都由专职人员进行处理。Project department possesses the welding technician, welding team leader, and system validation personnel. They are in charge of welding, including note welding port number, welder code, non-destruction inspection parts on the single line diagram, fill in the non-destruction inspection sheet, contact and coordination with the lab non-destruction inspection, welding seam preheating and heat treatment record, perspective report maintenance, welding and heat treatment record, welding rot roasting, and record storage and maintenance. These works will be done by special personnel.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第19页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

  每个焊工均有一个固定的代号。公司焊接试验室应把经考试合格的焊工姓名、代号及合格项目表及时发给焊工所在的施工队及检验部门备查。焊后在其所焊的焊缝旁用记号笔写上代号，并要标注在单线图上。 Each welder has his own stable code. Our company will hand over the welder’s name, code, and qualified project sheet to the construction team and inspection department for reference in time. The welder will mark his code close to the weld seam and note on the single line diagram after welding.

  焊好的管线经自检、互检合格后按规定的 X 射线透视比例由施工队委托试验进行透视，X光底片以区域为单位，以管线号为依据，建立流水号。同一焊口在透视委托单、底片、透视记录、检验报告以及在单线图上的标注必须一致，使抽查任何一张底片就可知道焊接位置。透视一定要及时，未经透视或抽透不足及需要重新返修的管线一般不要去安装，以减少高空作业，对透视不合格的焊口应立即在管线上作出明显标志，并及时组织返修，直至合格为止。返修次数不锈钢管不超过两次，并作好返修记录。 Self-check and cross check the pipelines after welding. If it is qualified, the construction team shall carry out perspective operation according to the specified X-ray perspective ratio. The X-ray negative film is divided by units of area. Set up a numerical order according to the pipeline number. The marks should be unified for the same weld port on perspective sheet, negative file, perspective record, inspection record, and single line diagram for the convenience of knowing the welding position just by checking only one negative film. The perspective should be taken in time. The pipeline without perspective or with less insufficient perspective or repair needed should not be installed so as to reduce aloft work. Make obvious marks on the pipelines that have welding ports with unqualified perspective. Arrange repairs timely, until it is qualified. The

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第20页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

repair times should not be more than twice for stainless steel pipes. Do not forget to make repair records.

  对所有预制完并经检验合格的管段，暂不安装的，管口应予以封闭。To all the pipes that have being prefabricated and qualified, but will not be installed immediately, seal the pipe ends.

  对不锈钢管道，在预制和安装时不得与其它管道接触。 To the stainless steel pipes, do not contact them with other pipes when under prefabracation and installation.

1.5.2.4. 检验管理checking management

  建立以自检、互检和专职检查相结合的检验体系，把检验工作贯穿于预制、安装的全过程。对各个质量控制点，一定要按有关规范要求进行严格的检查、验收，验收不合格的工序坚决不允许转入下道工序。Establish a checking system combining self-check, cross check, and special check. The checking operation should be implemented through the prefabrication and installation. The quality control points should be checked and accepted by all relative regulations. Do not turn to the next procedure of the process if the previous procedure is unqualified.

1.5.2.5. 质量控制

  项目质量控制重点参照业主工艺的要求，结合本公司在类似工程的 施工经历，初步明确下列质量控制重点： according to the owner’s requirements and our similar construction experiences in the past, we’ve established the following key quality control points:

设备、材料的选择与采购The selection and purchasing of equipment and material

焊接工程 Welding

电气、仪表 Electricity and instruments

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第21页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

清洁清扫Cleaning

资料管理 Documentation management

  质量控制的原则the principles for quality control

预防为主、检验把关； Focus on prevention and inspection

以 FD A、SFDA 的标准作为项目施工和验收的依据；Set FDA and SFDA criteria as the standards for project construction and acceptance

设备、材料的选择和采购必须经过技术部检验合格后方可使用；The equipment and material can be used only after being verified by the technique department

工序质量否决制：即上一道工序不合格，坚决不允许进入下一道工序；Process quality veto system: Namely no entrance to the next procedure if the previous one is unqualified.

施工记录、质量记录与施工同步，确保施工过程得到有效控制；Construction record and quality record should be simultaneous with the construction, ensuing the construction procedure can be effectively controlled.

所有施工机具、检验、检测、计量设备符合项目施工技术、施工质量要求；All the construction devices and checking, measuring, and accounting instruments accord with the technical and quality requirements

参加和参与施工的人员必须符合施工技术的要求，主要工种须持证上岗，所有人员须经技术、安全培训合格。People who are involved in the construction should meet the technical requirements for construction. Person at important job position shall have certificate. All the staff must pass technical and safety training.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第22页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

1.5.2.6. 针对性质量保证措施Pertinent quality assurance measures

  焊接质量保证措施Welding quality assurance measures 焊接质量是施工质量中关键的组成部分。本工程为制药项目，有洁净度要求，为保证管道焊接质量，我们采取以下措施：Welding quality is the key in construction quality. This is a pharmaceutical project, which have high requirement on sanitation. To ensure the pipe welding quality, we will take the following measures:

不锈钢管道采用全自动氩气保护焊接；The stainless steel pipes are auto welded with argon gas protection

设置专门的不锈钢材料堆放场所；Set up special stainless steel storage place

成立专门的不锈钢管道施工队；Establish a special stainless steel pipe engineering team

每个焊工均有一个固定的代号。公司焊接试验室应把经考试合格的焊工姓名、代号及合格项目表及时发给焊工所在的施工队及检验部门备查。焊后在其所焊的焊缝旁用记号笔写上代号，并要标注在单线图上；Each welder has his own code. Our company will hand over the welder’s name, code, and qualified project sheet to the construction team and inspection department for reference in time. The welder will mark his code close to the weld seam and note on the single line diagram after welding.

对所有预制完并经检验合格的管段，暂不安装的，管口应予以封闭。To all the pipes that have being prefabricated and qualified, but will not be installed immediately, seal the pipe ends.

对不锈钢管道，在预制和安装时不得与其它管道接触。To the stainless steel pipes, do not contact them with other pipes when under prefabracation and

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第23页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

installation.

试压时使用的水源必须为纯化水，必须有效控制游离氯和氯离子的含量. The source water for pressure test should be purified water, which can effectively control the free chlorine and chlorine ion.

保温工程质量保证措施 Quality assurance measures for heat preservation

管道保温须进行错缝连接；Breaking joints for pipe heat preservation

保温层的包扎应严密不漏，符合规范的要求。The bandage for heat insulating layer should be tight and accords with the specification 。

  清洁文明保证措施Assurance measures for cleaning

施工现场保持清洁文明，特别是有洁净要求的厂房，每个工种完成工作后，清理干净工作区域；Keep the construction field clean. Especially in the plant building that have special requirements on sanitation, clean the working area each time after finish operation.

进入洁净厂房施工前，工具、设备、材料、防护用品都必须进行清洁，经检查后方可进入洁净厂房施工；Before entering the sanitary plant for construction, the tools, equipment, materials, and protective articles should be cleaned and inspected.

洁净厂房管道施工内外壁清理干净，焊口内外清除干净，并及时封闭，室内所有缝隙、电仪管口、接线盒必须清扫干净。Clean the inner and outer pipe walls. Clean the weld ports and timely seal them. Clean all the seams, electric instrument pipe ports, and connection box

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第24页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

1.5.2.7. 资料管理

  对下发到各部门的图纸、方案、技术规范联络笺、材料代用单等必须指定专人统一管理，并登记收发，各技术员应做好施工原始资料，交工资料的整理工作，并协助施工班组填写各种施工记录表、卡，施工技术员每天必须记录施工日记。All the drawings, proposals, technical standards, contact list, material sheet should be unitedly managed by a special person and have a registration record. The technicians should compile and pack all the original construction data and project handing over data, and assist the construction group to fill in all kinds of construction records and cards. The technicians should write the construction log daily.

  项目部设立专职验证员和资料员，专门负责相关文件的填写、交接、整理、归档等管理工作，使在施工过程中的每一道工序、每一个变更、每一次变更等都有相应的记录，具有可追溯性。施工过程中材料的质量证明文件，材料的自查、委托检查记录；施工方案的确定；施工人员的安排、施工机械的调配以及所有施工资源的分配全部有案可查。施工过程中与建设单位，其他施工单位的协调也相应作详尽的记录。最终目标使工程顺利通过建设单位、国家职能部门等检查，验证。The project department has verification officer and data officer to be specially in charge of document filling handing over, management and filing. Each procedure or each change should have relative record and is traceable.We have the history documents for material quality certificates, material self-check and cross check record, construction proposal determination, construction personnel arrangement, construction mechanics arrangement, and construction resources deployment. The detailed record of coordination with the constructed company and other construction

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第25页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

companies should also be available.

安装现场临时库房--分类存放

1.6. 施工进度管理schedule manage

1.6.1. 进度管理及程序progress management and procedure

  向业主及工程总包递交的进度文件清单：The Progress list supplied to the owner:

进度周报、进度月报、进度计划（总体计划、季度计划、月度计划）、纠偏计划 Progress Weekly, Progress Monthly, Progress Plan (whole plan, quarterly plan, monthly plan), Correction Plan

进度管理职责表：Progress Management Responsibility Sheet

进度管理程序图Progress Management Process Chart

1.6.2. 全面资源保障Strategy for Deploying All Resources

  充分调动公司内部的资源Sufficiently Deploy Resources in Our

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第26页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

Company

  我们充分认识到此项目的重要性，公司总部将从各个方面对此项目进行支持政策的倾斜 We fully understand the importance of this project. Our headquarter will offer privileged support on this project

  项目经理长驻现场。Project manager will stay at the construction field for a long time.

  向此项目选择经验的项目经理，优秀的工程师，有丰富经验的工人和完好的施工设备。We will select experienced project manager, excellent engineers, skillful workers, and whole package of engineering equipment

  我们已做好劳动力的充分保障。We have sufficient labor insurance

  充分调动当地资源 Sufficiently Deploy Local Resources

  充分与兄弟施工单位加强联系，利用当地在水、电、气、材料供应，人力资源，加工能力，运输能力等优势。Sufficiently contact with other construction companies and make advantages of local water, electricity, gas, material, labor, and machining ability

1.6.3. 应急预案emergency preparation

  冬季施工工期保证措施Assuring Measures for Construction in Winter

因工程主要施工时间在主体厂房施工完成之后，且装修、装饰基本施工完成之后，所以在冬季施工的寒冷气候对工程施工的影响并不是特别大。Our construction will start after the main part of the plant building is finished and its decoration is done, therefore the cold weather won’t have big influences to our construction

尽量避免室外施工，应全面检查防冻保暖工作，充分做好防寒、防冻、防滑、防火和防止一氧化碳中毒的措施。Try to

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第27页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

avoid outdoor construction. Fully check the antifreeze and heat protection measures. Take measures for anti-cold, anti-freeze, skid proof, fire proof, and carbon monoxide poisoning proof.

尽量避免冬季登高作业。Try to avoid ascending work

遇暴风雪应停止室外工作，严禁在冰冻的湿地上施工。Stop working at snowstorm. Do not work on cold and moist field.

  夏季施工工期保证措施Assuring Measures in Summer

首先调整作息时间，使施工的主要时间集中在早晚比较凉爽的时间进行。 Adjust the work and rest time at first to focus the engineering time on morning and evening, when it is cold.

要配备必要的防暑降温设施、器材、药品和茶水饮料。Prepare necessary heatstroke preventative devices, equipment, drugs, and waters.

高温作业场所，应加强通风和降温措施。Reinforce ventilation and cooling measures for

通风机和排风扇等设备应由防护网罩。The ventilator and exhaust fan should have protection shield

要加强食堂的清洁卫生工作，严格执行检查消毒制度，防止职工食物中毒。Strengthen the sanitary conditions in dining room. Strictly execute the disinfection system. Avoid food poisoning.

  雨季施工工期保证措施Assuring Measures in Rain Season

暴雨前后，要检查工地临时设施，脚手架、机电设备、临时用电线路等，发现倾斜、变形、下沉、漏雨、漏电等现象应及时修理加固，有严重危险的应立即排除；After rainstorm, check the temporary equipment, scaffold, electric devices, temporary electric loop, etc. Repair it if any

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第28页/ 共30 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

incline, deformation, sinking, rain leakage, and electricity leakage is found. Remove it if it is severely dangerous.

雷雨时，严禁管道焊接工作。Pipe welding is strictly forbidden at thunder storm.

1.6.4. 排除施工干扰之政策Strategy to Expel Interference

  当设备材料、设计图纸因特殊原因不能正点到位时，立即调整施工计划，制定补救工期的对策。一旦到位，立即施工，将失去的工期补回来。If the equipment, material, or design drawings can not arrive in place in time, adjust the construction plan immediately and set up countermeasure. Once they arrive, carry out construction immediately to offset the time limit.

  供的材料合理安排采购计划，确保不影响施工进度计划，对于因施工计划改变可能需紧急采购的材料，应在施工前做工供应商的评估。 For the materials that are supposed to be purchased by ourselves, reasonably arrange the purchasing plan. Verify the supplier before construction if urgent purchasing is necessary because of construction plan changes.

  与生产运行有交叉的，在施工开始前做好防护隔离措施，保证施工与生产的安全顺利进行。 Take protective measures before construction if production operation is involved, so as to ensure the successful operation of construction and manufacturing.

  坚持逐月检查，警惕和预防传染病的袭击，发现病员，立即隔离。Carry out checking month by month. Look out and guard against the attack of infection. If any patients are found, separate them from others.

  管线及其它设施的加固措施 Solidifying Measures for Pipes and Other Devices

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第29页/ 共30 页

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	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

 

  管道在安装过程中，严格执行工艺作业规程，一般现做支架固定，并手工点焊固定，并在短期内施焊完成。During installation procedures, strictly implement the process working specifications. Normally use a bracket for the sake of solidifying and weld it in short time.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第30页/ 共30 页

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	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

第 7 部分

Part 7

管道系统施工规范

Construction Regulation for

Piping System

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

T:021 54306717      F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation

目 录

1. 管道系统施工规范Construction Regulation	3
1.1. 焊接总则General	3
1.2. 焊接规范Welding regulation	4
1.2.1. 总体要求General requirements	4
1.2.2. 材料Material	5
1.2.3. 焊接准备Weld joint preparation and fit-up	6
1.2.4. 预热温度Preheating temperature	8
1.2.5. 供电Electrical characteristics	8
1.2.6. 焊接程序Welding procedure	8
1.2.7. 焊接修补Weld repair	8
1.2.8. 自动焊接程序Automatic welding program	9
1.2.9. 文档Documentation	10
1.2.10. 非破坏性检查Non destructive examination	11
1.2.11. 每日焊接样品Weld daily samples	11
1.3. 装配和安装Fabrication and erection	12
1.3.1. 范围Scope	12
1.3.2. 管件材料接收储存Tubing materials receipt storage	12
1.3.3. 分类Identification	13
1.3.4. 装配Fabrication	13
1.3.5. 布管，切割和装备Lay-out, cutting and fitting up	13
1.3.6. 焊接程序和资格Welding procedure and qualifications	14
1.3.7. 安装Erection	15
1.3.8. 焊接接口Welded joints	15
1.3.9. 法兰接口Flanged joints	15

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/ 共26 页

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	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation

1.3.10. 快装接口Clamped joints	16
1.3.11. 支撑和穿管Support of tubing and penetrations	16
1.4. 检查Inspection	17
1.4.1. 范围Scope	17
1.4.2. 配件和焊接编号Component & weld identification	17
1.4.3. 焊接准备Weld preparation	18
1.4.4. 焊接检验Weld inspection	20
1.4.5. 预装配件的保护Protection of prefabricated spools	22
1.4.6. 验收Acceptance	22
1.4.7. 其它要求Other requirements	22
1.5. 水压测试与清洁water pressure test and cleaning	23
1.5.1. 压力测试Pressure testing	23
1.5.2. 测试报告Test reports	25
1.5.3. 水压压力测试Hydrostatic test pressure	25
1.5.4. 系统清洁和清洗System cleaning and flushing	26

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2页/ 共26 页

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	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation

1. 管道系统施工规范Construction Regulation

1.1. 焊接总则General

 

  本规范适用于卫生管道的焊接、装配和安装。The specification applies for welding, fabrication and erection of sanitary piping.

  本规范特别用于不锈钢316L 管件间之圆周对接焊头之连接In particular such specification is to be used for circumferential butt joints between sanitary piping components made of stainless steel type AISI 316 L. 。

  在项目中与本规范有冲突的其它规格必须与朗脉公司讨论，以便澄清和定义。Existing discrepancies between this specification and others applicable for the project, must be discussed with MACROPROCESS for clarification and definition

  本规范中的焊接连接将需要符合FDA 的验收标准和3A 标准。Welded joints in the scope of this specification shall require the acceptance by FDA and shall comply with Sanitary Standard 3A.

  本规范中术语装配者是指朗脉公司，他负责管道的装配和安装。In the scope of this specification the term FABRICATOR is referred to MACROPROCESS, who is encharged for fabrication and erection of piping.

  “业主”是指用户或其代表。the term OWNER is referred to CUSTOMER or his representative.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第3页/ 共26 页

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  焊接检查员”是指业主或用户代表，他将负责检查管道承建商的焊接操作。the term WELDING INSPECTOR is referred to the Owner or Customer representative who is en charged to inspect the welding operation and examination performed by piping construction Contractor.

1.2. 焊接规范Welding regulation

本规范覆盖用自动轨迹焊接机或手动TIG 设备的气体钨电弧不锈钢焊接设备。

This specification covers the gas tungsten arc welding of austenitic stainless steel using automatic orbital tube welding machines or manual TIG equipments.

“管道”应包括所有需要焊接元件。

The term TUBING shall include all components of the welding.

1.2.1. 总体要求General requirements

  采用这些程序的手动TIG 焊接工，将用实际工作材料作焊接试样测 试以确认合格。这些焊接试样和自动焊接试样进行同样的独立检验。Manual Tungsten Inert Gas (TIG) welders using these procedure shall be qualified by making coupon test welds using actual job material. These coupons shall be subject to the same Independent examination as the automatic welds.

  自动焊接机的操作人员将用样品材料做焊接测试以确认其资格。焊 接测试应该选用项目常用的管材尺寸材料。Automatic welding

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第4页/ 共26 页

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	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation

machine operators shall be qualified by making acceptable test welds on sample materials. The welds shall be made on the prevalent job size tube material.

  组件的定位点焊必须避免对完全焊接的不良影响。Tack welding of the components must avoid deleterious effect on the complete weld.

  定位点焊应该尽可能的轻，以降低过热而导致材料的内部结构变化。Tack should be as light as possible to reduce over heat that might cause structural changes to the granular composition of the material.

  定位点焊不应焊透内表面。Tacks should not penetrate the inner surfaces.

  定位点焊完成后，需要检查线定位焊接的对准性和缝隙。After the tack welding completion it’s necessary to check the alignment and gap

1.2.2. 材料Material

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第5页/ 共26 页

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	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation

 

  用于焊接的材料须符合甲方的技术规格。The material to be welded shall comply with the owner specification, .

 

  所有管道和配件须完全焊透。All tubing and fittings shall have complete weld penetration.

 

  采用的焊接电极为2%涂钍平头钨焊电极。Welding electrode to be used shall be a pointed 2% thoriated tungsten electrode with a flat tip.

 

  焊接电极如有污染须更换。The electrode shall be replaced if contaminated.。

 

  焊接管道内、外部保护氩气的最低纯度为99.99%。Welding grade argon gas shall be use inside the pipe for back-up purge and shall be 99.99%minimum purity.

 

  焊接过程中必须要通入氩气进行保护，以防止焊接的内表面被氧化。在开始焊接前，吹走焊接区域的所有氧气。Argon gas back-up has to be provided to prevent oxidative attack of the inner weld surface.Before starting the welding all oxygen is purged from the welding area.

1.2.3. 焊接准备Weld joint preparation and fit-up

  当焊接表面潮湿时，不得进行任何焊接。除非有适当的保护措施，在严酷气候或风速高或不良大气条件下不得进行室外焊接。No weld is carried out when surfaces to be welded are wet. No outside welding is carried cut during inclement weather or during periods of high wind or negative atmospheric agent unless the work is properly protected.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第6页/ 共26 页

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  焊接接头两端面的清洁，圆整和平直是重要的。It is essential that the two surfaces of the joint are clean, circular and squared.

  金属加工方法应确保焊接端表面光滑，无划痕或其它有害的不规则形状。The machining method of base metal preparation shall leave the weld end with smooth surfaces, free from notches or other harmful irregularities.

  建议采用G+F 或同类设备来处理切割和最终处理。It is recommended to carry out the cut-off and final preparation using a G+F equipment or equivalent.

  切割必须平直和不会造成管件变形或损坏。砂轮切割的管件端面必须清洁以除去磨屑。Cut-off must be squared and not cause any distortion or damage to the tubing. The pipe cut-off by an abrasive wheel must be cleaned to remove the abrasive dust.

  碳钢切割工具在任何情况下都不得使用。Carbon steel cutting tools are not admitted in any circumstance,

  用于焊接端面的处理、装配和安装工具，在使用前须检查是否是没有生锈的认可合金钢，清洁无油脂，和无其它污染残留物。Tools used for weld joint and preparation, fabrication and installation, shall be stainless of approved alloy steel, cleaned free of oil, grease and other contamination residuals before they are used.

  不得使用硫基切割油，除非在焊接前管件的内外表面都被彻底清除所有残留油渍。Non sulphur based cutting oil may be used, provided all traces of such oil are completely removed from both the interior and exterior surfaces on the tubing prior to

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第7页/ 共26 页

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	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation

welding.

  需与焊接检查员一起设定焊接设备。The welding equipment shall be set up together with WELDING INSPECTOR.

  此检查员将检查所有设置是否符合主程序。他将签署焊接日志和注明日期。The inspector will check that all settings comply with the master program. He shall sign and date the welding log to that effect.

  每天的开始时，每个操作人员要作焊接测试。这些焊样将编号，并呈交给焊接检查员。每台自动焊接机都需做测试。At the start of each day, each operator shall make acceptable test welds on plain tubing, These pieces shall be identified and made available to the welding inspector. Test shall be made for each automatic welding machine.

1.2.4. 预热温度Preheating temperature

  在焊接材料的温度不得低于10 ºC。一般来说，不需要预热。The minimum base material temperature shall not be less than 10 0 C prior to welding. In general, no preheating shall be required.

1.2.5. 供电Electrical characteristics

  电流应与注明在相应的焊接表相符。Current shall be as specified on the applicable welding schedule.

1.2.6. 焊接程序Welding procedure

  焊接工艺，如焊接次序，焊接程序设置，焊极位置等，都将与相应的焊接表相符。The welding technique, such as weld sequence, welding program settings, electrode positioning etc., shall be as shown in the applicab le welding schedule。

1.2.7. 焊接修补Weld repair

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第8页/ 共26 页

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  经检查，如发现不符合标准的缺陷并且此缺陷是可修复的，有必要进行修复焊接。最可能的修复是在已有的焊接上进行再焊接；A weld repair is required when, through inspection, it is determined that an unacceptable defect exists and that the defect is correctable . The first repair may be a re-weld over one existing.

  可做修补的缺陷包括不佳的准备，不良线性，过量或不适当的焊接穿透，多孔性和沙眼；The allowable defects which may be repaired include poor fit up, misalignment, excessive or inadequate weld penetration, porosity and pin holes.

  所有有裂纹的焊接将被视为不合格，并须与受热区一起去除。All welds with cracks shall be rejected and removed together with the heat affected zone.

1.2.8. 自动焊接程序Automatic welding program

  所有主程序都规定了不同尺寸管件焊接的一组参数；Calibration of the automated tube welding system shall be in accordance with the procedures to be defined by the welding operator together with the inspector.

  自动管道焊接系统的焊接程序都须符合焊接操作员与检查员一起制定的程序； Any master program defined a set of parameters for different size of tubing to be welded.

  正式和测试焊接需采用已认可的焊接程序；Production and test welds shall be made only using approved welding programs.

  焊接样品必须按顺序编号(如T1，T2 等)。焊接样品，具备完全的可追朔性，将备独立机构检验；Welding samples must be

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第9页/ 共26 页

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numbered in sequence ( ex.: T1, T2, etc.). Welding samples, with complete traceability, are subject to independent laboratory examination.

  在整个施工阶段，所有每天的现场样品将留予业主；All daily samples will be available in site to the owner, during all the construction period.

  自动管道焊接系统的校正都须符合焊接操作员与检查员一起制定的程序。Welding programs of the automated tube welding system shall be in accordance with the procedures to be defined by the welding operator together with the inspector.

1.2.9. 文档Documentation

  朗脉将提供此系统所有焊接记录报告。此焊接记录报告表格，必须完全填写，最少包含：MACROPROCESS will provide a written log on all welds carried out on the system. The weld log forms, that must be fully filled, will minimally contain :

系统名称system name

焊接号weld number

焊接工姓名welder name

设备编号machine identification

焊接日期welding date

焊接程序编号welding program number

焊接操作工(如有，还加上检查员)签名welding operator ( and in addition inspector, if any ) signature

  设备将打印相应自动焊接的报告。在此焊接报告中要有焊接编号。In addition the machine will print out an automatic log that will refer to the weld carried. This weld number shall be then

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第10页/ 共26 页

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identified on the welding log.

  透视简图 (标示相应的坡度，尺寸和长度，所有焊点编号)将在整个施工期间使用并且更新，在工程完成生成竣工图。Each weld shall be numbered in progressive way. All welds will be shown on isometric sketches and on the related Welding Report ( FORMAT 5, already mentioned ).

  每个焊点以累进方式编号。所有焊点标示在透视简图和焊接报告中。Isometrics sketches (showing installed elevations for proper sloping, dimensions and lengths, all weld numbers) will be available during site activity and will be updated ( “ as-built” issue ) at the end of job.

1.2.10. 非破坏性检查Non destructive examination

  当相应的条例或合同规格要求时，非破坏性检查将在符合条例或合同规格下进行。须考虑到因此而造成的时间延误。Non destructive examination, when required by the applicable by the applicable code or contract specification, shall be performed in accordance with the code rules of contract specification. The time delay due to these controls must be considered.

1.2.11. 每日焊接样品Weld daily samples

  每日焊接样品应采用设备焊接程序。这些样品必须按顺序编号(如P1，P2 等)。所有这些焊接样品将在整个施工期间提供给业主；Weld daily samples shall be made using the machine welding programs. These samples must be numbered in sequence ( ex.: P1, P2, etc.). All of those will be available to the owner in site during all the construction period.

  每日样品结果必须收集在完全填写的自动焊接设备测试报告中。The daily samples results must be collected in the Automatic

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第11页/ 共26 页

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  Welding Machine Test Report that must be fully f illed。

1.3. 装配和安装Fabrication and erection

1.3.1. 范围Scope

  本节和引用的图纸标准以及条例将适合所有管道现场装配和安装。This section and drawings standard and codes referenced shall apply to the field fabrication and erection of all tubing.

  本规格中的内容不得用于解释使供应商从完全符合引用条例的责任中解脱。Nothing in this specification shall be interpreted as in any way relieving SUPPLIER from the responsibility for complete compliance with the referenced codes wherever they apply.

1.3.2. 管件材料接收储存Tubing materials receipt storage

管件材料接收储存和现场处理如下：Tubing materials receipt storage and handling at site：

  管件材料需由其他人确认和检验；Tubing materials shall be identified and inspected by others.

  管材和预装配件的存放应注意不会被油脂，潮湿或其它物质污染；管材和预装配件应处理得当，以避免变形，刮伤或任何有形损伤；It shall be taken care to keep all tubing materials and prefabricated assemblies free from contamination by grease, moisture or other matter does not occur, Tubing materials and prefabricated assemblies must be handed in order to avoid any denting, scraping or any other physical damage.

  所有不锈钢材料应与其它施工材料分开检查和储存。储存区必须在

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  建筑物内，并且有防护任何腐蚀性环境和温度变化的措施；All stainless steel materials should be checked and stocked separately from other construction materials. The storage area must be located inside a building and protected from any corrosive atmosphere and temperature changes.

  通道应严格限制以确保材料不会受损伤和丢失。只有在施工需要时才能从储存区提取材料。Access shall be strictly limited in order to guarantee a protection against physical damage and losses. Material shall be released from storage only when needed for construction purposes.

1.3.3. 分类Identification

  所有材料将按规格进行分类，并且适当储存和处理以便于辨认。All materials will be identified in accordance with the applicable specification and shall be stored and handled in order to allow their proper identification.

1.3.4. 装配Fabrication

  装配应按照此规格的要求和如有的详细安装要求(图纸或其它)进行。Fabrication shall be in accordance with the requirements of this specification and with installation specific details ( drawings or others ), if any.

1.3.5. 布管，切割和装备Lay-out, cutting and fitting up

  管件应按图纸上的尺寸精确切割以适应现场情况。Tubing shall be cut accurately to measurements shown on drawing to suit field conditions.

  所有待焊接的管件端面需清理毛刺，并且切割面应平直，边角无切

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第13页/ 共26 页

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割园弧。管件边缘的端面处理和清理毛刺应使用终端处理工具，并且其公差与配件一致以确保适当的焊接线性。All tube ends to be welded shall be deburred and have square cut edges, free of shear radii at the corner. Tube edge facing and deburring shall be done with an end prep tool and be of equal tolerance as the fittings to assure proper alignment for welding.

  检查切割管件终端，以确保其平直。The end of the cutted pipe shall be checked to insure its squareness.

  清除毛刺应避免破坏内外径，或损伤管件的内抛光。Burs shall be removed in such a manner as not to level I.D. or O.D. or damage polished interior of the tubing.

  在管件端口积聚的磨屑必须擦拭干净。Abrasive dust accumulated near the end of the tube must be wiped clean.

  所有安装在管线上的管件不应受过分弹力和受力下装配。All tubing shall be worked in place without excessive springing or forcing.

  不允许通过管件加热和弯曲以达到线性整齐。Heating and bending tubing to achieve alignment is not allowed.

1.3.6. 焊接程序和资格Welding procedure and qualifications

  所有焊工应具备6 个月现场工作经验经过工厂培训All welders shall be qualified either by 6 months field experience or by factory training.；

  在开始焊接前，焊接程序应提交给焊接检查员核准Welding

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procedures shall be submitted to welding inspector for approval before starting the welding activities.

1.3.7. 安装Erection

  所有组装管件应在不受过分弹力和受力下装配。不允许有切割或弱化的支撑物作管道安装；All assembled tubing shall be installed without excessive springing of forcing . Cutting or other weakening of structural members to facilitate tubing installation will be not permitted.

  所有管件安装应可以自由膨胀和收缩，而不至于损坏连接和支撑；All tubing shall be installed to permit free expansion and contraction without damage to joints or supports.

  所有管道必须有适当的坡度(0.3% 最大0.5% )以确保完全排水。All lines must guarantee the complete drainage with proper slope (0.3% max. 0.5%).

1.3.8. 焊接接口Welded joints

  所有焊接应按照本规格所述的要求进行准备和装配。All welded joints shall be prepared and made in accordance with described of this specification.

1.3.9. 法兰接口Flanged joints

  所有法兰接口，应用全新的密封圈和螺栓。在拧紧螺栓前应确保所有密封圈定位准确。应注意防止将螺栓拧的过紧。所有被拧得过紧的螺栓螺帽都应更换；All flanged joints, if any, shall be made with gaskets and bolting materials brand new. It shall be taken care to assure that all gaskets are properly positioned prior to bolts tightening. It shall be taken care to avoid

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overtorquing any bolts. All bolts and nuts which are overtorqued shall be replaced.

  法兰螺栓孔应跨骑于管道中心线，除非图纸上另有说明。 Flange bolt holes shall straddle pipe center lines except when noted otherwise on drawings.

1.3.10. 快装接口Clamped joints

  不得使用螺纹接口。Threated joints shall not be used.

1.3.11. 支撑和穿管Support of tubing and penetrations

  管件的支撑应按管件支撑图纸上的参数和细节设计、装配和安装。Support to tubing shall be designed, fabricated and installed in accordance with the details and parameters of the pipe support drawings.

  不锈钢管件的安装按制造商的建议进行。Stainless steel tubing is to be installed in accordance with manufacturers recommendations.

  吊架和支撑的安装应尽量的经济，并符合支撑图纸或规格上的描述。Hangers and/or support should be installed as economically possible and be in accordance with the charts and notes on the pipe support drawings or specifications.

  管道的支撑应符合管道图纸上要求的坡度。Tubing shall be supported in such a way to comply with the slope required on piping drawings.

  所有装配的管道应最少符合检查，检验和测试要求规格。All

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第16页/ 共26 页

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fabricated tubing shall as a minimum meet the examination, inspection and testing requirements specifications.

1.4. 检查Inspection

1.4.1. 范围Scope

  本技术规格适用于不锈钢管件自动焊接检查，该焊接检查按照技术规格中的焊接要求；This specification covers the inspection of automatic welding stainless steel tube and fittings, in accordance with the welding specification.

  焊接日志检查清单将用于查核主要信息，准备和质量要求；The weld log inspection check list shall be used to verify the principal information, preparation and quality requirements.

  焊接检查员按照焊接要求，检视分包商的焊接记录、检查和设置、非破坏性测试，以及目检。在双方同意并理解相应的时间延误下，此工作须在任何时间进行；The welding inspector shall witness the required subcontractor records, checks and setups, non-destructive tests, and visually inspect the welds, as specified herein and in accordance with the welding specification. This activity must be carried out at any time with the agreement of both parties involved and knowing the related time delay.

  焊接检查员或其指定代表应目检所有焊接。The welding inspector or his appointed representative shall visually examine all welds .

1.4.2. 配件和焊接编号Component & weld identification

  每个焊接应在其立体图中编号；Each weld shall be numbered on

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his isometrics.

  检查员应保留焊接检查清单，而且实际的焊点以此编号辨别；The inspector shall maintain a weld inspection check list and the actual weld shall be identified primarily by this number.

  每个焊点的记录应包括所有相关的条目。The record for each weld which shall include all items listed

1.4.3. 焊接准备Weld preparation

焊接检查员决定是否进行下列检查/确认。 The following inspection/verification could be made at the welding inspector option.

  管道截面确认Tube section verification

管道的长度按要求在管道图纸中标示；The length of tube is as required to give dimensions as shown on the piping drawings.

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要去掉管道端口切割产生的任何可能之污物；Tube ends are removed any possible contamination from the cut off.

工具不得被碳钢所污染；No tool has been contaminated by contact with carbon steel.

确认管道圆度公差。Verify tube roundness to tolerance.

  清洁确认Cleaning verification

用认可的溶剂清洁配件。Components are cleaned with approved solvent.

在焊接前，已清洁和准备好的端口不得接触皮肤。The cleaned and prepared ends should not come into contact with the skin prior to welding.

在部件的端口不得有可目见的异物，此包括清洁布的纤维。No visible foreign material is acceptable at the weld ends of the components. This includes lint from cleaning cloths.

钨焊极必须清洁和无污染。Tungsten electrode must be clean and uncontaminated.

  接口准备Joint fit-up

焊接组件端口间隙用厚度塞尺测量，不得超过0.25 mm。The gap between ends of welding components shall not exceed 0.25 mm as checked by     thickness gauge.

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钨焊极应置于焊点中央。The tungsten electrode shall be centered on the joint。

  焊机设置Weld machine settings

参数的设置应按焊接程序中相应的焊接表进行。Parameters shall be set in accordance with appropriate welding schedule as shown in the welding procedure.

确认气源就位。Verify that purge bladder is in place.

1.4.4. 焊接检验Weld inspection

每个焊接样品和所有装配焊都要目检管道内侧。如焊接有可修复的缺陷，在焊接部件拆离焊机前进行第二次焊接以修复缺陷。如果重新焊接未修复缺陷，则此焊接视为不合格并不得装配。

Every sample weld and all production welds shall be visually inspected on the interior, If the weld has correctable defects, a second weld pass may be made to try to correct them before the spool is removed from the welding machine . If the rewelding does not remove the defect, the weld shall be rejected and not mounted.

所有自动焊接按如下控制：

All automatic welds will be controlled as follows：

  对每日样品，用选定的焊接程序完成一个焊接，进行X 射线检验For each daily sample a weld carried out with the same welding program will be chosen. The check will be done with Rx will be carried out.

  对于所有完成的自动焊接，含有焊接参数的焊机打印报告For all executed automatic welds, a welding machine print out with

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welding parameters will be annexed.

  10%的自动焊接，进行X 射线检验10% of executed automatic welds, Rx will be carried out.

所有手工焊接要进行X 射线检验。All the manual weldings will be Rx inspected.

如有表面缺陷，则本规格条目适用。For surface defects, the headlines of this specification are valid.

表1：Table 1

A	B
须进行重新焊接的缺陷	不合格的缺陷：须与受热区(棕色)一起切除：
Defects for which rewelding may be	Defects to be rejected : Cut out
attempted	required together with its heat affected
	zone ( brown color ):
1.     未焊透incomplete penetration 2.     多孔porosity 3.     沙眼pin hole 4.     冷隔cold lap 5.     过度穿透( <0.4 mm )excessive penetration 6.     未对准( <0.55 mm)misalignment	1.     裂纹cracks 2.     过烧burn out 3.     解块sugaring 4.     冷隔cold lap 5.     过度穿透(>0.4 mm ) excessive penetration 6.     未对准(> 0.55 mm)misalignment

点焊如有破裂、完全焊透、过烧、组件未对准，则视为不合格。Tack welds shall be rejected if : cracked, full penetrated, burned, components misalignment.

焊件移离焊机后，对焊接外观进行目检。The outside of the weld is visually inspected after the spool is removed from the welding machine.

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1.4.5. 预装配件的保护Protection of prefabricated spools

  所有开口应有适当的保护，保持密封；All openings shall be kept sealed at all times with proper protection.

  快装接口和法兰端面应有保护措施以防止损坏；Clamp ends and flange face shall be protected from damage in handling by approved protective devices.

  除了在工作台上，在处理和存放期间，预装配件应置于保护区内的木支架上。 During handling and storage other than on work tables, spools shall be on wooden skids of racks in a protected area.

1.4.6. 验收Acceptance

  焊接检查员应完成焊接检查清单并须在完成的清单上共同签署和注明日期。如在任何地方有不合格焊接，则不合格原因应被记录。焊接检查员应在焊接完成时签署清单。The welding inspector shall complete the weld inspection check-list. When it has been completed. It shall be jointly signed and dated. If at any place the weld is rejected, the reason for rejection shall be recorded. The welding supervisor shall sign each list at the time the weld is made.

1.4.7. 其它要求Other requirements

  检查员应确认吹刷气体和后备气体流量计处于准确工作状态。The inspector shall insure that the flow gauges on the purge gas and back up gas be in accurate working condition, where applicable.

  如任何工具或组件被怀疑有污染，应按ASTM 标准程序进行清洁和

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测试。If any tool or component is suspected of having contamination, it shall be cleaned and tested in accordance with ASTM standard procedures.

1.5. 水压测试与清洁water pressure test and cleaning

本规程包含在管道系统完成后，为测试系统性能和特性而进行的所有工作。This specification covers the activities to be carried out after the system pipe construction, to test and improve his capability to perform the required characteristics.

1.5.1. 压力测试Pressure testing

  所有压力测试应当同检查员一起进行；All pressure tests shall be complete system tests carried out together with the inspector.

  所有测试进行时应对操作人员的安全作好预防，要进行水压测试的系统应该带有合适的表和压力安全泻载装置；Every test shall be carried out with all the precaution needed to insure the safety of the operator, Systems to be hydraulically tested will be provided with appropriate gauges and pressure relieving devices.

  所有连接点，包含焊缝应该去除绝热保温以便在测试过程中观察；All joints, including welds, are to be left un-insulated and exposed for examination during testing.

  不需要进行压力测试的设备，在测试过程中应该与系统断开或使用其他合适的方式与测试系统隔离开；Equipment which is not to be

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subjected to the pressure test shall be either disconnected from the tubing or isolated by proper means during the test.

  可以安装测试过程需要的阀门；Valves may be used provided that they are suitable for the proposed test procedure.

  在管线上的压力计不应在超过量程的压力下测试。没有表明测试压力的部件和设备应排除在测试内容之外；In line pressure gauges shall not be subjected to pressure in excess of their scale range. All pieces of equipment which do not have their test pressures indicated or declared or not proper shall be excluded from these tests.

  在进行所有测试之前，需目测管线系统以保障没有可见的缺陷且所有连接紧密；Before every test the tubing systems shall have visually inspected to assure that there are no visual defects and that all connections are tightened.

  控制阀门只要不是正在被测试，应该打在全开的位置；Control valves, unless being tested, shall be set and maintained in the wide open position.

  只要有可能应将所有在管线上的设备，表玻璃，流量计，漂浮液位计和所有其他受压部分包含在测试之内；All in-line instruments, gauge glasses, flow meters, liquid level float gauges and all other pressure parts of instruments shall be included in these test, where feasible.

  水压测试的压力应由测试压力在其量程一半处的计量表测量；Hydrostatic test pressure must be measured by gauges having the test pressure value approximately in its mid-range.

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  有缺陷的连接点应该被移除并重新测试；Joints found to be defective shall be removed and retested.

  在修复后重新进行测试后测试压力需和原来指定测试压力相同。Retesting of lines after repair shall be done at pressures originally specified for the test

1.5.2. 测试报告Test reports

承包商应为每个测试做相应记录，记录包含‘水压测试证书’和测试编号。The subcontractor shall make a record of the test as per specimen included “Hydraulic Test Certificate “, Certification Code

“ CER-003 ”

  测试编号test number；

  测试日期date of test

  系统名称system name；

  测试媒介，压力和相应压力下维持的时间test media, pressure applied and length of time at test pressure 。

1.5.3. 水压压力测试Hydrostatic test pressure

  水压测试压力需根据项目技术要求进行，不需进行压力测试的容器和组件应被隔离。The hydrostatic test pressure shall be calculated in accordance with the project specifications: vessels or components which are not designed for the testing pressure shall be isolated.

  所有水压测试系统应在设计压力的1.5 倍和至少3.5 巴的压力下进行测试。在进行连接点目测前测试压力需维持至少15 分钟。All

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	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation

hydrostatically tested systems shall be tested to a one-half ( 1 1/2 ) times the design pressure or to a minimum pressure for 3.5 bar whichever is greater. All test pressures shall be maintained a minimum of 15 minutes before visual examination of joints beings.

  在待测试的管线系统和测试的媒介达到热平衡之后再进行水压测试。Hydrostatic test pressure shall not be applies until the tubing system and the testing medium reached thermal equilibrium.

  在测试过程中需对所有连接点进行目测。All joints shall be visually examinated for leakage during the test.

  水压测试压力至少需维持两个小时。Hydrostatic test pressure will be maintained for at least two hours.

  在含有水的管线部分不能做任何修复焊接。No repairs welding shall be done on any section of tubing that contains water.

  所有不锈钢管线在水压测试结束后需立即排空。All stainless steel lines shall be emptied immediately after hydrostatic tests completion.

1.5.4. 系统清洁和清洗System cleaning and flushing

  清洗和清洁全部安装好的管线，应按照供应商要求：不锈钢清洗，酸洗和钝化规程执行。Washing and cleaning of the whole piping installed will be carried out according to Supplier document requirement : STAINLEES STEEL WASHING, PICKLING AND PASSIVATION”.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第26页/ 共26 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第8 部分售后服务和技术承诺 Technical Promise and after-sale Service

第 8 部分

Part 8

售后服务和技术承诺

Technical Promise and

After-sale Service

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

T:021 54306717      F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第8 部分售后服务和技术承诺 Technical Promise and after-sale Service

目 录

1.售后服务和承诺Technical Promise and after-sale Service	2
1.1. 技术承诺Technical Promise	2
1.2. 售后服务After-sale Service	2

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/ 共3 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第8 部分售后服务和技术承诺 Technical Promise and after-sale Service

1.售后服务和承诺Technical Promise and after-sale Service

1.1. 技术承诺Technical Promise

上海朗脉科技有限公司，拥有先进的焊接设备和质量检测设备，以及完全符合中国GMP 标准，FDA 认证以及其他国家标准的文件系统。工程中将使用验证过的全自动轨迹焊机进行焊接。所有的焊工都具有相关的上岗资格，至少要有2 年的实际工作经验或者经过工厂培训。上海朗脉科技有限公司承诺，我们承接的工程将完全按照GMP 标准进行施工。

工程质量保证期为1 年。

Macroprocess Technologies Co., Ltd. has advanced welding machine, quality-checking equipment and integrated files system according with Chinese GMP standard, FDA GMP standard and other country’s standards. Qualified automatic orbital welding machines will be used in our projects. All welders are qualified either by 2 year field experience or by factory training. The seller promises that the project we will do is completely according to GMP.

The Quality Guarantee Period of project will be 1 year.

1.2. 售后服务After-sale Service

  售后服务联络：买方可直接与卖方联系，并将派自己的维修人员到买方工厂进行售后服务。After-sale service contact: The Buyer can contact the Seller directly. The seller will dispatch its’ own technicians to provide after-sale service on the Buyer’s site.

  售后服务的响应时间：接到买方报修传真后2 天内 (公共假日除外)。Responding time: within two day from the receipt of written report from the Buyer (public holidays are excluded).

  售后服务的质量要求：卖方应派遣有实际工作经验的工程技术人员来买方工厂进行维修。卖方技术人员需在接到通知后48 小时内到达

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2页/ 共3 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第8 部分售后服务和技术承诺 Technical Promise and after-sale Service

买方现场 (公共假日除外)。Requirement of service quality: The seller shall dispatch engineers with good experience to the Buyer’s premise. The seller should arrive the buyer’s site within 48 hours after receipt of notice (public holidays are excluded).

  售后服务的费用：质保期内免费维修，维修人员的差旅费、人工费、食宿费等由卖方承担 (因买方操作不当、未采用合同文件中规定的主材和操作环境条件、合同供货范围以外的工作除外)。质保期外的维修费由买方承担，收费标准由双方友好协商。Expense for after-sale service: The seller is responsible to provide free technical service within the Quality Guarantee Period. All the travel and accommodation expenses as well as the labor costs of the service engineer are to be born by the seller (exclusive of situations that problems are brought by incorrect operation and works beyond the scope of supply). The Buyer should be responsible for the service expenses after the guarantee period and the price is determined through friendly discussion.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第3页/ 共3 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第9 部分偏离和图纸 Deviation and Drawings

第 9 部分

Part 9

偏离及图纸

Deviation and Drawings

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

T:021 54306717      F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第9 部分偏离和图纸 Deviation and Drawings

目 录

9. 偏离及图纸Deviation and Drawings	2
9.1. 商务偏离表Deviation Form for Commercial Terms	2
9.2. 技术偏离表Deviation Form for Technical Specifications	3
9.3. 图纸Drawings	4

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/ 共4 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第9 部分偏离和图纸 Deviation and Drawings

9. 偏离及图纸Deviation and Drawings

9.1. 商务偏离表Deviation Form for Commercial Terms

商务偏离表

 Deviation Form for Commercial Terms

项目名称	压缩空气及工艺气体系统 Compressed Air and Process Gas System
数 量	1 套	规格型号
标 书要求		投标参数及其它
付款方式： 合同签订后10 日内，甲方支付合同总额10%给乙方，同时乙方向甲方提供相同金额的发票； 乙方根据甲方提供的设计资料完成工程的二次设计，并经甲方书面确认后10 日内，甲方支付合同总额20%给乙方，同时乙方向甲方提供相同金额的发票；全部设备和材料运输到施工现场指定位置，甲乙双方开箱验收完毕，10 日内甲方支付合同总额30%给乙方， 同时乙方向甲方提供相同金额的发票。安装、调试、验收、验证合格并交付甲方使用后，10日内甲方再支付合同总价30%，同时乙方向甲方提供相同金额的发票；余合同总价10%的作为质量保证金，质量保证期1 年， 质保期满，无质量问题，10 日内甲方付清全部余款，同时乙方向甲方提供相同金额的发票。		付款方式： 合同签订后，10日内甲方支付合同总额30%预付款；全部设备和材料运输到施工现场指定位置前，甲方支付合同总额40%； 安装、调试、验收合格并交付甲方使用后，10 日内甲方再支付合同总额25%， 余合同总价5%作为质量保证金，质量保证期1 年， 质保期满，无质量问题，10日内甲方付清全部余款。

投标人(公章)： 上海朗脉科技有限公司

授权代表人（签字或盖章）：

日期：

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2页/ 共4 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第9 部分偏离和图纸 Deviation and Drawings

9.2. 技术偏离表Deviation Form for Technical Specifications

技术偏离表

Deviation Form for Technical Specifications

项目名称	压缩空气及工艺气体系统 Compressed Air and Process Gas System
数 量		1 套	规格型号
标 书 要 求			投标参数及其它
			无偏离

投标人(公章)： 上海朗脉科技有限公司

授权代表人（签字或盖章）：

日期：

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第3页/ 共4 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	压缩空气及工艺气体系统 Compressed Air and Process Gas System
	投标文件 Bidding Documents	第9 部分偏离和图纸 Deviation and Drawings

9.3. 图纸Drawings

●PID 流程图 PID

●项目进度表 Schedule

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第4页/ 共4 页

N

EX-4.7.11

Exhibit 4.7.11 - Appendix 5 - Bidding Document 3

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投标书 Part 1 Tender

第 1 部分

Part 1

投 标 书

Tender

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

上海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室     201100

T:021 54306717     F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

目 录

1. 报价书	3
1.1. 法定代表人资格证明书	3
1.2. 法人授权委托书	4
1.3. 授权代表人身份证复印件	5
1.4. 投标书	6
2. 方案一 管材管件为ALFA LAVAL	7
2.1. 报价一览表	7
2.2. 分项报价一览表	9
2.2.1. 纯化水系统材料清单及报价	9
2.2.2. 注射用水系统材料清单及报价	14
2.2.3. 纯蒸汽系统材料清单及报价	21
2.2.4. 纯化水、注射用水控制系统报价	24
2.2.5. 储罐配置清单	26
2.2.6. 焊点费	30
2.2.7. 管道保温价格清单	31
2.2.8. 系统所用辅材数量清单	32
2.2.9. 验证服务报价	33
3. 方案二 管材管件为NEUMO	34
3.1. 报价一览表	34
3.2. 分项报价一览表	35
3.2.1. 纯化水系统材料清单及报价	36
3.2.2. 注射用水系统材料清单及报价	41
3.2.3. 纯蒸汽系统材料清单及报价	48
3.2.4. 纯化水、注射用水控制系统报价	51

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

3.2.5. 罐体清单说明	53
3.2.6. 焊点费	57
3.2.7. 管道保温价格清单	58
3.2.8. 系统所用辅材数量清单	59
3.2.9. 验证服务报价	60

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

1. 报价书

1.1.1. 法定代表人资格证明书

法定代表人资格证明书

单位名称：上海朗脉科技有限公司

单位地址：上海市闵行区罗阳路168 号A 座1 层

经营期限：2007年7 月26 日到2017 年7 月25 日

姓名：王伟

性    别： 男

年    龄： 36

职务：法人代表

王伟先生系上海朗脉科技有限公司的法定代表人,签署本招标项目的投 标文件,进行合同谈判,签署合同和处理与之有关的一切事务。

特此证明。

投标单位（盖章）： 上海朗脉科技有限公司

日期：2009-1-15

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第3页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

1.2. 法人授权委托书

法人授权委托书

沈阳三生制药有限责任公司:

本授权委托书声明： 我王伟先生系上海市闵行区罗阳路168 号A 座101室的上海朗脉科技有限公司的法定代表人，现代表公司授权委托下面签字的上海朗脉科技有限公司的销售经理张松为本公司的合法代理人，代表本公司参加沈阳三生制药有限责任公司组织的纯化水、注射用水、纯蒸汽系统项目的投标活动。代理人在本次投标中所签署的一切文件和处理与之相关的一切事务，我均予以承认。

代理人无转委权

本授权于2009 年1 月15 日签字生效，特此声明。

代理人：张松          性别：男          年龄：35

单位：上海朗脉科技有限公司          职务：销售经理

地址：上海市闵行区罗阳路168 号A 座101 室

投标人：（公章）上海朗脉科技有限公司

法定代表人：（印鉴）

2009 年1 月15 日

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第4页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

1.3. 授权代表人身份证复印件

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第5页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

1.4. 投标书

投标书

致沈阳三生制药有限责任公司：

我们收到贵方纯化水、注射用水、纯蒸汽系统招标文件，经详细研究，我们决定参加该项目投标。并授权张松销售经理，全权代表我投标方提交下述文件正本一份，副本叁份。并同时宣布愿意遵守下列条款：

1、承认和愿意按照招标文件中的各项规定和要求，提供纯化水、注射用水、纯蒸汽系统的供货、安装、调试及维保等。

2、投标总报价方案一为6,707,782.17元（管材管件为ALFA LAVAL），方案二为6,512,069.68 元（管材管件为NEUMO），；供货周期承诺120日历天，安装周期承诺90日历天，安装质量承诺符合GMP 要求。

3、愿意按照《合同法》和《中华人民共和国招标投标法》履行自己的责任和义务。

4、如果我们投标函被接受，我们将履行招标文件中规定的每一项要求，按期、按质、按量完成任务。

5、我们愿意提供招标方在招标文件中要求的所有资料。

6、我们理解，最低报价不是中标的唯一条件。

7、我们同意按招标文件规定，交纳投标保证金，遵守有关招标的各项规定。

8、我方的投标书在开标后60 天内有效。

9、与本投标有关的一切往来通讯请寄：

地址：上海市闵行区罗阳路168号A座101室邮编：201100

电话：021-54306717/ 13901375676           传真：021-54306718投标方(公章)： 上海朗脉科技有限公司

授权代表人（签字或盖章）：____________________

日期：________________

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第6页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

2.方案一 管材管件为ALFA LAVAL

2.1. 报价一览表

Item 序号	Scope of Supply 供货范围	Price (RMB) 价格
1	Price Breakdown for  PW Distribution System 纯化水系统材料清单及报价	846,747.18
2	Price Breakdown for  WFI Distribution System 注射用水系统材料清单及报价	3,292,200.05
2	Price Breakdown for PS Distribution System 纯蒸汽系统材料清单及报价	423,468.40
3	Automatic Control System 自动化控制系统	275,825.00
4	Insulation Fee 保温费	147,500.00
5	Piping surport 辅助材料，洁净区用不锈钢支架，非洁净区用镀锌角铁	188,130.00
	Subtotal 1 for Material 材料费用	5,173,870.63
6	Welding Point Cost 焊点费用	351,600.00
7	Cost of  Welding Point marking  (100% of total welding point ) 20RMB /point 焊点刻码费用, 100% 自动焊点刻码,20 元/焊点	46,280.00
8	Endoscopic Check (20% of total welding point ) 80 RMB /point                    内窥镜检测, 自动焊点的20% 取样, 80 元/焊点	37,024.00
9	X-ray Check (100% of total hand-welding point,all welded samples) 180 RMB /point X-光检测, (100% 手工焊点,所有焊样), 180 元/焊点,	32,400.00
10	Insurance and Transportation 保险和运输	50,000.00
	Subtotal 2 for Piping fabrication 管道装配	517,304.00
11	Detail Design, Shop Drawings and As-built Drawings       详细设计, 施工图纸和竣工文件	60,000.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第7页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

12	Quotation For Validation Activities 验证服务报价	315,000.00
13	Project Management & Supervision 项目管理&监督	50,000.00
14	COMPANY Management     公司管理	500,000.00
	Subtotal 3 for Project Service 项目服务	925,000.00
	Subtotal 1, 2, 3,         合计	6,616,174.63
	Tax 税金(主材部分开增值税，其他开工程发票）	91,607.54
	Total Price 总价	6,707,782.17

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第8页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

2.2. 分项报价一览表

2.2.1. 纯化水系统材料清单及报价

Price Breakdown for PW Distribution System

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
1	纯化水储罐（包含附件）	10m3,常压容器,卧式,	316L	1	RITAI		185,000.00	185,000.00
2	纯化水循环泵	20T/hr,55m扬程,带下排口	316L	1	ALFA LAVAL		36,250.00	36,250.00
3	纯化水循环泵	30T/hr,55m扬程,带下排口	316L	1	ALFA LAVAL		41,250.00	41,250.00
4	管式热交换器	4T,循环加热1h,25C-85C	316L	1	NEUMO		156,483.13	156,483.13
5	温度变送器	4-20 mA output	316L	3	CHINA		812.50	2,437.50
6	压力表	0-6 kgf/cm2, 1 1/2”	316L	2	CHINA		437.50	875.00
7	电导仪	4-20 mA output		2	BURKERT		8,375.00	16,750.00
8	流量计	4-20 mA output,DN50		2	YAKOGAWA		9,375.00	18,750.00
9	变频器	7.5KW		1	SIEMENS		6,250.00	6,250.00
10	变频器	11KW		1	SIEMENS		6,750.00	6,750.00
11	疏水器	DN20(浮球式)	碳钢	1	Spirax Sarco		1,500.00	1,500.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第9页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
12	气动调节阀	DN50	316L	1	BURKERT		11,125.00	11,125.00
13	气动隔膜阀	DN50	316L	2	GEMU	铸造，Ra≤0.4	5,992.50	11,985.00
14	气动隔膜阀	DN40	316L	4	GEMU	铸造，Ra≤0.4	4,668.75	18,675.00
15	气动隔膜阀	DN25	316L	7	GEMU	铸造，Ra≤0.4	3,201.25	22,408.75
16	气动角座阀	DN50	316L	1	GEMU	铸造，Ra≤0.4	3,312.50	3,312.50
17	气动角座阀	DN25	316L	2	GEMU	铸造，Ra≤0.4	1,562.50	3,125.00
18	气动角座阀	DN20	316L	2	GEMU	铸造，Ra≤0.4	1,375.00	2,750.00
19	隔膜阀	DN80	316L	1	GEMU	铸造，Ra≤0.4	24,412.50	24,412.50
20	隔膜阀	DN65	316L	1	GEMU	铸造，Ra≤0.4	23,075.00	23,075.00
21	隔膜阀	DN25	316L	26	GEMU	铸造，Ra≤0.4	2,428.75	63,147.50
22	隔膜阀	DN15	316L	2	GEMU	铸造，Ra≤0.4	1,665.00	3,330.00
23	限流孔板	DN25	316L	22	CHINA		218.75	4,812.50
24	法兰	DN50	316L	4	CHINA		306.25	1,225.00
25	卡接头	DN76.1	316L	5	ALFA LAVAL	ISO 2037,Ra≤0.5	95.06	475.29
26	卡接头	DN63.5	316L	6	ALFA LAVAL	ISO 2037,Ra≤0.5	79.01	474.07
27	卡接头	DN51	316L	12	ALFA LAVAL	ISO 2037,Ra≤0.5	62.67	752.05

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第10页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
28	卡接头	DN38	316L	8	ALFA LAVAL	ISO 2037,Ra≤0.5	59.28	474.26
29	卡接头	DN25	316L	45	ALFA LAVAL	ISO 2037,Ra≤0.5	48.04	2,161.59
30	卡接头	DN19	316L	20	ALFA LAVAL	ISO 2037,Ra≤0.5	47.40	948.00
31	卡环	DN76.1	304	5	ALFA LAVAL	ISO 2037,Ra≤0.5	81.64	408.18
32	卡环	DN63.5	304	6	ALFA LAVAL	ISO 2037,Ra≤0.5	72.04	432.21
33	卡环	DN51	304	12	ALFA LAVAL	ISO 2037,Ra≤0.5	58.72	704.61
34	卡环	DN38	304	16	ALFA LAVAL	ISO 2037,Ra≤0.5	49.56	793.04
35	卡环	DN25	304	80	ALFA LAVAL	ISO 2037,Ra≤0.5	49.56	3,965.18
36	卡环	DN19	304	4	ALFA LAVAL	ISO 2037,Ra≤0.5	95.79	383.15
37	密封圈	DN76.1	PTFE	5	ALFA LAVAL	ISO 2037,Ra≤0.5	67.52	337.59
38	密封圈	DN63.5	PTFE	6	ALFA LAVAL	ISO 2037,Ra≤0.5	53.38	320.26
39	密封圈	DN51	PTFE	12	ALFA LAVAL	ISO 2037,Ra≤0.5	46.51	558.07
40	密封圈	DN38	PTFE	16	ALFA LAVAL	ISO 2037,Ra≤0.5	41.88	670.12
41	密封圈	DN25	PTFE	80	ALFA LAVAL	ISO 2037,Ra≤0.5	46.51	3,720.47
42	密封圈	DN19	PTFE	4	ALFA LAVAL	ISO 2037,Ra≤0.5	37.12	148.47
43	U型弯	DN63.5/25	316L	4	ALFA LAVAL	ISO 2037,Ra≤0.5	503.26	2,013.04

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第11页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
44	U型弯	DN51/25	316L	13	ALFA LAVAL	ISO 2037,Ra≤0.5	446.07	5,798.92
45	变径三通(WCW)	DN76.1/38	316L	1	ALFA LAVAL	ISO 2037,Ra≤0.5	303.92	303.92
46	变径三通(WCW)	DN63.5/51	316L	1	ALFA LAVAL	ISO 2037,Ra≤0.5	264.15	264.15
47	变径三通(WCW)	DN63.5/38	316L	3	ALFA LAVAL	ISO 2037,Ra≤0.5	255.67	767.01
48	变径三通(WCW)	DN63.5/25	316L	1	ALFA LAVAL	ISO 2037,Ra≤0.5	306.64	306.64
49	变径三通(WCW)	DN51/38	316L	5	ALFA LAVAL	ISO 2037,Ra≤0.5	221.58	1,107.88
50	变径三通(WCW)	DN51/25	316L	3	ALFA LAVAL	ISO 2037,Ra≤0.5	271.68	815.05
51	变径三通(WWW)	DN63.5/38	316L	2	ALFA LAVAL	ISO 2037,Ra≤0.5	102.27	204.54
52	变径三通(WWW)	DN51/38	316L	2	ALFA LAVAL	ISO 2037,Ra≤0.5	68.18	136.35
53	正三通(WCW)	DN25	316L	11	ALFA LAVAL	ISO 2037,Ra≤0.5	195.25	2,147.72
54	90°弯头	DN76.1	316L	5	ALFA LAVAL	ISO 2037,Ra≤0.5	94.15	470.76
55	90°弯头	DN63.5	316L	48	ALFA LAVAL	ISO 2037,Ra≤0.5	56.49	2,711.72
56	90°弯头	DN51	316L	100	ALFA LAVAL	ISO 2037,Ra≤0.5	39.61	3,961.18
57	90°弯头	DN38	316L	10	ALFA LAVAL	ISO 2037,Ra≤0.5	34.26	342.59
58	90°弯头	DN25	316L	36	ALFA LAVAL	ISO 2037,Ra≤0.5	26.95	970.31
59	90°弯头	DN19	316L	20	ALFA LAVAL	ISO 2037,Ra≤0.5	220.33	4,406.59

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第12页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
60	45°弯头	DN63.5	316L	1	ALFA LAVAL	ISO 2037,Ra≤0.5	60.55	60.55
61	45°弯头	DN51	316L	1	ALFA LAVAL	ISO 2037,Ra≤0.5	45.29	45.29
62	偏心大小头	DN63.5/51	316L	3	ALFA LAVAL	ISO 2037,Ra≤0.5	163.62	490.87
63	同心大小头	DN63.5/38	316L	1	ALFA LAVAL	ISO 2037,Ra≤0.5	191.59	191.59
64	管道	DN76.1	316L	6	ALFA LAVAL	ISO 2037,Ra≤0.5	433.98	2,603.86
65	管道	DN63.5	316L	138	ALFA LAVAL	ISO 2037,Ra≤0.5	369.41	50,978.82
66	管道	DN51	316L	330	ALFA LAVAL	ISO 2037,Ra≤0.5	234.02	77,227.76
67	管道	DN38	316L	12	ALFA LAVAL	ISO 2037,Ra≤0.5	178.44	2,141.22
68	管道	DN25	316L	18	ALFA LAVAL	ISO 2037,Ra≤0.5	125.53	2,259.53
69	管道	DN19	316L	6	ALFA LAVAL	ISO 2037,Ra≤0.5	102.22	613.34
	以上为纯化水洁净管道系统管材，管件配置清单及报价							846,747.18
	可选项

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
1	管式热交换器	4T,循环加热1h,25C-85C	316L	1	ABC		159,212.94	159,212.94

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第13页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

2.2.2. 注射用水系统材料清单及报价

Price Breakdown for WFI Distribution System

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第14页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第15页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第16页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第17页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第18页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
76	变径三通(WWW)	DN25/19	316L	4	ALFA LAVAL	ASME BPE,Ra≤0.5	480.72	1,922.87
77	变径三通(WWW)	DN63.5/38	316L	2	ALFA LAVAL	ASME BPE,Ra≤0.5	480.72	961.44
78	变径三通(WWW)	DN63.5/25	316L	2	ALFA LAVAL	ASME BPE,Ra≤0.5	480.72	961.44
79	变径三通(WWW)	DN51/25	316L	2	ALFA LAVAL	ASME BPE,Ra≤0.5	382.70	765.41
80	弯头	DN76.1	316L	5	ALFA LAVAL	ASME BPE,Ra≤0.5	366.29	1,831.47
81	弯头	DN63.5	316L	32	ALFA LAVAL	ASME BPE,Ra≤0.5	272.24	8,711.64
82	弯头	DN51	316L	60	ALFA LAVAL	ASME BPE,Ra≤0.5	183.14	10,988.19
83	弯头	DN38	316L	16	ALFA LAVAL	ASME BPE,Ra≤0.5	155.93	2,494.93
84	弯头	DN25	316L	108	ALFA LAVAL	ASME BPE,Ra≤0.5	150.98	16,306.22
85	弯头	DN19	316L	20	ALFA LAVAL	ASME BPE,Ra≤0.5	165.82	3,316.33
86	45°弯头	DN63.5	316L	1	ALFA LAVAL	ASME BPE,Ra≤0.5	217.80	217.80
87	45°弯头	DN51	316L	1	ALFA LAVAL	ASME BPE,Ra≤0.5	183.14	183.14
88	偏心大小头	DN63.5/51	316L	3	ALFA LAVAL	ASME BPE,Ra≤0.5	698.39	2,095.16
89	管道	DN76.1	316L	6	ALFA LAVAL	ASME BPE,Ra≤0.5	1,265.14	7,590.85
90	管道	DN63.5	316L	90	ALFA LAVAL	ASME BPE,Ra≤0.5	1,094.62	98,515.69
91	管道	DN51	316L	240	ALFA LAVAL	ASME BPE,Ra≤0.5	888.23	213,175.91

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第19页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
92	管道	DN38	316L	48	ALFA LAVAL	ASME BPE,Ra≤0.5	672.96	32,302.02
93	管道	DN25	316L	330	ALFA LAVAL	ASME BPE,Ra≤0.5	529.34	174,682.20
94	管道	DN19	316L	6	ALFA LAVAL	ASME BPE,Ra≤0.5	690.90	4,145.37
	以上为注射用水洁净管道系统管材，管件配置清单及报价							3,292,200.05
	可选项
1	管式热交换器	10T/H, 75C-85C.2T,循环加热1h,85℃-121℃	316L	1	ABC		168,235.29	168,235.29
2	管式热交换器	15T/H, 75C-85C.2T,循环加热1h,85℃-121℃	316L	1	ABC		168,235.29	168,235.29
3	管式热交换器	8T/H,85-60C,7C冷媒	316L	1	ABC		121,435.29	121,435.29
4	管式热交换器	4T/H,85-60C,7C冷媒	316L	1	ABC		97,147.06	97,147.06
5	管式热交换器	4T/H,85-30C,7C冷媒	316L	2	ABC		115,400.00	230,800.00
6	管式热交换器	0.6T/H,85-30C,7C冷媒	316L	1	ABC		95,294.12	95,294.12
7	管式热交换器	0.6T/H,85-60C,7C冷媒	316L	1	ABC		85,952.94	85,952.94
8	管式热交换器	1.0T/H,85-30C,7C冷媒	316L	1	ABC		100,000.00	100,000.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第20页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

2.2.3. 纯蒸汽系统材料清单及报价

Price Breakdown for PS Distribution System

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第21页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
15	密封圈	DN63.5	PTFE	2	ALFA LAVAL	ASME BPE,Ra≤0.5	53.38	106.75
16	密封圈	DN38	PTFE	2	ALFA LAVAL	ASME BPE,Ra≤0.5	41.88	83.76
17	密封圈	DN25	PTFE	135	ALFA LAVAL	ASME BPE,Ra≤0.5	46.51	6,278.29
18	密封圈	DN19	PTFE	8	ALFA LAVAL	ASME BPE,Ra≤0.5	37.12	296.94
19	变径三通(WCW)	DN63.5/38	316L	2	ALFA LAVAL	ASME BPE,Ra≤0.5	519.64	1,039.29
20	变径三通(WWW)	DN63.5/51	316L	1	ALFA LAVAL	ASME BPE,Ra≤0.5	382.57	382.57
21	变径三通(WWW)	DN63.5/38	316L	1	ALFA LAVAL	ASME BPE,Ra≤0.5	480.72	480.72
22	变径三通(WWW)	DN63.5/19	316L	1	ALFA LAVAL	ASME BPE,Ra≤0.5	480.72	480.72
23	变径三通(WWW)	DN51/25	316L	14	ALFA LAVAL	ASME BPE,Ra≤0.5	382.70	5,357.87
24	变径三通(WWW)	DN38/25	316L	6	ALFA LAVAL	ASME BPE,Ra≤0.5	304.79	1,828.75
25	变径三通(WWW)	DN38/19	316L	2	ALFA LAVAL	ASME BPE,Ra≤0.5	286.16	572.33
26	三通(WWW)	DN25	316L	25	ALFA LAVAL	ASME BPE,Ra≤0.5	174.18	4,354.44
27	三通(WWW)	DN19	316L	3	ALFA LAVAL	ASME BPE,Ra≤0.5	183.35	550.04
28	弯头	DN63.5	316L	12	ALFA LAVAL	ASME BPE,Ra≤0.5	272.24	3,266.87
29	弯头	DN51	316L	24	ALFA LAVAL	ASME BPE,Ra≤0.5	183.14	4,395.28
30	弯头	DN38	316L	18	ALFA LAVAL	ASME BPE,Ra≤0.5	155.93	2,806.79
31	弯头	DN25	316L	112	ALFA LAVAL	ASME BPE,Ra≤0.5	150.98	16,910.16

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第22页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
32	弯头	DN19	316L	15	ALFA LAVAL	ASME BPE,Ra≤0.5	165.82	2,487.25
33	大小头	DN63.5/51	316L	1	ALFA LAVAL	ASME BPE,Ra≤0.5	698.39	698.39
34	大小头	DN51/25	316L	2	ALFA LAVAL	ASME BPE,Ra≤0.5	479.94	959.87
35	大小头	DN38/25	316L	2	ALFA LAVAL	ASME BPE,Ra≤0.5	475.66	951.32
36	管道	DN63.5	316L	36	ALFA LAVAL	ASME BPE,Ra≤0.5	1,094.62	39,406.28
37	管道	DN51	316L	108	ALFA LAVAL	ASME BPE,Ra≤0.5	888.23	95,929.16
38	管道	DN38	316L	60	ALFA LAVAL	ASME BPE,Ra≤0.5	672.96	40,377.53
39	管道	DN25	316L	150	ALFA LAVAL	ASME BPE,Ra≤0.5	529.34	79,401.00
40	管道	DN19	316L	36	ALFA LAVAL	ASME BPE,Ra≤0.5	690.90	24,872.23
以上为纯蒸汽洁净管道系统管材，管件配置清单及报价								423,468.40

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第23页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

2.2.4. 纯化水、注射用水控制系统报价

Quotation for Control System

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第24页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

序号	供货范围	订货号	规格 型号	厂家	数量	单价(RMB)	价格(RMB)
Item	Scope of Supply	Order No.	Specification	Manufacturer	Quantity	Unit Price	Price
14	开关电源	6EP1 334-3BA00	SITOP 24V/10A	SIEMENS	1	1,500.00	1,500.00
15	控制柜		2000×800×600(含继电器、端子等柜内电气元件)	shanghai	1	14,000.00	14,000.00
16	上位机电脑		Core 2\1024MB\160G\19"LCD	DELL	1	7,200.00	7,200.00
17	上位机软件	6AV6 381-1BE06-2AV0	WINCC V6.2 RT(1024 点)	SIEMENS	1	32,892.00	32,892.00
18	打印机		A4 激光打印机	HP	1	2,400.00	2,400.00
19	触摸屏	6AV6 643-0CD01-1AX1	MP 277 10" Touch 64K 颜色	SIEMENS	1	12,000.00	12,000.00
20	交换机	6 RJ45 口	工业以太网交换机	MOXA	1	1,200.00	1,200.00
21	编程电缆	6ES7 972-0CB20-0XA0	PLC 编程电缆USB	SIEMENS	1	2,646.00	2,646.00
22	网线						500.00
23	电缆						12,000.00
24	电缆						12,000.00
25	电缆						10,125.00
26	桥架						13,750.00
一、	控制系统所用材料						200,825.00
二、	编程费 Programme Cost（1 人30 个工作日）						35,000.00
三、	安装费用（3人10 个工作日）						40,000.00
四、	调试费 Commissioning Cost（2 人10 个工作日，含住宿交通等）						275,825.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第25页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

2.2.5. 储罐配置清单

Configuration list for PW Bank

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Remarks 备注
1	纯化水储罐	10m3,常压容器,卧式,	316L	1	RiTai	内部抛 Ra<0 .5um，外部亚光处理Ra<0.8um
2	呼吸器	10" 0.22um	316L	1	PALL
3	喷淋球	DN40	316L	3	Alfa Laval	固定式
4	液位计	4-20 mA output		1	E+H	电容式
5	温度变送器	DN40,4-20 mA output		1	CHINA	卡接
6	压力传感器	DN40,4-20 mA output		1	CHINA	卡接
7	气动球阀	DN40	316L	1	King Lai
8	气动球阀	DN20	316L	3	King Lai
9	气动隔膜阀	DN40	316L	1	GEMU
10	隔膜阀	DN15	316L	1	GEMU
11	减压阀	DN20		1	中国
12	疏水器	DN20(浮球式)	碳钢	1	Spirax Sarco
13	卡接头	DN40	316L	3	Alfa Laval	ISO 2037

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第26页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Remarks 备注
14	卡接头	DN19	316L	8	Alfa Laval	ISO 2037
15	卡环	DN40	304	6	Alfa Laval	ISO 2037
16	卡环	DN19	304	10	Alfa Laval	ISO 2037
17	密封圈	DN40	PTFE	6	Alfa Laval	ISO 2037
18	密封圈	DN19	PTFE	10	Alfa Laval	ISO 2037
19	变径三通	DN38/19	316L	4	Alfa Laval	ISO 2037
20	三通	DN19	316L	2	Alfa Laval	ISO 2037
	以上为纯化水储罐配置清单

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第27页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Configuration list for WFI Bank
注射水储罐清单及报价
Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Remarks 备注
1	注射水储罐	10m3,压力容器,卧式,保温	316L	1	RiTai	内部抛光Ra<0 .5um，外部亚光处理Ra<0.8um
2	呼吸器	10“ 0.22um	316L	1	PALL
3	电加热套			1	CHINA
4	喷淋球	DN50	316L	1	Alfa Laval	固定式
5	喷淋球	DN40	316L	2	Alfa Laval	固定式
6	液位计	4-20 mA output	316L	1	E+H	电容式
7	压力传感器	DN40,4-20 mA output	316L	1	CHINA	卡接
8	温度变送器	DN40,4-20 mA output	316L	2	CHINA	卡接
9	爆破片	0.5-4bar	316L	1	FIKE
10	疏水器	DN20(浮球式)	碳钢	1	Spirax Sarco
11	气动球阀	DN40	316L	1	King Lai
12	气动球阀	DN20	316L	1	King Lai
13	球阀	DN20	316L	1	King Lai

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第28页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Remarks 备注
14	气动隔膜阀	DN40	316L	1	GEMU
15	隔膜阀	DN15	316L	1	GEMU
16	减压阀	DN20		1	中国
17	卡接头	DN40	316L	3	Alfa Laval	ASME BPE-EP
18	卡接头	DN19	316L	8	Alfa Laval	ASME BPE-EP
19	卡环	DN40	304	6	Alfa Laval	ASME BPE-EP
20	卡环	DN19	304	6	Alfa Laval	ASME BPE-EP
21	密封圈	DN40	PTFE	6	Alfa Laval	ASME BPE-EP
22	密封圈	DN19	PTFE	6	Alfa Laval	ASME BPE-EP
23	变径三通	DN38/19	316L	2	Alfa Laval	ASME BPE-EP
24	三通	DN19	316L	1	Alfa Laval	ISO 2037
	以上为注射用水储罐配置清单

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第29页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

2.2.6. 焊点费

Welding Point Cost

Item 序号	Supply Scope 供货范围	Location 位置		Quantity 数量	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
1	纯化水系统		自动焊点	729	150.00	109,350.00
2	注射用水系统		自动焊点	899	150.00	134,850.00
3	纯蒸汽系统		自动焊点	716	150.00	107,400.00
	总价（元）					351,600.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第30页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

2.2.7. 管道保温价格清单

Insulation Price List

		洁净室内保温管套管保温			非洁净室保温
		Clean Area Piping Insulation			Non-clean Area Piping Insulation
		Pipe-in-Pipe Asbestos Insulated			Stainless Steel Jacket Asbestos Insulated
		数量（m）	单价	合计	数量（m）	单价	合计
1	WFI 管道	90	350.00	31500.00	630	100.00	63000.00
2	PS 管道	60	350.00	21000.00	320	100.00	32000.00
		共计Total：		52500.00	共计Total：		95000.00
					合计(元）		147500.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第31页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

2.2.8. 系统所用辅材数量清单

Accessories List

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第32页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

2.2.9. 验证服务报价

Quotation For Validation Activities

序号 No.	验证项目 Scope		报价 Quotation(RMB)
1	纯化水储存和分配系统 PW storage and distribution system	DQ，TM,RA	20,000
2		FAT,SAT	15,000
3		IQ	15,000
4		OQ	25,000
4		PQ 方案 PQ protocol	10,000
6	注射用水储存和分配系统 WFI storage and distribution system	DQ，TM,RA	20,000
7		FAT,SAT	10,000
8		IQ	15,000
9		OQ	25,000
9		PQ 方案 PQ protocol	10,000
11	纯蒸汽分配系统 Pure steam distribution system	DQ，TM,RA	10,000
12		FAT,SAT	10,000
13		IQ，OQ	20,000
14		PQ 方案 PQ protocol	10,000
11	控制系统 Automatic control system	控制系统验证 Validation of control system	100,000
15	总价		315,000
	Remarks 备注：
	1) 包含本报价服务范围内的朗脉验证人员在客户现场的差旅食宿费用。 The cost of trips and living in client site are included in abo ve price。
	2) 包含验证仪器费用。 The fee of validation instruments are included in above price.。
	3) 验证不包括系统中仪表和传感器的校准工作。 The calibration work for instruments and sensors in the systems is not validation wor k。
	4) 本报价有效期：3 个月内。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第33页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

3.方案二 管材管件为NEUMO

3.1. 报价一览表

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第34页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

12	Quotation For Validation Activities 验证服务报价	315,000.00
13	Project Management & Supervision 项目管理&监督	50,000.00
14	COMPANY Management 公司管理	500,000.00
	Subtotal 3 for Project Service 项目服务	925,000.00
	Subtotal 1, 2, 3,合计	6,420,462.14
	Tax 税金(主材部分开增值税，其他开工程发票	91,607.54
	总价 Total Price	6,512,069.68

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第35页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

3.2. 分项报价一览表

3.2.1. 纯化水系统材料清单及报价

Price Breakdown for PW Distribution System

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
1	纯化水储罐（包含附件）	10m3,压力容器	316L	1	RITAI		185,000.00	185,000.00
2	纯化水循环泵	20T/hr,55m 扬程,带下排口	316L	1	ALFA LAVAL		36,250.00	36,250.00
3	纯化水循环泵	30T/hr,55m 扬程,带下排口	316L	1	ALFA LAVAL		41,250.00	41,250.00
4	管式热交换器	4T ,循环加热1h,25°C-85°C	316L	1	NEUMO		156,483.13	156,483.13
5	温度变送器	4-20 mA output	316L	3	CHINA		812.50	2,437.50
6	压力表	0-6 kgf/cm2, 1 1/2"	316L	2	CHINA		437.50	875.00
7	电导仪	4-20 mA output		2	BURKERT		8,375.00	16,750.00
8	流量计	4-20 mA output,DN50		2	YAKOGAWA		9,375.00	18,750.00
9	变频器	7.5KW		1	SIEMENS		6,250.00	6,250.00
10	变频器	11KW		1	SIEMENS		6,750.00	6,750.00
11	疏水器	DN20(浮球式)	碳钢	1	Spirax Sarco		1,500.00	1,500.00
12	气动调节阀	DN50	316L	1	BURKERT		11,125.00	11,125.00
13	气动隔膜阀	DN50	316L	2	GEMU	铸造，Ra≤0.4	5,992.50	11,985.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第36页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
14	气动隔膜阀	DN40	316L	4	GEMU	铸造，Ra≤0.4	4,668.75	18,675.00
15	气动隔膜阀	DN25	316L	7	GEMU	铸造，Ra≤0.4	3,201.25	22,408.75
16	气动角座阀	DN50	316L	1	GEMU	铸造，Ra≤0.4	3,312.50	3,312.50
17	气动角座阀	DN25	316L	2	GEMU	铸造，Ra≤0.4	1,562.50	3,125.00
18	气动角座阀	DN20	316L	2	GEMU	铸造，Ra≤0.4	1,375.00	2,750.00
19	隔膜阀	DN80	316L	1	GEMU	铸造，Ra≤0.4	24,412.50	24,412.50
20	隔膜阀	DN65	316L	1	GEMU	铸造，Ra≤0.4	23,075.00	23,075.00
21	隔膜阀	DN25	316L	26	GEMU	铸造，Ra≤0.4	2,428.75	63,147.50
22	隔膜阀	DN15	316L	2	GEMU	铸造，Ra≤0.4	1,665.00	3,330.00
23	限流孔板	DN25	316L	22	CHINA		218.75	4,812.50
24	法兰	DN50	316L	4	CHINA		306.25	1,225.00
25	卡接头	DN76.1	316L	5	ALFA LAVAL	ISO 2037,Ra≤0.5	95.06	475.29
26	卡接头	DN63.5	316L	6	ALFA LAVAL	ISO 2037,Ra≤0.5	79.01	474.07
27	卡接头	DN51	316L	12	ALFA LAVAL	ISO 2037,Ra≤0.5	62.67	752.05
28	卡接头	DN38	316L	8	ALFA LAVAL	ISO 2037,Ra≤0.5	59.28	474.26
29	卡接头	DN25	316L	45	ALFA LAVAL	ISO 2037,Ra≤0.5	48.04	2,161.59

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第37页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
30	卡接头	DN19	316L	20	ALFA LAVAL	ISO 2037,Ra≤0.5	47.40	948.00
31	卡环	DN76.1	304	5	ALFA LAVAL	ISO 2037,Ra≤0.5	81.64	408.18
32	卡环	DN63.5	304	6	ALFA LAVAL	ISO 2037,Ra≤0.5	72.04	432.21
33	卡环	DN51	304	12	ALFA LAVAL	ISO 2037,Ra≤0.5	58.72	704.61
34	卡环	DN38	304	16	ALFA LAVAL	ISO 2037,Ra≤0.5	49.56	793.04
35	卡环	DN25	304	80	ALFA LAVAL	ISO 2037,Ra≤0.5	49.56	3,965.18
36	卡环	DN19	304	4	ALFA LAVAL	ISO 2037,Ra≤0.5	95.79	383.15
37	密封圈	DN76.1	PTFE	5	ALFA LAVAL	ISO 2037,Ra≤0.5	67.52	337.59
38	密封圈	DN63.5	PTFE	6	ALFA LAVAL	ISO 2037,Ra≤0.5	53.38	320.26
39	密封圈	DN51	PTFE	12	ALFA LAVAL	ISO 2037,Ra≤0.5	46.51	558.07
40	密封圈	DN38	PTFE	16	ALFA LAVAL	ISO 2037,Ra≤0.5	41.88	670.12
41	密封圈	DN25	PTFE	80	ALFA LAVAL	ISO 2037,Ra≤0.5	46.51	3,720.47
42	密封圈	DN19	PTFE	4	ALFA LAVAL	ISO 2037,Ra≤0.5	37.12	148.47
43	U 型弯	DN63.5/25	316L	4	ALFA LAVAL	ISO 2037,Ra≤0.5	503.26	2,013.04
44	U 型弯	DN51/25	316L	13	ALFA LAVAL	ISO 2037,Ra≤0.5	446.07	5,798.92
45	变径三通(WCW)	DN76.1/38	316L	1	ALFA LAVAL	ISO 2037,Ra≤0.5	303.92	303.92

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第38页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
46	变径三通(WCW)	DN63.5/51	316L	1	ALFA LAVAL	ISO 2037,Ra≤0.5	264.15	264.15
47	变径三通(WCW)	DN63.5/38	316L	3	ALFA LAVAL	ISO 2037,Ra≤0.5	255.67	767.01
48	变径三通(WCW)	DN63.5/25	316L	1	ALFA LAVAL	ISO 2037,Ra≤0.5	306.64	306.64
49	变径三通(WCW)	DN51/38	316L	5	ALFA LAVAL	ISO 2037,Ra≤0.5	221.58	1,107.88
50	变径三通(WCW)	DN51/25	316L	3	ALFA LAVAL	ISO 2037,Ra≤0.5	271.68	815.05
51	变径三通(WWW)	DN63.5/38	316L	2	ALFA LAVAL	ISO 2037,Ra≤0.5	102.27	204.54
52	变径三通(WWW)	DN51/38	316L	2	ALFA LAVAL	ISO 2037,Ra≤0.5	68.18	136.35
53	正三通(WCW)	DN25	316L	11	ALFA LAVAL	ISO 2037,Ra≤0.5	195.25	2,147.72
54	90°弯头	DN76.1	316L	5	ALFA LAVAL	ISO 2037,Ra≤0.5	94.15	470.76
55	90°弯头	DN63.5	316L	48	ALFA LAVAL	ISO 2037,Ra≤0.5	56.49	2,711.72
56	90°弯头	DN51	316L	100	ALFA LAVAL	ISO 2037,Ra≤0.5	39.61	3,961.18
57	90°弯头	DN38	316L	10	ALFA LAVAL	ISO 2037,Ra≤0.5	34.26	342.59
58	90°弯头	DN25	316L	36	ALFA LAVAL	ISO 2037,Ra≤0.5	26.95	970.31
59	90°弯头	DN19	316L	20	ALFA LAVAL	ISO 2037,Ra≤0.5	220.33	4,406.59
60	45°弯头	DN63.5	316L	1	ALFA LAVAL	ISO 2037,Ra≤0.5	60.55	60.55
61	45°弯头	DN51	316L	1	ALFA LAVAL	ISO 2037,Ra≤0.5	45.29	45.29

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第39页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item	Supply Scope	Specification	Material	Quantity	Manufacturer	Standard	Unit Price	Total Price
序号	供货范围	规格	材料	数量	供应商	标准	单位价格(RMB)	总价(RMB)
62	偏心大小头	DN63.5/51	316L	3	ALFA LAVAL	ISO 2037,Ra≤0.5	163.62	490.87
63	同心大小头	DN63.5/38	316L	1	ALFA LAVAL	ISO 2037,Ra≤0.5	191.59	191.59
64	管道	DN76.1	316L	6	ALFA LAVAL	ISO 2037,Ra≤0.5	433.98	2,603.86
65	管道	DN63.5	316L	138	ALFA LAVAL	ISO 2037,Ra≤0.5	369.41	50,978.82
66	管道	DN51	316L	330	ALFA LAVAL	ISO 2037,Ra≤0.5	234.02	77,227.76
67	管道	DN38	316L	12	ALFA LAVAL	ISO 2037,Ra≤0.5	178.44	2,141.22
68	管道	DN25	316L	18	ALFA LAVAL	ISO 2037,Ra≤0.5	125.53	2,259.53
69	管道	DN19	316L	6	ALFA LAVAL	ISO 2037,Ra≤0.5	102.22	613.34
	以上为纯化水洁净管道系统管材，管件配置清单及报价							846,747.18
	可选项

1 管式热交换器 4T,循环加热1h,25C-85C 316L 1 ABC 159,212.94 159,212.94

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第40页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

3.2.2. 注射用水系统材料清单及报价

Price Breakdown for WFI Distribution System

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
1	注射水储罐(包含附件）	10m3,压力容器	316L	1	RITAI		350,000.00	350,000.00
2	注射用水循环泵	20T/hr,55m 扬程,带下排口	316L	1	ALFA LAVAL		38,750.00	38,750.00
3	注射用水循环泵	30T/hr,55m 扬程,带下排口	316L	1	ALFA LAVAL		43,750.00	43,750.00
4	管式热交换器	10T/H, 75°C-85°C.2T, 循环加热1h,85°C-121°C	316L	1	NEUMO		143,879.00	143,879.00
5	管式热交换器	15T/H, 75°C-85°C.2T, 循环加热1h,85°C-121°C	316L	1	NEUMO		136,656.50	136,656.50
6	管式热交换器	8T/H,85-60C,7C冷媒	316L	1	NEUMO		152,026.88	152,026.88
7	管式热交换器	4T/H,85-60C,7C冷媒	316L	1	NEUMO		135,135.00	135,135.00
8	管式热交换器	4T/H,85-30C,7C冷媒	316L	2	NEUMO		184,539.38	369,078.75
9	管式热交换器	0.6T/H,85-30C,7C冷媒	316L	1	NEUMO		119,852.13	119,852.13
10	管式热交换器	0.6T/H,85-60C,7C冷媒	316L	1	NEUMO		105,743.13	105,743.13
11	管式热交换器	1.0T/H,85-30C,7C冷媒	316L	1	NEUMO		129,070.00	129,070.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第41页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
12	温度变送器	4-20 mA output	316L	11	E+H		2,375.00	26,125.00
13	压力表	0-6 kgf/cm2,1 1/2"	316L	2	BRIGHT		437.50	875.00
14	电导仪	4-20 mA output		2	METTLER TOLEDO		14,000.00	28,000.00
15	TOC 测试仪			2	METTLER TOLEDO		137,000.00	274,000.00
16	流量计	4-20 mA output,DN65		1	YAKOGAWA		9,625.00	9,625.00
17	流量计	4-20 mA output,DN50		1	YAKOGAWA		9,375.00	9,375.00
18	流量计	4-20 mA output,DN40		1	YAKOGAWA		9,000.00	9,000.00
19	流量计	4-20 mA output,DN25		4	YAKOGAWA		9,000.00	36,000.00
20	变频器	7.5KW		1	SIEMENS		6,250.00	6,250.00
21	变频器	11KW		1	SIEMENS		6,750.00	6,750.00
22	疏水器	DN20	316L	2	Spirax Sarco		2,875.00	5,750.00
23	疏水器	DN20(浮球式)	碳钢	2	Spirax Sarco		1,500.00	3,000.00
24	气动调节阀	DN50	不锈钢	1	Burkert		11,125.00	11,125.00
25	气动调节阀	DN40	不锈钢	2	Burkert		10,625.00	21,250.00
26	气动调节阀	DN25	不锈钢	6	Burkert		9,375.00	56,250.00
27	气动角座阀	DN50	316L	1	GEMU	铸造，Ra≤0.4	3,312.50	3,312.50

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第42页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
28	气动角座阀	DN40	316L	1	GEMU	铸造，Ra≤0.4	2,725.00	2,725.00
29	气动角座阀	DN25	316L	4	GEMU	铸造，Ra≤0.4	1,562.50	6,250.00
30	气动角座阀	DN20	316L	4	GEMU	铸造，Ra≤0.4	1,375.00	5,500.00
31	气动调节隔膜阀	DN40	316L	1	GEMU	铸造，Ra≤0.4	18,103.75	18,103.75
32	气动调节隔膜阀	DN25	316L	4	GEMU	铸造，Ra≤0.4	15,996.25	63,985.00
33	气动隔膜阀	DN65	316L	1	GEMU	铸造，Ra≤0.4	34,375.00	34,375.00
34	气动隔膜阀	DN50	316L	2	GEMU	铸造，Ra≤0.4	5,992.50	11,985.00
35	气动隔膜阀	DN40	316L	3	GEMU	铸造，Ra≤0.4	4,668.75	14,006.25
36	气动隔膜阀	DN25	316L	17	GEMU	铸造，Ra≤0.4	3,201.25	54,421.25
37	隔膜阀	DN80	316L	1	GEMU	铸造，Ra≤0.4	24,412.50	24,412.50
38	隔膜阀	DN65	316L	1	GEMU	铸造，Ra≤0.4	23,075.00	23,075.00
39	隔膜阀	DN25	316L	26	GEMU	铸造，Ra≤0.4	2,428.75	63,147.50
40	隔膜阀	DN15	316L	2	GEMU	铸造，Ra≤0.4	1,665.00	3,330.00
41	冷水点控制盘		不锈钢	11	CHINA		525.00	5,775.00
42	法兰	DN65	316L	2	CHINA		337.50	675.00
43	法兰	DN50	316L	2	CHINA		306.25	612.50

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第43页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
44	法兰	DN40	316L	2	CHINA		262.50	525.00
45	法兰	DN25	316L	8	CHINA		225.00	1,800.00
46	限流孔板	DN25	316L	27	CHINA		218.75	5,906.25
47	卡接头	DN76.1	316L	5	NEUMO	ASME BPE PM,Ra≤0.5	340.80	1,704.00
48	卡接头	DN63.5	316L	12	NEUMO	ASME BPE PM,Ra≤0.5	292.09	3,505.13
49	卡接头	DN51	316L	12	NEUMO	ASME BPE PM,Ra≤0.5	215.40	2,584.80
50	卡接头	DN38	316L	12	NEUMO	ASME BPE PM,Ra≤0.5	180.46	2,165.51
51	卡接头	DN25	316L	60	NEUMO	ASME BPE PM,Ra≤0.5	168.86	10,131.53
52	卡接头	DN19	316L	12	NEUMO	ASME BPE PM,Ra≤0.5	134.06	1,608.71
53	卡环	DN76.1	304	5	NEUMO	ASME BPE PM,Ra≤0.5	98.96	494.82
54	卡环	DN63.5	304	12	NEUMO	ASME BPE PM,Ra≤0.5	91.07	1,092.85
55	卡环	DN51	304	12	NEUMO	ASME BPE PM,Ra≤0.5	83.19	998.26
56	卡环	DN38	304	20	NEUMO	ASME BPE PM,Ra≤0.5	76.08	1,521.65
57	卡环	DN25	304	90	NEUMO	ASME BPE PM,Ra≤0.5	76.08	6,847.41
58	卡环	DN19	304	4	NEUMO	ASME BPE PM,Ra≤0.5	58.14	232.56
59	密封圈	DN76.1	PTFE	5	NEUMO	ASME BPE PM,Ra≤0.5	22.42	112.12

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第44页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
60	密封圈	DN63.5	PTFE	12	NEUMO	ASME BPE PM,Ra≤0.5	20.72	248.61
61	密封圈	DN51	PTFE	12	NEUMO	ASME BPE PM,Ra≤0.5	17.79	213.46
62	密封圈	DN38	PTFE	30	NEUMO	ASME BPE PM,Ra≤0.5	16.08	482.47
63	密封圈	DN25	PTFE	90	NEUMO	ASME BPE PM,Ra≤0.5	14.69	1,322.47
64	密封圈	DN19	PTFE	4	NEUMO	ASME BPE PM,Ra≤0.5	15.62	62.49
65	U 型弯	DN51/25	316L	6	NEUMO	ASME BPE PM,Ra≤0.5	4,543.00	27,258.00
66	U 型弯	DN38/25	316L	2	NEUMO	ASME BPE PM,Ra≤0.5	3,987.58	7,975.15
67	U 型弯	DN25/25	316L	15	NEUMO	ASME BPE PM,Ra≤0.5	3,987.58	59,813.65
68	变径三通(WCW)	DN76.1/38	316L	1	NEUMO	ASME BPE PM,Ra≤0.5	944.94	944.94
69	变径三通(WCW)	DN63.5/51	316L	1	NEUMO	ASME BPE PM,Ra≤0.5	720.73	720.73
70	变径三通(WCW)	DN63.5/38	316L	7	NEUMO	ASME BPE PM,Ra≤0.5	720.73	5,045.11
71	变径三通(WCW)	DN63.5/25	316L	4	NEUMO	ASME BPE PM,Ra≤0.5	720.73	2,882.92
72	变径三通(WCW)	DN51/38	316L	6	NEUMO	ASME BPE PM,Ra≤0.5	528.21	3,169.27
73	变径三通(WCW)	DN51/25	316L	5	NEUMO	ASME BPE PM,Ra≤0.5	528.21	2,641.06
74	变径三通(WCW)	DN38/25	316L	2	NEUMO	ASME BPE PM,Ra≤0.5	419.35	838.71
75	变径三通(WCW)	DN25	316L	23	NEUMO	ASME BPE PM,Ra≤0.5	310.80	7,148.40

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第45页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
76	变径三通(WWW)	DN25/19	316L	4	NEUMO	ASME BPE PM,Ra≤0.5	242.61	970.45
77	变径三通(WWW)	DN63.5/38	316L	2	NEUMO	ASME BPE PM,Ra≤0.5	596.25	1,192.49
78	变径三通(WWW)	DN63.5/25	316L	2	NEUMO	ASME BPE PM,Ra≤0.5	596.25	1,192.49
79	变径三通(WWW)	DN51/25	316L	2	NEUMO	ASME BPE PM,Ra≤0.5	408.69	817.39
80	弯头	DN76.1	316L	5	NEUMO	ASME BPE PM,Ra≤0.5	582.33	2,911.65
81	弯头	DN63.5	316L	32	NEUMO	ASME BPE PM,Ra≤0.5	457.54	14,641.32
82	弯头	DN51	316L	60	NEUMO	ASME BPE PM,Ra≤0.5	310.19	18,611.29
83	弯头	DN38	316L	16	NEUMO	ASME BPE PM,Ra≤0.5	244.32	3,909.08
84	弯头	DN25	316L	108	NEUMO	ASME BPE PM,Ra≤0.5	197.93	21,376.38
85	弯头	DN19	316L	20	NEUMO	ASME BPE PM,Ra≤0.5	226.68	4,533.65
86	45°弯头	DN63.5	316L	1	NEUMO	ASME BPE PM,Ra≤0.5	438.06	438.06
87	45°弯头	DN51	316L	1	NEUMO	ASME BPE PM,Ra≤0.5	294.41	294.41
88	偏心大小头	DN63.5/51	316L	3	NEUMO	ASME BPE PM,Ra≤0.5	600.74	1,802.22
89	管道	DN76.1	316L	6	NEUMO	ASME BPE PM,Ra≤0.5	1,108.79	6,652.73
90	管道	DN63.5	316L	90	NEUMO	ASME BPE PM,Ra≤0.5	786.26	70,763.29
91	管道	DN51	316L	240	NEUMO	ASME BPE PM,Ra≤0.5	594.69	142,726.59

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第46页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
92	管道	DN38	316L	48	NEUMO	ASME BPE PM,Ra≤0.5	463.75	22,260.14
93	管道	DN25	316L	330	NEUMO	ASME BPE PM,Ra≤0.5	362.89	119,755.06
94	管道	DN19	316L	6	NEUMO	ASME BPE PM,Ra≤0.5	514.11	3,084.64
	以上为注射用水洁净管道系统管材，管件配置清单及报价							3,162,938.98
	可选项

1	管式热交换器	10T/H, 75C-85C.2T, 循环加热1h,85C-121C	316L	1	ABC	168,235.29	168,235.29
2	管式热交换器	15T/H, 75C-85C.2T, 循环加热1h,85C-121C	316L	1	ABC	168,235.29	168,235.29
3	管式热交换器	8T/H,85-60C,7C冷媒	316L	1	ABC	121,435.29	121,435.29
4	管式热交换器	4T/H,85-60C,7C冷媒	316L	1	ABC	97,147.06	97,147.06
5	管式热交换器	4T/H,85-30C,7C冷媒	316L	2	ABC	115,400.00	230,800.00
6	管式热交换器	0.6T/H,85-30C,7C冷媒	316L	1	ABC	95,294.12	95,294.12
7	管式热交换器	0.6T/H,85-60C,7C冷媒	316L	1	ABC	85,952.94	85,952.94
8	管式热交换器	1.0T/H,85-30C,7C冷媒	316L	1	ABC	100,000.00	100,000.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第47页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

3.2.3. 纯蒸汽系统材料清单及报价

Price Breakdown for PS Distribution System

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
1	压力表	0-6 kgf/cm2,1 1/2"	316L	1	CHINA		437.50	437.50
2	温度表	0C-160C,1 1/2"	316L	1	CHINA		525.00	525.00
3	疏水器	DN20	316L	16	Spirax Sarco		2,875.00	46,000.00
4	气动球阀	DN25	316L	8	KINGLAI		1,002.98	8,023.80
5	手动球阀	DN65	316L	1	KINGLAI		1,275.00	1,275.00
6	手动球阀	DN25	316L	42	KINGLAI		257.03	10,795.05
7	手动球阀	DN20	316L	5	KINGLAI		232.45	1,162.25
8	卡接头	DN63.5	316L	2	NEUMO	ASME BPE PM,Ra≤0.5	292.09	584.19
9	卡接头	DN25	316L	100	NEUMO	ASME BPE PM,Ra≤0.5	168.86	16,885.88
10	卡接头	DN19	316L	8	NEUMO	ASME BPE PM,Ra≤0.5	134.06	1,072.47
11	卡环	DN63.5	304	2	NEUMO	ASME BPE PM,Ra≤0.5	91.07	182.14
12	卡环	DN38	304	2	NEUMO	ASME BPE PM,Ra≤0.5	76.08	152.16
13	卡环	DN25	304	135	NEUMO	ASME BPE PM,Ra≤0.5	76.08	10,271.12
14	卡环	DN19	304	8	NEUMO	ASME BPE PM,Ra≤0.5	58.14	465.13

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第48页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
15	密封圈	DN63.5	PTFE	2	NEUMO	ASME BPE PM,Ra≤0.5	20.72	41.44
16	密封圈	DN38	PTFE	2	NEUMO	ASME BPE PM,Ra≤0.5	16.08	32.16
17	密封圈	DN25	PTFE	135	NEUMO	ASME BPE PM,Ra≤0.5	14.69	1,983.71
18	密封圈	DN19	PTFE	8	NEUMO	ASME BPE PM,Ra≤0.5	15.62	124.99
19	变径三通(WCW)	DN63.5/38	316L	2	NEUMO	ASME BPE PM,Ra≤0.5	720.73	1,441.46
20	变径三通(WWW)	DN63.5/51	316L	1	NEUMO	ASME BPE PM,Ra≤0.5	596.25	596.25
21	变径三通(WWW)	DN63.5/38	316L	1	NEUMO	ASME BPE PM,Ra≤0.5	596.25	596.25
22	变径三通(WWW)	DN63.5/19	316L	1	NEUMO	ASME BPE PM,Ra≤0.5	596.25	596.25
23	变径三通(WWW)	DN51/25	316L	14	NEUMO	ASME BPE PM,Ra≤0.5	408.69	5,721.72
24	变径三通(WWW)	DN38/25	316L	6	NEUMO	ASME BPE PM,Ra≤0.5	326.41	1,958.47
25	变径三通(WWW)	DN38/19	316L	2	NEUMO	ASME BPE PM,Ra≤0.5	326.41	652.82
26	三通(WWW)	DN25	316L	25	NEUMO	ASME BPE PM,Ra≤0.5	204.56	5,114.12
27	三通(WWW)	DN19	316L	3	NEUMO	ASME BPE PM,Ra≤0.5	500.22	1,500.67
28	弯头	DN63.5	316L	12	NEUMO	ASME BPE PM,Ra≤0.5	457.54	5,490.49
29	弯头	DN51	316L	24	NEUMO	ASME BPE PM,Ra≤0.5	310.19	7,444.52
30	弯头	DN38	316L	18	NEUMO	ASME BPE PM,Ra≤0.5	244.32	4,397.72
31	弯头	DN25	316L	112	NEUMO	ASME BPE PM,Ra≤0.5	197.93	22,168.09

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第49页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Standard 标准	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
32	弯头	DN19	316L	15	NEUMO	ASME BPE PM,Ra≤0.5	226.68	3,400.24
33	大小头	DN63.5/51	316L	1	NEUMO	ASME BPE PM,Ra≤0.5	600.74	600.74
34	大小头	DN51/25	316L	2	NEUMO	ASME BPE PM,Ra≤0.5	734.34	1,468.68
35	大小头	DN38/25	316L	2	NEUMO	ASME BPE PM,Ra≤0.5	277.56	555.13
36	管道	DN63.5	316L	36	NEUMO	ASME BPE PM,Ra≤0.5	786.26	28,305.32
37	管道	DN51	316L	108	NEUMO	ASME BPE PM,Ra≤0.5	594.69	64,226.96
38	管道	DN38	316L	60	NEUMO	ASME BPE PM,Ra≤0.5	463.75	27,825.18
39	管道	DN25	316L	150	NEUMO	ASME BPE PM,Ra≤0.5	362.89	54,434.12
40	管道	DN19	316L	36	NEUMO	ASME BPE PM,Ra≤0.5	514.11	18,507.81
		以上为纯蒸汽洁净管道系统管材，管件配置清单及报价						357,016.99

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第50页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

3.2.4. 纯化水、注射用水控制系统报价

Quotation for Control System

序号 Item	供货范围 Scope of Supply	订货号 Order No.	规格 型号 Specification	厂家 Manufacturer	数量 Quantity	单价(RMB) Unit Price	价格(RMB) Price
1	导轨	6ES7 390-1AF30-0AA0	标准导轨 530mm	SIEMENS	2	228.00	456.00
2	电源	6ES7 307-1EA00-0AA0	PS 307 电源 5 A	SIEMENS	2	988.00	1,976.00
3	CPU	6ES7 315-2EH13-0AB0	315-2 PN/DP 256KB RAM； MPI/PROFIBUS DP；PROFINET 接口	SIEMENS	1	13,227.00	13,227.00
4	扩展卡	6ES7 953-8LF11-0AA0	MMC 64 kB	SIEMENS	1	380.00	380.00
5	接口模块	6ES7 365-0BA01-0AA0	IM365 接口模块	SIEMENS	1	838.00	838.00
6	DI 模块	6ES7 321-1BH02-0AA0	16 点数字输入24V DC(20 针)	SIEMENS	2	1,013.00	2,026.00
7	DO 模块	6ES7 322-1BH01-0AA0	16 点数字输出24V DC(20 针)	SIEMENS	3	1,409.00	4,227.00
8	AI 模块	6ES7 331-7KF02-0AB0	8 通道模拟输入(20 针)	SIEMENS	5	3,899.00	19,495.00
9	AO 模块	6ES7 332-5HF00-0AB0	8 通道模拟输出(40 针)	SIEMENS	3	6,065.00	18,195.00
10	连接端子	6ES7 392-1AJ00-0AA0	20 针，螺钉型端子	SIEMENS	10	149.00	1,490.00
11	连接端子	6ES7 392-1AM00-0AA0	40 针，螺钉型端子	SIEMENS	3	234.00	702.00
12	变频器		MM420 7.5KW	SIEMENS	4	3,600.00	14,400.00
13	变频器操作面板	6SE6 400-0BP00-0AA0	BOP 面板	SIEMENS	4	300.00	1,200.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第51页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

序号	供货范围	订货号	规格 型号	厂家	数量	单价(RMB)	价格(RMB)
Item	Scope of Supply	Order No.	Specification	Manufacturer	Quantity	Unit Price	Price
14	开关电源	6EP1 334-3BA00	SITOP 24V/10A	SIEMENS	1	1,500.00	1,500.00
15	控制柜		2000×800×600(含继电器、端子等柜内电气元件)	shanghai	1	14,000.00	14,000.00
16	上位机电脑		Core 2\1024MB\160G\19"LCD	DELL	1	7,200.00	7,200.00
17	上位机软件	6AV6 381-1BE06-2AV0	WINCC V6.2 RT(1024 点)	SIEMENS	1	32,892.00	32,892.00
18	打印机		A4 激光打印机	HP	1	2,400.00	2,400.00
19	触摸屏	6AV6 643-0CD01-1AX1	MP 277 10" Touch 64K 颜色	SIEMENS	1	12,000.00	12,000.00
20	交换机	6 RJ45 口	工业以太网交换机	MOXA	1	1,200.00	1,200.00
21	编程电缆	6ES7 972-0CB20-0XA0	PLC 编程电缆USB	SIEMENS	1	2,646.00	2,646.00
22	网线						500.00
23	电缆						12,000.00
24	电缆						12,000.00
25	电缆						10,125.00
26	桥架						13,750.00
一、	控制系统所用材料						200,825.00
二、	编程费 Programme Cost（1 人30 个工作日）						35,000.00
三、	安装费用（3人10 个工作日）						40,000.00
四、	调试费 Commissioning Cost（2 人10 个工作日，含住宿交通等）						275,825.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第52页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

3.2.5. 罐体清单说明

Configuration list for Bank

Configuration list for PW Bank 纯化水储罐配置清单
Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity  数量	Manufacturer 供应商	Remarks  备注
1	纯化水储罐	10m3,常压容器,卧式,	316L	1	RiTai	内部抛光Ra<0 .5um，外部亚光处理Ra<0.8um
2	呼吸器	10" 0.22um	316L	1	PALL
3	喷淋球	DN40	316L	3	Alfa Laval	固定式
4	液位计	4-20 mA output		1	E+H	电容式
5	温度变送器	DN40,4-20 mA output		1	CHINA	卡接
6	压力传感器	DN40,4-20 mA output		1	CHINA	卡接
7	气动球阀	DN40	316L	1	King Lai
8	气动球阀	DN20	316L	3	King Lai
9	气动隔膜阀	DN40	316L	1	GEMU
10	隔膜阀	DN15	316L	1	GEMU
11	减压阀	DN20		1	中国

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第53页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Remarks 备注
12	疏水器	DN20(浮球式)	碳钢	1	Spirax Sarco
13	卡接头	DN40	316L	3	Alfa Laval	ISO 2037
14	卡接头	DN19	316L	8	Alfa Laval	ISO 2037
15	卡环	DN40	304	6	Alfa Laval	ISO 2037
16	卡环	DN19	304	10	Alfa Laval	ISO 2037
17	密封圈	DN40	PTFE	6	Alfa Laval	ISO 2037
18	密封圈	DN19	PTFE	10	Alfa Laval	ISO 2037
19	变径三通	DN38/19	316L	4	Alfa Laval	ISO 2037
20	三通	DN19	316L	2	Alfa Laval	ISO 2037
	以上为纯化水储罐配置清单

Configuration list for WFI Bank 注射水储罐清单及报价
Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Remarks 备注
1	注射水储罐	10m3,压力容器,卧式,保温	316L	1	RiTai	内部抛光Ra<0 .5um，外部亚光处理Ra<0.8um
2	呼吸器	10“ 0.22um	316L	1	PALL

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第54页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Remarks 备注
3	电加热套			1	CHINA
4	喷淋球	DN50	316L	1	Alfa Laval	固定式
5	喷淋球	DN40	316L	2	Alfa Laval	固定式
6	液位计	4-20 mA output	316L	1	E+H	电容式
7	压力传感器	DN40,4-20 mA output	316L	1	CHINA	卡接
8	温度变送器	DN40,4-20 mA output	316L	2	CHINA	卡接
9	爆破片	0.5-4bar	316L	1	FIKE
10	疏水器	DN20(浮球式)	碳钢	1	Spirax Sarco
11	气动球阀	DN40	316L	1	King Lai
12	气动球阀	DN20	316L	1	King Lai
13	球阀	DN20	316L	1	King Lai
14	气动隔膜阀	DN40	316L	1	GEMU
15	隔膜阀	DN15	316L	1	GEMU
16	减压阀	DN20		1	中国
17	卡接头	DN40	316L	3	NEUMO	ASME BPE-EP
18	卡接头	DN19	316L	8	NEUMO	ASME BPE-EP
19	卡环	DN40	304	6	NEUMO	ASME BPE-EP

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第55页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

Item 序号	Supply Scope 供货范围	Specification 规格	Material 材料	Quantity 数量	Manufacturer 供应商	Remarks 备注
20	卡环	DN19	304	6	NEUMO	ASME BPE-EP
21	密封圈	DN40	PTFE	6	NEUMO	ASME BPE-EP
22	密封圈	DN19	PTFE	6	NEUMO	ASME BPE-EP
23	变径三通	DN38/19	316L	2	NEUMO	ASME BPE-EP
24	三通	DN19	316L	1	NEUMO	ASME BPE-EP
	以上为注射用水储罐配置清单

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第56页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

3.2.6. 焊点费

Welding Point Cost

Item 序号	Supply Scope 供货范围	Location 位置		Quantity 数量	Unit Price 单位价格(RMB)	Total Price 总价(RMB)
1	纯化水系统		自动焊点	729	150.00	109,350.00
2	注射用水系统		自动焊点	899	150.00	134,850.00
3	纯蒸汽系统		自动焊点	716	150.00	107,400.00
					总价（元）	351,600.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第57页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

3.2.7. 管道保温价格清单

Insulation Price List

		洁净室内保温管套管保温			非洁净室保温
		Clean Area Piping Insulation			Non-clean Area Piping Insulation
		Pipe-in-Pipe Asbestos Insulated			Stainless Steel Jacket Asbestos Insulated
		数量（m）	单价	合计	数量（m）	单价	合计
1	WFI 管道	90	350.00	31500.00	630	100.00	63000.00
2	PS 管道	60	350.00	21000.00	320	100.00	32000.00
		共计Total：		52500.00	共计Total：		95000.00
					合计（元）		147500.00

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第58页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

3.2.8. 系统所用辅材数量清单

Accessories List

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第59页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmaceutical Steam storage and Distributions System
	投标文件 Bidding Documents	第 1 部分 投价书 Tender

3.2.9. 验证服务报价

Quotation For Validation Activities

序号 No.	验证项目Scope		报价Quotation(RMB)
1	纯化水储存和分配系统 PW storage and distribution system	DQ，TM,RA	20,000
2		FAT,SAT	15,000
3		IQ	15,000
4		OQ	25,000
4		PQ 方案 PQ protocol	10,000
6	注射用水储存和分配系统 WFI storage and distribution system	DQ，TM,RA	20,000
7		FAT,SAT	10,000
8		IQ	15,000
9		OQ	25,000
9		PQ 方案 PQ protocol	10,000
11	纯蒸汽分配系统 Pure steam distribution system	DQ，TM,RA	10,000
12		FAT,SAT	10,000
13		IQ，OQ	20,000
14		PQ 方案 PQ protocol	10,000
11	控制系统 Automatic control system	控制系统验证 Validation of control system	100,000
15	总价		315,000
Remarks 备注：
1) 包含本报价服务范围内的朗脉验证人员在客户现场的差旅食宿费用。 The cost of trips and living in client site are included in above price。
2) 包含验证仪器费用。 The fee of validation instruments are included in above price.。
3) 验证不包括系统中仪表和传感器的校准工作。 The calibration work for instruments and sensors in the systems is not validation work。
4) 本报价有效期：3 个月内。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第60页/共60 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

第 2 部分

Part 2

公司介绍及资质文件

Company introduction and Certificate

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

上海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室     201100

T:021 54306717     F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

目录 Index

1. 资质证明文件 Certificate	3
1.1. 资质证书 Certificate	3
1.1.1. 营业执照复印件 Business license	3
1.1.2. 组织机构代码证 Organization code certificate	4
1.1.3. 税务登记证 Business Registration	5
1.1.4. 银行开户证明 The opening of bank accounts permits	6
1.1.5. 代理证书 Agency	7
1.1.6. 协会证书 CAPE Certificate	13
1.2. 部分业绩 Part reference	14
1.2.1. 部分竣工项目一览表 Part finished project List	14
1.2.2. 部分在建同类工程一览表 Part constructing project List	19
1.3. 2007 年财务报表 Financial statement	20
2. 公司介绍 Company Introduction	21
2.1. 公司概述 Brief introduction	21
2.1.1. 公司实力 Strength	21
2.1.2. 公司历史 History	25
2.1.3. 公司文化 Corporate cuture	26
2.1.4. 公司组织结构 Organize chart	28
2.2. 朗脉的服务Service	29
2.2.1. 专业领域服务 Professional service	29
2.2.2. 工程总承包 Contractor	32
2.2.3. 植物提取工艺优化 Process optimization	33
2.2.4. 自动化控制系统业务 Automation Control system	34
2.2.5. 过程控制系统 Process Flow	35
2.2.6. 空调自控系统 HVAC automation system	36
2.2.7. 在线清洗系统 Clean in place	38

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.3. 洁净管道系统业务Sanitary piping system business	39
2.3.1. 完善的工艺设计Perfect in process design	39
2.3.2. 材料选型及采购Material Selection and Procurement	41
2.3.3. 齐全的施工设备Construction facility	42
2.3.4. 现场管理及现场施工Project management and construction	44
2.3.5. 先进的检测设备Testing equipment	45
2.3.6. 系统调试和人员培训Training and system commission	45
2.3.7. 验证服务Validation service	46

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1. 资质证明文件 Certificate

1.1. 资质证书 Certificate

1.1.1. 营业执照复印件 Business license

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第3页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.1.2. 组织机构代码证 Organization code certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第4页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.1.3. 税务登记证 Business Registration

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第5页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.1.4. 银行开户证明 The opening of bank accounts permits

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第6页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.1.5. 代理证书Agency

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第7页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第8页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第9页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第10页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第11页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第12页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.1.6. 协会证书 CAPE Certificate

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第13页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.2. 部分业绩 Part reference

1.2.1. 部分竣工项目一览表 Part finished project List

序号	客户名称	地点	项目概况	认证情况
1	北京凯因生物技术有限公司	北京	纯水/注射用水/纯蒸气分配系统/干扰素发酵物料管道转运系统和空 调自控（工艺管道）
2	北京万泰制药有限公司	北京	纯水/注射用水/纯蒸汽/物料分配系统
3	北京三元基因工程有限公司	北京	纯水/注射用水/纯蒸汽/物料分配系统
4	常州四药有限公司	常州	注射用水/纯化水管道分配系统	依照FDA cGMP 规范，提供IQ/OQ 文件
5	河北恒利药业有限公司	河北	CIP 系统
6	成都普仕医塑公司	成都	纯水/注射用水/纯蒸汽及物料管道分配系统
7	扬子江药业集团广州海瑞药业有限公司	广州	纯蒸汽/纯水/注射用水/物料分配管道系统
8	齐鲁海南药业有限公司	海南	纯蒸汽/注射用水/纯水以及工艺管道系统
9	杭州天元生物制药有限公司	杭州	注射用水/纯蒸汽/纯化水/洁净压缩空气/氮气等工艺管道系统	依照FDA cGMP 规范，提供IQ/OQ 文件
10	杭州九源基因工程有限公司	杭州	纯蒸汽/注射用水/纯水以及工艺管道系统和空调自控	依照FDA cGMP 规范，提供IQ/OQ 文件

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第14页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

序号	客户名称	地点	项目概况	认证情况
11	上海博莱科信谊制药有限公司	上海	(蒸馏水生产装置MS304S，纯蒸汽生产装置PSG500DTS，纯水& 蒸馏水&纯蒸汽分配系统)	依照FDA cGMP 规范，提供IQ/OQ 文件
12	齐鲁安替比奥制药有限公司	济南	纯水& 注射用水分配系统/ 发酵物料转运管道系统（二期）	无菌原料药已通过欧盟认证
13	齐鲁制药厂	济南	纯水/注射用水/纯蒸汽/物料分配系统
14	齐鲁安替比奥制药有限公司	济南	注射用水/纯化水/纯蒸汽管道分配系统
15	齐鲁天和惠世制药有限公司	济南	注射用水/纯化水/纯蒸汽管道分配系统
16	山东鲁抗辰欣药业有限公司	济宁	注射用水/纯化水/纯蒸汽管道分配系统和空调自控
17	山东鲁抗立科制药有限公司	济宁	注射用水/纯化水/纯蒸汽管道分配系统和空调自控
18	浙江耐斯康制药有限公司	金华	注射用水/纯蒸汽/纯化水分配系统改造项目	依照FDA cGMP 规范，提供IQ/OQ 文件
19	扬子江药业集团南京海陵药业有限公司	南京	纯蒸汽,注射用水分配系统工艺管道工程
20	宝利化（南京）制药有限公司	南京	注射用水/纯化水管道分配系统	无菌注射剂已通过TGA 认证
21	青岛生化制药有限公司	青岛	纯蒸汽/纯水/注射用水/压缩空气分配系统
22	GE Healthcare	上海	纯蒸汽/注射用水工艺管道工程	无菌注射剂已通过FDA 认证

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第15页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

序号	客户名称	地点	项目概况	认证情况
23	石药集团中润制药有限公司	石家庄	注射用水/纯化水/纯蒸汽及物料分配系统
24	上海天士力药业有限公司	上海	纯蒸汽/注射用水分配系统工艺管道工程
25	上海百特医疗用品有限公司	上海	纯水/注射用水/配液分配系统
26	上海惠生生物工程有限公司	上海	纯水/注射用水/纯蒸汽管道分配系统
27	上海迪赛诺制药有限公司	上海	注射用水/纯化水管道分配系统	符合WHO 规范
28	上海惠生生物工程有限公司	上海	抗体实验室纯化水分配系统（二期）
29	上海莱士血液制品股份有限公司	上海	注射用水分配系统过热水灭菌系统改造项目	依照FDA cGMP 规范，提供IQ/OQ 文件
30	深圳海王英特龙生物科技有限责任公司	深圳	纯蒸汽/注射用水/纯水系统工艺管道系统	依照FDA cGMP 规范，提供IQ/OQ 文件
31	华北制药奥奇德有限公司	石家庄	纯水/注射用水/纯蒸气分配系统/干扰素发酵物料管道转运系统
32	华北制药华胜有限公司	石家庄	纯蒸汽/注射用水/纯水系统及物料工艺管道分配系统
33	华北制药集团北元有限公司	石家庄	注射用水，纯化水，纯蒸汽分配系统改造项目	依照FDA cGMP 规范，
34	石家庄欧意制药有限公司	石家庄	纯化水分配系统改造项目	依照FDA cGMP 规范，

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第16页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

序号	客户名称	地点	项目概况	认证情况
35	无锡台裕制药有限公司	无锡	注射用水/纯化水/纯蒸汽系统及物料分配管道系统
36	厦门北大之路药业有限公司	厦门	注射用水/纯化水纯蒸汽系统及物料分配管道系统
37	苏州东瑞药业有限公司	苏州	纯蒸汽/注射用水/纯水系统及物料工艺管道分配系统	依照FDA cGMP 规范，提供IQ/OQ 文件
38	贝朗医疗（苏州）有限公司	苏州	纯水/注射用水/配液分配系统
39	苏州东瑞制药有限公司	苏州	104 车间物料系统改造	依照FDA cGMP 规范，提供IQ/OQ 文件
40	苏州东瑞制药有限公司	苏州	原料车间物料系统改造	依照FDA cGMP 规范，提供IQ/OQ 文件
41	贝朗医疗（苏州）有限公司	苏州	注射用水系统改造项目
42	扬子江药业集团有限公司	泰州	纯蒸汽,注射用水分配系统工艺管道工程
43	天津天士力药业有限公司	天津	纯蒸汽/纯水/蒸馏水/压缩空气分配系统
44	天津百特医疗用品有限公司	天津	纯蒸汽/注射用水分配系统工艺管道工程
45	天津天士力药业有限公司	天津	实验室纯水管道系统
46	通化东宝药业	通化	(蒸馏水生产装置MS3005S， 纯蒸汽生产装置PSG500DTS， 纯水& 蒸馏水&纯蒸汽分配系统， 大输液配制系统)

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第17页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

序号	客户名称	地点	项目概况	认证情况
47	香港美达制药有限公司	香港	纯水分配系统
48	厦门科兴生物制品有限公司	厦门	(预处理，二级反渗透,蒸馏水生产装置MS504S， 纯蒸汽生产装置PSG500DTS ，纯水&蒸馏水&纯蒸汽分配系统)
49	劲牌有限公司	湖北	保健酒仪表、计量控制系统
50	贝朗医疗(苏州)有限公司	苏州	改造公用洁净设施工程

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第18页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.2.2. 部分在建同类工程一览表 Part constructing project List

序号	客户名称	地点	项目概况	认证情况
1	成都生物制品所	成都	洁净室配套公用工程系统	符合WHO 标准
2	株洲千金药业有限公司	湖南	煮提、浓缩自控总包项目
3	浙江普洛康裕药业有限公司	浙江	冻干粉针洁净管道和配料系统工程合同
4	赣州菊隆高科技食品有限公司	江西	萃取、提纯车间自控系统工程项目合同
5	山东先声麦得津生物制药有限公司	山东	工艺管道安装工程项目
6	成都生物制品所	成都	乙脑疫苗车间改造	符合WHO 标准
7	成都生物制品所	成都	病毒疫苗车间PW/WFI/PS 系统
8	杭州中美华东制药有限公司	杭州	冻干粉针201 车间洁净工艺管道系统工程
9	苏州东瑞制药有限公司	苏州	103 车间洁净管道系统改造
10	江苏正大丰海制药有限公司	江苏	输液车间注射水及物料洁净管道系统

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第19页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

1.3. 2007 年财务报表Financial statement

针对本招标文件，公司提供2007 年度财务审计报告复印件作为参考。

We provided the copy of 2007 financial statement as reference for the project bidding requirement.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第20页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2. 公司介绍 Company Introduction

2.1. 公司概述 Brief introduction

2.1.1. 公司实力 Strength

公司上海朗脉科技有限公司由上海双赢洁净科技有限公司和上海朗和系统集成有限公司整合重组而成，公司注册资金一千万，现有员工一百多人。我们致力于成为中国最好的制药工程专业提供商。

Shanghai Macroprocess Co., Ltd. was founded by integrating Shanghai WinWin Process System Co., Ltd. and Shanghai Longhorn System Integration Co., Ltd. We have over one hundred employee with RMB 10 million pay up capital. We are committed to become a leading supplier for the total solution in pharmaceutical industry.

“朗脉” 本着 “以人为本、技术为核心” 的原则，聘请多位国内外技术专家，经过长期发展，打造了一支经验丰富的设计、安装、调试及验证的专业队伍。我们为您的药厂建设提供专业的概念设计 、详细设计、工艺设备、洁净管道、暖通空调系统、洁净室系统、自动化系统、采购管理、施工管理、安装调试、验证等一体化服务。

Following the principle “putting employee first, setting technology as core”, Macroprocess has accomplished an experienced professional team made up of experts on design , installation and validation by recuiting many technical experts both from home and abroad after a long-time development. We can provide your pharmaceutical factory contruction with integrated services, including professional conceptual design, detailed design , process equipments , sanitary pipelines , HVAC system, cleanroom system, automation system , procurement management, construction management, installation with commissioning , validation and etc.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第21页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

“朗脉” 的客户涵盖了许多国内外知名的制药企业，其中已有多家客户通过FDA 、EME A、TGA 等国外认证，并建立了良好的长期合作关系。

Macroprocess has served many famous pharmaceutical enterprises both from home and abroad, of which many enterprises have passed foreign validation ( USA FDA, EU EMEA, Australian TGA and etc.) We are maintaining excellent cooperative relationship with our clients.

目前我们用户中已经通过国外验证的有some of our clients have gained International certification：

♦ GE Healthcare 通用医疗（上海）药业有限公司是美国GE 通用的独资企业，是目前为止国内唯一一家无菌小容量注射剂通过美国FDA 认证的制药企业；GE Healthcare Located in Shanghai City , Sterility injection was certified by USA FDA and also this is the only one which approvaled in China.

♦ 山东齐鲁安替比奥制药有限公司是意大利安替比奥公司与齐鲁制药有限公司的合资企业，是国内第一家无菌原料药（相当于注射剂）通过欧盟EMEA 认证的制药企业；Qilu Antibiotics Pharmaceutical Co., Ltd. is the joint venture company of Italy Antibiotics and Qilu pharmceutical company, it is the first one of China which Sterile API was certified by EU EMEA.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第22页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

♦ Polifarma 宝利化（南京）制药有限公司是意大利Polifarma 公司控股的企业，无菌制剂以及口服固体制剂于2007 年通过了澳大利亚TGA 认证。Polifarma (Nanjing) Co. Ltd. is a holding company of Italy Polifarma, Sterile injection was certified by TGA in 2007.

我公司在生物制药领域的部分客户有as the following there are some reference in bio pharmaceutical domain：

♦ 北京凯因生物技术有限公司作为病毒生物技术国家工程研究中心，是由中国疾病预防控制中心病毒所和大连国际合作（集团）股份有限公司共同投资建立，我公司多次承接其洁净管道系统安装工程；Kawin Technology's core R&D organization – National Engineering Research Center for Viral Bio-Technology (NERC) was established with the approval & support of National Development and Reform Commission. Beijing Kawin Technology Share-Holding Co., Ltd. (Kawin Technology) was invested by Beijing Kawin Bio-Tech Co., Ltd. We cooperation in piping system many times.

♦ 成都生物制品研究所作为我国西南六省、市、自治区计划免疫协作中心，是中国最大的生物制品研究、生产基地之一，我公司先后承接乙脑疫苗车间水系统、病毒性疫苗项目水系统、洁净室配套公用工程系统等多个符合GMP 标准的工程；  The Chengdu Institute of Biological Products (CDIBP), part of the China National Biotec Corporation, is one of the largest research and manufacturing bases for biological products in China.And we are participated in some sanitary piping system with GMP standard.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第23页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

♦ 浙江天元生物药业股份有限公司是中国国内规模最大的流感疫苗生产企业之一。所有的生产车间都通过国家药监局的GMP 认证。我公司先后承接其疫苗车间的洁净管道施工安装项目，按照WHO 的标准实施项目。Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. is one of China's largest private manufacturers of influenza vaccine. All manufacturing lines of Tianyuan have been granted with cGMP certificates from the State Food and Drug Administration (SFDA) of China. Our company carried on some sanitary piping system project in bacterin factory with WHO standard.

“朗脉” 以 “专业成就未来”为使命，打造中国真正意义上的制药领域的专业工程公司，不断增强公司的核心竞争力，推动更多的本土药厂走向世界。

With the mission that “expertise for future”, Macroprocess is committed to become a Chinese professional engineering company that can bring more and more local pharmaceutical companies to the world by continuously improving core competiton capability in pharmaceutical industry.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第24页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.1.2. 公司历史History

♦ 上海双赢洁净科技有限公司成立。Shanghai WinWin Process System Co., Ltd was founded

♦ 上海双赢洁净科技有限公司与意大利STILMAS 建立合作关系。Shanghai WinWin Process System Co., Ltd commenced business relationships with Italian STILMAS.

♦ 上海朗和系统集成有限公司成立，进入到中药现代化领域。Shanghai Longhorn System Integration Co., Ltd was founded with the entry into TCM modernization field.

♦ 上海双赢洁净科技有限公司将国际化的验证概念融入项目实施。WinWin brought the international validation concept into project execution.

♦ 聘请国外资深工艺及验证专家。International experienced process and validation experts were recruited.

♦ “朗脉”的多名技术成员成为国际制药工程协会(ISPE )会员。Several Macroprocess engineers are members of ISPE

♦ 融合工艺、管道、自控、HVAC 及洁净室系统、验证等各专业，成立技术中心。A technical center was operated with integration of process, piping, automation, HVAC and validation sections.

♦ 双赢与朗和整合，成立上海朗脉科技有限公司。WINWIN and LONGHORN were intergrated into MACROPROCESS.

♦ “朗脉”与国外公司合作开发了连续式真空带式干燥机。Macroprocess invented Vacuum belt dryer with cooperation with foreign enterprises.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第25页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.1.3. 公司文化 Corporate cuture

● 朗脉的愿景The Vision of MACROPROCESS：

我们致力于成为中国最好的制药工程专业提供商。

We are committed to become a leading supplier for the total solution in pharmaceutical industry.

● 朗脉的使命 Mission of Macroprocess：

专业成就未来！Experitise for future!

● 朗脉的核心价值观 Core values of Macroprocess：

合作、创新、负责、分享

Collaboration, Innovation, Responsibility and Sharing.

● 朗脉的核心竞争力 Core Competitiveness of Macroprocess：

♦ 朗脉的专业能力将永远是我们引以为荣的核心竞争力Expertise of Macroprocess is always our core competitiveness；

♦ 因为我们专业，完成了一个又一个的高标准项目Owing to our expertise, we have successfully completed a large number of high-standard projects；

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第26页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

♦ 因为我们专业，建立了与客户的长久合作关系 Owing to our expertise, we have built long-term cooperation relationship with our clients;

♦ 专业，成就朗脉的未来，也将成就朗脉伙伴的未来 Our expertise is creating the future for both MACROPROCESS and our clients！

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第27页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.1.4. 公司组织结构 Organize chart

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第28页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.2. 朗脉的服务 Service

2.2.1. 专业领域服务 Professional service

“朗脉”在引进吸收国际先进项目管理理念的基础上，经过多年积累，建立了完善的项目管理体系，对工程整个周期进行全方位的管理，最大限度提高项目的成功率，降低过程控制的成本，规避项目风险。

With the introduction of advanced international project management ideology and many years’ experiences, Macroprocess has established a perfect project management system to conduct all-round management to the entire cycle of project. This system can facilitate project success , cost reduction and risk avoidance.

“朗脉”真诚的为您提供以下各专业服务Macroprocess can offer the following professional service：

● 洁净管道系统 Sanitary piping system

♦ 配料系统 Formulation system：

● 小容量注射剂配料及输送系统 SVP formulation and distribution system

● 大输液配料及输送系统 LVP formulation and distribution system

● 冻干制剂配料及输送系统 Lyophilized product formulation and distribution system

● 生物工程、血液制品等配料及输送系统 preparation and distribution system for bioengineering and blood products

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第29页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

● 无菌原料药生产工艺系统等 Sterile raw material production process system etc.

♦ 工艺用水、汽系统 Process used water and steam system：

● 纯化水系统、注射用水系统、纯蒸汽系统等 Purified water system, water for injection system and pure steam system etc.

♦ 洁净气体（空气、氮气等）输送系统Clean gas( air/nitrogen etc.) delivering system

♦ CIP 在线清洗工作站及系统CIP（Clean In Place）work stations and systems

♦ SIP 在线消毒工作站及系统SIP（Sterilization-in-Place）work stations and systems

● 自动化系统 Automation control system

♦ 工艺过程自动化控制系统 Automation control system of process procedure

♦ 洁净室空调自动化控制系统 HVAC automation system

● 洁净厂房系统 Clean room system

♦  洁净厂房系统的设计、安装、调试及验证（中国GMP、欧盟EMEA 及美国FDA 等） 。Professional design , installation, commissioning and validation (Chinese GMP, EMEA, FDA , etc.) of clean room system.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第30页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

● 验证服务Validation services

“朗脉”专门的验证部门为您研究全球的认证规范，涉及FDA 、EMEA 、T GA、WHO 等。我们熟悉验证的重要性和复杂性，为顾客提供切实有效的验证服务，确保项目符合国内外GMP 法规要求。我们提供以下专业验证服务    Macroprocess Validation department can provide world class validation service, such as cGMP of SFDA, FDA, EMEA, TGA, WHO and etc. With great familiarity and complexity of validtion, we can provide pragmatic and effective validation services to ensure the uniformity of your project with GMP standards. We can provide the following professional validation services：

♦ 编写验证主计划 Writing of VMP (Validation Master Plan)

♦ 设计cGMP 审核 Design cGMP Review

编写 URS Writing of URS

♦ HVAC 系统和洁净室的验证 Validation of HVAC system and Cleanroom

♦ 水系统、纯蒸汽和压缩空气系统的验证 Validation of Water system, Pure steam and compressed air system

♦ 灭菌设备的性能确认 PQ of Sterilization equipments

♦ 关键工艺设备的验证指导 Guiding of Critical Process Equipments Validation

♦ 清洗验证的指导 Guiding of Cleaning Validation

♦ 工艺验证的指导 Guiding of Process Validation

♦ 计算机系统的验证 Computer System Validation

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第31页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

♦ 验证培训 Validation Training

2.2.2. 工程总承包 Contractor

对于任何一个项目，工程设计、安装调试、投资控制、工期控制和质量控制以及环保健康和安全管理等对于投资商的利益和发展都是至关重要。“朗脉”提供的专业化工程服务最大限度地避免了工程建设的风险，给投资方带来最大的经济效益。

For any project, the key to the benefit and development of investors are engineering design, installation and commissioning, investment control, project period control, quality control, environment protection, safety and security managemnt. Besides, GMP inspection consultation and validation services also play a special role in pharmaceutical factory project. Professional engineering services that offered by Macroprocess maximize the project risk avoidance and the benefit.

“朗脉” 通过采用国际通用的工程总承包（EPC）模式，将 “朗脉” 自身的各子专业服务整合及与国际知名的工程公司合作，为您的药厂建设提供符合国际GMP 规范的概念设计 、详细设计、工艺设备、洁净管道、暖通空调系统、洁净室系统、自动化系统、采购管理、施工管理、安装调试、验证等一体化整体解决方案。

Through adoption of EPC formula, integration of different specialties and cooperation with international famous engineering companies, Macroprocess can provide integrated total solution ,including conceptual design, detailed design, process equipments, sanitary piping , HVAC, cleanroom system, automation system , procurement management, construction management, installation, commissioning and validation etc. which are in conformity with international cGMP for pharmaceutical factory construction.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第32页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.2.3.植物提取工艺优化 Process optimization “朗脉” 致力于植物提取工艺的优化及中药现代化。

we are committed to process optimization of plant extraction and TCM modernization

● 植物提取工艺优化 Optimization of Plant extraction

我们提供植物提取生产线的工艺设计优化、工艺成套设备、管道安装及自动化集成等专业服务。

We can provide process optimization for plant extraction production line, process equipment, piping installation and integration of automation control and etc.

● VBD 系列全自动连续式真空带式干燥机VBD series --fully automatic continuous vaccum band-type dryer “朗脉”在引进消化国外先进技术基础上,研制开发的一种全新概念的高效

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第33页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

节能、环保型干燥设备。彻底解决了其它干燥设备难以解决的高粘度、高脂、高糖、高热敏性等物料的干燥。

Based on the introduction of foreign advanced technology , Macroprocess has developed this kind of new drying machine of high efficiency and ecological characteristics which can thoroughly solve the problem of drying substances of high vicosity, high fat, high sugar content and heat sensitivity etc. that other drying machines cannot overcome.

2.2.4.自动化控制系统业务Automation Control system

制药及相近行业自动化系统的设计、安装、调试及验证（中国GMP、欧盟EMEA 及美国FDA 的cGMP）的工程是上海朗脉科技有限公司主营业务之一。

Professional design, installation and validation (Chinese GMP,EU EMEA and USA FDA ) of automation systems for the pharmaceutical and relevant industry fields is one of Macroprocess Technology’s core business.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第34页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

“朗脉科技” 本着 “以技术为核心” 的原则，聘用多位国内外技术专家，经过长期发展，造就了一批经验丰富的设计、安装、调试及验证的专业团队。

In line with the principle “take the technology as the core”, we recruits lots of domestic and foreign technical experts. After the extensive experience we have cultivated and accomplished a group of specialized experts in design, installation and validation for domestic and foreign projects.

2.2.5. 过程控制系统Process Flow

在工业生产中，各单元操作集合而成的生产流程，例如：提取、发酵、合成、萃取、过滤、配料、浓缩、精馏、沉淀、结晶、干燥等，实现生产过程的自动化，并且可以大大提高生产效率，减少人为差错，保证产品质量，降低生产成本，提高生产质量管理水品，为企业现代化和信息化管理搭建数据平台。

In pharmaceutical factory，the process flow integrated by each unit operation, i.e. extraction, fermentation, chemosynthesis, filtration, preparation, concentration, distillation, deposition, crystallization, drying and so on, and the process flow with automation could maximize production efficiency, reduce human error, ensure product quality, reduce production cost, advance the quality management level, set up the data platform for company modernization and informationization.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第35页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

● 工艺状态的实时监控管理

● Real time supervision of process situation

● 过程整定使控制过程更加完美

● Optimizing control process

● 简单友好的操作界面，操作方便

● Friendly interface, more convenient for operation

● 过程参数在线检测、实时显示并记录存档Process parameters can be measured online, displaying in real time, recorded and saved.

● 实时在线分析、在线解决问题和历史查询Easy for online analysis, trouble shooting and searching history.

● 加强生产数据管理，保证产品质量Enhancement for production data management to ensure product quality. 2.2.6. 空调自控系统HVAC automation system

2.2.6. 空调自控系统HVAC automation system

上海朗脉科技有限公司拥有自己的洁净室项目实施管理团队，对制药厂房实 施项目实施。

Macroprocess has own team to manage clean room project, and to proceed the project for whole pharmaceutical facotory.

朗脉公司采用国际先进的板材保证洁净厂房的质量，采用先进的HVAC 系统，尤其对HVAC 系统进行自动化控制和门禁一卡通系统，实现EMS 管理和空气缓冲的互锁，符合FDA 的要求；对于空气质量要求高的厂房引入文丘里

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第36页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

风阀系统保证压差。

朗脉公司认为一个好的洁净室项目的实施，离不开好的集成化的设计，公 司各个富有施工经验的专业人员利用三维设计对项目进行预演。

We believe that to proceed a HVAC Automation system project without a integrated design, and we will preview the system via 3D software.

空调运行需要用大量的能源，系统在满足生产要求的前提下，实现能耗最 小化、运行效率最高化，可以提高设备运行安全可靠性和使用寿命。

HVAC’s operation needs lot of energy. BA system could minimize consumption, maximize operation efficiency, enhancing the reliaboperation and working life and achieving the process requirements.

系统具有数据记录、查询、报警、打印及趋势曲线图功能，利于管理。

● 可动态图形显示各参数值

● 新风、回风风阀的开度控制

● 过滤网脏堵报警

● 温湿度控制

● 风机变频控制

● 送风与排风风机联锁控制

● Illustrating display of real-time parameters

● Regulation control of the valve for fresh air and return air

● Alarm for filter block

● Temperature control and humidity control

● Inverter control of fan

● Interlock control of inlet air fan and discharge fan

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第37页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

● 自动调整主机、冷却塔运行数量、达到最佳节能目的

● 旁路压差控制

● 故障时备用设备自动切换

● 冷机和泵的缺水保护

● 冷冻站设备的顺序启停控制

● 自动补水控制

● Adjusting the quantity of air conditioning units and cooling towers automatically in operation to save energy

● Bypass pressure control

● Automatic shift of backup machine in case of machine failure

● Protection of chillers and pumps against lack of water.

● Sequence of on-off control for freezing station

● Automatic control of water feeding

BA System has the functions of data logging, search, alarm, printout and trend graph for easy operation.

2.2.7. 在线清洗系统Clean in place

全自动CIP 清洗是指设备（罐体、管道、泵等）及整个生产线在封闭的系 统中，无需人工拆卸便能进行有效的清洗和消毒。系统由酸、碱、热水、纯化 水、注射用水、酸碱配置罐和换热器组成，根据工艺特点设定酸碱浓度、清洗 流程、清洗液温度、清洗时间、保证产品质量，便于QA 工作的自动化和清洗 工作的规范化。

CIP means that the equipment and the whole production line could be efficiently cleaned and sanitized without disassembly in close system. A CIP system is composed by detergents, hot water, purified water, WFI, preparation tank and heat exchanger. Concentration of detergents, clean flow, water temperature and cleaning time can be set according to process specification, which could ensure the product quality, automation of QA affairs and standardization of cleaning.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第38页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

● 可分区同时清洗一个或者两个以上区域，大大缩短CIP 清洗时间，使生产计划合理化，提高生产能力CIP system could clean one or more areas simultaneously. It can reduce time for cleaning, and enhance production capacity.

● 减少工艺用水量、节省清洗剂、减低生产成本CIP system conduces to reduce process water consumption, saving detergent and reducing production cost

● 对清洗过程进行自动检测、显示和控制CIP system conduces to automatic measurement, display and control in cleaning process.

● 形成电子记录，符合GAMP4 和FDA 21 CFR PART 11 的要求CIP system generates electronic record compliance with the requirement of GAMP4 and 21 CFR PART 11

2.3. 洁净管道系统业务Sanitary piping system business

2.3.1. 完善的工艺设计Perfect in process design

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第39页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

对于我们承接的每一个项目，我们的设计团队在公司具有丰富管理施工经验的项目经理的领导下，并充分结合客户的URS 进行详细的优化设计，为客户做出具精确的P&ID 图、平面布局图、乃至施工图。这种优化设计是重要的，也是必须的，精确了材料数量，节省了施工时间，是为客户争取最大利益的保证。

For each project in which we are participated, our project manager in construction; Our design team can provide fully integrated and optimized detailed design according to the URS of our clients, the precise P&ID chart, layout plans, as well as construction plans. This kind of optimized design is a must. The precise amount of material, the organization of time, guarantees to act in the best interests of customers.

对于复杂的工艺管道系统，根据客户的需要和现场实际情况，我们的设计团队可以制作模拟现场的3D 效果图，从而保证了整个系统的精确定位和合理布置。3D 效果图可以衍生出相应的平面图，单管图及材料清单便于控制投资成本及施工周期，大大提高了施工效率和质量，是为提供给客户良好工程的重要保证。

Regarding complex piping systems, the needs of the customers and the actual conditions, our design team can produce 3D simulation of the complete site, thus ensuring the accurate positioning and rational layout of the whole system. The corresponding plan can be developed from the 3D effect chart; singular pipeline plans can facilitate inventory control and materials costs and also the investment in the construction cycle, greatly increasing the efficiency and quality of construction.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第40页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.3.2. 材料选型及采购Material Selection and Procurement

“质量和信誉是企业生存之本”，优质的材料供应商是高质量工程的基石。Quality materials suppliers -- the cornerstone of high-quality works.

采购部门，根据技术部门的提供的参数和要求，为客户选择可靠的供应商及高性价比的产品。通过对供应商的评估、采购数据、所购产品的认证并结合客户的URS 为我们良好的工程提供重要的保证。Procurement departments, according to provided technical parameters and requirements, purchase products from reliable suppliers with high performance. Through vendor evaluation, procurement data, certificate of products and integration with URS provide an important guarantee for our work.

目前“朗脉科技”已经成为国内外许多知名公司的长期合作伙伴，如：After years of development, "Win Win" becomes the long-term partner of many well-known domestic and foreign enterprises:

瑞典：Alfa laval

德国：Gemu、Burker t、E+H、+GF+、Siemens

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第41页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

瑞士：Mettler-Toledo

丹麦：Grundfos

台湾：Kinglai

优质的材料供应商，加上“朗脉科技”先进的优化设计理念、科学的工程管 理、丰富的国内外验证经验，以及科学严谨地规范每一个工作流程；确保您的整个自控系统工程准时、高质量地完成。

Good cooperative relations with suppliers and ensuring their quality plans to ensure that the project completed on time and according to the specified quality of the Client.

2.3.3. 齐全的施工设备Construction facility

我们齐全的施工设备能够承担任何作业。Our organization is fully equipped with hardware to undertake any task.

洁净管道专业切割设备Import cutting machinery specially for pipelines:

● 切割端面平整 Flat cutting surface

● 切割端面无氧化 Non-oxidized cutting surface

● 切割端面无变形 Non-deformed cutting surface

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第42页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

平口机完成专用切割机无法完成的其他任务，如特殊位置用的管件需要修整或对管道的端面进行平整等等。Tube square machine that can complete the mission that special cutting machine can not complete, e.g. special positions and surface in the pipeline which need trimming.

● 全自动轨道焊接设备 World-class automatic orbital welding machinery

● 焊缝内外充氩气保护，无氧化 Welding is argon-protected without being oxidized

● 操作简单、方便 Simple and convenient handling

● 避免人为的焊接缺陷 Manual welding defect can be avoided

所有的焊接点都是经过专业处理，设备与材料具有可追溯型，手动焊接由受过培训的具有职业资格证书的人员操作。All welding joints are professionally treated; all materials and equipments are certified and traceable; Manual welding is accomplished by trained personnel with appropriate qualifications and certification.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第43页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.3.4. 现场管理及现场施工 Project management and construction

项目经理根据公司制定的良好工程规范组建项目组来进行质量管理、设计 变更控制、文件和数据的控制、采购控制、过程控制、检查和测试控制、检测 设备的控制、不合格品的控制、纠正和预防措施、安全防护控制、包装、运输、储存控制、培训以及验证等。

The project manager sets up the project team according to Clients Company for complete project quality management. Control in change of design, document and data control, procurement control, process control, inspection and control testing, testing of equipment control, control of defective products, corrective and preventive measures, security control, packaging, transport, storage control, training, testing and validation is also strictly monitored.

严谨规范的安装队伍是良好工程的保证。Installation team with stringent standards is our Guarantee for good work.

公司富有多年施工经验的施工人员将会按照公司制定的操作规范和客户要求进行施工操作。Our experienced construction staff are rich in experience and they will strictly follow the rules and regulations of operation, and customer requirements.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第44页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

2.3.5. 先进的检测设备Testing equipment

先进的检测设备确保高质量的完成工程安装，公司拥有完善的焊接质量检测系统。Advanced testing equipment ensure the quality of the completed work.and Welding quality examination system as the follow aim:

● 焊缝质量检测 Welded joint quality test

● 焊缝质量评定 Welded joint quality assessment

● 提供焊接质量检测报告表 Provide welding quality inspection reports

为了确保每一个焊缝的焊接质量。公司结合科学的检测手段配备了先进的检测仪表，如X 光烫伤机、内窥镜、钝化检测仪等。To ensure the quality of welding, the company utilises the scientific detection means equippedwith advanced instrumentation, such as the X-ray crack detection machine、Slope meter 、Passivation test and endoscope.

2.3.6. 系统调试和人员培训 Training and system commission

根据包含的系统及其范围，我们将编制详细的调试计划。这个计划将包括范围内的每一个系统和设备的描述，包括自控系统；确定个系统进行调试顺利，及相关前后工序；与项目施工进度结合在一起。

According to the scope and contents of the system, we will establish the detailed commissioning plan. This plan will include descriptions of the scope for each system and equipment, including automatic control system and ensure all systems are commissioned in the correct order, and in their correlation to working procedures.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第45页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

我们确保所有人员的培训是有文件证明的。直到接受培训的人员能胜任他们各自的任务。

We ensure that all staff training is well documented with certification. Until those trained personnel are capable of performing their respective tasks.

所有人员的培训过程是必须可以被记录的。对于所有人员来说，都需要资格、经验和培训的记录。所有室内和室外的记录都将被保存。

All the training process must be documented for easy reference. For all the staffs they are required to acquire qualifications, experience and training records. All training records will be preserved.

2.3.7. 验证服务 Validation service

作为药品生产过程中的关键系统。洁净管道在设计施工中面对的是严格的 规范要求和质量标准。朗脉聘用的是曾经在跨国制药及工程公司服务多年的技术专家，按照国际GMP 规范进行洁净管道系统的验证。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第46页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第2 部分公司介绍及资质文件 Part 2 Company intruduction and Certificate

As one of the critical systems in pharmaceutical production facility, clean piping faces more and more stringent requirement on quality assurance and regulatory compliance. Macroprocess employs experts who have served at multinational pharmaceutical and engineering companies and provide qualification/validation services in accordance with international GMP guidelines.

我们在洁净管道系统方面的验证范围包括 The scope of our qualification service include:

• 系统的风险分析System Risk Analysis

• 确认文件的准备 Preparation of IQ/OQ/PQ protocol

• 确认执行 Execution of IQ/OQ/PQ

• 验证报告的编制 Final Qualification Report

• 现有系统的差距分析及整改建议 Gap analysis on existing system and recommendations on retrofits

• 回顾性验证 Retrospective Validation

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第47页/ 共47 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第 3 部分 技术及控制方案 Technical and control system proposal

第 3 部分

Part 3

技术及控制方案

Technical and control system proposal

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

上海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

T:021 54306717      F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第 3 部分 技术及控制方案 Technical and control system

目 录

1. 技术方案 Technical	3
1.1. 项目背景 Project Background	3
1.2. 管道系统设计标准和规范 Design Standards	6
1.3. 施工规范和法规 Construction Regulations and Guidance	9
1.3.1. GMP 法规 GMP regulations	9
1.3.2. ISPE 指南	10
1.3.3. 工艺管道标准 Process pipe system standards	11
1.4. 生产工艺描述 Process Description	11
1.4.1. 概要 General	11
1.4.2. 纯化水的储存和分配系统 PW Storage and Distribution	12
1.4.3. 注射用水储存分配系统 WFI storage and distribution	17
1.4.4. 纯蒸汽分配系统 Pure Steam Distribution	24
2. 控制方案 Technical	25
2.1. 项目配置 Project Configuration	25
2.1.1. 系统拓扑结构 Topological Structure of System	25
2.1.2. 现场仪表层 The Scene Instrument Layer	27
2.1.3. 过程控制层 Process Control Layer	28
2.1.4. 数据监控层 Datamonitor Layer	30

2.2. 注射用水控制系统 WFI Supply Control System	45
2.2.1. 系统功能描述 Function to Control System	46
2.2.2. 主要控制回路 The Main Loop of Control System	47
2.2.3. 联锁逻辑 Logic Diagram of Interlock	48
2.2.4. 关键控制点 The Critical Control Point	54

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

23. 纯化水控制系统 PW Supply Control System	54
2.3.1. 系统功能描述 Function to Control System Description	54
2.3.2. 主要控制回路 The main loop of Control System	56
2.3.3. 联锁逻辑 Logic Diagram of Interlock	57

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

1. 技术方案 Technical

1.1. 项目背景 Project Background

沈阳三生制药有限责任公司是集生物药品的研发、生产和销售一体化的高新技术企业。公司的生产基地位于沈阳经济技术开发区，生产车间面积3000 平方米，通过了国家GMP 认证。公司计划建设新的厂房，提高生产能力，来满足日益增长的市场需求

Shenyang Sunshine Pharmaceutical Company Limited (SUNSHINE) is an integrated biopharmaceutical company engaged in research/development, manufacture and marketing/sales of biopharmaceutical products in China. Its clinical and commercial manufacturing operations are based in Shenyang, China, where Chinese current Good Manufacturing Practice, or cGMP, certified, 3,000 square meters, and state-of-the-art facility resides. SUNSHINE plan to expand the plant in Shenyang to increase the manufacturing capacity and take further advantage of his favorable cost structure.

本次项目为沈阳三生制药有限责任公司的新建车间纯化水、注射用水、纯蒸汽的洁净管道储存及分配系统的设计、材料、安装、检查和测试、调试、文件和交付。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第3页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

This project is invited tender for design, supply & install of distribution loops for new plant of SUNSHINE Company. And The distribution loops is for purified water & WFI and PS . this is a turnkey project.

上海朗脉科技有限公司被邀请参加本次洁净管路项目的招标，我们的系统方案以及设计完全按照业主2009 年1 月发布的招标要求以及系统设计要求。

Macroprocess was invited to provide a quotation for the clean piping/utilities systems of this facility. Our proposal is based on SUNSHINE’s tendering specification distributed in January 2009.

本次方案我们提供以下各系统的施工图设计，交货，安装，测试，调试和确认：

Our Scope of Work consists of final detail design, delivery, installation, testing, commissioning and qualification of following packages:

● Purified Water system 纯化水系统

● Water for Injection system 注射用水系统

● Pharmceutical Steam system 纯蒸汽系统

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第4页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

● Related control system 相关的自控系统

● Other related Accessories   其他相关辅助材料系统

各循环系统根据客户的要求进行详细设计，具体详见相关技术描述和PID 图。我们按照 GMP 的要求对贵公司的系统进行验证，此部分验证内容和报价可以参见报价清单说明。

All loop is designed to meet owner's requirement and for details see technical description and PID.and we also provide the quotation on validtion to meet GMP requirement. And this part of validation scope and pricelist please refer to the related section.

公司聘认了国外专家专门从事FD A、WHO、欧盟、TGA 等法规的验证工作。“朗脉”的客户涵盖了许多国内外知名的制药企业，其中已有多家客户通过FDA 、EMEA 、TGA 等国外认证，并建立了良好的长期合作关系。

Macroprocess has accomplished an experienced professional team made up of experts on FDA ,WHO,EMEA,TGA validation by recuiting many technical experts both from home and abroad . Macroprocess has served many famous pharmaceutical enterprises both from home and abroad, of which many enterprises have passed foreign validation ( USA FDA, EU EMEA, Australian TGA and etc.) We are also maintaining excellent cooperative relationship with our clients.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第5页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

1.2. 管道系统设计标准和规范 Design Standards

• According to related national and local government pipeline construction standards and stipulations 根据国家及当地政府管道施工的相关标准及规定

• WHO about Guidelines for Drinking-water Quality

WHO 关于饮用水水质的指南

• WHO about water treatment guide & aqueous system

Examination guide

WHO 关于水处理指南和水系统检测指南

• Drugs production quality control in 1998 amended

药品生产质量管理规范1998 年修订

• ASE BPE 2002 Edition

ASE BPE 2002 年版

• ICH Q7A GMP of Bulk Pharmaceutical Chemicals, November 2000 ICH Q7A 原料药的GMP， 2000 年11 月

• USP-29 2006 Edition

USP-29 2006 年版

• FDA federation laws & regulations related stipulation

FDA 联邦法规有关规定

• European pharmacopoeia

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第6/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

欧洲药典

• According to JBJ23- 96 edition (Code for Construction & acceptance of machinery and equipment installation) 根据JBJ23- 96 版《机械设备安装工程施工及验收规范》

• According to HGJ203-83 edition (Code for Construction & acceptance of chemical machinery installation) 根据HGJ203-83 版 《化工机器安装工程施工及验收规范》

▪ According to GB50236-98 Edition (Code for Construction & acceptance of field equipment installation & industry pipeline welding) 根据GB50236-98 版《现场设备、工业管道焊接工程施工及验收规范》

• According to DL5017-93 Edition (Code for Construction, Manufacturing & acceptance of Pressure Piping) 根据DL5017-93 版 《压力管道制造安装及验收规范》

• According to (Pharmaceutical chemicals overall examination Guide) 根据《医药化学品总体检验指南》

• According to (Code for Drugs production & management) 根据《药品生产管理规范》

• According to (Code for Clean room construction and Acceptance) 根据《洁净室施工及验收规范》

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第7页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

• According to Planning & Design Ordinance of Macroprocess Technology 根据朗脉科技设计条例

• According to PW piping system design & standards of Macroprocess Technology 根据朗脉科技高纯度管道系统的设计标准

• According to Construction requirements for Clean Room & High purified water pipeline system of Macroprocess Technology 根据朗脉科技高纯度管道工程洁净厂房施工守则

• According to guide to Construction safety of Macroprocess Technology 根据朗脉科技安全施工注意事项

• According to Construction procedure for High purified water piping system of Macroprocess Technology 根据朗脉科技高纯度管道系统的施工程序

• According to operational procedure for testing of Macroprocess Technology 根据朗脉科技高纯度管道系统的测试作业程序

• Code & requirements of China, the United States and the European in production of vaccine for Human 用于生产人用疫苗的中国、欧洲和美国的规范和要求

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第8页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

• Laws and regulations for Electric appliance & installation

电器设备和安装的法规

• Laws & regulations for safety standards

安全标准、法典和规范

• According to drawings and relevant requirements of products provided by owner. 根据业主提供的图纸及产品的相关要求

1.3. 施工规范和法规 Construction Regulations and Guidance

本洁净管道系统项目，将按照以下法规和指南进行设计、施工、调试和验证：This project for sanitary piping system will be assured that its design, construction, commissioning and qualification will be in accordance with the following regulations and guidance:

1.3.1. GMP 法规 GMP regulations

a) (SFDA) 药品生产质量管理规范 1998 年修订版

Good Manufacturing Practice, revised in 1998

b) (SFDA) 药品生产质量管理规范附录 1998 年

Annex of GMP, in 1998

c) (FDA) 联邦法规第21 篇第210-211 部分，现行的成品药生产质量管理规范

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第9页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

21 CFR parts 210 and 211, Current Good Manufacturing Practice (cGMP) for finished pharmaceuticals.

d) (FDA) 联邦法规第21 篇第11 部分，电子记录和电子签名

21 CFR part 11, Electronic Records; Electronic Signatures

e) (FDA) 无菌工艺生产的无菌产品的GMP 的行业指南， 2004 年9 月

Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing- Current Good Manufacturing Practice, September 2004

f) (FDA) 高纯水系统的检查指南，1993年7 月

Guide to Inspections of High Purity Water Systems, July 1993

g) (Europe) 欧盟最新的GMP European Current GMP

1.3.2. ISPE 指南

a) ISPE 工程指南卷3：无菌生产厂房设施，2000年6 月

ISPE Baseline Guide Volume 3: Sterile Manufacturing Facilities, June 2000

b) ISPE 工程指南卷4：水和蒸汽系统，2000年12 月

ISPE Baseline Guide Volume 4: Water and Steam System, December 2000

c) ISPE 工程指南卷5：调试和确认，2000年6 月

ISPE Baseline Guide Volume 5: Commissioning and Qualification, June 2000

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第10页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

d) ISPE 工程指南卷6：生物制药，2003年1 月

ISPE Baseline Guide Volume 6: Biopharmaceuticals, January 2003

e) GAMP 5 : 制药生产中的自动化系统验证的良好规范

Good Automated Manufacturing Practice for Validation of Automated Systems in Pharmaceutical Manufacture

1.3.3. 工艺管道标准 Process pipe system standards

a) GB50235-97 工业金属管道工程施工及验收规范

Code for construction and acceptance of industrial metallic piping.

b) ASME BPE-2005 生物工艺设备

Bioprocess equipment

1.4. 生产工艺描述 Process Description

1.4.1. 概要 General

以下技术描述基于UR S（用户需求规格）。我们提供各系统的详细设计包括设备，控制系统，以及各类仪表，并按照标准提供整个系统的设计、安装、交货、调试、验证、培训方案。我们的设计图纸（包括管路平面走向示意图、系统流程图和P&ID’s 等）将作为主要设计依据。另外，我们提供必要的条款，确保整个设计系统符合生产要求。

The following description is based on the URS. Upon award of the bid, we shall carry out detail design of the entire system including equipment, controls, and instrumentation, and use the approved design as guideline for the procurement, delivery, installation, commissioning and qualification of the system. Our design drawings, including Piping and Instrument Diagrams (P&ID's), piping layout and so on, will become the master documents to which and for which the Chengdu Institute’s documents will be modified. We shall provide necessary items to ensure that the overall system performs to meet the process requirements.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第11页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

整个系统的符合中国、WHO、EU和 FDA 的标准。

The sanitary aspects of the system will meet GMP requirements for China, WHO, EU and FDA.

1.4.2.纯化水的储存和分配系统PW Storage and Distribution

     ● 概述 General

纯化水储存和分配系统描述如下：纯化水由纯化水设备制出，并接入到纯化水储罐，储罐作为满足系统要求用水量缓冲所用。纯化水电导率通过在线的电导率仪表检测，如果纯化水电导率高于要求，电导率仪表发出警报信号给PLC， 同时PLC 控制打开在线的两位三通阀门，将不合格水排放，或者进行重新处理。

The PW storage and distribution system will receive PW from the purified water generation system into PW storage tank which will act as a capacity buffer unit to cover the usual demand peaks. The feed PW conductivity is in-line measured by the conductivity meter located in the PW feed line. When the feed PW conductivity is higher than limit, it will flow back to the soft water tank for re-treatment and send alarm signal to the PLC panel. The feed PW flow is controlled via a three-way automatic valve. The feed PW is heated to desired temperature prior to flow to the storage tank.

合格的纯化水储存密闭的不锈钢储罐内，通过分配系统，纯化水供各个

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第12页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

纯化水使用点使用。

The qualified feed PW will be stored in a closed stainless steel tank. From the storage tank, purified water will be circulated around the distribution loop continuously.

用户将手动开启使用点的隔膜阀来使用纯化水。经过使用点后，纯化水经过喷淋球回到纯化水储罐。当回水电导率高于设定值，水将自动被排到下水道并将一个警报信号送至控制面板。这由一个两位三通隔膜阀控制。

User will manually open the diaphragm valve of point of use to use PUW. After serving the user-points, the PW shall return to the purified water storage tank via spray ball. When the return PW conductivity is higher than limit, it will be drained to the sewer and send alarm signal to the control panel. It is controlled via a three-way automatic diaphragm valve.

纯化水的储存和分配系统的加热通过在线的卫生级双壳管式热交换器，热源介质为工业蒸汽。为了保证整个系统微生物含量，在管路长时间没有使用或者一段生产周期之后，一定要对管路进行重新灭菌。通过热交换器对纯化水加热至80° C，在灭菌过程中，热交换器将循环的纯化水持续加热至80°C，并在80°C 的温度状态下，保持1 小时。在灭菌过程中，管路和罐内的温度、压力、流量、以及电导率都会被控制系统记录下来。在灭菌过程中，所有的使用点的阀门必须保持关闭状态。

PW storage and distribution system is heated via one sanitary shell & tube heat exchanger located in the PW return line to make up the distribution heat loss. Industrial steam is supplied as heating media. To prevent microbial contamination of the system after longer periods of shut down or after maintenance of the system, PW will be completely sterilized through heating the PW up to 80°C by heat exchanger. Industrial steam is supplied as heating media. During sanitization operation, the heating heat exchanger will heat the PW loop temperature up to 80°C and circulate the PW with validated time e.g. 1 hour for sterilization. During the sterilization operation, the loop temperature, pressure, flow rate and conductivity shall be monitored and recorded, all point of use valves are locked. During sterilization operation, the storage tank Nitrogen supply line valve and PW feed line valve must be closed. All the circulation function shall be shut down including points of use diaphragm valve.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第13页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

灭菌过后，纯化水将被排掉，为了控制纯化水系统微生物含量，在较长时间没有使用系统或者一段生产周期过后，必须对系统进行过热水灭菌，通过热交换器对纯化水加热至80°C 并保持1 小时。

After Sanitization, the PW should be cooled down to drain. To prevent microbial contamination of the system after longer periods of shutting down or after maintenance of the system, the purified water will be completely sterilized through heating the PW loop temperature up to 80°C and circulating the PW with validated time

e.g. 1hours.

●  技术描述Technical Description

该纯化水分配循环系统供应整个车间的纯化水使用点。纯化水管路分两路循环，一路供蒸馏水机、纯蒸汽发生器、制剂车间；一路供EPO、TPO 生产线。

Since this PW storage and Distributions System supply all PW to whole plant, and system separate two different loops, one for pure steam header, distilled water machine, preparation plant, another one supply to EPO, TPO Loop.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第14页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

纯化水采用变频恒压输送泵来根据瞬间用水量的大小实现自动变频控制，当监测到管道回路末端的流量<1.0m/s时，增大循环水泵的频率。

Because of different demands, supply pumps with different efficiency, supply PW to different workshops, and according to the instantaneous water demand to carry out automatic frequency control, when we monitoring the flow rate at return end of the loop, once the flow rate is less than 1.0m/s, we will increase the power supply to the pumps.

在纯化水系统循环泵出口设有在线隔膜式压力表，便于直观的看到泵的运行状况是否正常。在纯化水管道系统的出水和回水口均设计了取样口，以便随机检测水质情况。并且在循环的末端设有气动隔膜阀来根据在线电导的检测情况做出回罐与排放的切换。

There is online diaphragm water pressure gauge at the outlet of the PW circulation pump. Therefore it is easier to see whether each pump is under normal operation. There are sampling points at the inlet and outlet of each distribution loop; therefore it is easier to carry out random testing of water quality. Since, the distribution loops must take possession of the channels, and they are at the lowest point of the system, Therefore, the design of each loop in the pipe trench will installed with a drainage valve for full discharge of the system, moreover, these are outdoor trenches, in order to facilitate the control. The discharge valve is designed to be automatic and can be control in the PW generator.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第15页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

由于整套系统较为复杂，为了保证每个系统能够单独检测水质情况并及时做出判断，所以在每个系统的末端设有阀门来根据在线电导的检测情况做出回罐与排放的切换，

Since the entire system is more complicated, to ensure the separate detection of water quality of each system and timely judgment, so in the end of each loop there is valve, then according to the testing of the online conductivity, we can decide the interchange between discharge or switching back the PW to the tank.

当电导率合格时，打开进水阀，关闭排放阀，水流回储罐，当电导率不合格时打开排放阀，关闭进水阀，水排向下水并发出报警信号。在纯化水主回路回水口设有一台换热器供给热源以便纯化水管道系统进行巴氏灭菌。所有水平管道均设计有0.5%的坡度，以便于排净管道中积水。

When the conductivity qualified, the inlet valves open, discharge valve will be closed, PW flow back to tank. When the conductivity is not qualified, the discharge valve open, the inlet valves will be closed, water flow to discharge and issued warning signals. At the inlet of PW back to the tank will facilitate with a heat exchanger in order to carry out sterilization by super heated water. All lines must guarantee the complete drainage with proper slop of 0.5%.

所有的选型设备将满足每年24 小时/天， 7 天/周的工作强度要求。系统包含的主要设备如下All the equipment will be guaranteed for 24 hours/day X 7 days/week per year operation. The major equipment within this system scope includes:

♦ 卫生级纯化水循环泵

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第16页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

♦  Sanitary Purified Water centrifugal circulation pump

♦ 卫生级热交换器

♦ Sanitary shell and tube heat exchanger

♦ 控制系统及各类仪表

♦ Quality Monitoring Device

1.4.3. 注射用水储存分配系统 WFI storage and distribution

●  概述 general

注射用水储存和分配系统描述如下：注射用水由注射用水设备制出，并接入到注射水储罐，储罐作为满足系统要求用水量缓冲所用。注射水电导率和TOC 通过在线的电导率仪表和TOC 检测，如果注射水电导率或者TOC 检测高于要求，电导率仪表和TOC 发出警报信号给PL C，同时PLC 控制打开在线的两位三通阀门，将不合格水排放。

The WFI storage and distribution system will receive WFI from the WFI generation system into WFI storage tank which will act as a capacity buffer unit to cover the usual demand peaks. When the feed WFI conductivity or TOC value are higher than these standards, the conductivity meter and TOC will send an alarm signal to PLC, and PLC will control and open the three-way valve, the water will flow to the drain. The feed WFI flow is controlled via a three-way automatic valve.

合格的注射用水储存在不锈钢罐内。注射水的储存和循环温度都是在80°C 以上，因此我们建议采用带夹套保温的储罐。注射水会通过循环系统分配给车间内的各使用点，所有注射水循环管路内的水温都是通过在线的回罐前的管壳式热换器进行加热。同时，注射水的循环通过在线的卫生级循环泵，并带有变频控制，通过在线的管路回水流量计信号，自动调节泵的出水压力，以保证整个管路内住射水的流速达到要求。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第17页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

The qualified feed WFI is stored in a stainless steel vessel. WFI is stored, distributed and recirculated at high temperature (>80°C). So we suggest we should use the storage tank with insulation jacket. WFI is distributed to every point of use via loop system. Temperature of WFI is maintained by an industrial steam heated heat exchanger in the return loop. From the storage tank, WFI will be circulated around the distribution loop by one ultra pure sanitary centrifugal pump operating continuously. WFI circulation pump is equipped with Variable Speed Drive (VSD) control interlock with the flow meter located in the WFI return line to ensure the return flow rate. One pressure regulating valve (back pressure valve) shall be installed in the WFI return line to ensure the flow speed achieve our requirement.

管路内的注射用水流经各个使用点之后，返回缓冲罐，并通过罐内喷淋球喷淋，当注射水回水的电导率大于1us/cm 或者TOC 大于500 ppb 时，在线的电导率仪和TOC 会发出报警信号给PLC 控制系统，并显示在控制界面，同时管路的两位三通阀门自动打开，对不合格水进行排放，防止进罐。如果电导率或者TOC 持续大于1us/cm 或者500 ppb 一段设定时间，控制系统将自动关掉整个管路循环，并发出警报提醒操作人员进行检查。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第18页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

After serving the user-points, WFI shall return to the WFI storage tank via spray ball. When the return WFI conductivity is higher than 1us/cm or TOC value higher than 500 ppb, the conductivity meter and TOC will send a alarm signal to PLC control system and will be displayed on the interface. At the meantime, the three-way valve will be opened automatically the unqualified water will be drained to the sewer. If the conductivity >1us/cm or TOC > 500ppb time persist for a fixed time, the system will shut down and send an alarm to tell operation person to check.

使用点使用冷注射用水时，在每个使用点上或每条支路加一个管壳式换热器，当我们需要使用冷水时，热交换器将水温降低到我们所要的温度，打开使用点的阀门，就可以使用冷水。在平时，不使用冷水的时候，热交换器不工作，使用点阀门关闭，热水经过换热器回到主环路。

When using the cooling WFI, we should install an ALFA LAVAL PHARM X series double shell & tube heat exchanger on the every point of use or every loops which need cooling WFI. When we need use the cooling WFI, the ALFA LAVAL PHARM X series double shell & tube heat exchanger will cool the WFI achieve to the temperature we need. We can open the valve and use the cooling WFI. Normally when we need not use cooling WFI, the heat exchanger will not operate and the valve of point of use is closed. And the WFI pass through the heat exchanger with natural temperature and back to main loop.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第19页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

注射用水的储存和分配系统的加热通过在线的卫生级管壳式热换器，热源介质为工业蒸汽。为了保证整个系统微生物含量，在管路长时间没有使用或者一段生产周期之后，一定要对管路进行重新灭菌。通过热换器对注射水加热至121°C， 在灭菌过程中，热换器持续将循环的注射用水加热至121°C， 并在121°C 的温度状态下，保持0.5 小时。在灭菌过程中，管路和罐内的温度、压力、流量、以及电导率都会被控制系统记录下来。在灭菌过程中，所有的使用点的阀门必须保持关闭状态。

WFI storage and distribution system is heated via one sanitary shell & tube heat exchanger located in the WFI return line to make up the distribution heat loss. Industrial steam is supplied as heating media. To prevent microbial contamination of the system after longer periods of shut down or after maintenance of the system, WFI will be through heating the WFI up to 121°C by heat exchanger. Industrial steam is supplied as heating media. During sanitization operation, the heating heat exchanger will heat the WFI loop temperature up to 121°C and circulate the WFI with validated time e.g. 0.5 hour for sterilization. During the sterilization operation, the loop temperature, pressure, flow rate and conductivity shall be monitored and recorded, all point of use valves are locked. During sterilization operation, the storage tank Nitrogen supply line valve and WFI feed line valve must be closed. All the circulation function shall be shut down including points of use diaphragm valve.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第20页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

● 技术描述 Technical Description

根据用水量的不同采用不同的功率的泵来供给不同的生产车间，为了防止瞬间用水量增大而造成管道系统的流量和流速降低，设有变频器在线控制水的流动状态，当监测到管道回路末端的流量<1m/s时，增大循环水泵的频率。在每套注射水系统循环泵出口设有在线隔膜式压力表，便于直观的看到每台泵的运行状况。在每套注射水管道系统的出水和回水口均设计了取样口，以便随机取样进行水质的检测。在每个注射水管道系统的末端设有两位三通阀来根据在线电导率、温度值和TOC 情况做出回罐与排放的切换；当电导率和TOC 合格且温度达到设定的温度时，打开进水阀，关闭排放阀，水流回储罐，当电导率和TOC 不合格或温度低于设定的温度时打开排放阀，关闭进水阀，水排向下水并发出报警信号。在注射水回水口设有管壳式换热器，正常工作下主要用于温度补偿，当整个系统需要灭菌间可做为热源来为注射水加热，使注射水管道系统达到过热水状态以便消毒灭菌。所有水平管道均设计有1 %的坡度，以便于排净管道中积水。为了防止系统在完全排放的过程中外界空气污染该系统和水中的溶解氧,在储罐上接入氮气使系统对外界保持正压和减少了水中的溶解氧。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第21页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

Because of different demands, pumps with different efficiency, supply WFI to different workshops; in order to prevent instantaneous increases in demand cause reduce in capacity and the speed of flow within the distribution loop, it equipped with the frequency changer which provide on-line control of the water flow, when we monitoring the flow rate at return end of the loop, once the flow rate is less than 1m/s, we will increase the power supply to the pumps. There is online diaphragm water pressure gauge at the outlet of the PW circulation pump; therefore it is easier to see whether each pump is under normal operation. There are sampling points at the inlet & outlet of each distribution loop; therefore it is easier to carry out random testing of water quality. In the end of each loop there are two three-way valve, then according to the testing of the online conductivity, temperature and TOC value, we can decide the interchange between discharge or switching back the WFI to the storage tank; when the temperature reached the pre-set point & the conductivity qualified, the inlet valves open, discharge valve will be closed, WFI flow back to storage tank; when the conductivity is not qualified & the temperature is below the pre-set point, the discharge valve open, the inlet valves will be closed, water flow to discharge and issued warning signals. At the inlet of WFI back to the tank will facilitate with a double tube heat exchangers, under normal working condition it mainly serve for temperature compensation, when the whole system of WFI needs to be sterilized it serve as a heat source, then the WFI loop can be sterilized by super heated water. All lines must guarantee the complete drainage with proper slop of 1%. To prevent the contamination from ambient and oxygen hydronium in the water, we will connect the Nitrogen to the storage tank and let the tank maintain the positive pressure relation to ambient.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第22页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

所有的选型设备将满足24 小时/天 7 天/周/年的工作使用频率。系统包含的主要设备如下：

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第23页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

All the equipment will be guaranteed for 24 hours/day X 7 days/week per year operation. The major equipment within this system scope includes：

♦ 卫生级注射水离心循环泵

♦ Ultrapure WFI centrifugal circulation pump (1X100%))

♦ 卫生级管板式热换器

♦ Sanitaryshell and tube heat exchanger

♦ 控制系统及各类仪表

♦ Quality Monitoring Device

1.4.4. 纯蒸汽分配系统 Pure Steam Distribution

纯蒸汽通过纯蒸汽发生器制备，蒸汽压力为3.0barg， 并通过纯蒸汽管路分配给各个使用点，根据不同的使用点要求，通过每个使用点的蒸汽压力调节器，控制在1,1 – 2,2 barg 的使用范围。每个使用点安装了疏水器，在使用过程中，保证冷凝水的排出。同时，在每个车间的最未端设置了纯蒸汽冷凝水检测口。

Pure steam will be fed to a pure steam header and distributed (3.0 barg). For different users the pressure will be reduced to 1,1 – 2,2 barg (adjustable) via a pressure regulator.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第24页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

2. 控制方案 Technical

2.1. 项目配置 Project Configuration

2.1.1. 系统拓扑结构 Topological Structure of System

对于纯化水和注射用水系统的控制共用一套控制系统，控制层分为三层，总体结构如下图描述：

第一层为现埸仪表、执行器，即数据采集层和执行层；第二层为PLC 控制器，即过程控制层，第三层为人机界面，通过彩色触摸屏的形式，实现对系统的监控；系统实时状态、联动、报警、相关参数可以实现控制和记录，通常，至少实现三级密码保护。另外配置一台上位机，通过以太网（PN）与两套物料配置系统共用，实现打印、记录和存档等工作。

To the PW and WFI’s systems control,the control layer is divided into three layers. The following diagram describes the overall structure:

The first layer is local instruments and actuators,just Data acquisition layer and implementation layer，PLC is the second layer,just process control layer.the third is a HMI device in the on the control cabniet.Through the in’touch ,the system is real-time monitored.The system’s real-time data and status,interlock,alarms,general parameters can be controlled and recorded.Usually,it’s needed three grade password at least.Moreover,the system configured a computer as Engnieer Station. It is share with others system through Ethernet( PN ),to achieve print,record and store.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第25页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第26页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

2.1.2. 现场仪表层 The Scene Instrument Layer

该层主要由电气执行设备和在线仪表组成，采集现场的参数信号，并执行PLC 下达的控制命令。The layer is mainly constituted by electrial devices and online instruments.It recives the scene’s parameters signals and actuates commands,which PLC sends.

现场自动检测仪表对水处理和物料系统过程中的各个参数自动、连续地进行检测，通过变送器转换为4～20mA 标准信号，并将信号传送给PLC 控制站。

The online instruments in the scene auotomatical and continuous detect parameters in water process and material systems,which are very importment to process control.And then these signals are transformed to 4～20mA standard signals by transmitters. These 4～20mA standard signals are transmitted to PLC,the control center.

现场设备状态信号（如阀门的开关状态、泵的运行、故障状态）、报警信号直接传送到PLC 站，控制按钮、开关的动作信号等一般先经现场电控盘，以无源接点开关量信号的形式送至相应区域的PLC 站。

The scene device’s status(for example valve’s O/C status,pump’s status,fault status) and alarms’ signals  are tranmittered to PLC plant.The actuator signals of buttons and switchs are through the electrial control panels ,which are installed in the scene,to PLC plant with passive contact switch signal forms.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第27页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

电气执行元件（如接触器、继电器、电磁阀线圈等）接收PLC 站开关量输出卡件送出的控制逻辑信号，用于改变现场设备的状态（如开关阀门、起停水泵）和信号屏指示灯的状态。

Electrial actuators(contactors),relays,solenoid valves) recives the logic signals which output cards send on PLC plant,so that changing the scene’s devices’status(open/close valves,run/stop pump) and signal lights’status.

执行系统一般具有现场手动/自动转换功能，功能便于设备的维护和调试，当某个设备切换到现场手动模式下，该设备就不受PLC 的控制，只接受现场的操作命令。

The actuator systems usually have manual/auto conversion function,so that these devices can be maintenanced and tested.When at manual mode,these devices are not controlled by PLC,instead of local operating commands.

2.1.3. 过程控制层 Process Control Layer

● 主要功能 Major Function

主要是完成控制联锁功能（PLC 控制站是本系统核心），系统的测控联锁功能主要是在这里完成的，包括：

This layer's function is controlling the function of interlock(PLC plant is the center of this system ).System's function of measure and interlock are mainly finished in this layer.including：

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第28页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

♦  检测各设备的操作模式和状态Check up all devices' operating mode and status.

♦  检测液位、压力、流量、TOC 值等工艺参数；Check up parameters,for example level,pressure,flow,TOC ,and so on.

♦  根据工艺参数组态形成控制策略，并据此对处理系统的全过程实现自动控制和关键工序的PID 调节；According to these process parameters,this system's control program is formated.

● 操作方式 Computed Mode

根据工艺要求，完成对阀门，仪表，电机等控制；阀门的开关，仪表数据的采集，电机的启停；通过在程序中设计功能块，完成对这些阀门，电机等的控制；通过在上位机或者触摸屏上发命令，开启或者关闭阀门，启动或者停止电机，现场的阀门，电机收到信号动作，再反馈信号给PLC， 程序中采集到这些信号后，得出是否启动，是否动作，或者是否没有反馈，如果有反馈，在触摸屏上会显示一个运行状态，以颜色来区分。如果报警，又会以另外一种颜色来显示，提醒现场操作人员及时发现问题，解决问题；仪表反馈回来的信号，关键点都有工艺设定值，而一些不是很重要的点，只是在触摸屏中作为显示；象一些温度，流量，电导率，PH，压力等关键点通过PID 功能块来实现特定的控制功能。

According to the technical requirements, completion of the valves, meters, motor control, etc.Valves' O/C, Instruments data acquisition, motor start and stop. Through the process design function blocks to complete on these valves, electrical and machinery control. Through the PC or a touch screen, give an order to open/close the valve, start/stop the motor,then the scene of the valves,motors receive the electrical signals and act , and then feedback signals to PLC, PLC receives these signals ,and it is aware of status of these valves and motors, whether there is no feedback or not. If there is feedback ,on the touch screen,it will display a running status, to distinguish between colors. If alarm, with anothor color to show in the screen to remind the operator to detect and solve problems. Instrumentation feedback signal, the key point of both technology settings, and some not very important point, just display in a touch-screen.Such as temperature, flow, conductivity, PH, pressure , through the PID function blocks , achieve specific control functions.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第29页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

2.1.4. 数据监控层 Datamonitor Layer

控制系统采用西门子人机界面，完成数据的采集、设定参数、处理和储存记录数据、实时时钟控制、监视、通讯等功能。

Adopting PLC and touch screen control of Siemens as control system to gather, setup parameter，deal with and store data, to control real-time clock, to complete the display and communication etc.

● 显示功能 Display Function

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第30页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

控制系统提供计算机图形化过程监控功能，操作人员可通过HMI 液晶屏观察生产线各自控设备单元的单元操作过程（例如生产品种、批号设备、所处的操作阶段，温度、压力、液位、时间等数据）。显示的画面种类如下：

The control system provides graphical process monitoring function. The operator can observe each unit control process of equipment of corrsponding production line (for example, the production of varieties, lot equipment, the operation phase, temperature, pressure, liquid level, time, etc. data)on computer screen. Displayed screen types as follows:

»	工艺流程图（Process Flow Diagram）
»	测量值显示（Measurement display）
»	趋势图显示（Trend display）
»	报警显示（Alarm display）
»	生产参数管理（Process parameters mangement）

不同产品在生产过程中，其工艺参数/控制参数可能各不相同，为了减轻工艺员烦琐的参数重复设定，减少参数输入出错率，保证系统非客观因素的正常运行，系统提供完善的生产参数管理功能；

Different products in the production process, the process parameters / control parameters may vary.In order to reduce cumbersome craft duplicate set of parameters, to reduce the error rate ofinput parameters, and to ensure the system’s normal running ofnon-objective factors , System provides comprehensive management capabilities of production parameters.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第31页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

» 工艺参数输入存储，工艺参数以文件形式存储在上位机；Process parameters into storage, processing parameters in the form of a document stored in the HMI.

» 生产流程（含指令点）编辑；Production processes (including command points) Editor.

» 输入文件名即可打开相应参数；Enter the file name to open the corresponding parameters.

» 参数修改，输入新的参数值同配方名存储即可完成文件参数修改；Modify the parameters: Enter the new parameter values and the formula to complete to modify parameters.

» 下载功能，点击下载按钮将文件参数传进PLC， 系统将依据文件参数运行控制；Download function: click the button of download, the file parameters transfromed to PLC, the system will be controlled based on operational control file parameters.

» 上载功能，点击上载按钮将PLC 运行控制参数上传到上位机并显示，以此确定当前PLC 运行控制参数，防止因生产参数的不匹配影响生产；Upload function: click the upload button to let the PLC control parameters uploads to the host computer and display in order to determine the current PLC operational control parameters,to prevent production parameters does not match to impact the production.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第32页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

» 生产程序（生产流程、工艺参数）存储、调用。The production process (the production process, process parameters) to store, call.

● 报警及报警查询Alarm and Alarm Query

控制系统提供即时报警和电子永久报警记录、查询功能，具体包括如下：

Control system  provides real-time alarm and electronic permanent alarm records, the inquiry, including the following:

» 报警内容全面，编号、日期、持续时间、报警描述、报警设定值、单位、当前报警值、提示处理、状态确认和操作员姓名；Comprehensive of alarm report : number, date, duration, alarm description, alarm settings, units, the current alarm value, prompt treatment, state to confirm and the names of the operators.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第33页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

» 报警出现、报警消失、报警确认显示不同颜色区分；Alarm occurred, alarm disappeared, alarm acknowledged that the distinction with different colors.

» 根据报警持续时间和确认时间可以判断出设备自动或操作员报警处理情况；According to the alarm duration time and the recognition time ,judge the equipments' statment or operator handle statement.

» 通过报警处理提示操作员可快速、准确的处理报警（不能自动解决情况下）；Prompted the adoption of the alarm ,the operator can quickly and accurately deal with the alarm(can not automatically resolve the case).

» 强大的报警存储容量，连续开机记录五年报警信息，当报警存储空间满时系统自动导出存储于用户指定的硬盘上；Powerful alarm storage capacity, boot record consecutive five-year report of alarm information, when the alarm storage space is full,it will automatically export storage to a user-specified hard drive.

» 报警信息永久记录不随断电而消失，不可更改，并提供方便而快速的查询，完全符合FDA 要求，做到责任明确化。Permanent record of alarm messages, do not disappear with no power, can not be changed, and provide convenient and speedy inquiry, in full compliance with FDA requirements, and let the responsibility clearly.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第34页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

● 工艺控制和手动操作 process control and manual operation

操作人员可通过操作触摸屏编辑生产工艺，进行联动或单机启动/停 止生产线的任一单元设备的单元操作过程和两个单元间的料液传输过程， 还可暂停这些操作，进行人工干预。干预结束恢复正常控制，也可对各个 控制环节和整个控制系统实施强制结束操作；

Operators can modify production process in in' touch sceen, so that carry out joint or signle start / stop any unit equipment ,unit operation process of production line and operate liquid transfer process  between  the two units, but also to suspend these operations, carry out human intervention. After interfere, the restoration of normal control, and also end each link or the entire control system in a mandtory operation.

● 泵、阀等执行器的点动操作 Pump,valve etc.acutor step operation

在授权允许的情况下，可通过操作触摸屏控制生产线的任何自控阀门 开关、泵启停和电机启停、流量计清零操作，每次手动操作都会出现相应提示确认操作对话框，防止人为误操作。点动操作同样能够完成生产。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第35页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

Authorization permission, through the operation of touch screen to control any self-control valve O/C, pump motor start or stop, flowmeter Clear operation of production line,.Each manual operation,it will be prompted to confirm the operation with corresponding dialogue box, to prevent man-made misoperation.JOG operation can also complete the production.

● 计算机批量生产数据管理及报表打印 data management of mass production and print statements

计算机批量生产数据管理及报表功能如下Data management of mass production and print statements,function as follows：

» 自动采集各批次产品在各工艺阶段的生产过程数据，存储于数据库； Automatic acquisition production process data of the batch process at all stages, store in a database.

» 按要求自动生成各批次产品在整个生产报表；According to request, automatically generate the batch statements throughout the production.

» 生产报表不可更改、永久电子储存； The production of statements can not be changed, permanent electronic storage.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第36页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

» 生产数据提供多种查询；Production data provide a wide range of inquiries.

» 可按要求提供多种方式打印。It can be requested to print in a variety of ways.

● 操作记录 Operator records

系统完善的操作记录及查询显示：

Perfect System operation records and inquiries show：

» 记录阀门操作、泵电机操作、参数操作、工艺编辑等； Record valve operation, pump motor operation, parameters operation, process modification.

» 记录操作内容、操作时间和操作者； Record on operational content, operation time and the operator.

» 电子永久记录不随断电而消失，不可更改，并提供方便而快速的查询，

完全符合FDA 要求，做到责任明确化。

Permanent record of alarm messages, do not disappear with no power, can not be changed, and provide convenient and speedy inquiry, in full compliance with FDA requirements, and let the responsibility clearly.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第37页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

● 报警管理 Alarm mangement

完善报警管理是系统安全操作控制保障。根据实践经验固化的报警管理系统已不再适应配液系统安全操作控制，报警管理控制系统提供全面的报警后台管理功能具体如下：

Perfect alarm management ensures the safe operation of system control. In accordance with practical experience in curing the alarm management system,which is no longer equipped to adapt to the safe operation of hydraulic control systems.Alarm management control systems provide comprehensive background alarm management functions ,as follows:

» 报警值设定；Alarm set value

» 报警有效/失效设定；Alarm valid / invalid setting

» 报警延迟时间设定；Alarm delay time settings

» 报警等级设定，通过蜂鸣器与指示灯组合操作员不在控制室的情况下即可判断出报警内容。Alarm level settings.Through the combination of buzzer and light,  operator can judge the alarm contents in the case of operator not in control room.

● 系统安全性 Security of System

为了满足GAMP5 等规范的要求，本系统同时具有安全性及电子权限的设定、电子签名和电子记录功能。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第38页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

In order to satisfy requirement of GMP5 etc, the System have security and electronic access settings, electronic signatures and electronic records functions.

系统采用封闭的系统管理，建立、修改、维保、或传送电子记录能够保持记录真实性、完整性和适当的机密性。电子签名和电子记录具有真实性，完整性，不可抵赖性，和不可篡改性。这样的程序和控制应包括如下:

The system uses a closed system management, to establish, modify, Maintenance, or send electronic records to maintain records of authenticity, integrity and appropriate confidentiality. Electronic signatures and electronic records have the functions of authenticity, integrity, non-repudiation, and not tamper with nature.

● 安全策略 Security Policy

» 系统的验证保证准确、可靠、稳定地预期性能,有能力识别无效的和被改变的记录；Verification of system ensures accuration, reliable and stable performance which are expected,.It can identify invalid and changed records.

» 确保产生人们易读的电子形式的正确的、完整的记录副本，记录的保护以使记录能够在整个的保护期内是准确的易于检索的；It is to ensure to generate Correct, completed copy of record with the form of electronic document ,which people can read easily. The protection of records ,so that records can be accurate, easy retrieval in the whole protected period.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第39页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

» 通过授权个人用户以限制系统的登录。使用安全的、计算机产生的、时间印记的审核跟踪以便独立的记录操作者登陆和建立、修改、或删除电子记录的行为的日期和时间。记录的改变不能使先前的记录信息被覆盖。使用验证检查以保证只有被授权用户才可以使用系统，以电子方式署名记录，使用和操作计算机系统的输入输出设备，改变记录或手动执行操作；It is to limit the system registry by empowering individual users. The use of safe, computer-generated, the time of the audit trail ,so that the records of independent operators establish, land, modify, or delete the conduct of electronic records of the date and time. The previous record of information Changed Records can not be covered by the changed records. Using verification check is to ensure that only authorized users can use the system , electronically sign records, use and operation input and output devices of computer systems, change the record or manually operate.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第40页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

» 电子签名的显示：电子签名记录应能包含清晰显示如下所有与签名相关的信息：Electronic signature display: Electronic signatures should be able to contain all below relevant informations with the signatures recordclearly：

» 用印刷体写出签名者的名字 Write the name of the signer with printing font.

» 签名生效的日期和时间，和签名相关的含义（例如：批准，职责，或备注等）Sign of the date and time, and signature-related meaning (for example: approval, duties, or notes, etc.)

» 电子签名的唯一性 The uniqueness of electronic signatures.

» 每一个电子签名应是唯一对应单独一个人的并且不能再使用、或再分配给其他任何人；Each electronic signature should be the only corresponding to a single person and can no longer be used by another, or the redistribution to any other person.

» 在一个组织建立，分配，证明或者批准一个人的电子签名或者其他的任何这样的电子签名的要素之前，组织将校验个人身份；Before establishment of an organization, distribution, certification or approval of a person's electronic signature, or any other such elements of electronic signatures, the organization will check their personal capacitis.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第41页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

● 电子签名成分及管理 Composition and management of electronic signatures

» 使用至少两种截然不同的证明成分，例如识别码和密码；It must be used with two distinct proof components, such as ID and password.

» 当一个人在一个独立的持续受控的系统登陆期间内签署一系列的签名，签署的第一个签名将使用所有的电子签名成分。后续签署的签名应使用至少一种的电子签名的成分。该成分只能由个人签署，并且设计只能由个人来使用；When a person signs a series of signatures in an period of independent ,controlled, landing sustained system's time, the sign of the first signature will use all of the electronic signature components. Follow-up signature should be used at least one component of electronic signatures. The ingredients can only be signed by individuals, and designed to be only used by the individual.

» 管理和签署以保证任何除其真正所有使用者外的其他尝试使用该电子签名时需要第二个或更多的人的协作；Management and signature are to ensure that another except for real user try to use the electronic signature,which is required a second or more people collaboration.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第42页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

●     识别代码和密码的管理

Identification code and password management.

使用基于识别码和密码混合的电子签名应使用管理以保证他们的安全和完整，这种管理包括：

Using a mixture of electronic signatures based on ID and password ,people should study to manage it ,in order to ensure their safety and integrity, this management should include:

»保持每一个的识别码和密码发布能定期被检查、收回或是修订；

To ensure that each of the ID and password can be issued to regular inspection, to recover or to amend.

»按照损失管理过程对丢失、被盗、找不到的用户和密码进行电子失效；

In accordance with loss management process ,these ID and password,such as thefting,losing and not finded should be conducted of electronic failure.

●     实施措施 Implementing Measures

系统安全性由工艺的合理性、系统硬件、组态软件、二次开发软件操作安全性四部分组成，这里系统安全性是指二次开发软件操作安全性，为此本系统安全性由以下三部分组成：

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第43页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

System security is composed by the rationality of technology, system hardware, software configuration, the security of secondary development of software. System security here refers to the secondary development of software security, for it , the security of the system is composed by the following three parts:

» 报警管理及报警处理 Alarm management and alarm deal

» 电子权限管理 Electronic Permissions management

» 根据操作类型、管理层次、安全等级系统实施多权分配 According to the type of operation, management-level, multi-level of security, the system is distributed.

» 根据安全管理和操作权限，分为四个级别：一级：初级操作员（可以进行任何设备的开启或者关闭）。二级：高级操作员（进行系统监督和改变系统参数）。三级：维护工程师（校正和修改工艺仪表参数）。四级：系统管理员（分配和确认每个人的权限和密码和系统管理）;权限间互不包含, 系统中任何操作都有相应权限配置，只有经过登录并具有相匹配权限才能对其操作；权限用户的建立统一由车间管理员在管理室建立，操作室只具有操作登录功能不具备权限管理功能，操作员在第一次使用车间配置的用户时系统强制要求操作员对自己操作密码更改，该方式保证了多级权限安全和规范性。According to security management and operation of authority, it is divided into four levels: level1: junior operators (operate all devices to open or close). level2: Senior Operator (monitor system and change the system parameters). level3: maintenance engineer (instrument calibration and modification process parameters). level4: System Administrator (distribution , acknowledge each person's permission and password and system management).

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第44页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

Permission does not include inter-interoperability 。Any operation in the system has corresponding permission, only to log on and have the permissions to match their operation,and then operate it.

Permission of users to establish is  unified by the workshop manager in the management room. It has the function to operate the registry and hasn’t the competence management capabilities in the operation room.When operators first use the user of workshop,operators are asked to mandatorily change their own passwords, so that it ensures a multi-level security and regulatory authority.

2.2. 注射用水控制系统 WFI Supply Control System

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第45页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

2.2.1. 系统功能描述 Function to Control System

» 根据注射用水管路流程以及客户要求配置该控制系统；The Monitor and Control System will be configured and constructed according to WFI process requirement and URS.

» 控制系统用于注射用水系统的信号检测和过程控制；This Monitor and Control System will be used for WFI supply signal monitoring and process control

» 现场安装控制柜，并附带警报报警装置；Control cabinet will be installed on site, It will be provide with Alarms.

» 现场控制系统带有密码权限功能，不同级别的操作人员设有不同的操作权限；Different levels pass word are availably on control system, each operator will be assigned with different levels of access.

» 系统可以设定手动和自动操作，并可以设定管路中各类仪表的参数；Manual and automatic operation modes are availably, It is possible to set parameters for   instruments

» 在注射用水纯蒸汽灭菌过程中，系统自动记录并保存灭菌时间，灭菌过程中的温度、压力、流量、电导率参数以及每次操作人员资料，供以后查询追溯；During the Sterilization of WFI, system will automatically record and store such important data like: Temperature, Pressure, Flow Rate, Conductivity during the Sterilization Time and Operator’s Information for easy tracking in feature.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第46页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

» 系统可以记录并保存生产过程中的流量变化曲线；During production process, Flow Cycle will be recorded and stored on the system.

» 现场控制系统的各类数据信号，可以上传至总厂监控系统。All data on site system can be uploaded to the control system of factory central monitor office.

2.2.2. 主要控制回路 The Main Loop of Control System

» 根据注射用水液位信号，自动控制罐顶的气动隔膜阀开关以及泵的开关；当罐内液位大于最大设定值，罐顶阀门关闭，当罐内液位小于最小设定值，循环泵关闭；According to the filling level signal inside the /WFI tank, system will automatically turn on/off the pneumatic diaphragm valve which on the top of the tank and turn on/off the feed pump. The pneumatic diaphragm valve will be turned off when the filling level reaches the high set point. The feed pump will be turned off when the filling level below the low set point.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第47页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

» 根据注射用水管路流量信号，自动调整变频泵，保证管路流速大于要求值；According to the WFI loop's flow rate signal, system will modulate the feed pump ensuring the loop's flow rate meets requirement.

» 根据注射用水管路电导率信号，自动开关在进水阀和排水阀，保证不合格水不流入罐内，如果电导率一段时间持续大于规定，系统将自动停机，并发出警报信号。According to the loop's conductivity signal, system will automatically turn on/off three-way automatic valve, ensuring range water not flow into tank. If the conductivity is higher than limit for a fixed time, the system will shut down. And send alarm signal to the control system.

2.2.3. 联锁逻辑 Logic Diagram of Interlock

a. 逻辑图 Logic Diagram

» 注射用水循环控制逻辑图WFI's logic diagram for circulation control

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第48页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第49页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

»注射用水灭菌控制逻辑图 WFI's logic diagram for disinfection control

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第50页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

b. 控制说明 Description of Control

注射用水控制分为注射用水循环控制和注射用水灭菌控制，在控制过程中主要对注射用水循环时水罐液位控制，水循环时电导率控制，水循环时流量控制，注射用水循环时温度控制。

WFI’s control system includes WFI’s circulation control system, WFI’s disinfection control system.In the control process,mainly control the water level of tank,control the water conductivity ,control flow of water and control the water temperture.

»注射用水循环控制说明WFI's Description for circulation control

♦ 注射用水循环液位控制 WFI's level control

注射用水储罐的液位可按实际情况自行设定为高，中，低三个液位标志。当注射用水循环泵启动后（手动启动和自动启动），当罐内的实际液位低于低液位时，为防止电机空转损坏设备，达到保护系统安全的目的，系统自动停机，并发出声光报警，需要重新启动注射用水循环（手动启动和自动启动），需要注射用水罐液位达到中液位，并且有操作员的确认，系统才能启动。

According to actual condition, WFI's level can be setted to high ,middle and low level signs.After the circulation pump for WFI running(handle start or auto start),when the actual level is lower than low level,avoiding to detroy the motor and keeping the system safety,the system will stop automatically and appear sound and light alarm.Before the system can be restated,it must be restarted the WFI’s circulation system(handle start or auto start); the actual level equal to middle level;and it must be acknowledged by operator.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第51页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

♦注射用水循环电导率控制 WFI's conductivity control

为保证生产质量，对电导率的控制很重要，系统启动时（电机启动）根据回水电导率控制排水阀的开关，当电导率大于设定值（根据需要可自行设定）时，系统自动打开排水阀，让超标的回水排往罐外，并且记录一次报警；当电导率小于设定值时，系统延时30 秒后关闭排水阀。如果是连续超标时间达到1 分钟，系统自动停机，并发出声光报警，提示检查故障，处理好故障重新开机时，必须有操作员的确认。

In order to ensure production quality, it's important to Control the WFI's conductivity.When the system is running(the motor running), draining valve's O/C is according to actual conductivity of retuning water.When thr actual conductivity is higher than setting(setting according to requiement),the drainage valve will be opened automatically,so that the excessive water drain outside.at the same time,reporting alarm once.When the actual conductivity is lower than setting,after 30 seconds, the drainage valve will be closed automatically.If the excessive time reachs to 1 minute, the system will stop automatically and appear sound and light alarm,so that the operator check up it.After inspecting it,before restarting the system ,it must be acknowledged by the operator.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第52页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

♦ 注射用水循环流量控制 WFI's flow control

根据注射用水回水的实际流量反馈与系统设定值比较，通过PID 调节，增加或者是减少注射用水循环泵的频率，保证注射用水循环系统恒流供水。

In accordance with the actual flow and system settings comparison，using the PID regulator，adding or reducing the frequence of the WFI's pump,so that it ensures constant supply water for WFI's system.

♦ 注射用水灭菌控制WFI's Description for disinfection control 进行注射水系统的灭菌，只要将控制柜旋钮打到 "灭菌" 位置，则注射用水进水阀打开，此时打开注射用水纯蒸汽阀，系统灭菌进行。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第53页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

When start the WFI’s disinfection system ,the button on the Control cabinet must be switched to ‘disinfection’,then the inlet valve will be opened.After a moment, opening steam valve for WFI, WFI’s disinfection system is running .

2.2.4. 关键控制点 The Critical Control Point

» 注射用水罐内温度 WFI Tank's Temperature

» 注射用水罐内压力 WFI Tank's Pressure

» 注射水管路循环温度 WFI Loop's Temperature

» 注射用水罐内液位WFI Tank's Filling Level

» 注射用水水管路电导率 WFI Loop's Conductivity

» 注射用水管路流量 WFI Loop's Velocity

2.2.3. 纯化水控制系统 PW Supply Control System

3.2.3.1. 系统功能描述 Function to Control System Description

» 根据纯化水管路流程以及客户要求配置该控制系统；The Monitor and Control System will be configured and constructed according to PW process requirement and URS

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第54页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

» 控制系统用于纯水系统的信号检测和过程控制；This Monitor and Control System will be used for Entire water supply signal monitoring and process control.

» 现场安装控制柜，并附带警报报警装置；Control cabinet will be installed on site, It will be provide with Alarms.

» 现场控制系统带有密码权限功能，不同级别的操作人员设有不同的操作权限；Different levels pass word are availably on control system, each operator will be assigned with different levels of access.

» 系统可以设定手动和自动操作，并可以设定管路中各类仪表的参数；Manual and automatic operation modes are availably, It is possible to set parameters for   instruments

» 在纯化水双氧水灭菌和注射水纯蒸汽灭菌过程中，灭菌过程中的温度、压力、流量、电导率参数以及每次操作人员资料，供以后查询追溯；During the Pasteurization of PW and Over Heat Water Sterilization of WFI, system will automatically record and store such important data like: Temperature, Pressure, Flow Rate, Conductivity during the Sterilization Time and Operator's Information for easy tracking in feature.

» 系统可以记录并保存生产过程中的流量变化曲线；During production process, Flow Cycle will be recorded and stored on the system.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第55页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

» 现场控制系统的各类数据信号，可以上传至总厂监控系统。All data on site system can be uploaded to the control system of factory central monitor office.

2.3.2. 主要控制回路 The main loop of Control System

» 根据纯化水液位信号，自动控制罐顶的气动隔膜阀开关以及泵的开关。当罐内液位大于最大设定值，罐顶阀门关闭，当罐内液位小于最小设定值，循环泵关闭；According to the filling level signal inside the PW/WFI tank, system will automatically turn on/off the pneumatic diaphragm valve which on the top of the tank and turn on/off the feed pump. The pneumatic diaphragm valve will be turned off when the filling level reaches the high set point. The feed pump will be turned off when the filling level below the low set point.

» 根据纯化水管路流量信号，自动调整变频泵，保证管路流速大于要求值；According to the PW loop's flow rate signal, system will modulate the feed pump ensuring the loop's flow rate meets requirement.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第56页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

» 根据纯化水管路电导率信号，自动开关在线两位三通阀，保证不合格水不流入罐内，如果电导率一段时间持续大于规定，系统将自动停机，并发出警报信号。According to the loop's conductivity signal, system will automatically turn on/off three-way automatic valve, ensuring range water not flow into tank. If the conductivity is higher than limit for a fixed time, the system will shut down. And send alarm signal to the control system.

2.3.3. 联锁逻辑Logic Diagram of Interlock

a. 逻辑图 Logic diagram

» 纯化水循环控制逻辑图 PW's logic diagram for circulation control

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第57页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第58页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

» 纯化水灭菌控制逻辑图 PW’s logic diagram for disinfection control

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第59页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

b. 控制说明 (Description of Control）

纯化水控制分为纯化水循环控制和纯化水灭菌控制，在控制过程中主要对：纯化水循环时水罐液位控制，纯化水循环时电导率控制，纯化水循环时流量控制，纯化水循环时温度控制。

PW’s control system includes PW’s circulation control system, PW’s disinfection control system.In the control process,mainly control the water level of tank,control the water conductivity ,control flow of water and control the water temperture.

»纯化水循环控制说明（PW's Description for circulation control）

♦纯化水循环液位控制：(PW's level control)

纯化水储罐的液位可按实际情况自行设定为高，中，低三个液位标志。当纯化水循环泵启动后（手动启动和自动启动）， 当罐内的实际液位低于低液位时，为防止电机空转损坏设备，达到保护系统安全的目的，系统自动停机，并发出声光报警，需要重新启动纯化水循环（手动启动和自动启动），需要纯化水罐液位达到中液位，，并且有操作员的确认，系统才能启动。

According to actual condition, PW's level can be setted to high ,middle and low level signs.After the circulation pump for PW running(handle start or auto start),when the actual level is lower than low level,avoiding to detroy the motor and keeping the system safety,the system will stop automatically and appear sound and light alarm.Before the system can be restated,it must be restarted the PW’s circulation system(handle start or auto start); the actual level equal to middle level;and it must be acknowledged by the operator.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第60页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

♦ 纯化水循环电导率控制：(PW's conductivity control)

为保证生产质量，对电导率的控制很重要，系统启动时（电机启动）根据回水电导率控制两位三通阀的开关，当电导率大于设定值（根据需要可自行设定）时，系统自动打开两位三通阀，让超标的回水排往罐外，并且记录一次报警；当电导率小于设定值时，系统延时30 秒后关闭阀门。如果是连续超标时间达到1 分钟，系统自动停机，并发出声光报警，提示检查故障，处理好故障重新开机时，必须有操作员的确认。

In order to ensure production quality, it'smportant to Control the PW'sonductivity.When the system is running(the motor running), draining valve /C is according to actual conductivity of retuning water.When thr actual conductivity is higher than setting(setting according to requiement),the drainage valve will be opened automatically,so hat the excessive water drain outside.at the same time,reporting alarm once.When the actual conductivity is lower than setting,after 30 seconds, the drainage valve will be closed automatically.If the excessive time reachs to 1 minute, the system will stop automatically and appear sound and light alarm,so that the operator check up it.After inspecting it,before restarting the system ,it must be acknowledged by the operator.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第61页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

♦ 纯化水循环流量控制：(PW's flow control)

根据纯化水回水的流量反馈与系统设定值比较，通过PID 调节，增加或者是减少纯化水循环泵的频率，保证纯化水循环系统恒流供水。

In accordance with the actual flow and system settings comparison，using the PID regulator，adding or reducing the frequence of the PW's pump,so that it ensures constant supply water for PW's system.

♦ 纯化水循环时温度控制：(PW's temperture control)

为保证纯化水循环系统水温<=20度，我们通过冷凝器和调节阀对纯化水系统进行温度控制，以保证纯化水循环时温度满足要求。

To ensure the PW's temperture lower than 20℃,we can control it through condensator and adjust valve , so that the temperture reach to our need.

» 纯化水灭菌控制 (PW's Description for disinfection control)

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第62页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第3 部分技术及控制方案 Technical and control system

为节约水源和能源，同时达到灭菌目的，可设定一个合适的液位，能够保证系统循环，而且纯化水罐液位不能低于设定液位，控制柜旋钮打到“灭菌”位置，操作画面在”自动操作”和“纯化水循环”位置，纯化水灭菌运行。

To economize water and energy， and reach to disinfection aid,we can set proper level,which ensure the sysytem’s safe running;and that the level of tank is not lower than setting. The button on the Control cabinet must be switched to ‘disinfection’,on the picture,it displays ‘auto’and ‘PW circulation’, PW’s disinfection system is running.

c. 关键控制点（The Critical Control Point）

♦ 纯化水罐内温度PW Tank's Temperature

♦ 纯化水罐内压力PW Tank's Pressure

♦ 纯化水管路循环温度PW Loop's Temperature

♦ 纯化水管路循环压力PW Loop's Pressure

♦ 纯化水罐内液位PW Tank's Filling Level

♦ 纯化水水管路电导率PW Loop's Conductivity

♦ 纯化水管路流量PW Loop's Velocity

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第63页/ 共63 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第 4 部分 验证方案 Validtion

第 4 部分

Part 4

验证方案

Validation

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

上海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室     201100

T:021 54306717     F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第 4 部分 验证 Validation Service

目 录

Index

1. 介绍 Introduction	3
2. 验证范围 Work scope of validation	3
3. 验证方法 Validation approach	4
3.1. 总要求 General Requirement	4
3.2. 风险评估 Risk Assessment	6
3.3. 追溯矩阵表 Traceability Matrix	8
3.4. 设计确认 Design Qualification	9
3.5. 工厂验收测试 Factory Acceptance Test	12
3.6. 现场验收测试 Site Acceptance Test	14
3.7. 校准 Calibration	14
3.8. 安装确认 Installation Qualification	16
3.9. IQ 接受标准 IQ Acceptance Criteria:	18
3.10. 运行确认 Operation Qualification	19
3.11. 控制系统的验证 Validation of Automatic Control System	22
3.12. 性能确认 Performance Qualification	22
4. 质量项目计划 Quality and Project Plan	23

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

验证服务范围

Work Scope of Validation Service

纯化水、注射用水和纯蒸汽系统

PW, WFI, PS systems

提供方：上海朗脉科技有限公司

Provided by: Shanghai Macroprocess Co., Ltd.

January 2009

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

1. 介绍 Introduction

沈阳三生制药有限责任公司（“沈阳三生”） 将新建一个生物制药车间，现对纯化水、注射用水和纯蒸汽的洁净管道系统的详细设计、施工、调试和确认（验证）的工程服务项目进行招标。

Shenyang Sunshine Pharmaceutical Co., Ltd. (3SBIO) will build one new biopharmaceutical plant, and now invite the bidding for the project of detailed design, construction, commissioning and qualification (validation) of sanitary piping systems including purified water, water for injection and pure steam.

上海朗脉受邀参与投标，本文件将为本次的项目中验证范围进行做出说明，并给出最优的报价。

Shanghai Macroprocess is invited to bid for this project. This document will define the work scope of validation activities and give a best quotation.

2.2. 验证范围 Work scope of validation

我们提供的验证服务范围，见以下验证矩阵表。

We provide the validation services shown in Validation Matrix.

表 Table 1-验证矩阵表 Validation Matrix

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第3页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

备注 Remark：

1） RA- 风险评估 Risk Assessment ; TM- 追溯矩阵表 Traceability Matrix; DQ- 设计确认 Design Qualification; FAT -工厂验收测试 Factory Acceptance Test; SAT- 现场验收测试Site Acceptance Test; IQ-安装确认 Installation Qualification; OQ- 运行确认 Operational Qualification; PQ- 性能确认 Performance Qualification

2） PQ 方案由朗脉提供，实施由客户负责。

PQ protocols are prepared by Macroprocess, but the execution will be done by client.

详细的验证要求描述见后面章节。

Detailed validation requirement description will be found in the following section.

1.3.     验证方法 Validation approach

2.3.1.   总要求 General Requirement

我们将按照以下V 模型对关键系统开展验证工作。

We will conduct the validation/qualification activities according to the following V-Model.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第4页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

Figure 1- V-model

在设计开始之时，验证工作也将同时开展。在详细设计完成的后期，进行设计确认，并对系统进行风险评估，编写追溯矩阵表。在采购和施工过程中，任何的关键性变更(影响产品质量或安全的变更) ， 需要提交给验证人员进行审核。

Validation activities should begin with design. In the end of detailed design stage, Design Qualification and Risk assessment will be conducted, and also Traceability matrix will be prepared. During purchase and construction, any significant change(impact product quality or safety) should be submitted to validation person for review.

系统施工结束后，进行调试，在合适的时候组织客户相关人员，进行FAT 或SA T。然后，进行安装确认和运行确认。性能确认，由客户自己负责实施。

When the finish of construction and commissioning, we will invite related persons from client to conduct FAT or SAT. Then Installation and Operational qualification will be done by us with witness by client. Performance qualification will be done by client own.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第5页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

3.2. 风险评估 Risk Assessment

风险评估将决定哪些系统/部件需在GEP 基础上还须进行确认，哪些仅仅需要按照GEP 规范进行安装和调试。

Risk assessment is the process of determining which systems/components should be subject to qualification practice in addition to Good Engineering Practices (GEP) and which systems/components should be commissioned in accordance with GEP.

评估通过衡量某一系统对产品质量的影响进行。在系统完成评估之后，系统的部件也将被评估，来确定它们是否对保证和维持产品质量有关键影响。 有直接影响的系统和部件将进行确认，而有间接影响的仅按照GEP 进行设计，安装和调试。

The assessment is made by evaluating the impact that a system has on the quality of the product. After the system assessment, the components of the system are evaluated to determine if they are critical to establish or maintain the quality of the product. The appropriate qualification practices are then applied to the ‘direct impact’ systems and components, while the ‘indirect impact’ systems and their components shall be designed, installed and commissioned according to GEP.

根据这种方式，工作的重点集中在对产品质量有关的系统和部件上。评估的完成途径多种多样，由每个公司最终确定。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第6页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

Following this approach, the appropriate effort and focus can be maintained on the quality impacting systems and components. The assessment process can be done in a variety of ways, which will be ultimately defined by each individual operation company.

风险评估的基本步骤 Basic Steps of Risk Assessment:

- 了解系统或设备，以及工艺流程

Identification of System/Equipment, Process

- 识别可能出现风险、产生的原因、带来的影响

Identification of the risk event, cause and effects

- 评估该风险出现的可能性

Evaluation of the probability that the event occurs

- 评估该风险带来的影响的严重程度

Evaluation of the Impact of the Risk

- 评估该风险被发现的可能性

Evaluation of the probability of detection of the event

- 建议采取的措施

Suggested actions

报告 Reporting:

风险评估的结果将报告下列内容：

The results of the risk assessment will be reported with the following typical contents:

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第7页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

- 目的

Objective

- 风险评估的参与者

Participants in the risk analysis

- 工艺参数、功能、关键组件

Process parameters, Function and Components

- 潜在的风险

Potential risk

- GMP 关键性的判断

Identification if it is GMP critical

- 风险的原因和后果

Cause and consequences of risk

- 风险评估（出现的可能性、影响的程度、被发现的可能性）

Risk Assessment (probability of occur, Impact, probability of detection)

- 处理的措施（如测试要求、特别措施等）

Measures (e.g. Test requirement, specific measures etc.)

3.3. 追溯矩阵表 Traceability Matrix

追溯矩阵表对验证项目的质量关键及基本要求自用户需求标准到功能标准直至测试方案进行追溯。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第8页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

Traceability Matrix traces the quality critical and essential requirements from the User Requirements Specification (URS) to the functional specifications and onto the test protocols for this validation project.

3.4. 设计确认 Design Qualification

DQ 是对系统的设计进行审核，以确认它们符合预定功能及运行要求，并符合GMP 要求。

DQ is the review for the design of system which ensures that these are according to advanced function and operation requirement as well as GMP requirement.

DQ 是贯穿于项目设计阶段的一个持续的过程，它保证与特定设备和系统相关的所有的设计文件符合现行GMP 的要求。我们将积极采取行动，保证项目的设计符合国际GMP 及客户的内控标准。

DQ is a continuous progress throughout project design stage. DQ ensure the design documents related to specific equipment and system according to current GMP requirement. We will act for it and ensure the project design meet the international GMP and internal standard of Client.

DQ 的关键工作是对系统的设计进行GMP 审查。该审查由朗脉验证专家主持，双方人员均参加。此审查将提供一个正式文件，证明设计按照GMP 各方面要求。会议的记录，完整的文件检查清单及变更清单将是DQ 的质量记录，被妥善保存。

The critical work of DQ is GMP review to system design. This review is conducted by specialist from Macroprocess, both sides would join it. This review will provide an official document to prove the design meet the GMP requirement of each aspect. Meeting memo, complete document check list and change list will be quality record of DQ and will be preserved appropriately.

设计确认（DQ ）并非法规的恶强制要求。然而，从正式性和加强的设计审核角度，我们推荐执行DQ。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第9页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

Design Qualification (DQ) is not a mandatory requirement of the regulations. However, in this formal format or through enhanced design reviews, it is recommended that it be carried out.

DQ 通过对系统进行有组织的设计审查来进行。这种审查将在严格要求下进行，因为它在IQ、OQ之前能够更好地发现设计问题或不符合要求的方面，否则将对项目的工期和费用造成巨大影响。

The DQ will be executed by applying a structured review of the design of the systems. The review should be rigorous as it is better to discover any design problems or non-conformance issues before reaching IQ or OQ, where remedial work may have a significant impact on the project schedule and cost.

方案将用采用书面格式。详细的检查清单将确保设计和文件的所有方面均被涉及。方案被各方正式签署后执行。

A protocol will be prepared with a written description of the format and approach for the reviews. Detailed checklists will be prepared to enable all aspects of the design and documentation to be interrogated. The requirements of the risk assessment and cGMP reviews will also be reviewed to ensure that their requirements are incorporated. The protocol will be formally signed off as approved prior to execution and post execution by all parties.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第10页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

DQ 文件的通常标准包括：

Typical criteria, which would be used to generate the DQ protocol are:

- 设计确保满足GMP 的要求

Design satisfies GMPs and regulatory requirements

- 设计符合性能标准

Design meets performance criteria

- 材料材质

Materials of construction

- 清洗要求

Cleaning requirements

- 操作的可靠性和有效性

Reliability and Efficiency of operation

- 设备安装

Equipment Installation

- 系统调试

System commissioning

- 关键仪表的参数，量程和精度是否满足工艺要求和控制要求

parameters of critical instruments, verify if the measuring range and accuracy satisfy the process and control requirement

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第11页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

- 关键组件的结构

Structure of critical components

- 文件要求

Documentation requirements

3.5. 工厂验收测试 Factory Acceptance Test

工厂验收测试应该关注设备关键的方面，包括进行测试活动。这些测试将在设备起运之前进行，以保证该设备已按照设计标准进行制造，并提供所需要的文件。因此，FAT 可帮助避免可能影响现场测试的问题的产生。

Factory acceptance test could be applied to any critical aspect and includes test activity, that will be carried out before the shipment, to get assurance that a new critical equipment/ package has been built following the design specifications and it is provided with the required documentation; moreover the FAT will help to avoid problems that could affect the on site activities progress. FAT 可适用于所有关键的设备或设备包。

FAT could be applied to any critical equipment or components.

FAT 将包括IQ OQ 所包含的一些测试内容。任何不受运输或安装所影响的测试内容，如果其得到合适的执行、复核和记录，在以后的确认中，可以不需重复进行。下面是一些被认为可以作为确认目的的测试内容，但不仅限于此：

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第12页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

FAT will already include some tests foreseen by the IQ and OQ; any test, which reliability will not be affected by the shipment and the installation could not be repeated for qualification purpose, if properly executed, witnessed and documented. Test activity that typically could be considered validated for qualification purpose, but not limited, are the following:

- 文件确认

Documents verification

- 图纸的确认（P&ID、布置图、电子和气路图）

Drawings verification (P&ID, Lay Out, electrical and pneumatic scheme)

- 材料和表面抛光的检查

Materials and surfaces finishing verification

- 控制系统图形界面的检查

Control system graphical pages check

- 报警和联锁

Alarms and interlocks

FAT 将要求进行记录；相关的测试报告或方案，将被提交给客户审核和批准。

FAT 将在客户批准后进行。

FAT will be documented; the relevant test report or protocol, will be submitted to client for review, comments and approval; FAT execution will begin after client approval.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第13页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

本项目仅要求对水系统储罐进行 FAT。

It is required to conduct FAT only for Tank of water system.

3.6. 现场验收测试 Site Acceptance Test

此工作适用于关键的系统或设备。 SAT 包含动态的和静态的测试活动，测试活动在现场由供应商在移交系统给客户之前进行。每一项SAT 工作将被文件记录下来。我们将提交测试文件（定义为SAT 报告或方案）给客户，以审核和批准。

Activity Applicable to critical system or equipment; SAT consists of Dynamic and static testing activities performed on site by the vendor before hand over the system to the client. Each SAT activity will be documented. Macroprocess will submit the test document (defined as SAT report or protocol) to Client (for comments and approval).

那些不会因为系统/设备的改变而影响可靠性的测试，如果已得到正确的执行、证明和文件记录，那么在验证过程中不必重复进行。

All tests which reliability will not be affected by the system/equipment modification could not be repeated for qualification purpose, if properly executed (in conformity with Qualification Protocols), witnessed and documented.

3.7. 校准 Calibration

因为是新的安装， 所有的仪器仪表和变送器应被校准并产生校准证书。

Since this is a new installation all transmitter instruments will be calibrated, and calibration certificate will be produced.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第14页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

所有不受安装影响的仪器仪表将经过校准后送到现场，并提供校准证书（溯源为NIST 或中国国家计量基准）。其它的仪器仪表将在现场使用计量标准进行校准。在任何情况下，应提供参考仪器的校准证书和校准程序。

All instruments not affected by the installation will be bench calibrated and then, supplied to the field, provided with NIST or Chinese National measurement standards  traceable calibration certificate; the others will be calibrated in field using traceable standards references. In a case copy of the reference instrument calibration certificate and approved procedures will be provided. 下列是对不同等级仪器仪表的处理方法。 On the following different dedicated approach for class of instruments.

不受安装影响的仪表

Instruments not affected by the installation:

温度和压力变送器，需要校准证书（溯源为NIST 或中国国家计量基准）。确认工作，仅为确认安装情况（是否有合适的配置、范围、计量单位、信号）和带有相关显示器或相关监督和控制站的信号定位。

Temperature and pressure transmitters; for which will be required (to the vendor) a bench calibration certificate (NIST or Chinese National measurement standards traceable) and during the qualification will only be verified the set up (if smart the relevant configuration, range, engineering unit, signals) and the signal alignment with the relevant indicator or the eventual supervision and control station.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第15页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

会受安装影响的仪表

Instruments affected by the installation:

流量和液位变送器，不需要实验室校准。校准将在现场使用可溯源为NIST 或中国国家计量标准的仪器进行校准。

Flow rate and level transmitters; for which will not be required a bench calibration. The calibration will be performed after the installation in field using NIST or Chinese National measurement standards traceable reference instruments.

电导仪和PH 计将在现场通过使用相关的指示器与标准溶液进行确认/校准。

conductivity and pH probe will be verified/calibrated in field reading the measurement using the relevant indicator in comparison with a reference standard solution.

仪表的校准工作不属于验证工作。本项目的仪表校准工作由哪方负责，将由合同进行约定。

Calibration is not included into Validation work. The responsible party for calibration work will be according to the contract.

3.8. 安装确认Installation Qualification

安装确认将检查每一个设备/系统的安装是否符合设计和相应的GMP 规范。IQ 将确认所有的需要用于设备/系统的管理和操作的文件的可用性。

The Installation Qualification will determine that each equipment/system has been installed in accordance with the design (if new or renovated) and the applicable current good manufacturing practice (either if new or existing). IQ will confirm the availability of all the required documentation useful to manage and operate with the equipment/system itself.

在执行IQ 之前，系统的机械安装工作已完成。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第16页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

Prior to the IQ, systems will have to be mechanically completed.

IQ 方案编写 IQ Protocols Preparation:

在所有对产品质量有影响的系统上都要进行IQ。每个IQ 方案都是针对特定 系统的，但是水系统的所有方案都包含以下内容：

For all of the system that affect product quality must undergo IQ.

Each IQ protocol are targeted at specific system, but all protocols for water systems contain the following elements:

- 方案批准页 Protocol Review and Approval Sheet

- 目的 Purpose

- 验证范围 Scope of Validation

- 职责 Responsibility

- 参考文件 Reference documents

- 系统描述 System description

- 文件检查 Document verification

- 系统图和布局图检查 P&ID and Layout verification

- 设备确认 Equipment verification

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第17页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

- 仪表确认 Instrument verification

- 材质和表面抛光的检查 Materials and Surface finishes verification

- 组件结构的检查 Components construction verification

- 死角的确认 Deadleg verification

- 安装情况的检查 Installation verification

- 公用设施的检查 Utilitites verification

- 人员的确认 Personnel identification

- 偏差报告 Deivation report

- 实施结果批准 Execution review and approval

3.9. IQ 接受标准 IQ Acceptance Criteria:

- 所有的参与IQ 执行的人员在实施前须经相关培训。 All personnel participation in IQ execution must pass through the correlation pre-job training.

- 所有文件（如操作手册，维修手册，焊点图，焊接记录，焊接检查，坡度确认，压力测试文件，内窥镜检查测试记录等）将被检查，文档位置将被记录。

All documents (such as operating manuals, maintenance manuals, solder joint plans, records of welding, welding inspection, slope confirmation, pressure test document, endoscopies test records, etc.) will be examined, file location will be recorded.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第18页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

- 所有的图纸（如管道和仪表流程图，管道轴测图，电气图，气动图等）和材质证明等将被检查，文档位置将被记录。

All drawings (For example pipeline and measuring appliance flow chart, three dimensional pipeline schematic drawing, electrical chart, pneumatic operated chart and so on) and with the material quality proved and inspection file location will be recorded.

- 特定系统的备件清单须完备 The detailed list of spare parts for specific system must be completed

- 所有的设备，仪表和配套将被检查并须符合预设标准 All equipment, instrument and accessory will be inspected and they are required to meet the pre-set standards

- 仪表的校正已经成功完成 Instrument calibration has been successfully completed

3.10. 运行确认 Operation Qualification

运行确认是按照预设的操作范围和机械性能进行，通过记录的文件，证明系统和设备能正确运行。

OQ could be executed and operated according to the pre-set operation arrange and mechanism performance through the recorded documentations prove that the system and equipment have been proper operated.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第19页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

OQ 方案编写 OQ Protocols Preparation:

在所有对产品质量有影响的系统上都要进行OQ。我们会为每一个系统写一份OQ 方案。每个OQ 方案都是针对特定系统的，但是所有方案都包含以下内容：

All systems which influence the product quality are needed to execute OQ. We will write a OQ protocol for each system. Each OQ protocol aims at specific system separately, but all protocols are including:

- 方案批准页 Protocol Review and Approval Sheet

- 目的 Purpose

- 验证范围 Scope of Validation

- 职责 Responsibility

- 参考文件 Reference documents

- 系统描述 System description

- 验证仪器的检查 Validation Instruments verification

- 功能检查 Function Verification

- 报警和联锁的检查 Alarms and interlocks verification

- 人员的确认 Personnel identification

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第20页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

- 偏差报告 Deivation report

- 实施结果批准 Execution review and approval

OQ 接受标准 OQ Acceptance Criteria:

- 所有的参与IQ 执行的人员在实施前须经相关培训。 All personnel participation in IQ execution must pass through the correlation pre-job training.

- 所有的OQ 工作将按照已批准的方案执行 All OQ activities should be conducted according to approved protocols.

- OQ 测试仪器应被校准过的， 相关的证书应可溯源NIST 或中国国家计量基准， 并附在相应的方案中OQ Test instruments should be calibrated; the relevant certificate should be NIST or Chinese National measurement standards traceable to the National Institute of Standard Technology and attached to the relevant protocol.

- 系统报警和联锁的情况应符合设计标准 The system’s alarms and interlocks should operate in accordance with the design specification.

- 系统功能运行应符合设计标准 The system’s function should operate in accordance with the design specification.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第21页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

- 系统所用的公用设施应当在规定范围以内（ 温度、压力、流量） Utilities, used by the system, should be available at the battery limit within the specified range (temperature, pressure, flow-rate).

3.11. 控制系统的验证 Validation of Automatic Control System

所有的跟产品生产、质量控制和分销有关的自控系统及其他数据采集，存储和处理系统都属于验证的范围。自控/计算机系统的验证将依据美国FDA （包括21CFR 第11 部分有关电子记录和电子签名的规定）、欧盟的GMP 指南和良好自控生产规范（GAMP）进行。

All automatic control system and other data collection, storage and treatment system related to production, quality control and distribution are involved in the scope of validation. The validation of automatic system would be held according to the US FDA (21 CFR Part 11), GMP guideline of EU and GAMP.

3.12. 性能确认 Performance Qualification

OQ 的成功完成之后，将进行PQ 工作。PQ 将整合考虑规程、人员、物料、设备和工艺。 Upon successful completion of the OQ, Performance Qualification will be carried out. The PQ will integrate procedures, personnel, material, equipment, and process.

测试、规程和接受标准将在系统的挑战性实验之前确立，并在执行完PQ 之后进行审核。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第22页/ 共23 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第4 部分验证 Validation Service

Tests, procedures and acceptance criteria will be defined before challenging the systems and review after PQ execution.

PQ 将证明设备、工艺步骤和参数、公用设施、原料、中间体和标准操作程序可以生产出预先所建立的生产和质量要求。

PQ will demonstrate that equipment, process phases and parameters, utilities, raw materials, intermediates and standard operating procedures allow to reach the pre-established manufacturing and quality requirements.

测试可能包括化学的、物理的、微生物的分析。

Testing may include analysis for chemical, physical, microbiological constituents.

任何显著变化的情况将被要求进行审核和调查，以最终决定适当的纠偏措施。

Any outstanding condition will be identified for review and investigated to eventually determine the appropriate corrective action.

4. 质量项目计划 Quality and Project Plan

参见附件 See attachment.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第23页/ 共23 页

Quality and Project Plan	Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽)
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Quality and Project Plan

质量项目计划

Sanitary Piping System(PW, WFI, PS)

洁净管道系统（纯化水、注射用水、纯蒸汽）

User 用户：	Shenyang Sunshine Pharmaceutical Co., Ltd.
	沈阳三生制药有限责任公司
Department 部门：
Location 位置：
Document No. 文件编号：	3SBIO-01-QPP
Revision 版本：	00

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Review and Approval

审核和批准

	Name 名字	Company 公司	Function 职能	Signature 签名	Date 日期(yyyy.mm.dd)
Prepared by		Macroprocess	Project Manager
编写		朗脉	项目经理
Reviewed by		Macroprocess	Validation Director
审核		朗脉	验证总监
Reviewed by		3SBIO	Production Manager
审核		三生	生产经理
Reviewed by		3SBIO	Engineering Manager
审核		三生	工程部经理
Reviewed by		3SBIO	Validation Manager
审核		三生	验证经理
Approved by		3SBIO	QA Manager
批准		三生	QA 经理

Revision History

版本历史

Revision	Date	Name of Author(s)	Description of Changes
版本	日期	编写人	变更描述
00	2009-01-12		Draft 草案

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INDEX 目录

1. Introduction 介绍	4
2. Overview 概况	4
3. Quality Plan 质量计划	4
3.1. User Quality Requirements 用户质量要求	4
3.2. Quality System 质量体系	6
3.2.1. References 参考文件	6
3.2.2. Work Flow 工作流程	7
3.2.3. Kick off meeting 项目启动会	8
3.2.4. Design Review and Design Qualification 设计审核和设计确认	8
3.2.5. Receiving Inspection 收货检查	8
3.2.6. Construction Control 施工控制	8
3.2.6.1. Welding Documentation and Inspection 焊接文件和检查	8
3.2.6.2. Slope Inspection 坡度检查	10
3.2.6.3. Hydraulic Testing 水压测试	10
3.2.6.4. Cleaning and Passivation 清洗和钝化	11
3.2.7. Acceptance Test 验收测试	12
3.2.7.1. Factory Acceptance Test 工厂验收测试	12
3.2.7.2. Site Acceptance Test 现场验收测试	13
3.2.8. Installation Qualification and Operational Qualification 安装确认和运行确认	13
3.2.9. Documentation Management 文件管理	15
3.2.10. Change Control 变更控制	16
3.2.11. Deviation Handling 偏差处理	16
4. Project Plan 项目计划	17
4.1. Project Organization 项目组织	17
4.2. Deliverable Items 移交清单	18
4.3. Project Schedule 项目进度表	20
5. Glossary 词汇	20
6. Attachment 附件	20
6.1. Attach.1- Project Organization Chart 项目组织结构图	21
6.2. Attach.2- Project Schedule 项目进度表	21

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1. Introduction

介绍

This Quality and Project Plan (QPP) is used for project management and quality control of new plant of Shenyang Sunshine pharmaceutical company limited. This document is written by Shanghai Macroprocess and is reviewed and approved by 3Sbio.

本质量项目计划是为了沈阳三生制药有限责任公司的新建车间的项目管理和质量控制而制定。本文件由上海朗脉科技有限公司编写完成，经三生审核和批准。

2. Overview

概况

This project include the design, construction, commissioning and qualification for the following systems:

本项目包括了以下系统的设计、施工、调试和确认：

- Purified water storage and distribution system

纯化水储存和分配系统

- Water for Injection storage and distribution system

注射用水储存和分配系统

- Pure steam distribution system

纯蒸汽分配系统

3. Quality Plan

质量计划

3.1. User Quality Requirements

用户质量要求

These systems of the project should be in accordance with Chinese GMP (1998) and FDA cGMP requirements, as well as Chinese Pharmacopeia (2005) and USP 30.

本项目建设的系统，应该符合中国GMP（1998 年修订版）要求和美国cGMP 要求，以及中国药典（2005）和美国药典（30 版）标准。

Purified water quality as follows:

纯化水水质标准如下：

-   Conductivity 电导率：≤1.3 μS/cm (25℃)

-   Microbiology 微生物：≤100 CFU/ml

-   TOC: ≤500 ppb

-   Other chemical attribute should be in accordance with Chinese pharmacopeia(2005) 其它化学指标应符合中国2005 版药典要求

WFI Quality as follows:

注射用水水质标准如下：

-   Conductivity 电导率：≤1.3 μS/cm (25℃)

-   Microbiology 微生物：≤10 CFU/100ml

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-   Endotoxin 内毒素：≤0.25 EU

-   TOC: ≤500 ppb

-   Other chemical attribute should be in accordance with Chinese pharmacopeia(2005) 其它化学指标应符合中国2005 版药典要求

For pure steam, its condensate water quality is consistent with WFI quality standard.

纯蒸汽的冷凝水应符合注射用水水质标准。

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3.2. QualitySystem

质量体系

3.2.1. References

参考文件

The project will conduct the design, construction, commissioning and qualification according to the following regulations and guidance.

本项目将按照以下标准和法规进行设计、施工、调试和确认：

No. 序号	Document Name 名称	Document Number 编号	Revision/date 版本/日期
1	User requirement specification (tender technical part) 用户需求说明（URS）（招标文件技术部分）	NA	2008.12.31
2	Chinese GMP 2005 中国GMP（1998 年修订版）	NA	1998 revised
3	US cGMP 美国cGMP	21 CFR part 210-211	Current 现行
4	Eu GMP 欧盟GMP	NA	2008
5	ISPE Baseline Volume 4: water and steam system ISPE 指南第4 卷：水和蒸汽系统	NA	First edition/January, 2001
6	GAMP 5	NA	2008 年

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3.2.2. Work Flow

工作流程

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3.2.3. Kick off meeting

项目启动会

After the contract is signed and effective, our project manager will arrange the Kick-off meeting in order to confirm the project schedule, persons resource, detailed design and procurement etc.

合同签订生效之后，项目经理将召开项目启动会，进行技术交底，并讨论和确定项目进度、人员安排、详细设计和采购事项等等。

3.2.4. Design Review and Design Qualification

设计审核和设计确认

In the end of detailed design phase, the project manager will arrange our project team persons including validation person to do design review in order to the design is in accordance with user requirements and cGMP requirements. Finally, the reviewed design documents will be submitted to client for review and approval.

详细设计完成之后，项目经理将组织项目各专业人员，包括验证人员，对详细设计图纸进行设计审核，以确保设计能够符合用户需求和GMP 要求。最后，审核后的详细设计文件将提交给客户进行批准。

If the contract require that a formal DQ document should be provided, our validation engineer will write the DQ document and submit to client for review and approval.

如果合同规定要提供正式的DQ 文件，那么我们的验证人员将编写一份DQ 文件，并提交给客户审

核和批准。

3.2.5. Receiving Inspection

收货检查

When the material arrival at construction site, the receiving inspection will be done by our project engineer and a “material receiving inspection sheet” will be filled in.

材料到达现场时，项目人员将对材料进行检查，并填写“材料检查记录”。

As a minimum, the inspection items should at least include the following”

检查的项目，至少包括以下几项内容：

-  packaging inspection外观检查，是否完好

-  check if the name, model and quantity of goods conform with purchase orders

与供货单进行对照，检查物品、型号规格、数量是否一致

- documentation,such as material certificate

文件资料是否完整，如材质证明。如没有随货一起，那么另外进行收集和检查

3.2.6. Construction Control

施工控制

3.2.6.1. Welding Documentation and Inspection

焊接文件和检查

Prior to welding ,sample welds will be made to ensure highest quality of welding:

在正式焊接之前，要进行焊样焊接，以检查焊样是否合格。以下情况要进行焊样焊接和检查：

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- Daily at at the beginning and finishing of each work shift|

每班开始和结束

- when changing welding machine, pipe size or pipe lot.

当更换焊机、管子规格或管子批号时

Each sample weld shall be given a subsequent number and welding parameters shall be noted on the “welding report of sample welds”. If contract requires that the report should be signed and approved by client representative, then the report shall be submitted to client for approval.

每个焊样都有一个独自的焊点编号，并编写“焊样焊接报告”。如果合同规定，焊样焊接报告由客户项目负责人或代表进行签字确认，则将此报告提交给客户签字。

Once the samples found satisfactory, the welding on the piping can begin.

焊样合格之后，才能进行正式焊接。

Welding type includes orbital welding and manual welding. After each welding, the visual inspection should be done for welding appearance, and fill result in the “welding report”, such as material, diameter, welding type, welding number, welder and welding date etc. Each weld will be consecutively numbered and marked on the isometric drawing.

焊接类型分为自动轨道氩弧焊和手工氩弧焊。每次焊接之后，要对焊点的外观进行检查，并填写“焊接报告”，包括焊接的物料、管径、焊接类型、焊点编号、焊接人和焊接日期等。每个焊接都有独自的焊点编号，并在管道轴测图上标注。

Generally, inspection for welding will be performed:

对焊点的检查，通常包括了以下项目：

-  Visual inspection of external surface on 100% of the welds

100%的焊点需进行外表面的外观检查\

-  Borescopic Inspections of internal surface on 20% of the welds

20%的自动焊点需进行内表面的内窥镜检查

-  Borescopic Inspections of internal surface on 100% of the welds

100%的手工焊点需进行内表面的内窥镜检查

Borescopic inspection result is recorded on photograph or video.

内窥镜检查的结果以照片或录像的形式记录下来，并保存。

If contract requires that X-ray inspection should be done, X-ray inspection will be done after complete of pipe installation. Generally, the following inspection will be performed: (final sample quantity is according to contract)

如果合同规定需进行焊点的X 光探伤检查，则安排进行X 光探伤检查，一般可对以下项目进行X 光探伤检查（最终的取样量以合同约定为准）：

-  100% of sample welds

100%的焊样

-  100% of manual welds

100%的手工焊点

X-ray inspection result is recorded on radiograph.

X 光探伤检查的结果以X 光片的形式记录下来，并保存。

Welding documents include:

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焊接文件包括了以下：

-  Isometric drawing with welds marked and numbered

带焊点的管道轴测图

-  Welding report for sample welds

焊样的焊接报告

-  Welding report

焊接报告

-  Welding machine print-out

机器打印报告

- Borescopic inspection report and photograph or video

内窥镜检查报告和照片或录像

-  X-ray inspection report and radiograph (if applicable)

X 光探伤检查报告和X 光片（如果需要）

-  Welder’s certificates

焊工资质文件

3.2.6.2. Slope Inspection

坡度检查

In order to assure the complete drainability, it is required 0.5-1.0% of slope for horizontal line.

为了使洁净管道系统能够实现完全排放，对于水平管道，要求有至少为0.5%-1%的坡度，以使管道残留水能够顺着管道排出。

During installation of pipe, the slope inspection will be done and recorded in the “slope inspection report”, if non-conformity, modification should be done.

在管道安装时，须对管道的坡度进行检查，并填写“坡度检查报告”， 如不符合要求，须进行调整。

Membrane valves on horizontal pipe should have a slope according to valve supplier and Diameter in order to completely drain.

水平管道上的隔膜阀的安装，须有一定的倾斜角度，以使管道的水能够完全排放。

3.2.6.3. Hydraulic Testing

水压测试

Prior to hydraulic testing, the preliminary pneumatic testing shall be carried out with compressed air or nitrogen in order to check the networks tightness and no leakage.

在进行水压测试之前，先用压缩空气或氮气进行气压测试，以确保系统无泄漏。

Hydraulic Testing procedure and criteria: DI water or Purified water is used. The hydraulic test pressure is equal to 1.5 times the design pressure and not less than 0.6 MPa. The test time is not less than 2 hours. As criteria, there should be no leakage and pressure loss is not more than 0.03MPa.

水压测试程序和标准：用去离子水或纯化水充满整个系统，用水压测试泵加压至设计压力的1.5 倍，且至少0.6 MPa 压力，保压至少2 小时，系统无泄漏，压力降低不大于0.03MPa。

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3.2.6.4. Cleaning and Passivation

清洗和钝化

The purpose of cleaning and passivation is to remove the grease, oxidation layer of welding and free iron etc. in the internal pipe and form a chromium oxide film.

清洗和钝化目的是为了去除管道系统内表面油脂、焊接氧化皮、游离铁离子等污物，并在管道内部形成一层铬保护膜。

The solution of cleaning and passivation should not contain chlorine. DI water (de-ionized water, purified water or more quality water should be used. In the document, DI water is in lieu of all others. 清洗钝化过程使用不含氯的溶液，使用的水为去离子水,纯化水或更高水质的水，以下以去离子水统称。

Cleaning and passivation of sanitary pipe usually include the following stages:

洁净管道的清洗和钝化，大致分为以下步骤：

1) Degreasing and cleaning 脱脂清洗

2)DI water rinse 去离子水冲洗

3) Passivation 钝化处理

4)DI water rinse 去离子水冲洗

For loop system, such as purified water and WFI loops, the below procedure will be followed:

对于循环管路系统，如纯化水和注射用水分配系统，清洗和钝化程序如下：

Degreasing and cleaing 脱脂清洗

Chemical 化学品	NaOH
Cleaning Solution	2% NaOH
清洗溶液	98% DI water
Procedure 程序	Recirculate at 0.1-0.3 MPa 泵压循环 0.1-0.3 MPa
Temperature 温度	Ambient 室温
Time 时间	45 min

Passivation 钝化

Chemical 化学品	HNO3, HF
Passivation solution 钝化溶液	20% HNO3 3% HF 77% DI water
Procedure 程序	Recirculate at 0.1-0.3 MPa 泵压循环 0.1-0.3 MPa
Temperature 温度	Ambient 室温
Time 时间	30 min

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For one way pipe system, such as pure steam distribution, the below procedure will be followed:

 对于单路管路系统，如纯蒸汽分配系统，清洗和钝化程序如下：

Degreasing and cleaning 脱脂清洗

Chemical 化学品	NaOH
Cleaning Solution	2% NaOH
清洗溶液	98% DI water
Procedure 程序	Completely filled 浸泡
Temperature 温度	Ambient 室温
Time 时间	60 min

Passivation 钝化

Chemical 化学品	HNO3, HF
Cleaning Solution 清洗溶液	20% HNO3 3% HF 77% DI water
Procedure 程序	Completely filled 浸泡
Temperature 温度	Ambient 室温
Time 时间	45 min

After passivation, rinse with DI water until neutral pH is reached for each use point.

钝化之后，进行去离子水冲洗，直至所有区域，包括每个使用点，用pH 试纸测试为中性为止。

For non-water pipe system such as compressed air, nitrogen, only cleaning is required and passivation is not required.

对于压缩空气、氮气等非水介质的管道系统，只需进行脱脂清洗，无需进行钝化。

3.2.7. Acceptance Test

验收测试

3.2.7.1. Factory Acceptance Test

工厂验收测试

Factory acceptance test could be applied to any critical aspect and includes test activity, that will be carried out before the shipment, to get assurance that a new critical equipment/ package has been built following the design specifications and it is provided with the required documentation; moreover the FAT will help to avoid problems that could affect the on site activities progress.

工厂验收测试应该关注设备关键的方面，包括进行测试活动。这些测试将在设备起运之前进行，以保证该设备已按照设计标准进行制造，并提供所需要的文件。因此，FAT 可帮助避免可能影响现场测试的问题的产生。

FAT will be documented; the relevant test report or protocol, will be submitted to client for  review, comments and approval; FAT execution will begin after client approval.

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FAT 将要求进行记录；相关的测试报告或方案，将被提交给客户审核和批准。FAT 将在客户批准后进行。

It is required to conduct FAT only for Tank.

本项目仅要求对水系统储罐进行FAT 。

3.2.7.2. Site Acceptance Test

现场验收测试

Activity Applicable to critical system or equipment; SAT consists of Dynamic and static testing activities performed on site by the vendor before hand over the system to the client. Each SAT activity will be documented. Macroprocess will submit the test document (defined as SAT report or protocol) to Client (for comments and approval).

此工作适用于关键的系统或设备。 SAT 包含动态的和静态的测试活动，测试活动在现场由供应商在移交系统给客户之前进行。每一项SAT 工作将被文件记录下来。我们将提交测试文件（定义为SAT 报告或方案）给客户，以审核和批准。

All tests which reliability will not be affected by the system/equipment modification could not be repeated for qualification purpose, if properly executed (in conformity with Qualification Protocols), witnessed and documented.

那些不会因为系统/设备的改变而影响可靠性的测试，如果已得到正确的执行、证明和文件记录，那么在验证过程中不必重复进行。

3.2.8. Installation Qualification and Operational Qualification

安装确认和运行确认

After SAT is finished, IQ and OQ will be conducted. In some case, IQOQ will be concurrent conducted with SAT .

在进行SAT 之后，进行安装确认（IQ）和运行确认（OQ）。有时，IQOQ 可与SAT 同时进行。

The Installation Qualification will determine that each equipment/system has been installed in accordance with the design (if new or renovated) and the applicable currjent good manufacturing practice (either if new or existing). IQ will confirm the availability of all the required documentation useful to manage and operate with the equipment/system itself.

安装确认将检查每一个设备/系统的安装是否符合设计和相应的GMP 规范。IQ 将确认所有的需要 用于设备/系统的管理和操作的文件的可用性。

Prior to the IQ, systems will have to be mechanically completed.

在执行IQ 之前，系统的机械安装工作已完成。

IQ Acceptance Criteria IQ 接受标准:

-  All personnel participation in IQ execution must pass through the correlation pre-job training. 所有的参与IQ 执行的人员在实施前须经相关培训。

-  All documents (such as operating manuals, maintenance manuals, solder joint plans, records of welding, welding inspection, slope confirmation, pressure test document, endoscopies test records, etc.) will be examined, file location will be recorded.

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所有文件（如操作手册，维修手册，焊点图，焊接记录，焊接检查，坡度确认，压力测试文件，内窥镜检查测试记录等）将被检查，文档位置将被记录。

- All drawings (For example pipeline and measuring appliance flow chart, three dimensional pipeline schematic drawing, electrical chart, pneumatic operated chart and so on) and with the material quality proved and inspection file location will be recorded.

所有的图纸（如管道和仪表流程图，管道轴测图，电气图，气动图等）和材质证明等将被检查，文档位置将被记录。

- All equipment, instrument and accessory will be inspected and they are required to meet the pre-set standards

所有的设备，仪表和配套将被检查并须符合预设标准

- Instrument calibration has been successfully completed仪表的校正已经成功完成

OQ could be executed and operated according to the pre-set operation arrange and mechanism performance through the recorded documentations prove that the system and equipment have been proper operated.

运行确认是按照预设的操作范围和机械性能进行，通过记录的文件，证明系统和设备能正确运行。

OQ Acceptance Criteria:OQ 接受标准

-  All personnel participation in IQ execution must pass through the correlation pre-job training. 所有的参与IQ 执行的人员在实施前须经相关培训。

-  All OQ activities should be conducted according to approved protocols.

所有的OQ 工作将按照已批准的方案执行

-  OQ Test instruments should be calibrated; the relevant certificate should be NIST or Chinese National measurement standards traceable to the National Institute of Standard Technology and attached to the relevant protocol. OQ测试仪器应被校准过的，相关的证书应可溯源NIST 或中国国家计量基准，并附在相应的方案中

-  The system’s alarms and interlocks should operate in accordance with the design specification.

系统报警和联锁的情况应符合设计标准

- Thesystem’s function should operate in accordance with the design specification.

系统功能运行应符合设计标准

- Utilities, used by the system, should be available at the battery limit within the specified range (temperature, pressure, flow-rate).

系统所用的公用设施应当在规定范围以内（温度、压力、流量）

For some simple system, such as pure steam distribution, because OQ tests are not much, usually IQ and OQ will be combined into one document.

对于简单的系统，如纯蒸汽分配系统，因为OQ 测试项目较少，可将IQOQ 文件合二为一。

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3.2.9. Documentation Management

文件管理

The effective control of all documentation is vital to the Project Management System. This control is important to the technical documents that form the primary elements for the Project.

对所有文件的有效控制对项目管理是十分重要的。特别对于技术类文件的有效控制，是项目中的基本要素。

Documents controlled under this system include:

受控的文件，包括以下：

- Design documents 设计文件

- Project management documents 项目管理文件

- Contract documents 合同文件

- All other documents that affect or control the quality of the Project

其它与本项目的质量相关的文件

Document Control 文件控制

Design Specifications and Test Specifications will be reviewed and approved by Macroprocess and client. Documents within Design, Tests and Inspections are controlled as minimum by revision and document history, date, author’s initials and project information.

对于设计、测试和检查等的文件，应进行控制，起草之后，经过客户方授权的人审核和批准，并有版本、变更历史、日期和签名。

Modification of approved documents should be reviewed and approved by Macroprocess and Client and upgraded to next version.

批准后的文件的修改，需要经过朗脉和客户双方的审核和批准，版本进行更新。

Documentation and associated information should be stored safely and securely, They should be protected against accidental and malicious damage, and should be retrievable throughout the defined retention period.

文件档案应妥善保管，保证安全，避免遗失和损坏。

Document number and version 文件编号和版本

Every document should have a Document Number and Version. Document Number has the following structure:

每份文件应该有文件编号和版本。文件编号由以下几个部分组成：

- Abbreviation for the project 项目缩写词

- Abbreviation for system/equipment, if applicable 系统或设备的缩写词（如果适用）

- Abbreviation for different project phase 项目活动缩写词

- Serial Number (three digitals), if applicable 三位数字的顺序号（如果适用）

Documents should be under version control and in draft form prior to formal issue. Their version number should clearly distinguish between draft and approved versions. Version numbers are assigned to each project document, ranging from 00, 01, 02, until 99. The project document has to be distributed as a new version, when any changes are made. If a new draft document is issued, the author assigns the version number 00 to it and distributes this under the “draft” status to the review team.

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文件应进行版本控制，正式发布之前为草案。每个项目文件的版本号，从00、01、02 到99 进行一次编号。当文件有变更时，版本也进行更新。起草一份新的文件时，版本为00，意为“草案”， 经过审核和批准后，正式首次发布的版本为01。

3.2.10. Change Control

变更控制

All system changes that affect already approved documents and GMP Compliance have to be managed according to a change control procedure. All these changes are demonstrably planned, evaluated, approved, and GMP-conform executed and documented.

| 所有影响已经批准的文件和GMP 有关的变更，需要按照变更程序进行管理。所有这些变更需要进 行书面提出，经过合适的评估和批准，然后实施，并进行记录。

3.2.11. Deviation Handling

偏差处理

A Deviation report will be generated during execution of tests. If a test result is not accepted according to the given acceptance criteria the report will be filled in. The deviation should be evaluated and documented and the action measures also should be evaluated, reviewed and approval before execution. Finally, follow-up should be done to check the action result.

如果在测试过程中，出现不符合要求的项目，需编写偏差报告。偏差情况需进行书面的评估、提出偏差处理意见，并经书面审核和批准，然后实施。而且，跟踪实施情况，记录实施的结果。

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4. Project Plan

项目计划

4.1. Project Organization

项目组织

For good management and control of whole project, one project team should be founded which include persons from Macroprocess and client. The project organization chart please see attachment 1. List of main project members is following:

为了对整个项目进行良好的管理和控制，成立一个项目组织团队，包括了朗脉的项目人员和客户的项目人员，项目组织结构图请见附件1。以下是主要项目人员的清单：

Title 职务	Name 姓名	Contact 联系方式
Macroprocess
上海朗脉
Project manager
项目经理
Site manager
现场经理
Design engineer
设计
Procurement engineer 采购
Automatic engineer 自控
Electrical engineer 电气
Validation 验证
3SBIO 三生
Project manger
项目负责人
Project coordinator
项目协调员
Production manager
生产部经理
Engineering manager
工程部经理
QA manager
QA 经理

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4.2. Deliverable Items

移交清单

No. 序号	Document Number 文件编号	Document Name 文件名称	Macroprocess 朗脉	3SBIO 三生
	General 通用部分
1	3SBIO-01-QPP	Quality and Project Plan  质量项目计划	W	A
	标准和说明
2	3SBIO-PW-FS	Functional Specification of Purified water Storage and Distribution 纯化水储存和分配系统的功能说明	W	A
3	3SBIO-WFI-FS	Functional Specification of Water for Injection Storage and Distribution 注射用水储存和分配系统的功能说明	W	A
4	3SBIO-PS-FS	Functional Specification of Pure Steam Distribution 纯蒸汽分配系统的功能说明	W	A
	Design 设计-Mechanical Part 机械部分
5	3SBIO-PW-PID-01	P&ID of Purified water Storage and Distribution 纯化水储存和分配系统的管道仪表流程图	W	A
6	3SBIO-WFI-PID-01	P&ID of Water for Injection Storage and Distribution 注射用水储存和分配系统的管道仪表流程图	W	A
7	3SBIO-PS-PID-01	P&ID of Pure Steam Distribution 纯蒸汽分配系统的管道仪表流程图	W	A
8	3SBIO-PL-01	Pipe Layout of sanitary pipe system 洁净管道平面布置图	W	A
	Design 设计-Control Part 自控部分
9	3SBIO-HDS	Hardware Design Specification 硬件设计说明	W	A
10	3SBIO-SDS	Software Design Specification 软件设计说明	W	A
	Construction Documents 施工文件
11	QMS-SOP-SP-03-F01	Welding Report of sample welds 焊样的焊接报告	W	A
12	QMS-SOP-SP-03-F02	Welding Report 焊接报告	W	A
13	QMS-SOP-SP-03-F03	Borescopic Inspection Report 内窥镜检查报告	W	A

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No. 序号	Document Number 文件编号	Document Name 文件名称	Macroprocess 朗脉	3SBIO 三生
14	QMS-SOP-SP-03-F04	X-Ray Inspection Report X 光探伤检查报告	W	A
15	QMS-SOP-SP-04-F01	Slope Test Report 坡度测试报告	W	A
16	QMS-SOP-SP-05-F01	Hydraulic Test Report 水压测试报告	W	A
17	QMS-SOP-SP-06-F01	Cleaning and Passivation Report 清洗和钝化报告	W	A
	Qualification Documents 确认文件
18	3SBIO-PW-DQ	DQ of PW Storage and Distribution 纯化水储存和分配系统的DQ	W, E	A
19	3SBIO-WFI-DQ	DQ of WFI Storage and Distribution 注射用水储存和分配系统的DQ	W, E	A
20	3SBIO-PS-DQ	DQ of PS Distribution 纯蒸汽分配系统的DQ	W, E	A
21	3SBIO-PW-RA	RA of PW Storage and Distribution 纯化水储存和分配系统的RA	W, E	A
22	3SBIO-WFI- RA	RA of WFI Storage and Distribution 注射用水储存和分配系统的RA	W, E	A
23	3SBIO-PS- RA	RA of PS Distribution 纯蒸汽分配系统的RA	W, E	A
24	3SBIO-PW-TM	TM of PW Storage and Distribution 纯化水储存和分配系统的TM	W, E	A
25	3SBIO-WFI-TM	TM of WFI Storage and Distribution 注射用水储存和分配系统的TM	W, E	A
26	3SBIO-PS-TM	TM of PS Distribution 纯蒸汽分配系统的TM	W, E	A
27	3SBIO-PW-IQ	IQ of PW Storage and Distribution 纯化水储存和分配系统的IQ	W, E	A
28	3SBIO-WFI-IQ	IQ of WFI Storage and Distribution 注射用水储存和分配系统的IQ	W, E	A
29	3SBIO-PW-OQ	OQ of PW Storage and Distribution 纯化水储存和分配系统的OQ	W, E	A
30	3SBIO-WFI-OQ	OQ of WFI Storage and Distribution 注射用水储存和分配系统的OQ	W, E	A
31	3SBIO-PS-IQOQ	IQOQof PS Distribution 纯蒸汽分配系统的IQOQ	W, E	A
32	3SBIO-PW-PQ	PQ of PW Storage and Distribution 纯化水储存和分配系统的PQ	W	E, A
33	3SBIO-WFI-PQ	PQ of WFI Storage and Distribution 注射用水储存和分配系统的PQ	W	E, A
34	3SBIO-PS-PQ	PQ of PS Distribution 纯蒸汽分配系统的PQ	W	E, A

Note 备注: W-Writing 编写, R-Review 审核, A-Approval 批准, E-Execution 实施

Quality and Project Plan	Sanitary Piping System (PW, WFI, PS) 洁净管道系统(纯化水、注射用水、纯蒸汽)
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4.3. Project Schedule

项目进度表

The project will include the following activities:

本项目包括了以下活动：

- Detailed design 二次设计

- Design review 设计评审

- Procurement 采购

- Construction 现场施工

- Commissioning 调试

- Qualification 确认

The detailed Project Schedule is shown in attachment 2. (see bidding document)

详细的项目进度表，请见附件2 (见标书其它部分)。

5. Glossary

词汇

CFR	Code of Federal Regulations 美国联邦法规
FAT	Factory Acceptance Test 工厂验收测试
FS	Functional Specification 功能说明
GAMP	Good Automated Manufacturing Practice 良好的控制系统生产规范
GMP	Good Manufacturing Practice 药品生产质量管理规范
HDS	Hardware Design Specification 硬件设计说明
IQ	Installation Qualification 安装确认
OQ	Operational Qualification 运行确认
PQ	Performance Qualification 性能确认
QP	Qualification Protocol 确认方案
QPP	Quality and Project Plan 质量和项目计划
QR	Qualification Report 确认报告
RA	Risk Assessment 风险评估
SAT	Site Acceptance Test 现场验收测试
SDS	Software Design Specification 软件设计说明
SOP	Standard Operating Procedure 标准操作规程
TM	Traceability Matrix 追溯矩阵表
URS	User Requirement Specification 用户需求说明
VP	Validation Plan 验证计划
VR	Validation Report 验证报告

6. Attachment

附件

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6.1. Attach.1- Project Organization Chart 项目组织结构图 (见标书 see bidding document)

6.2. Attach.2- Project Schedule 项目进度表 (见标书see bidding document)

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第5 部分 施工组织 Construction Scheme

第 5 部分

Part 5

施工组织

Construction Scheme

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

上海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

T:021 54306717      F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第5 部分 施工组织 Construction Scheme

1.工程施工人员组织设计 Staff organization	2
1.1. 人员组成结构图 Organization Chart	2
1.2. 项目组成人员角色及职责  team and responsibility	2
1.3. 验证经理资质 Validation manager qualification	5
1.4. 施工人员组织 Construction organize	10
1.5. 项目经理负责人资质 project manager qualification	11
1.6. 质量控制组织图 Quality control	15
2.施工设备材料投入计划Tools list	16

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

1.工程施工人员组织设计 Staff organization

1.1. 人员组成结构图 Organization Chart

目前拟定结构如下：At present,we study out the staff organization chart as the following:

 

1.2. 项目组成人员角色及职责 team and responsibility

● 项目经理 Project manager

项目负责人；协调和负责整个项目执行，确保项目执行达到各节点要求；安全第一负责人；是业主用户和上海朗脉科技有限公司的联系人；确认来往资料及传真，负责所有项目资料的归档。

Take charge of the whole project , ensure the project proceed to the right requirement and conduct the construction staff. As the window between the owner and Macroprocess; clarify the letter  and fax and all document of the project.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

● 项目组 project team

负责监督完成系统的工艺设计、自动化控制系统设计、CAD 图纸制作等的设计，出图、资料准备、组态及实施监控，完成整个项目设计工作。

Work together to take charge of all design 、drawings of technical and control system. Also prepare the document 、configration and inspection to achieve the design task.

● 施工经理 construction manager

负责项目系统的现场调度、实施、安装、检测和系统正常运行等现场技术支持服务，同时负责协调工程培训事宜，包括培训日程、地点、人员安排等。该职位作为项目实施过程中朗脉公司人员直接与业主沟通。

Take charge of technical support for implement 、installation 、test and operation of whole project, and also response to training including the p lace、schedul e。This position is used to communicate with owner directly.

●  品质管理和质量 quality manager

负责协调和监督工程实施过程中项目质量符合系统设计要求，满足客户需求，同时监控项目实施中的安全操作，确保人力物力的安全。

Ensure the quality meet the owner’s requirement and comply with sepecification, and also control the operation in the construction work, ensure the safty of human resource and material resources.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第3 页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

·   采购经理 purchase manager

具体负责系统设备的预算、采购、物流等管理和支持工作，是项目正常实施的物流枢纽。

Take charge of project’s budget 、purchase 、logistic and other support. As a hinge of all project.

·   验证经理 Validation manager

评估项目质量要求和提供项目实施验证方案确保符合顾客要求，验证与行业规范相符合。

Evaluate the whole project quality requirement and provide the validation proposal to meet the client regulation requirement.

·   用户项目经理 owner project manager

为了使双方的共同渠道畅通，顾客需任命一名项目经理，该项目经理要保证用户的招标承诺实现。并且确认上海朗脉科技有限公司的项目经理定期与用户沟通。用户项目经理是用户与上海朗脉科技有限公司的交流窗口。

In order to push the project smothly,client need to appoint one project manager to ensure promises of whole work. And also need to communicate with Macroprocess stablely.this postion is also a window between owner and client.

·   用户工程组 user team

用户工程组为上海朗脉科技有限公司提供实施项目质量保证的支持工作。作为设计、质量、验证、工程、安全卫生环保的沟通机构。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第4 页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

This team shall provide support to Macroprocess to ensure quality.

·   用户工程师代表 Engineer representation

工程的成功需要用户工程组的努力及配合，参与设计方案的准备有助于他们理解系统，而系统最终要由他们来维护。参与设计及以后的培训使他们能够更加彻底的了解系统。Engineer representation of client need join with Macroprocess to understand the whole design and the proposal, and they will maintain the system by themselves. That to take part in the design is good for them to familiar with whole project.

1.3. 验证经理资质 Validation manager qualification

验证是项目不可或缺的组成部分，验证的过程将直接确保项目的实施是否符合国际法规的要求，确认是否满足验证指定要求。上海朗脉科技有限公司的验证部门派出质量总监全权与其验证团队监督项目的执行。

Validation is one important part of the whole project, Macroprocess will delegate quality director with his team to monitor the project. And his qualification as the following:

他的履历情况如下：

验证经理 Validtion manager             陈国笋 Chen Guosun

学历教育 Education and Qualification：

浙江大学药学院 药学专业本科 执业药师

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第5 页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

Bachelor in Pharmacy,

Pharmacy College of Zhejiang University

Licensed Pharmacist

 专业技能Professional Competence：

有8 年多的制药行业经验，尤其在验证和质量管理方面。Has over 8years of professional experience in Pharmaceutical Industry, especially in Validation and Quality Management.

ü 熟悉中国、美国和欧盟GMP 法规和指南。Be familiar with Chinese, USA and EU GMP Regulations and Guidance.

ü 有GMP 培训和验证的经验，如HVAC 系统的确认、水系统的确认、设备确认、清洗验证和工艺验证等。Experience in GMP training and validation (i.e. HVAC system qualification, water system qualification, equipment qualification, cleaning validation, process validation etc.).

ü 有在制药公司进行生产和质量管理的经验。Experience in Production and Quality Management in Pharmaceutical Company.

 主要项目Key Projects：

● 石家庄欧意药业口服固体制剂 Shijiazhuang Ouyi Pharma.

Oral Solid Dosage Forms

验证经理。负责按照中国GMP 和FDA cGMP 的要求领导验证工作。对HVAC 系统和纯化水系统进行设计审核。编写HVAC 系统、洁净室和纯化水系统的IQOQ 方案，并实施。Validation Manager

Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, FDA cGMP. Design review of HVAC system and purified water system. IQOQ Protocols writing and execution of HVAC system, Clean room and purified water system. IQOQ protocols writing and execution of HVAC computerized system.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第6 页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

·   杭州九源基因 原料药 Hangzhou Jiuyuan Bio-Gene. API 验证经理。负责按照中国GMP 和FDA cGMP 的要求领导验证工作。  纯化水和注射用水系统的设计审核。纯化水和注射用水系统的IQOQ 方案的审核。 Validation Manager Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, FDA cGMP. Design review of Purified water, WFI systems. Review of IQOQ protocols of purified water, WFI systems.

·   齐鲁安替制药 无菌原料药 Qilu Antibiotics Pharma SterileAPI 验证经理。负责按照中国GMP 和FDA cGMP 的要求领导验证工作。 纯化水、注射用水和纯蒸汽系统的设计审核。 Validation Manager Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, FDA cGMP. Design review of Purified water, WFI system and pure steam system.

·   成都生物研究所 疫苗

Chengdu Institute of biological product Vccine

验证经理。负责按照中国GMP 和WHO GMP 的要求领导验证工作。

纯化水、注射用水、纯蒸汽和压缩空气的设计确认。

Validation Manager

Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, WHO GMP.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第7 页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

DQ of Purified water, WFI, Pure steam, compressed air.

·  浙江华海药业 口服固体制剂

Zhejiang Huahai Pharma. Oral Solid Dosage Forms GMP

咨询师。按照中国GMP、FDA cGMP 和欧盟GMP 对概念设计进行GMP 审核。(已于2007 年通过FDA GMP 检查)

GMP Consultant

GMP review of conceptual design in accordance with the requirement of Chinese GMP, FDA cGMP and EU GMP. (Already passed FDA GMP Inspection in 2007)

·  大连美罗制药厂 滴眼剂

Dalian Merro Pharma. Eye Drops

验证经理。负责按照中国GMP 和欧盟GMP 的要求领导验证工作。

负责验证主计划的编写。编写HVAC 系统、洁净室、纯化水、注射用水系统的IQOQ 方案，并实施。

Validation manager

Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, EU GMP. Responsible for VMP writing.

IQOQ protocols writing and execution of HVAC system, Clean room, PW/WFI system.

·  北京四环生物 疫苗

Beijing Four ring Bio-pharma Vaccine

验证经理。负责按照中国GMP 和欧盟GMP 的要求领导验证工作。

编写HVAC 系统、洁净室的IQOQ 方案，并实施。

Validation manager

Responsible for Design GMP review and VMP writing in accordance with the requirement of Chinese GMP, EU GMP.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第8 页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

IQOQ protocols writing and execution of HVAC system  and Clean room.

·  石家庄恩必普药业 软胶囊

Shijiazhuang NBP Pharma. Soft capsule

验证经理。负责按照中国GMP 和FDA cGMP 的要求领导验证 工作。

负责验证主计划的编写。编写HVAC 系统、洁净室、纯化水系

统的IQOQ 方案，并实施。工艺验证、清洗验证和分析方法验

证的培训。

工艺设备的计算机系统验证。

Validation manager

Responsible for Lead Validation work in accordance with the requirement of Chinese GMP, FDA GMP.

Responsible for VMP writing.

IQOQ protocols writing and execution of HVAC system, Clean room, PW system.

Training of process validation, cleaning validation and analytical method validation.  Computer validation of process equipments.

·  北京费森尤斯卡比医药 片剂

Beijing Fresenius Kabi Pharma. Tablet

验证工程师。HVAC 系统和洁净室的DQ/IQ/OQ 方案编写和实施。

(已于2005 年通过EMEA 的GMP 检查)

Validation engineer

DQ/IQ/OQ protocols writing and execution of HVAC system and Clean room.

(Already passed EMEA GMP Inspection in 2005)

·  上海莱士 血制品

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第9 页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

Shanghai RAAS Blood Products

验证工程师。HVAC 系统、纯化水和注射用水系统的DQ/IQ/OQ 方案编写和实施。

Validation engineer

DQ/IQ/OQ protocols writing and execution of HVAC system, Purified water and WFI systems.

1.4. 施工人员组织Construction organize

为保质，按时完成贵公司的管道系统的施工，特组织人员如下：In order to guarantee the quality, & to complete the distribution loop on time,  we especially organize our personnel as follows:

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第10 页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

1.5. 项目经理负责人资质

project manager qualification

针对本次项目的情况，目前暂时确定选择经验丰富的程千振经理作为项目经理人 负责整个项目的实施。他的履历情况如下：

Evaluating this project,we choose professional manager named Chen  Qianzhen as project manager to take charge the technical of whole  peoject. And the folloing is the qualification:

Cheng Qianzhen

程千振

Education and Qualifications 学历教育

• Bachelor of Science，Mechanic Design (1992-1996) 理学学士，机械设计(1992-1996) Shandong University 山东大学

Professional Experience 专业经验

Mr. Cheng has over 10 years of professional experience in project co-ordination, procurement and planning, facility design, generation of facility design drawings, commissioning in pharmaceutical engineering field.

程千振先生在制药工程领域内已有10 年以上专业的项目统筹经验，其中包括采购计划，设施设计，生产设备的设计图，设备调试等。

Key Projects 重点工程

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第11页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

MACROPROCESS TECHNOLOGY CO., LTD.

上海朗脉科技有限公司

Feb 2005– CHENGDU INSTITUTE OF BIOLOGICAL PRODUCTS 2005

年2 月至今 成都生物制品研究所

Project Manager, responsible for engineering design, construction, commissioning and validation execution for clean utilities system which complies to WHO GMP

项目经理，负责疫苗工厂按照WHO 的GMP 进行水系统设计，安装和验证执行。

NCPC NORTHBEST

华北制药集团北元有限公司

Project Manager, responsible for complete a retrofitted Clean Piping system and validation execution which complies to FDA. Water for Injection distribution system, Purified Water distribution system, Pure Steam piping system and Clean Compressed air piping system are included.

项目经理，制药厂按照美国FDA 的GMP 标准进行水系统的改造和验证执行。水系统包括注射用水分配系统，纯化水分配系统，纯蒸汽管道系统，洁净压缩空气管道系统等。

B.BRAUN MEDICAL (SUZHOU) CO., LTD.

贝朗医疗（苏州）有限公司

Project Manager, responsible for complete a retrofitted material preparation system and validation execution which complies to EMEA.

项目经理，制药厂按照欧盟的GMP 标准进行对大输液配料系统进行改造和验证执行。

SHANGHAI WISON BIOENGINEERING CO., LTD.

上海惠生生物工程有限公司

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第12页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

 

Project Manager, responsible for complete a new clean piping system for a new vaccine plant and an antibody laboratory. Including WFI and PW distribution system.

项目经理，负责完成一个新的疫苗工厂和抗体实验室的洁净管道系统。包括注射用水系统和纯化水分配系统。

HANGZHOU TIANYUAN BIOPHARMA 杭州天元生物药业

Project Manager, responsible for engineering design, construction, commissioning and validation execution for clean utilities system which complies to WHO GMP

项目经理，负责疫苗工厂按照WHO 的GMP 进行水系统设计，安装和验证执行。

POLIFARMA (NANJING) CO., LTD.南京宝利化制药有限公司

Project Manager, responsible for complete a retrofitted Clean Piping system and validation execution which complies to TGA. Water for Injection distribution system, Purified Water distribution system are included.

项目经理，制药厂按照澳大利亚TGA 的GMP 标准进行水系统的改造和验证执行。水系统包括注射用水分配系统，纯化水分配系统等。

GE HEALTHCARE (SHANGHAI) CO., LTD.

通用电气（上海）药业有限公司

Project Manager, responsible for complete a retrofitted WFI piping and PS piping system which complies to FDA. This company has been certificated by FDA

项目经理，制药厂按照美国FDA 的标准进行注射用水系统和纯蒸汽系统的改造。该厂的无菌大容量注射剂已通过美国FDA 的认证。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第13 页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

 

Project Manager, responsible for complete the clean piping system for their extension project which complies to FDA. WFI distribution system, PW distribution system, PS system and CA system.

项目经理，扩建项目按照美国FDA 的标准进行洁净管道系统的建设。包括注射用水分配系统，纯化水分配系统，纯蒸汽系统以及压缩空气系统。

SUZHOU DOWNRAYS 苏州东瑞制药有限公司

Project Manager, responsible for process design, construction and commissioning for a clean piping for sterile API production.

项目经理， 负责无菌原料药生产，洁净管道的工艺设计，安装和调试。

BAXTER HEALTHCARE (SHANGHAI) CO., LTD. 百特医疗用品（上海）有限公司

Project Manager, responsible for complete a retrofitted material preparation system and validation execution which complies to EMEA.

项目经理，制药厂按照欧盟的GMP 标准进行对大输液配料系统进行改造和验证执行。

QILU ANTIBIOTICOS PHARMACEUTICAL CO., LTD.

齐鲁安替比奥制药有限公司

1996 – 2005

Project Engineer. Mr. Cheng, who has gotten rich  engineering experience in this ten years, through  organize and participate all the pharmaceutical project  constructed by QILU Group. Such as sterile API project, sterile small volume injection dosage, lyo-product  project and so on.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第14 页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

 

And the sterile API project of Qilu Antibioticos has passed the qualification of EU GMP. Mr. Cheng organized and participate the whole duration.

项目工程师，十年内，通过组织并参与了所有齐鲁集团建设的制药项目，有无菌原料药，无菌小容量液体制剂，冻干产品等一系列项目，他获得了丰富的工程经验。其中齐鲁安替比奥制药有限公司的无菌原料药通过了欧盟GMP 的检查。他参与了全过程。

1.6. 质量控制组织图 Quality control

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第15 页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

 

2.施工设备材料投入计划 Tools list

齐全的施工设备准备是一个项目能够顺利执行的前提条件，朗脉公司已经准备了设备随时按需入场，按照项目施工要求，公司拟定安排以下主要施工机械设备投入计划，清单参照如下（最终设备材料计划以项目经理实际安排为最终确认实施清单）：

Our construction equipment is ready to undertake any task. And acoording to the requirement,we draw a draft plan to launch into project. The list as the following: (the finally plan is refer to project manager’s arrangement)

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第16 页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

 

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第17 页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam storage and Distributions System
	投标文件 Bidding Documents	第5 部分施工组织 Construction Scheme

 

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第18 页/ 共18 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第 6 部分 施工工艺 Construction Technics

第 6 部分

Part 6

施工工艺

Construction Technics

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

上海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室      201100

T:021 54306717      F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分 施工工艺 Construction Technics

目  录Index

1 主要施工工艺 Construction Technics	2
1.1. 施工准备 Construction preparations	2
1.2. 施工步骤 Construction Flow	4
1.3. 配管质量检查流程  Pipline Quality Testing flow chart	6
1.4. 安全施工管理规范 Safety and Good Engineering Plan	6
1.4.1. 安全目标 safety target	6
1.4.2. 安全管理机构 management organization chart	6
1.4.3. 安全管理规范 health and safety guidance	7
1.4.4. 安全管理措施 safety management measures	11
1.5. 施工质量管理 Construction quality management	16
1.5.1. 质量保证体系 quality assurance system	16
1.5.2. 质量保证措施 quality assurance measures	18
1.6. 施工进度管理 schedule manage	27
1.6.1. 进度管理及程序 progress management and procedure	27
1.6.2. 全面资源保障 Strategy for Deploying All Resources	28
1.6.3. 应急预案 emergency preparation	28
1.6.4. 排除施工干扰之政策 Strategy to Expel Interference	30

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

1 主要施工工艺Construction Technics

1.1. 施工准备Construction preparations

施工准备按以下几个过程：Construction preparations refer to the following procedure:

直观检查Visual inspection

抽样检查，确认无损伤并符合要求，检查是否有塑料帽密封10% random checks, confirmed no damage and meet requirements, check whether there are any sealed plastic caps 10%

检查型号，数量及证书Check model No., quantities & Certificates

核对定货单Verification with materials order form

加工现场的准备Preparations for field fabrication

验收及接收由负责人完成确认 Acceptance and receipt of completion to be recognize by the person in charge

材料储存在指定区域内并根据型号，尺寸，洁净级别分类保存 Materials stored in the designated areas under the model, size and sanitary class for preservation & identification

材料运输不可弯曲，撞击，挤压等 When transport materials do not bending, impact and have other extrusion.

材料取用需有详细记录 Material shall be released from storage with detailed records

现场测量，相关设备的检查 Field survey and inspection of Related Equipment

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2 页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

样本制作Samples production

材料预制：管道切割，面处理，弯曲及预制焊接。Prefabricated materials: Pipeline Cutting, surface treatment. Bending and prefabricated welding

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第3页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

1.2. 施工步骤 Construction Flow

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第4 页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

Field welding include 现场焊接包括：

管道定位，现场焊接，质量检查。为保证每一焊缝内表面无氧化变色。必须使用高纯度保护气体，保证冲气时间不小于30 分钟。Pipeline positioning; field welding; quality inspection. To ensure that no surface oxidation color on inner weld surfaces; protection must use high-purity gases, air time is guaranteed – not less than 30 minutes.

非焊接连接：配件、设备连接 Non-Welding connection: accessories, equipment connection

施工后处理：管道检查。气密性测试。Procedure after Construction: pipeline inspection, gas tightness test.

文件移交：样本记录，施工记录及测试报告 Documents submission: samples records, test reports and construction records

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第5页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

1.3. 配管质量检查流程 Pipline Quality Testing flow chart

1.4. 安全施工管理规范 Safety and Good Engineering Plan

1.4.1. 安全目标 safety target

本项目的安全目标是“零事故”。

The safety target for this project is Zero Accident.

1.4.2. 安全管理机构 management organization chart

项目经理Project Manager：

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第6 页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

项目经理是健康安全环保工作的第一责任人,对健康安全环保工作负全面的责任。 Project manager is the first responsible person for safety works. He is fully responsible for the safety work.

安全员Safety Officer: 协助项目经理管理和执行健康安全环保计划,为健康安全环保工作的具体负责人。Assist the project manager to manage and execute safety plan. He is the specific person in charge for the safety work.

1.4.3. 安全管理规范health and safety guidance

施工现场应有专职安全员，每天应定期、不定期巡查，发现安全隐患可责令相关人员停工整顿。In the constructing site, there should have full time safety inspectors who go on a tour of inspection periodically or aperiodically. If any hidden problem is found, order relative personnel shutdown and make amendment.

进入施工现场应戴好安全帽，系紧帽扣，穿好工作服，工作鞋，并佩带工作牌。When entering the constructing site, wear safety helmet, tie the helmet buckle tightly, wear working clothes and shoes and carry working tablet.

严禁穿拖鞋、高跟鞋、泡沫底鞋在工地行走、作业；特别是高空作业（高空作业是指操作点高度在离地面或楼面 1.5m 以上的施工作业）。Strictly forbidden walking and working on the constructing site with slipper and high-heel shoe on, especially high altitude working (high altitude working indicates working at a position more than 1.5mhigh from the ground or floor). 在现场作业

在现场作业人员严禁与其它施工队发生纠打等现象。Forbidden in site working personnel fighting with other construction team.

施工现场人员在工作期间严禁赌博、喝酒。No gambling and drinking is allowed during working time for the in site construction personnel.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第7页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

施工机械（设备）进场前，应检查设备的完好状态；重要的工具在每次使用前，应检查其是否完好。Check the construction mechanism before entering the construction place. Important tools should be checked each time before usage.

施工现场应规范用电，严禁私拉乱接，所有接线应由电工进行；电箱内应有漏电保护开关，保险丝。每一个用电回路均应由单一的断路器（或刀闸） 控制。Regulate electricity usage in the construction site. No private electricity connection is allowed. All the wire connection should be carried out by electrician. The electricity box should be equipped with leakage protection switch and fuse. Each electric loop should be controlled by signal switch (or brake).

所有电气工具操作人员应穿绝缘鞋或带绝缘手套。All electric facility operators should wear insulating gloves or shoes.

电焊机、手工氩弧焊机、自动轨迹焊机均应有可靠接地，接线端子有防护罩，在雷雨天气应暂停焊接作业。 Electric weld machine, manual argon arc weld machine and automatic orbit weld machine should all reliably connected to the earth. The connection should have protective cover. Stop welding in thunder storm situation.

高速旋转的电动工具（如型材切割机、砂轮机、台钻）在操作时严禁带纱质手套。工件的夹持应牢固，不得松动，防止随转动轴旋转或飞出。Wearing gauze gloves when operating the electric equipments with high revolving (such as cutting machine, grinding wheel machine) is forbidden. Hold the tools tightly to prevent their revolving or flying out along the revolving of axis.

各种气品在存放使用时，要距离明火 10 米以上，并且避免在阳光下爆晒，钢瓶在搬动过程中应轻拿轻放，严禁在地面上滚动或拖拉，严禁抛掷。All kinds of gases shall be over 10 meters away from open flame and avoid being insolated in the sun when they are stored or used. Slightly lift and put sown the steel tank. No rolling, dragging and throwing is allowed.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第8页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

\登高作业时（高度超过 1. 5 米），应有专人配合，配合人员负责工具，材料的接送，并负责看护；作业人员应佩带安全带，安全带的搭扣应系在操作点的上方的牢固构件上。 Climbing work should be assisted by special person who is in charge of delivering materials and tools and watching. Working person should wear safety belt with its agraffe tied to substantial component on top of the operating point.

撑梯的张角应合适（一般为 60-70°为宜），梯子在摆放前应先清理地面，梯子严禁接长使用。Folding ladder should have a suitable open angle (60-70°preferred). Make up the ground before placing the ladder. Prolonging the ladder for usage is forbidden.

严禁病时酒后作业，严禁有恐高症、高血压等疾病的人员进行高空作业。Do not work when in sickness or after drinking alcohol. High altitude working is forbidden if operated by people with acrophobia, high blood pressure, etc.

在施工现场动火，应得到业主、工地安全员的书面批准，并在火源处摆放手提式灭火器。Making fire in the construction site should be approved by written permission given by the owner or safety personnel in construction place and a portable fire extinguisher should be put on the fire place.

动火前应先清理操作点附近的易燃易爆品，并由专业人员进行。Remove the flammable and explosive material around the fire place. This should be operated by professionals.

所有操作人员应按规定在进入施工现场施工时，签定安全施工责任书，实行安全奖惩制度。 All the operation personnel should sign safe construction duty sheet before entering construction site. Put the safety rewards and punishments regulation into use.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第9页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

在彩钢板上施工时。应先检查彩钢板是否已安装完成，（特别是彩钢板加强吊筋是否已安装。人员在行走时应尽量在隔墙、隔断、吊筋处或附近，重物应摆放在隔墙、隔断处。Before constructing on the colored steel sheet, first inspect if it has been completely installed (especially whether the reinforced hanger has been installed). People should walk on or near the partition, obstruct and hanger. Heavy things should be put at the place of partition and obstruct.

严禁在彩钢板开口处（如风口、灯孔等）行走、作业。 Walking and working at the colored steel sheet opening (e.g. air pot, lamp hole) are forbidden.

在容器和狭小管道内焊接时，应加强通风，严格执行双人监护制，监护人必须坚守岗位，发现问题要及时采取措施。When welding in containers or small-spaced pipes, ventilation shall be reinforced. Strictly execute the double-guardian system. The guardians shall stick to their post and take necessary measures once finding problems.

受压容器、密封容器、各种油桶、管道沾有可燃气体和溶液的工作进行时，必须先进行检查，并经过冲洗除掉有害、易燃、易爆物质并解除容器管道压力，清除容器 (包括密封空心、工件、管子 )的密封状态 (敞开口旋开盖)再进行工作，禁止在已做油漆或喷漆塑料的容器内焊接。When performing operations involving combustible gas and solution on the pressurized tanks, sealed tanks, various oil tanks and pipes, you should check them first, remove the harmful, combustive, and explosive material by flushing them, release the pressure of tanks and pipes, and remove the seals of the tanks (including the sealed cavity, work pieces, and pipes) before any work is done. To weld in the painted tanks is forbidden.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第10页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

在做酸洗时，先试压，保压后用碱液试纸擦抹每一个焊缝，观察有无泄漏，严格执行双人坚督制、签字确认制，应穿带好防酸手套及防毒面具防酸胶鞋等防护用品。有关硝酸、盐酸、硫酸的化学用品使用中应注意：配比稀释时应逐渐地缓慢地小剂量的混合，切忌大剂量强制溶合,防止爆溅伤人。When performing pickling, have a pressure test first. Then keep the pressure and erase each weld seam with alkali test paper to check if there is any leakage. Strictly execute the double-guardian system and signature-conforming system. Protective articles should be worn, such as acidproof gloves, gas mask, and acidproof rubber shoes. When using chemicals such as nitric acid, hydrochloric acid, and sulfuric acid, take care: When carrying out dilution practices, gradually and slowly mix with small volume. Do not mix with large volume, or it will cause explosion, spattering and damage.

废料、废水应妥善处理、不应污染工作环境Waste material and waste water should be treated properly without polluting the working environment.

进入甲方施工现场，应遵守甲方的一切安全规章制度。Obey party A‘s all safety regulations while entering party A’s construction site.

未尽事宜，应按国家有关规定的标准执行。Unmentioned matters are carried out in accordance with relative national criteria.

1.4.4. 安全管理措施safety management measures

健康安全管理措施 health and safety management measures 总的原则是执行业主的健康安全计划，执行我公司安全管理的制度及政府

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第11页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

的有关法规。The general principle is to execute the owner’s safety plan, our company’s safety management system and relative official regulations.

安全教育safety education 安全教育的目的是提高职工的安全意识和自我保护的能力，避免各类事故的发生。 The safety education aims to improve employee’s safety awareness and self-protection ability and avoid accidents.

安全教育的形式 forms of safety education

进场安全教育*（*表示教育后需进行考试）

Safety education on field entrance *（ *indicates tests will be held aftereducation）

方案技术交底教育 Technical notification on design proposal

星期一安全例会的教育 Regular safety meeting on Mondays

班前安全教育 Safety education before work

每一次教育都必须记录 ,记录教育的时间、地点、参加人员名单、教育的内容，进行考试的还应保存好考试成绩及试卷。 Each time the education should have a record to note the education time, location, person list and contents. Keep the test scores and test papers if test is taken.

安全作业单元与安全许可证safety operation unit and safety license

安全作业单 ,施工任务的布置通过安全作业单的方式下达 , 以保证安全工作与施工过程 ”五同时 ”(即计划、布置、检查、总结、评比五同时) Safety operation sheet. The construction tasks are assigned by safety operation sheets, which ensure the “five simultaneous” (simultaneous plan, assign, inspect, summarize, compare) of safety work and construction procedures

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第12页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

安全许可证，以下特殊作业必须有安全许可证：Safety license. The following special operations require safety licenses:

§ 进入设备作业许可证Equipment entry operation license

§ 电工作业许可证 Electrician operation license

§ 有毒有害作业许可证 Poisonous and deleterious  operation license

安全检查safety inspection

安全检查是做好健康安装工作的重要手段之一,能及时发现事故隐患,及时制止三违”(违章作业、违章指挥、违反劳动纪律)的行为发生，保证各项安全管理规章制度落到实处，从而杜绝事故的发生。Safety inspection is one of the key measures in safe installation. It can timely find the potential accident, prevent the "three breaches" activities (regulation-breaching operation, regulation-breaching direction, breach labor laws), and ensure all the safety regulations can be executed, so as to prevent the possibility of accidents.

安全检查的内容是：查领导、查制度、查机械设备、查安全设施、查教育培训、查操作行为、查劳保用品使用、查事故处理等。Contents of safety inspection: inspect the leaders, inspect the system, inspect the equipment, inspect the safety devices, inspect the education and training, inspect the operation, inspection the labor protection appliance, inspect the accident reasons, etc.

季节性安全检查。冬季应以防雪、解冻、跑漏、防临时建筑物倒塌为重点，秋季以防火防爆为重点。Seasonal safety inspection. In winters focus on snowproof, defreezing, and preventing the building collapse. In autumns focus on fireprotection and blameproof.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第13页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

所有检查均必须按安全检查表进行，并做好记录。 All the inspections should be taken as per safety inspection sheet with relative records done.

基层检查均必须按安全检查表进行，并做好记录。Grass roots inspection should accord with safety inspection sheet with relative records done.

代表性的安全检查种类 Typical Safety Inspection Category

领导检查中发现的隐患应下达书面的《事故隐患整改通知单》限期整改。If any hidden trouble is found during leader inspection, send out a Modification Notification on Hidden Trouble and ask them to modify it within a certain time.

隐患整改 hidden trouble modification

接《事故隐患整改通知单》后，责任人应立即组织整改，做到“三定”（定具体整改人员、定整改措施、定整改完成时间）; After receiving the Modification Notification on Hidden Trouble, the person in charge should arrange modification immediately, accomplishing “three establishes” (establish the persons involved in modification, establish the modification measures, and establish the finish time)

隐患整改完毕及时将整改结果书面反馈给通知单发出人。After finishing modifying the hidden troubles, timely feedback the modification results in paper to the person who sends out the modification notification.

通知发出人收到反馈情况后，要复验整改结果。The notification sender should re-inspect the modification results after having received the feedback.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第14页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

应急计划 emergency

目的正确、及时处理意外情况，防止事故扩大，将事故损失控制在最小范围内。 The plan aims to correctly and timely treat the accidental conditions, prevent the accident from extending, and control the damages to a smallest limit.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第15页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

1.5. 施工质量管理 Construction quality management

1.5.1. 质量保证体系 quality assurance system

1.5.1.1. 公司质量方针 guidance on quality

质量是永恒的追求，提供满足业主要求的工程和服务。

Quality is the goals to meet the requirement of owner on project and service.

1.5.1.2. 本项目质量目标 target quality for this project

标：保证我公司所提供的工程和服务，一次性通过相关认证。

Target: Ensure our engineering and services can pass relative certification only one time

1.5.1.3. 基本质量要求basic quality requirements

恰当的控制各项工程步骤；连续的保持各项质量的有效性。Control all the construction procedures correctly. Maintain all the quality indexes effective continuously.

要具有及时预防和及时纠偏的能力。Have the ability to timely prevent and correct the errors.

具有可追溯性，能正确方便的追溯到各项质量、生产状况、检验情况，能追溯到事和人，便于分析改进不断完善体系和提高工程质量。Traceability. We can trace back to quality, manufacturing, and checking status as well as matters and persons for the convenience of analyse and improving system and project quality.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第16页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

确保整个工程能顺利通过国家 GMP 验证，并达到美国 FDA 中要求的相应水平。 Ensure the whole project can pass the national GMP validation and FDA standards.

1.5.1.4. 现场质量保证体系 construction field quality assurance system

项目质量实行公司经理负责制，对现场项目质量负有全面监督和保证职责。The project quality is ensured by manager responsibility system, which will monitor the on-site project quality.

现场项目经理对现场质量负有组织、全面管理的职责。 The field project manager is responsible to organize and manage the field construction quality.

建立以自检、互检和专职检查相结合的检验体系，把检验工作贯穿于预制、安装的全过程。对各个质量控制点，一定要按有关规范要求进行严格的检查、验收，验收不合格的工序坚决不允许转入下道工序。Establish a checking system combining self-check, cross check, and special check. The checking operation should be implemented through the prefabrication and installation. The quality control points should be checked and accepted by all relative regulations. Do not turn to the next procedure of the process if the previous procedure is unqualified.

质量员负责现场项目施工中的质量的检查监督、检验和试验、质量记录和不合格品的控制，以及推动、监督现场质量保证体系的正常运行。Quality officer is in charge of the quality supervision, inspection, experiment, quality record, and unqualified product control during field project construction, so as to promote and monitor the normal operation of on-site quality assurance system.

材料员负责自行采购和业主提供设备、材料的质量控制。The material officer is in charge of on-site purchasing and the quality control of the equipment and materials provided by the owner

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第17页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

现场作业层的各专业、施工单位，统一在现场质量保证机构领导和控制下进行质量活动。All the construction companies will carry out activities involving quality under the united supervision and control of on-site quality assurance organization.

恰当的控制各项工程步骤；连续的保持各项质量的有效性。Correctly control all the engineering steps. Maintain all the quality index continuously effective.

具有及时预防和及时纠偏的能力。This system has the capacity to timely prevent and correct errors.

具有可追溯性，能正确方便的追溯到各项质量、生产状况、检验情况，能追溯到事和人，便于分析改进不断完善体系和提高工程质量。This system is traceable. We can trace back to quality, manufacturing, and checking status as well as matters and persons for the convenience of analyse and improving system and project quality.

确保整个工程能顺利通过国家 GMP 验证，并达到美国 FDA 中要求的相应水平。Ensure the whole project can pass the national GMP validation and FDA standards

1.5.2. 质量保证措施quality assurance measures 

 严格按公司质量体系要求进行，特别注意人员培训，资质审核，材料检验，焊接工艺评定，工机具、量器具检验，各质量控制点等方面严格把关。

Strictly operate according to the quality system. Pay special attentions to personnel training, qualification verification, material checking, welding verification, tools and instruments checking. Check all the quality control points.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第18页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

1.5.2.1. 图纸资料管理 drawings management

对下发到各部门的图纸、方案、技术规范联络笺、材料代用单等必须指定专人统一管理，并登记收发，各技术员应做好施工原始资料，交工资料的整理工作，并协助施工班组填写各种施工记录表、卡，施工技术员每天必须记录施工日记

All the drawings, proposals, technical standards, contact list, material sheet should be unitedly managed by a special person and have a registration record. The technicians should compile and pack all the original construction data and project handing over data, and assist the construction group to fill in all kinds of construction records and cards. The technicians should write the construction log daily.

1.5.2.2. 材料管理 material management

材料方面的资料由材料员管理，如产品合格证、材质说明书、收发料单等。根据专业技术负责人审核过单线图，材料表和预算并填写限额领料单到仓库领料时，对材质、规格、数量进行核实和验收。并且有合格证件（或复印件）确认无误，并在计算机上进行消料处理。收货人签字。领回后入库时应规格、型号、材质、分类挂牌存放并计入帐卡，按上述程序材料员向班组发料，每天将领、发料单装订成册备查，领回后不入库直接运到现场的材料，也应计入帐卡，交接清楚，按指定地方堆放整齐。The data concerning material, such as product certificates, material specification, material accepting and delivery sheet, are administered by material officer. Check the material, specification, and quality when receive material in the warehouse after fill in a material receiving sheet according to the drawings, material list, and budget. Check whether the certificates (or their copies) are valid and input it into the computer. The person who receives the material should sign on the receiving sheet. After accepting the material, put it into the inventory. Separate and store them according to the specifications, models, materials and category. Distribute the material to the construction teams according to the above procedures. Compile a material receiving and distribution booklet each day. If a certain material is moved to the construction field instead of being put into the warehouse after being received, it should also be registered with clear notes to identify its location.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第19页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

对所有材料特别是不锈钢，在切割后必须进行材质标识移置。The material marks should be moved after welding for all the materials, especially stainless steel.

1.5.2.3. 焊接管理 welding management

项目部设置焊接专业工程师、焊接组长及系统验证专职人员，具体负责焊接工作，包括在单线图上标注焊口号、焊工代号、无损检验部位，填写无损检验委托单，联系与配合试验室无损检验。焊缝预热和热处理记录，透视报告的保管，焊接及热处理施工记录，管理焊条的烘烤、存放和保管记录等验证文件都由专职人员进行处理。Project department possesses the welding technician, welding team leader, and system validation personnel. They are in charge of welding, including note welding port number, welder code, non-destruction inspection parts on the single line diagram, fill in the non-destruction inspection sheet, contact and coordination with the lab non-destruction inspection, welding seam preheating and heat treatment record, perspective report maintenance, welding and heat treatment record, welding rot roasting, and record storage and maintenance. These works will be done by special personnel.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第20页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

每个焊工均有一个固定的代号。公司焊接试验室应把经考试合格的焊工姓名、代号及合格项目表及时发给焊工所在的施工队及检验部门备查。焊后在其所焊的焊缝旁用记号笔写上代号，并要标注在单线图上。 Each welder has his own stable code. Our company will hand over the welder’s name, code, and qualified project sheet to the construction team and inspection department for reference in time. The welder will mark his code close to the weld seam and note on the single line diagram after welding.

焊好的管线经自检、互检合格后按规定的 X 射线透视比例由施工队委托试验进行透视，X光底片以区域为单位，以管线号为依据，建立流水号。同一焊口在透视委托单、底片、透视记录、检验报告以及在单线图上的标注必须一致，使抽查任何一张底片就可知道焊接位置。透视一定要及时，未经透视或抽透不足及需要重新返修的管线一般不要去安装，以减少高空作业，对透视不合格的焊口应立即在管线上作出明显标志，并及时组织返修，直至合格为止。返修次数不锈钢管不超过两次，并作好返修记录。 Self-check and cross check the pipelines after welding. If it is qualified, the construction team shall carry out perspective operation according to the specified X-ray perspective ratio. The X-ray negative film is divided by units of area. Set up a numerical order according to the pipeline number. The marks should be unified for the same weld port on perspective sheet, negative file, perspective record, inspection record, and single line diagram for the convenience of knowing the welding position just by checking only one negative film. The perspective should be taken in time. The pipeline without perspective or with less insufficient perspective or repair needed should not be installed so as to reduce aloft work. Make obvious marks on the pipelines that have welding ports with unqualified perspective. Arrange repairs timely, until it is qualified. The repair times should not be more than twice for stainless steel pipes. Do not forget to make repair records.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第21页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

对所有预制完并经检验合格的管段，暂不安装的，管口应予以封闭。To all the pipes that have being prefabricated and qualified, but will not be installed immediately, seal the pipe ends.

对不锈钢管道，在预制和安装时不得与其它管道接触。 To the stainless steel pipes, do not contact them with other pipes when under prefabracation and installation.

1.5.2.4. 检验管理 checking management

建立以自检、互检和专职检查相结合的检验体系，把检验工作贯穿于预制、安装的全过程。对各个质量控制点，一定要按有关规范要求进行严格的检查、验收，验收不合格的工序坚决不允许转入下道工序。Establish a checking system combining self-check, cross check, and special check. The checking operation should be implemented through the prefabrication and installation. The quality control points should be checked and accepted by all relative regulations. Do not turn to the next procedure of the process if the previous procedure is unqualified.

1.5.2.5. 质量控制

项目质量控制重点参照业主工艺的要求，结合本公司在类似工程的施工经历，初步明确下列质量控制重点： according to the owner’s requirements and our similar construction experiences in the past, we’ve established the following key quality control points:

设备、材料的选择与采购 The selection and purchasing of equipment and material

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第22页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

焊接工程 Welding

电气、仪表 Electricity and instruments

清洁清扫Cleaning

资料管理 Documentation management

质量控制的原则 the principles for quality control

预防为主、检验把关； Focus on prevention and inspection

以 FD A、SFDA 的标准作为项目施工和验收的依据；Set FDA and SFDA criteria as the standards for project construction and acceptance

设备、材料的选择和采购必须经过技术部检验合格后方可使用；The equipment and material can be used only after being verified by the technique department

工序质量否决制：即上一道工序不合格，坚决不允许进入下一道工序；Process quality veto system: Namely no entrance to the next procedure if the previous one is unqualified.

施工记录、质量记录与施工同步，确保施工过程得到有效控制；Construction record and quality record should be simultaneous with the construction, ensuing the construction procedure can be effectively controlled.

所有施工机具、检验、检测、计量设备符合项目施工技术、施工质量要求；All the construction devices and checking, measuring, and accounting instruments accord with the technical and quality requirements

参加和参与施工的人员必须符合施工技术的要求，主要工种须持证上岗，所有人员须经技术、安全培训合格。People who are involved in the construction should meet the technical requirements for construction. Person at important job position shall have certificate. All the staff must pass technical and safety training.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第23页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

1.5.2.6. 针对性质量保证措施 Pertinent quality assurance measures

焊接质量保证措施 Welding quality assurance measures 焊接质量是施工质量中关键的组成部分。本工程为制药项目，有洁净度要求，为保证管道焊接质量，我们采取以下措施：Welding quality is the key in construction quality. This is a pharmaceutical project, which have high requirement on sanitation. To ensure the pipe welding quality, we will take the following measures:

不锈钢管道采用全自动氩气保护焊接；The stainless steel pipes are auto welded with argon gas protection

设置专门的不锈钢材料堆放场所；Set up special stainless steel storage place

成立专门的不锈钢管道施工队；Establish a special stainless steel pipe engineering team

每个焊工均有一个固定的代号。公司焊接试验室应把经考试合格的焊工姓名、代号及合格项目表及时发给焊工所在的施工队及检验部门备查。焊后在其所焊的焊缝旁用记号笔写上代号，并要标注在单线图上；Each welder has his own code. Our company will hand over the welder’s name, code, and qualified project sheet to the construction team and inspection department for reference in time. The welder will mark his code close to the weld seam and note on the single line diagram after welding.

对所有预制完并经检验合格的管段，暂不安装的，管口应予以封闭。To all the pipes that have being prefabricated and qualified, but will not be installed immediately, seal the pipe ends.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第24页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

对不锈钢管道，在预制和安装时不得与其它管道接触。To the stainless steel pipes, do not contact them with other pipes when under prefabracation and installation.

试压时使用的水源必须为纯化水，必须有效控制游离氯和氯离子的含量. The source water for pressure test should be purified water, which can effectively control the free chlorine and chlorine ion.

保温工程质量保证措施 Quality assurance measures for heat preservation

管道保温须进行错缝连接；Breaking joints for pipe heat preservation

保温层的包扎应严密不漏，符合规范的要求。The bandage for heat insulating layer should be tight and accords with the specification。

清洁文明保证措施 Assurance measures for cleaning

施工现场保持清洁文明，特别是有洁净要求的厂房，每个工种完成工作后，清理干净工作区域；Keep the construction field clean. Especially in the plant building that have special requirements on sanitation, clean the working area each time after finish operation.

进入洁净厂房施工前，工具、设备、材料、防护用品都必须进行清洁，经检查后方可进入洁净厂房施工；Before entering the sanitary plant for construction, the tools, equipment, materials, and protective articles should be cleaned and inspected.

洁净厂房管道施工内外壁清理干净，焊口内外清除干净，并及时封闭，室内所有缝隙、电仪管口、接线盒必须清扫干净。Clean the inner and outer pipe walls. Clean the weld ports and timely seal them. Clean all the seams, electric instrument pipe ports, and connection box

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第25页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

1.5.2.7. 资料管理

对下发到各部门的图纸、方案、技术规范联络笺、材料代用单等必须指定专人统一管理，并登记收发，各技术员应做好施工原始资料，交工资料的整理工作，并协助施工班组填写各种施工记录表、卡，施工技术员每天必须记录施工日记。All the drawings, proposals, technical standards, contact list, material sheet should be unitedly managed by a special person and have a registration record. The technicians should compile and pack all the original construction data and project handing over data, and assist the construction group to fill in all kinds of construction records and cards. The technicians should write the construction log daily.

项目部设立专职验证员和资料员，专门负责相关文件的填写、交接、整理、归档等管理工作，使在施工过程中的每一道工序、每一个变更、每一次变更等都有相应的记录，具有可追溯性。施工过程中材料的质量证明文件，材料的自查、委托检查记录；施工方案的确定；施工人员的安排、施工机械的调配以及所有施工资源的分配全部有案可查。施工过程中与建设单位，其他施工单位的协调也相应作详尽的记录。最终目标使工程顺利通过建设单位、国家职能部门等检查，验证。The project department has verification officer and data officer to be specially in charge of document filling handing over, management and filing. Each procedure or each change should have relative record and is traceable.We have the history documents for material quality certificates, material self-check and cross check record, construction proposal determination, construction personnel arrangement, construction mechanics arrangement, and construction resources deployment. The detailed record of coordination with the constructed company and other construction companies should also be available.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第26页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

1.6. 施工进度管理 schedule manage

1.6.1. 进度管理及程序 progress management and procedure

向业主及工程总包递交的进度文件清单：The Progress list supplied to the owner:

进度周报、进度月报、进度计划（总体计划、季度计划、月度计划）、纠偏计划 Progress Weekly, Progress Monthly, Progress Plan (whole plan, quarterly plan, monthly plan), Correction Plan

进度管理职责表：Progress Management Responsibility Sheet

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第27页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

进度管理程序图 Progress Management Process Chart

1.6.2. 全面资源保障 Strategy for Deploying All Resources

充分调动公司内部的资源 Sufficiently Deploy Resources in Our Company

我们充分认识到此项目的重要性，公司总部将从各个方面对此项目进行支持政策的倾斜 We fully understand the importance of this project. Our headquarter will offer privileged support on this project

项目经理长驻现场。Project manager will stay at the construction field for a long time.

向此项目选择经验的项目经理，优秀的工程师，有丰富经验的工人和完好的施工设备。We will select experienced project manager, excellent engineers, skillful workers, and whole package of engineering equipment

我们已做好劳动力的充分保障。We have sufficient labor insurance

充分调动当地资源 Sufficiently Deploy Local Resources

充分与兄弟施工单位加强联系，利用当地在水、电、气、材料供应，人力资源，加工能力，运输能力等优势。Sufficiently contact with other construction companies and make advantages of local water, electricity, gas, material, labor, and machining ability

1.6.3. 应急预案 emergency preparation

冬季施工工期保证措施 Assuring Measures for Construction in Winter

因工程主要施工时间在主体厂房施工完成之后，且装修、装饰基本施工完成之后，所以在冬季施工的寒冷气候对工程施工的影响并不是特别大。Our construction will start after the main part of the plant building is finished and its decoration is done, therefore the cold weather won’t have big influences to our construction

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第28页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

尽量避免室外施工，应全面检查防冻保暖工作，充分做好防寒、防冻、防滑、防火和防止一氧化碳中毒的措施。Try to avoid outdoor construction. Fully check the antifreeze and heat protection measures. Take measures for anti-cold, anti-freeze, skid proof, fire proof, and carbon monoxide poisoning proof.

尽量避免冬季登高作业。Try to avoid ascending work

遇暴风雪应停止室外工作，严禁在冰冻的湿地上施工。Stop working at snowstorm. Do not work on cold and moist field.

夏季施工工期保证措施Assuring Measures in Summer

首先调整作息时间，使施工的主要时间集中在早晚比较凉爽的时间进行。 Adjust the work and rest time at first to focus the engineering time on morning and evening, when it is cold.

要配备必要的防暑降温设施、器材、药品和茶水饮料。Prepare necessary heatstroke preventative devices, equipment, drugs, and waters.

高温作业场所，应加强通风和降温措施。Reinforce ventilation and cooling measures for

通风机和排风扇等设备应由防护网罩。The ventilator and exhaust fan should have protection shield

要加强食堂的清洁卫生工作，严格执行检查消毒制度，防止职工食物中毒。Strengthen the sanitary conditions in dining room. Strictly execute the disinfection system. Avoid food poisoning.

雨季施工工期保证措施Assuring Measures in Rain Season

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第29页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

暴雨前后，要检查工地临时设施，脚手架、机电设备、临时用电线路等，发现倾斜、变形、下沉、漏雨、漏电等现象应及时修理加固，有严重危险的应立即排除；After rainstorm, check the temporary equipment, scaffold, electric devices, temporary electric loop, etc. Repair it if any incline, deformation, sinking, rain leakage, and electricity leakage is found. Remove it if it is severely dangerous.

雷雨时，严禁管道焊接工作。Pipe welding is strictly forbidden at thunder storm.

1.6.4. 排除施工干扰之政策 Strategy to Expel Interference

当设备材料、设计图纸因特殊原因不能正点到位时，立即调整施工计划，制定补救工期的对策。一旦到位，立即施工，将失去的工期补回来。If the equipment, material, or design drawings can not arrive in place in time, adjust the construction plan immediately and set up countermeasure. Once they arrive, carry out construction immediately to offset the time limit.

自供的材料合理安排采购计划，确保不影响施工进度计划，对于因施工计划改变可能需紧急采购的材料，应在施工前做工供应商的评估。 For the materials that are supposed to be purchased by ourselves, reasonably arrange the purchasing plan. Verify the supplier before construction if urgent purchasing is necessary because of construction plan changes.

与生产运行有交叉的，在施工开始前做好防护隔离措施，保证施工与生产的安全顺利进行。 Take protective measures before construction if production operation is involved, so as to ensure the successful operation of construction and manufacturing.

坚持逐月检查，警惕和预防传染病的袭击，发现病员，立即隔离。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第30页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第6 部分施工工艺 Construction Technics

Carry out checking month by month. Look out and guard against the attack of infection. If any patients are found, separate them from others.

管线及其它设施的加固措施 Solidifying Measures for Pipes and Other Devices

管道在安装过程中，严格执行工艺作业规程，一般现做支架固定，并手工点焊固定，并在短期内施焊完成。During installation procedures, strictly implement the process working specifications. Normally use a bracket for the sake of solidifying and weld it in short time.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第31页/ 共31 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第 7 部分 管道系统施工规范 Construction Regulation for Piping System

第 7 部分

Part 7

管道系统施工规范

Construction Regulation for

Piping System

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

上海朗脉科技有限公司

上海市闵行区罗阳路 168 号 A 座101 室     201100

T:021 54306717     F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第 7 部分 管道系统施工规范 Construction Regulation for Piping System

目 录

1. 管道系统施工规范 Construction Regulation	3
1.1. 焊接总则 General	3
1.2. 焊接规范 Welding regulation	4
1.2.1. 总体要求 General requirements	4
1.2.2. 材料 Material	5
1.2.3. 焊接准备 Weld joint preparation and fit-up	6
1.2.4. 预热温度 Preheating temperature	8
1.2.5. 供电 Electrical characteristics	8
1.2.6. 焊接程序 Welding procedure	8
1.2.7. 焊接修补 Weld repair	8
1.2.8. 自动焊接程序 Automatic welding program	9
1.2.9. 文档 Documentation	10
1.2.10. 非破坏性检查 Non destructive examination	11
1.2.11. 每日焊接样品 Weld daily samples	11
1.3. 装配和安装 Fabrication and erection	11
1.3.1. 范围 Scope	11
1.3.2. 管件材料接收储存 Tubing materials receipt storage	12
1.3.3. 分类 Identification	13
1.3.4. 装配 Fabrication	13
1.3.5. 布管，切割和装备 Lay-out, cutting and fitting up	13
1.3.6. 焊接程序和资格 Welding procedure and qualifications	14
1.3.7. 安装 Erection	14
1.3.8. 焊接接口 Welded joints	15
1.3.9. 法兰接口 Flanged joints	15

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

1.3.10. 快装接口 Clamped joints	15
1.3.11. 支撑和穿管 Support of tubing and penetrations	15
1.4. 检查 Inspection	16
1.4.1. 范围Scope	16
1.4.2. 配件和焊接编号 Component & weld identification	17
1.4.3. 焊接准备 Weld preparation	18
1.4.4. 焊接检验 Weld inspection	20
1.4.5. 预装配件的保护 Protection of prefabricated spools	21
1.4.6. 验收 Acceptance	22
1.4.7. 其它要求 Other requirements	22
1.5. 水压测试与清洁 water pressure test and cleaning	23
1.5.1. 压力测试 Pressure testing	23
1.5.2. 测试报告 Test reports	25
1.5.3. 水压压力测试 Hydrostatic test pressure	25
1.5.4. 系统清洁和清洗 System cleaning and flushing	26
1.6. 管道系统脱脂、酸洗和钝化 Chemical treatment	26
1.6.1. 安全 Safty	27
1.6.2. 处理方法Method Treatment	28
1.6.3. 纯水和分配系统的化学处理 treatment for PW and WFI	28
1.6.4. 蒸汽管道的化学处理 solution for pure steam distribution loop.	30
1.7. 水压、酸洗以及焊接报告 Report	32
1.7.1. 水压测试报告表 Certificate hydraulic test	32
1.7.2. 管道系统脱脂、酸洗、钝化报告表 Report	33
1.7.3. 焊接报告表 Welding inspection sheet	34

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

1. 管道系统施工规范 Construction Regulation

1.1. 焊接总则 General

本规范适用于卫生管道的焊接、装配和安装。The specification applies for welding, fabrication and erection of sanitary piping.

本规范特别用于不锈钢316L 管件间之圆周对接焊头之连接 In particular such specification is to be used for circumferential butt joints between sanitary piping components made of stainless steel type AISI 316 L. 。

在项目中与本规范有冲突的其它规格必须与朗脉公司讨论，以便澄清和定义。Existing discrepancies between this specification and others applicable for the project, must be discussed with MACROPROCESS for clarification and definition

本规范中的焊接连接将需要符合FDA 的验收标准和3A 标准。Welded joints in the scope of this specification shall require the acceptance by FDA and shall comply with Sanitary Standard 3A.

本规范中术语装配者是指朗脉公司，她负责管道的装配和安装。In the scope of this specification the term FABRICATOR is referred to MACROPROCESS, who is encharged for fabrication and erection of piping.

 “业主”是指用户或其代表。the term OWNER is referred to CUSTOMER or his representative.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第3页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

焊接检查员” 是指业主或用户代表，他将负责检查管道承建商的焊接操作。the term WELDING INSPECTOR is referred to the Owner or Customer representative who is en charged to inspect the welding operation and examination performed by piping construction Contractor.

1.2. 焊接规范 Welding regulation

本规范覆盖用自动轨迹焊接机或手动TIG 设备的气体钨电弧不锈钢焊接设备。

This specification covers the gas tungsten arc welding of austenitic stainless steel using automatic orbital tube welding machines or manual TIG equipments.

“管道” 应包括所有需要焊接元件。

The term TUBING shall include all components of the welding.

1.2.1. 总体要求 General requirements

采用这些程序的手动TIG 焊接工，将用实际工作材料作焊接试样测试以确认合格。这些焊接试样和自动焊接试样进行同样的独立检验。Manual Tungsten Inert Gas (TIG) welders using these procedure shall be qualified by making coupon test welds using actual job material. These coupons shall be subject to the same Independent examination as the automatic welds.

自动焊接机的操作人员将用样品材料做焊接测试以确认其资格。焊接测试应该选用项目常用的管材尺寸材料。Automatic welding machine operators shall be qualified by making acceptable test welds on sample materials. The welds shall be made on the prevalent job size tube material.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第4页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

组件的定位点焊必须避免对完全焊接的不良影响。Tack welding of the components must avoid deleterious effect on the complete weld.

定位点焊应该尽可能的轻，以降低过热而导致材料的内部结构变化。Tack should be as light as possible to reduce over heat that might cause structural changes to the granular composition of the material.

定位点焊不应焊透内表面。Tacks should not penetrate the inner surfaces.

定位点焊完成后，需要检查线定位焊接的对准性和缝隙。After the tack welding completion it’s necessary to check the alignment and gap

1.2.2. 材料 Material

用于焊接的材料须符合甲方的技术规格。The material to be welded shall comply with the owner specification, .

所有管道和配件须完全焊透。All tubing and fittings shall have complete weld penetration.

采用的焊接电极为2%涂钍平头钨焊电极。Welding electrode to be used shall be a pointed 2% thoriated tungsten electrode with a flat tip.

焊接电极如有污染须更换。The electrode shall be replaced if contaminated.。

焊接管道内、外部保护氩气的最低纯度为99.99%。Welding grade argon gas shall be use inside the pipe for back-up purge and shall be 99.99%minimum purity.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第5页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

焊接过程中必须要通入氩气进行保护，以防止焊接的内表面被氧化。在开始焊接前，吹走焊接区域的所有氧气。Argon gas back-up has to be provided to prevent oxidative attack of the inner weld surface.Before starting the welding all oxygen is purged from the welding area.

1.2.3. 焊接准备 Weld joint preparation and fit-up

当焊接表面潮湿时，不得进行任何焊接。除非有适当的保护措施，在严酷气候或风速高或不良大气条件下不得进行室外焊接。No weld is carried out when surfaces to be welded are wet. No outside welding is carried cut during inclement weather or during periods of high wind or negative atmospheric agent unless the work is properly protected.

焊接接头两端面的清洁，圆整和平直是重要的。It is essential that the two surfaces of the joint are clean, circular and squared.

金属加工方法应确保焊接端表面光滑，无划痕或其它有害的不规则形状。The machining method of base metal preparation shall leave the weld end with smooth surfaces, free from notches or other harmful irregularities.

建议采用G+F 或同类设备来处理切割和最终处理。It is recommended to carry out the cut-off and final preparation using a G+F equipment or equivalent.

切割必须平直和不会造成管件变形或损坏。砂轮切割的管件端面必须清洁以除去磨屑。Cut-off must be squared and not cause any distortion or damage to the tubing. The pipe cut-off by an abrasive wheel must be cleaned to remove the abrasive dust.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第6页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

碳钢切割工具在任何情况下都不得使用。Carbon steel cutting tools are not admitted in any circumstance,

用于焊接端面的处理、装配和安装工具，在使用前须检查是否是没有生锈的认可合金钢，清洁无油脂，和无其它污染残留物。Tools used for weld joint and preparation, fabrication and installation, shall be stainless of approved alloy steel, cleaned free of oil, grease and other contamination residuals before they are used.

不得使用硫基切割油，除非在焊接前管件的内外表面都被彻底清除所有残留油渍。Non sulphur based cutting oil may be used, provided all traces of such oil are completely removed from both the interior and exterior surfaces on the tubing prior to welding.

需与焊接检查员一起设定焊接设备。The welding equipment shall be set up together with WELDING INSPECTOR.

此检查员将检查所有设置是否符合主程序。他将签署焊接日志和注明日期。The inspector will check that all settings comply with the master program. He shall sign and date the welding log to that effect.

每天的开始时，每个操作人员要作焊接测试。这些焊样将编号，并呈交给焊接检查员。每台自动焊接机都需做测试。At the start of each day, each operator shall make acceptable test welds on plain tubing, These pieces shall be identified and made available to the welding inspector. Test shall be made for each automatic welding machine.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第7页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

1.2.4. 预热温度 Preheating temperature

在焊接材料的温度不得低于10 ºC。一般来说，不需要预热。The minimum base material temperature shall not be less than 10 0 C prior to welding. In general, no preheating shall be required.

1.2.5. 供电 Electrical characteristics

电流应与注明在相应的焊接表相符。Current shall be as specified on the applicable welding schedule.

1.2.6. 焊接程序 Welding procedure

焊接工艺，如焊接次序，焊接程序设置，焊极位置等，都将与相应的焊接表相符。The welding technique, such as weld sequence, welding program settings, electrode positioning etc., shall be as shown in the applicab le welding schedule。

1.2.7. 焊接修补 Weld repair

经检查，如发现不符合标准的缺陷并且此缺陷是可修复的，有必要进行修复焊接。最可能的修复是在已有的焊接上进行再焊接；A weld repair is required when, through inspection, it is determined that an unacceptable defect exists and that the defect is correctable . The first repair may be a re-weld over one existing.

可做修补的缺陷包括不佳的准备，不良线性，过量或不适当的焊接穿透，多孔性和沙眼；The allowable defects which may be repaired include poor fit up, misalignment, excessive or inadequate weld penetration, porosity and pin holes.

所有有裂纹的焊接将被视为不合格，并须与受热区一起去除。All welds with cracks shall be rejected and removed together with the heat affected zone.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第8页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

1.2.8. 自动焊接程序 Automatic welding program

所有主程序都规定了不同尺寸管件焊接的一组参数；Calibration of the automated tube welding system shall be in accordance with the procedures to be defined by the welding operator together with the inspector.

自动管道焊接系统的焊接程序都须符合焊接操作员与检查员一起制定的程序； Any master program defined a set of parameters for different size of tubing to be welded.

正式和测试焊接需采用已认可的焊接程序；Production and test welds shall be made only using approved welding programs.

焊接样品必须按顺序编号(如T1，T2 等)。焊接样品，具备完全的可追朔性，将备独立机构检验；Welding samples must be numbered in sequence ( ex.: T1, T2, etc.). Welding samples, with complete traceability, are subject to independent laboratory examination.

在整个施工阶段，所有每天的现场样品将留予业主；All daily samples will be available in site to the owner, during all the construction period.

自动管道焊接系统的校正都须符合焊接操作员与检查员一起制定的程序。Welding programs of the automated tube welding system shall be in accordance with the procedures to be defined by the welding operator together with the inspector.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第9页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

1.2.9. 文档 Documentation

朗脉将提供此系统所有焊接记录报告。此焊接记录报告表格，必须完全填写，最少包含：MACROPROCESS will provide a written log on all welds carried out on the system. The weld log forms, that must be fully filled, will minimally contain :

系统名称 system name

焊接号 weld number

焊接工姓名 welder name

设备编号 machine identification

焊接日期 welding date

焊接程序编号 welding program number

焊接操作工(如有，还加上检查员)签名 welding operator ( and in addition inspector, if any ) signature

设备将打印相应自动焊接的报告。在此焊接报告中要有焊接编号。In addition the machine will print out an automatic log that will refer to the weld carried. This weld number shall be then identified on the welding log.

透视简图 (标示相应的坡度，尺寸和长度，所有焊点编号)将在整个施工期间使用并且更新，在工程完成生成竣工图。Each weld shall be numbered in progressive way. All welds will be shown on isometric sketches and on the related Welding Report ( FORMAT 5, already mentioned ).

每个焊点以累进方式编号。所有焊点标示在透视简图和焊接报告中。Isometrics sketches (showing installed elevations for proper sloping, dimensions and lengths, all weld numbers) will be available during site activity and will be updated ( “ as-built” issue ) at the end of job.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第10页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

1.2.10. 非破坏性检查 Non destructive examination

当相应的条例或合同规格要求时，非破坏性检查将在符合条例或合同规格下进行。须考虑到因此而造成的时间延误。Non destructive examination, when required by the applicable by the applicable code or contract specification, shall be performed in accordance with the code rules of contract specification. The time delay due to these controls must be considered.

1.2.11. 每日焊接样品 Weld daily samples

每日焊接样品应采用设备焊接程序。这些样品必须按顺序编号(如P1，P2 等)。所有这些焊接样品将在整个施工期间提供给业主；Weld daily samples shall be made using the machine welding programs. These samples must be numbered in sequence ( ex.: P1, P2, etc.). All of those will be available to the owner in site during all the construction period.

每日样品结果必须收集在完全填写的自动焊接设备测试报告中。The daily samples results must be collected in the Automatic Welding Machine Test Report that must be fully f illed。

1.3. 装配和安装 Fabrication and erection

1.3.1. 范围 Scope

本节和引用的图纸标准以及条例将适合所有管道现场装配和安装。This section and drawings standard and codes referenced shall apply to the field fabrication and erection of all tubing.

本规格中的内容不得用于解释使供应商从完全符合引用条例的责任中解脱。Nothing in this specification shall be interpreted as in any way relieving SUPPLIER from the responsibility for complete compliance with the referenced codes wherever they apply.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第11页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

1.3.2. 管件材料接收储存 Tubing materials receipt storage

管件材料接收储存和现场处理如下：Tubing materials receipt storage and handling at site：

管件材料需由其他人确认和检验；Tubing materials shall be identified and inspected by others.

管材和预装配件的存放应注意不会被油脂，潮湿或其它物质污染；管材和预装配件应处理得当，以避免变形，刮伤或任何有形损伤；It shall be taken care to keep all tubing materials and prefabricated assemblies free from contamination by grease, moisture or other matter does not occur, Tubing materials and prefabricated assemblies must be handed in order to avoid any denting, scraping or any other physical damage.

所有不锈钢材料应与其它施工材料分开检查和储存。储存区必须在建筑物内，并且有防护任何腐蚀性环境和温度变化的措施；All stainless steel materials should be checked and stocked separately from other construction materials. The storage area must be located inside a building and protected from any corrosive atmosphere and temperature changes.

通道应严格限制以确保材料不会受损伤和丢失。只有在施工需要时才能从储存区提取材料。Access shall be strictly limited in order to guarantee a protection against physical damage and losses. Material shall be released from storage only when needed for construction purposes.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第12页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

1.3.3. 分类 Identification

所有材料将按规格进行分类，并且适当储存和处理以便于辨认。All materials will be identified in accordance with the applicable specification and shall be stored and handled in order to allow their proper identification.

1.3.4. 装配 Fabrication

装配应按照此规格的要求和如有的详细安装要求(图纸或其它)进行。Fabrication shall be in accordance with the requirements of this specification and with installation specific details ( drawings or others ), if any.

1.3.5. 布管，切割和装备 Lay-out, cutting and fitting up

管件应按图纸上的尺寸精确切割以适应现场情况。Tubing shall be cut accurately to measurements shown on drawing to suit field conditions.

所有待焊接的管件端面需清理毛刺，并且切割面应平直，边角无切割园弧。管件边缘的端面处理和清理毛刺应使用终端处理工具，并且其公差与配件一致以确保适当的焊接线性。All tube ends to be welded shall be deburred and have square cut edges, free of shear radii at the corner. Tube edge facing and deburring shall be done with an end prep tool and be of equal tolerance as the fittings to assure proper alignment for welding.

检查切割管件终端，以确保其平直。The end of the cutted pipe shall be checked to insure its squareness.

清除毛刺应避免破坏内外径，或损伤管件的内抛光。Burs shall be removed in such a manner as not to level I.D. or O.D. or damage polished interior of the tubing.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第13页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

在管件端口积聚的磨屑必须擦拭干净。Abrasive dust accumulated near the end of the tube must be wiped clean.

所有安装在管线上的管件不应受过分弹力和受力下装配。All tubing shall be worked in place without excessive springing or forcing.

不允许通过管件加热和弯曲以达到线性整齐。Heating and bending tubing to achieve alignment is not allowed.

1.3.6. 焊接程序和资格 Welding procedure and qualifications

所有焊工应具备6 个月现场工作经验经过工厂培训 All welders shall be qualified either by 6 months field experience or by factory training.；

在开始焊接前，焊接程序应提交给焊接检查员核准 Welding procedures shall be submitted to welding inspector for approval before starting the welding activities.

1.3.7. 安装 Erection

所有组装管件应在不受过分弹力和受力下装配。不允许有切割或弱化的支撑物作管道安装；All assembled tubing shall be installed without excessive springing of forcing . Cutting or other weakening of structural members to facilitate tubing installation will be not permitted.

所有管件安装应可以自由膨胀和收缩，而不至于损坏连接和支撑；All tubing shall be installed to permit free expansion and contraction without damage to joints or supports.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第14页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

所有管道必须有适当的坡度(0.3% 最大0.5% )以确保完全排水。All lines must guarantee the complete drainage with proper slope (0.3% max. 0.5%).

1.3.8. 焊接接口 Welded joints

所有焊接应按照本规格所述的要求进行准备和装配。All welded joints shall be prepared and made in accordance with described of this specification.

1.3.9. 法兰接口 Flanged joints

所有法兰接口，应用全新的密封圈和螺栓。在拧紧螺栓前应确保所有密封圈定位准确。应注意防止将螺栓拧的过紧。所有被拧得过紧的螺栓螺帽都应更换；All flanged joints, if any, shall be made with gaskets and bolting materials brand new. It shall be taken care to assure that all gaskets are properly positioned prior to bolts tightening. It shall be taken care to avoid overtorquing any bolts. All bolts and nuts which are overtorqued shall be replaced.

法兰螺栓孔应跨骑于管道中心线，除非图纸上另有说明。 Flange bolt holes shall straddle pipe center lines except when noted otherwise on drawings.

1.3.10. 快装接口 Clamped joints

不得使用螺纹接口。Threated joints shall not be used.

1.3.11. 支撑和穿管 Support of tubing and penetrations

管件的支撑应按管件支撑图纸上的参数和细节设计、装配和安装。Support to tubing shall be designed, fabricated and installed in accordance with the details and parameters of the pipe support drawings.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第15页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

不锈钢管件的安装按制造商的建议进行。Stainless steel tubing is to be installed in accordance with manufacturers recommendations.

吊架和支撑的安装应尽量的经济，并符合支撑图纸或规格上的描述。Hangers and/or support should be installed as economically possible and be in accordance with the charts and notes on the pipe support drawings or specifications.

管道的支撑应符合管道图纸上要求的坡度。Tubing shall be supported in such a way to comply with the slope required on piping drawings.

所有装配的管道应最少符合检查，检验和测试要求规格。All fabricated tubing shall as a minimum meet the examination, inspection and testing requirements specifications.

1.4. 检查 Inspection

1.4.1. 范围 Scope

本技术规格适用于不锈钢管件自动焊接检查，该焊接检查按照技术规格中的焊接要求；This specification covers the inspection of automatic welding stainless steel tube and fittings, in accordance with the welding specification.

焊接日志检查清单将用于查核主要信息，准备和质量要求；The weld log inspection check list shall be used to verify the principal information, preparation and quality requirements.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第16页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

焊接检查员按照焊接要求，检视分包商的焊接记录、检查和设置、非破坏性测试，以及目检。在双方同意并理解相应的时间延误下，此工作须在任何时间进行；The welding inspector shall witness the required subcontractor records, checks and setups, non-destructive tests, and visually inspect the welds, as specified herein and in accordance with the welding specification. This activity must be carried out at any time with the agreement of both parties involved and knowing the related time delay.

焊接检查员或其指定代表应目检所有焊接。The welding inspector or his appointed representative shall visually examine all welds .

1.4.2. 配件和焊接编号 Component & weld identification

每个焊接应在其立体图中编号；Each weld shall be numbered on his isometrics.

检查员应保留焊接检查清单，而且实际的焊点以此编号辨别；The inspector shall maintain a weld inspection check list and the actual weld shall be identified primarily by this number.

每个焊点的记录应包括所有相关的条目。The record for each weld which shall include all items listed

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第17页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

1.4.3. 焊接准备 Weld preparation

焊接检查员决定是否进行下列检查/确认。

The following inspection/verification could be made at the welding inspector option.

管道截面确认 Tube section verification

管道的长度按要求在管道图纸中标示；The length of tube is as required to give dimensions as shown on the piping drawings.

要去掉管道端口切割产生的任何可能之污物；Tube ends are removed any possible contamination from the cut off.

工具不得被碳钢所污染；No tool has been contaminated by contact with carbon steel.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第18页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

确认管道圆度公差。Verify tube roundness to tolerance.

清洁确认 Cleaning verification

用认可的溶剂清洁配件。Components are cleaned with approved solvent.

在焊接前，已清洁和准备好的端口不得接触皮肤。The cleaned and prepared ends should not come into contact with the skin prior to welding.

在部件的端口不得有可目见的异物，此包括清洁布的纤维。No visible foreign material is acceptable at the weld ends of the components. This includes lint from cleaning cloths.

钨焊极必须清洁和无污染。Tungsten electrode must be clean and uncontaminated.

接口准备 Joint fit-up

焊接组件端口间隙用厚度塞尺测量，不得超过0.25 mm。The gap between ends of welding components shall not exceed 0.25 mm as checked by thickness gauge.

钨焊极应置于焊点中央。The tungsten electrode shall be centered on the joint。

焊机设置Weld machine settings

参数的设置应按焊接程序中相应的焊接表进行。Parameters shall be set in accordance with appropriate welding schedule as shown in the welding procedure.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第19页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

确认气源就位。Verify that purge bladder is in place.

1.4.4. 焊接检验 Weld inspection

每个焊接样品和所有装配焊都要目检管道内侧。如焊接有可修复的缺陷，在焊接部件拆离焊机前进行第二次焊接以修复缺陷。如果重新焊接未修复缺陷，则此焊接视为不合格并不得装配。

Every sample weld and all production welds shall be visually inspected on the interior, If the weld has correctable defects, a second weld pass may be made to try to correct them before the spool is removed from the welding machine . If the rewelding does not remove the defect, the weld shall be rejected and not mounted.

所有自动焊接按如下控制：

All automatic welds will be controlled as follows：

对每日样品，用选定的焊接程序完成一个焊接，进行X 射线检验 For each daily sample a weld carried out with the same welding program will be chosen. The check will be done with Rx will be carried out.

对于所有完成的自动焊接，含有焊接参数的焊机打印报告 For all executed automatic welds, a welding machine print out with welding parameters will be annexed.

10%的自动焊接，进行X 射线检验 10% of executed automatic welds, Rx will be carried out.

所有手工焊接要进行X 射线检验。All the manual weldings will be Rx inspected.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第20页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

如有表面缺陷，则本规格条目适用。For surface defects, the headlines of this specification are valid.

表1：Table 1

	A		B
	须进行重新焊接的缺陷		不合格的缺陷：须与受热区(棕色)一起切除：
	Defects for which rewelding may be		Defects to be rejected : Cut out
	attempted		required together with its heat affected
			zone ( brown color ):
1.	未焊透 incomplete penetration	1.	裂纹 cracks
2.	多孔 porosity	2.	过烧 burn out
3.	沙眼 pin hole	3.	解块 sugaring
4.	冷隔 cold lap	4.	冷隔 cold lap
5.	过度穿透( <0.4 mm ) excessive penetration	5.	过度穿透(>0.4 mm ) excessive penetration
6.	未对准( <0.55 mm) misalignment	6.	未对准(> 0.55 mm) misalignment

点焊如有破裂、完全焊透、过烧、组件未对准，则视为不合格。Tack welds shall be rejected if : cracked, full penetrated, burned, components misalignment.

焊件移离焊机后，对焊接外观进行目检。The outside of the weld is visually inspected after the spool is removed from the welding machine.

1.4.5. 预装配件的保护 Protection of prefabricated spools

所有开口应有适当的保护，保持密封；All openings shall be kept sealed at all times with proper protection.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第21页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

快装接口和法兰端面应有保护措施以防止损坏；Clamp ends and flange face shall be protected from damage in handling by approved protective devices.

除了在工作台上，在处理和存放期间，预装配件应置于保护区内的木支架上。 During handling and storage other than on work tables, spools shall be on wooden skids of racks in a protected area.

1.4.6. 验收 Acceptance

焊接检查员应完成焊接检查清单并须在完成的清单上共同签署和注明日期。如在任何地方有不合格焊接，则不合格原因应被记录。焊接检查员应在焊接完成时签署清单。The welding inspector shall complete the weld inspection check-list. When it has been completed.  It shall be jointly signed and dated. If at any place the weld is rejected, the reason for rejection shall be recorded. The welding supervisor shall sign each list at the time the weld is made.

1.4.7. 其它要求 Other requirements

检查员应确认吹刷气体和后备气体流量计处于准确工作状态。The inspector shall insure that the flow gauges on the purge gas and back up gas be in accurate working condition, where applicable.

如任何工具或组件被怀疑有污染，应按ASTM 标准程序进行清洁和测试。If any tool or component is suspected of having contamination, it shall be cleaned and tested in accordance with ASTM standard procedures.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第22页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

1.5. 水压测试与清洁 water pressure test and cleaning

本规程包含在管道系统完成后，为测试系统性能和特性而进行的所有工作。This specification covers the activities to be carried out after the system pipe construction, to test and improve his capability to perform the required characteristics.

1.5.1. 压力测试 Pressure testing

所有压力测试应当同检查员一起进行；All pressure tests shall be complete system tests carried out together with the inspector.

所有测试进行时应对操作人员的安全作好预防，要进行水压测试的系统应该带有合适的表和压力安全泻载装置；Every test shall be carried out with all the precaution needed to insure the safety of the operator, Systems to be hydraulically tested will be provided with appropriate gauges and pressure relieving devices.

所有连接点，包含焊缝应该去除绝热保温以便在测试过程中观察；All joints, including welds, are to be left un-insulated and exposed for examination during testing.

不需要进行压力测试的设备，在测试过程中应该与系统断开或使用其他合适的方式与测试系统隔离开；Equipment which is not to be subjected to the pressure test shall be either disconnected from the tubing or isolated by proper means during the test.

可以安装测试过程需要的阀门；Valves may be used provided that they are suitable for the proposed test procedure.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第23页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

在管线上的压力计不应在超过量程的压力下测试。没有表明测试压力的部件和设备应排除在测试内容之外；In line pressure gauges shall not be subjected to pressure in excess of their scale range. All pieces of equipment which do not have their test pressures indicated or declared or not proper shall be excluded from these tests.

在进行所有测试之前，需目测管线系统以保障没有可见的缺陷且所有连接紧密；Before every test the tubing systems shall have visually inspected to assure that there are no visual defects and that all connections are tightened.

控制阀门只要不是正在被测试，应该打在全开的位置；Control valves, unless being tested, shall be set and maintained in the wide open position.

只要有可能应将所有在管线上的设备，表玻璃，流量计，漂浮液位计和所有其他受压部分包含在测试之内；All in-line instruments, gauge glasses, flow meters, liquid level float gauges and all other pressure parts of instruments shall be included in these test, where feasible.

水压测试的压力应由测试压力在其量程一半处的计量表测量；Hydrostatic test pressure must be measured by gauges having the test pressure value approximately in its mid-range.

有缺陷的连接点应该被移除并重新测试；Joints found to be defective shall be removed and retested.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第24页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

在修复后重新进行测试后测试压力需和原来指定测试压力相同。Retesting of lines after repair shall be done at pressures originally specified for the test

1.5.2. 测试报告 Test reports

承包商应为每个测试做相应记录，记录包含‘水压测试证书’和测试编号。The subcontractor shall make a record of the test as per specimen included “Hydraulic Test Certificate “, Certification Code “ CER-003 ”

测试编号 test number；

测试日期 date of test

系统名称 system name；

测试媒介，压力和相应压力下维持的时间 test media, pressure applied and length of time at test pressure 。

1.5.3. 水压压力测试 Hydrostatic test pressure

水压测试压力需根据项目技术要求进行，不需进行压力测试的容器和组件应被隔离。The hydrostatic test pressure shall be calculated in accordance with the project specifications: vessels or components which are not designed for the testing pressure shall be isolated.

所有水压测试系统应在设计压力的1.5倍和至少3.5巴的压力下进行测试。在进行连接点目测前测试压力需维持至少15分钟。All hydrostatically tested systems shall be tested to a one-half ( 1 1/2 ) times the design pressure or to a minimum pressure for 3.5 bar whichever is greater.  All test pressures shall be maintained a minimum of 15 minutes before visual examination of joints beings.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第25页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

在待测试的管线系统和测试的媒介达到热平衡之后再进行水压测试。Hydrostatic test pressure shall not be applies until the tubing system and the testing medium reached thermal equilibrium.

在测试过程中需对所有连接点进行目测。All joints shall be visually examinated for leakage during the test.

水压测试压力至少需维持两个小时。Hydrostatic test pressure will be maintained for at least two hours.

在含有水的管线部分不能做任何修复焊接。No repairs welding shall be done on any section of tubing that contains water.

所有不锈钢管线在水压测试结束后需立即排空。All stainless steel lines shall be emptied immediately after hydrostatic tests completion.

1.5.4. 系统清洁和清洗 System cleaning and flushing

清洗和清洁全部安装好的管线，应按照供应商要求：不锈钢清洗，酸洗和钝化规程执行。Washing and cleaning of the whole piping installed will be carried out according to Supplier document requirement :

STAINLEES STEEL WASHING, PICKLING AND PASSIVATION”.

1.6. 管道系统脱脂、酸洗和钝化 Chemical treatment

本技术文件说明的是纯水，纯蒸汽，分配系统的化学处理操作。用于该分配系统的管道和管件是机械或电抛光的AISI 316 L 不锈钢材料。This scope of this document is to describe the procedure for chemical conditioning of PW (purified water), PS (pure steam), WFI (water for injection) distribution loops. The pipes and fittings used for loops are in stainless steel (AISI 316L) and could be mechanically polished or electro polished.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第26页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

系统的化学处理包括以下步骤：The chemical conditioning consists of the following steps:

脱脂 DEGREASING

酸洗 PICKLING

钝化 PASSIVATION

脂是除去表面的油，油脂和微粒。

Degreasing removes from surfaces oil, grease and powders.

酸洗是除去焊接过程中产生的氧化物和机械抛光产生的沉淀层。

Pickling removes the oxides formed during welding and eventual deposits coming from mechanical polishing.

钝化是重新在表面镀上在机械和化学处理中除去的氧化防腐层。

Passivation restores on the surfaces the corrosion resistance layer of Cromo Oxides, that has been removed from previous mechanical and chemical operation

1.6.1. 安全 Safty

在化学处理中的安全防护措施 During the treatment observe the safety precautions listed here below:

操作者需配戴透明面或眼镜 The operators shall wear a transparent face mask or suitable glasses.。

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第27页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

操作者需配戴手套和围裙 The operators shall also wear gloves and apron or track resistant to the chemicals。

在加入和溶解化学品时必须连续搅拌 All chemical must be stirred continuously during addition and dissolution of the chemicals。

准备几袋石灰或碳酸氢钠，防备在有滴漏的地方中和溶液 Some bags of lime or sodium bicarbonate must be available to neutralize the acid solution in case leakage。

参照化学品的安全说明。

Safety instructions for chemicals used are annexed.

1.6.2. 处理方法 Method Treatment

根据参数用泵循环溶液处理管线。

Pipelines shall be treated by pumping and circulation solution according to parameter indicated in sectio

1.6.3. 纯水和分配系统的化学处理 treatment for PW and WFI

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第28页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第29页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

排放并用去离子水冲洗直到PH 中性 discharge and wash by demi water until neutral ph is reached

1.6.4. 蒸汽管道的化学处理 solution for pure steam distribution loop

脱脂

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第30页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

Time :                  -Min. 4 hours, Max. 72 hours

排放并用去离子水冲洗直到PH 中性 Discharge and wash by demi water until neutral ph is reached 。

备注：钝化检测仪

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第31页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

1.7. 水压、酸洗以及焊接报告 Report

1.7.1. 水压测试报告表 Certificate hydraulic test

CERTIFICATE HYDRAULIC TEST 水 压 测 试
CUSTOMER : 用户 :	PROJECT : 项目 :
SYSTEM : 系统 :	SERIAL NUMBER : 系列号 :
DATE : 日期 :	DRAWING NUMBER : 图号 :
CERTIFICATION CODE : Cer-001	Page 1 of 36

THE PIPING LINE HAS BEEN HYDRAULICALLY TESTED UNDER THE CONDITIONS SPECIFIED BELOW.

该管线已经在下列状况下进行水压测试。

PRESSURE 压力 TIME 时间 MANOMETER 压力表读数 RESULT 结果 OPERATOR 操作者

备注 REMARKS :

PLACE :	DATE :
地点	日期
OPERATOR :	INSPECTOR :
操作者	检查者
MACROPROCESS SIGNATURE :	CLIENT SIGNATURE:
朗脉代表签字	客户代表签字

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第32页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

1.7.2. 管道系统脱脂、酸洗、钝化报告表 Report

CERTIFICATE LOOP DEGREASING, PICKLING & PASSIVATION 管道系统脱脂、酸洗、钝化报告表
CUSTOMER : 用户 :	PROJECT : 项目 :
SYSTEM : 系统	DATE : 日期 :
CERTIFICATION CODE :	Page    of

THE DISTRIBUTION LOOP HAS BEEN DEGREASED, PICKLED AND PASSIVATED UNDER THE CONDITIONS SPECIFIED IN THE ATTACHED PROCEDURE 该管道分配系统已经在下列状况下进行脱脂、酸洗、钝化程序。

1.           脱脂: 10%无水酒精用90%的纯化水稀释,用泵在 2-3bar 压力下常温循环30 分钟后排放,并用纯化水冲洗干净。

2.           酸洗: 75%硝酸和 25%(重量)氢氟酸混合液用50%体积的纯化水稀释,用泵在 2-3 bar 压力下常温循环,1小时后排放,并用纯化水冲洗至中性。

3.           钝化: 20%的硝酸用80%体积的纯化水稀释,用泵在 2-3 bar 压力下常温循环 2 小时后排放,并用纯化水冲洗至中性。

PLACE :	DATE :
地点:	日期 :
OPERATOR :	INSPECTOR :
操作者 :	检查者 :
MACROPROCESS SIGNATURE :	CLIENT SIGNATURE:
朗脉代表签字 :	客户代表签字

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第33页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

1.7.3. 焊接报告表 Welding inspection sheet

FORMAT 1 表1 WELDING INSPCETION DATA SHEET 焊接检查单
用户CUSTOMER :		项目PROJECT :
系统SYSTEM :		日期DATE :
CERTIFICATION CODE :		Page    of
焊接程序说明
焊接程序号 焊接方式 管道 材质 连接方式 直径 壁厚 焊机型号 制造商 焊头型号 管道切割设备 端面清洁 焊接时间 焊头氩气 收弧氩气 管内氩气 电极缝隙	#
	自动
	ISO  2037
	AISI 316L
	管/管
	mm
	mm
	COBRATIG 150
	美国MK
	5002
	G+F 切割机
	乙醇
	SEC
	lt/min
	lt/min
	lt/min
	1.0 mm

地点PLACE :	日期DATE :
OPERATOR :	INSPECTOR :
操作者 :	检查者 :
MACROPROCESS SIGNATURE :	CLIENT SIGNATURE:
朗脉代表签字 :	客户代表签字

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第34页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

FORMAT 2 表2
WELDING REPORT
焊接报告
CUSTOMER :	PROJECT :
用户 :	项目 :
SYSTEM :	DATE :
系统 :	日期 :
CERTIFICATION CODE :	Page 1 of 36

焊接报告单

焊接打印单粘贴处

结果：接受□              拒绝□

PLACE :	DATE :
地点:	日期:
OPERATOR :	INSPECTOR :
操作者:	检查者:
MACROPROCESS SIGNATURE :	CLIENT SIGNATURE:
朗脉代表签字:	客户代表签字：

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第35页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第7 部分管道系统施工规范 Construction Regulation for Piping System

FORMAT 3 表3
WELDING REPORT
焊接报告
CUSTOMER :	PROJECT :
用户 :	项目 :
SYSTEM :	DATE :
系统 :	日期 :
CERTIFICATION CODE :	Page   of

焊 接 报 告

日期 焊接编号 直径 焊接类型 焊接程序 焊样编号 结果 签名

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第36页/ 共36 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第 8 部分 售后服务和技术承诺 Technical Promise and after-sale Service

第 8 部分

Part 8

售后服务和技术承诺

Technical Promise and

After-sale Service

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

上海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室     201100

T:021 54306717     F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第 8 部分 售后服务和技术承诺 Technical Promise and after-sale Service

目 录

1.售后服务和承诺 Technical Promise and after-sale Service	2
1.1. 技术承诺 Technical Promise	2
1.2. 售后服务 After-sale Service	2

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/共3 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第8 部分售后服务和技术承诺 Technical Promise and after-sale Service

1.售后服务和承诺 Technical Promise and after-sale Service

1.1. 技术承诺 Technical Promise

上海朗脉科技有限公司，拥有先进的焊接设备和质量检测设备，以及完全符合中国GMP 标准，FDA 认证以及其他国家标准的文件系统。工程中将使用验证过的全自动轨迹焊机进行焊接。所有的焊工都具有相关的上岗资格，至少要有2 年的实际工作经验或者经过工厂培训。上海朗脉科技有限公司承诺，我们承接的工程将完全按照GMP 标准进行施工。

工程质量保证期为1 年。

Macroprocess Technologies Co., Ltd. has advanced welding machine, quality-checking equipment and integrated files system according with Chinese GMP standard, FDA GMP standard and other country’s standards. Qualified automatic orbital welding machines will be used in our projects. All welders are qualified either by 2 year field experience or by factory training. The seller promises that the project we will do is completely according to GMP.

The Quality Guarantee Period of project will be 1 year.

1.2. 售后服务After-sale Service

售后服务联络：买方可直接与卖方联系，并将派自己的维修人员到买方工厂进行售后服务。After-sale service contact: The Buyer can contact the Seller directly. The seller will dispatch its’ own technicians to provide after-sale service on the Buyer’s site.

售后服务的响应时间：接到买方报修传真后2 天内 (公共假日除外)。Responding time: within two day from the receipt of written report from the Buyer (public holidays are excluded).

售后服务的质量要求：卖方应派遣有实际工作经验的工程技术人员来买方工厂进行维修。卖方技术人员需在接到通知后48 小时内到达买方现场 (公共假日除外)。Requirement of service quality: The seller shall dispatch engineers with good experience to the Buyer’s premise. The seller should arrive the buyer’s site within 48 hours after receipt of notice (public holidays are excluded).

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2页/ 共3 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第8 部分售后服务和技术承诺 Technical Promise and after-sale Service

售后服务的费用：质保期内免费维修，维修人员的差旅费、人工费、食宿费等由卖方承担 (因买方操作不当、未采用合同文件中规定的主材和操作环境条件、合同供货范围以外的工作除外)。质保期外的维修费由买方承担，收费标准由双方友好协商。Expense for after-sale service: The seller is responsible to provide free technical service within the Quality Guarantee Period. All the travel and accommodation expenses as well as the labor costs of the service engineer are to be born by the seller (exclusive of situations that problems are brought by incorrect operation and works beyond the scope of supply). The Buyer should be responsible for the service expenses after the guarantee period and the price is determined through friendly discussion.

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第3页/ 共3 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第9 部分偏离和图纸 Deviation and Drawings

第 9 部分

Part 9

偏离及图纸

Deviation and Drawings

上海朗脉科技有限公司

ShangHai MacroProcess Technology Co.,Ltd

上海朗脉科技有限公司

上海市闵行区罗阳路168 号A 座101 室     201100

T:021 54306717     F: 021 54306718

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第 9 部分 偏离和图纸 Deviation and Drawings

目 录

9. 偏离及图纸 Deviation and Drawings	2
9.1. 商务偏离表 Deviation Form for Commercial Terms	2
9.2. 技术偏离表 Deviation Form for Technical Specifications	3
9.3. 图纸 Drawings	4

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第1页/共4 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第 9 部分 偏离和图纸 Deviation and Drawings

9. 偏离及图纸 Deviation and Drawings

9.1. 商务偏离表 Deviation Form for Commercial Terms

商务偏离表

Deviation Form for Commercial Terms

项目名称	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmceutical Steam storage and Distributions System
数 量	1 套	规格型号

标 书要求	投标参数及其它
付款方式： 合同签订后10 日内，甲方支付合同总额10%给乙方，同时乙方向甲方提供相同金额的发票； 乙方根据甲方提供的设计资料完成工程的二次设计，并经甲方书面确认后10 日内，甲方支付合同总额20%给乙方，同时乙方向甲方提供相同金额的发票；全部设备和材料运输到施工现场指定位置，甲乙双方开箱验收完毕，10 日内甲方支付合同总额30%给乙方， 同时乙方向甲方提供相同金额的发票。安装、调试、验收、验证合格并交付甲方使用后，10日内甲方再支付合同总价30%，同时乙方向甲方提供相同金额的发票；余合同总价10%的作为质量保证金，质量保证期1 年， 质保期满，无质量问题，10 日内甲方付清全部余款，同时乙方向甲方提供相同金额的发票。	付款方式： 合同签订后，10日内甲方支付合同总额30%预付款； 全部设备和材料运输到施工现场指定位置前，甲方支付合同总额40%； 安装、调试、验收合格并交付甲方使用后，10 日内甲方再支付合同总额25%， 余合同总价5%作为质量保证金，质量保证期1 年， 质保期满，无质量问题，10日内甲方付清全部余款。

投标人(公章)： 上海朗脉科技有限公司

授权代表人（签字或盖章）：

日期：

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第2页/ 共4 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第 9 部分 偏离和图纸 Deviation and Drawings

9.2. 技术偏离表 Deviation Form for Technical Specifications

技术偏离表

Deviation Form for Technical Specifications

项目名称	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Pharmceutical Steam storage and Distributions System
数 量	1 套	规格型号
标 书要求		投标参数及其它
1. 纯化水：管件的外部抛光度Ra<0.8um，内部为Ra<0.5um		1. 纯化水：管件外部 Ra<1.0um 内部 Ra<0.5um

投标人(公章)： 上海朗脉科技有限公司

授权代表人（签字或盖章）：

日期：

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第3页/ 共4 页

	沈阳三生制药有限责任公司 Shenyang Sunshine Pharmaceutical Company Limited
	纯化水、注射用水、纯蒸汽系统 Purified water、water for Injection、Steam   storage and Distributions System
	投标文件 Bidding Documents	第 9 部分 偏离和图纸 Deviation and Drawings

9.3. 图纸 Drawings

● PID 流程图 PID

● 项目进度表 Schedule

上海市闵行区罗阳路168 号A 座101 室    201100 1F, building A, No.168 LuoYang Rd, Shanghai, China 201100 T:021 54306717    F: 021 54306718 第4页/ 共4 页

EX-4.7.12

EX 4.7.12 - Supplemental Translation to Bidding Document 1

Part 1

Tender

ShangHai MacroProcess Technology Co.,Ltd

Shenyang Sunshine Pharmaceutical Company Limited

Process Formulation System

Bidding Documents

Tender

1F，building A ,No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717 F: 021 54306718

Page 1 / Total 67Content

1. Quotation document	2
1.1. Qualification of legal representative	2
1.2. Power of attorney from legal representative	3
1.3. ID Card copy of legal representative	4
1.4. Tender	5
2. Proposal 1 pipes and fitness are ALFA LAVAL	6
2.1. Quotation list	6
2.2. Item quotation list	8
2.2.1. Material system list and quotation	8
2.2.2. CIP station material list and quotation	15
2.2.3. EPO	18
2.2.4. TPO	20
2.2.5. Tank	22
2.2.6. Cost of welding spot	34
2.2.7. Quantity list of accessories for system	35
2.2.8. Quotation for authentication service	36
3. Proposal 2  pipes and fitness are NEUMO	37
3.1. Price list	37
3.2. Item quotation list	39
3.2.1. Material system list and quotation	39
3.2.2. CIP station material list and quotation	45
3.2.3. EPO	48
3.2.4. TPO	50
3.2.5. Tank	52
3.2.6. Cost of welding spot	65
3.2.7. Quantity list of accessories for system	66
3.2.8. Quotation for authentication service	67

Shenyang Sunshine Pharmaceutical Company Limited

Process Formulation System

Bidding Documents

Tender

1F，building A ,No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717 F: 021 54306718

Page 2 / Total 67

1. Quotation document

1.1. Qualification of legal representative

Qualification of legal representative

Qualification of legal representative

Name of organization: ShangHai MacroProcess Technology Co.,Ltd

Address: 1F，building A ,No.168 LuoYang Rd, Shanghai

Operating period: 26th July 2007 -25th July 2017

Name: Wang Wei

Gender: Male

Name: 36

Title: Legal representative

Here by prove that Mr. Wang Wei, the legal representative of ShangHai MacroProcess Technology Co.,Ltd, is entitled to sign the tender document regarding to this tender, negotiate the contract and deal with all matters therein.

Tender unit (stamp): ShangHai MacroProcess Technology Co.,Ltd

Date: 15th January 2009

Shenyang Sunshine Pharmaceutical Company Limited

Process Formulation System

Bidding Documents

Tender

1F，building A ,No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717 F: 021 54306718

Page 3 / Total 67

1.2. Power of attorney from legal representative

Power of attorney from legal representative

Shenyang Sunshine Pharmaceutical Company Limited:

This power of attorney declares: I, Wang Wei, the legal representative of ShangHai MacroProcess Technology Co.,Ltd, 1F，building A ,No.168 LuoYang Rd, Shanghai, now sign on behalf of the company to authorize the sales Manager Zhang Song acting as the legal agent who will attend the tender of Process Formulation System project organized by Shenyang Sunshine Pharmaceutical Company Limited. Out company will bear all responsibilities on the signature of the agent upon all documents and actions.

The agent shall be not allowed to transfer the authorization.

This authorization has come into force since 15th January 2009.

Agent: Zhang Song, Gender: Male, Age: 35

Unit: ShangHai MacroProcess Technology Co.,Ltd  Title: Sales Manager

Address: 1F，building A ,No.168 LuoYang Rd, Shanghai

Bidder: (common seal) ShangHai MacroProcess Technology Co.,Ltd

Legal representative: (seal)

15th January 2009

Shenyang Sunshine Pharmaceutical Company Limited

Process Formulation System

Bidding Documents

Tender

1F，building A ,No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717 F: 021 54306718

Page 4 / Total 67

1.3. ID Card copy of legal representative

Shenyang Sunshine Pharmaceutical Company Limited

Process Formulation System

Bidding Documents

Tender

1F，building A ,No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717 F: 021 54306718

Page 5 / Total 67

1.4. Tender

Tender

To Shenyang Sunshine Pharmaceutical Company Limited:

We have received your tender documents regarding to Process Formulation System, and we decided to attend the tender. The Sales Manager Zhang Song is authorized to submit the following documents, 1 original and 2 copy on behalf of our company. Meanwhile, we are willing to abide by the following requirement:

1、Acknowledge and be willing to supply, install, debug and maintain the Process Formulation System according the rules and requirements in various tender documents.

2、The quotation for proposal 1 is 5,523,961.99 Yuan (pipes and fitness are ALFA LAVAL), for proposal 2 is 5,502,881.38 Yuan（pipes and fitness are NEUMO）; the promised supply period is 120 calendar days, installation period 70 calendar days, and the installation quality should live up to GMP requirement.

3、Be willing to fulfill the responsibility and obligation according to the law of contract and Law of the People's Republic of China on Tenders and Bids.

4、In the event we win the tender, we will perform all requirements in the tender document and finish the task with proper time, quality and quantity.

5、We are willing to provide all information required in the tender document.

6、We understand that the lowest quotation is not the only condition to win.

7、We agree to pay tender bond according the tender document and observe all regulations regarding to tender.

8、We tender is effective with 60 days after bid opening.

9、Please send all correspondences to the following address:

Address: 1F，building A ,No.168 LuoYang Rd, Shanghai

Tele: 021-54306717/ 13901375676 fax: 021-54306718

Bidder: (common seal) ShangHai MacroProcess Technology Co.,Ltd

Legal representative: (seal)

Date：__

Translation of other English bidding documents refers to the PDF. The part not being translated could be: Price Breakdown for PRO Distributiong System.

EX-4.7.13

EX 4.7.13 - Supplemental Translation to Bidding Document 2

Part 1

Tender

ShangHai MacroProcess Technology Co.,Ltd

Shenyang Sunshine Pharmaceutical Company Limited

Compressed Air and Process Gas System

Bidding Documents

Tender

1F，building A ,No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717 F: 021 54306718

Page 1 / Total 19

Content

1. Quotation document	2
1.1. Qualification of legal representative	2
1.2. Power of attorney from legal representative	3
1.3. ID Card copy of legal representative	4
1.4. Tender	5
1.5. Quotation list	6
2. Item quotation list	8
2.1. Compressed air system material list and quotation	8
2.2. Nitrogen piping system material list and quotation	11
2.3. Oxygen piping system material list and quotation	13
2.4. Carbon dioxide piping system material list and quotation	15
2.5. Cost of welding spot	17
2.6. Quantity list of accessories for system	18
2.7. Quotation for authentication service	19

Shenyang Sunshine Pharmaceutical Company Limited

Compressed Air and Process Gas System

Bidding Documents

Tender

1F，building A ,No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717 F: 021 54306718

Page 2 / Total 19

1. Quotation document

1.1. Qualification of legal representative

Qualification of legal representative

Name of organization: ShangHai MacroProcess Technology Co.,Ltd

Address: 1F，building A ,No.168 LuoYang Rd, Shanghai

Operating period: 26th July 2007 -25th July 2017

Name: Wang Wei

Gender: Male

Name: 36

Title: Legal representative

Here by prove that Mr. Wang Wei, the legal representative of ShangHai MacroProcess Technology Co.,Ltd, is entitled to sign the tender document regarding to this tender, negotiate the contract and deal with all matters therein.

Tender unit (stamp): ShangHai MacroProcess Technology Co.,Ltd

Date: 15th January 2009

Shenyang Sunshine Pharmaceutical Company Limited

Compressed Air and Process Gas System

Bidding Documents

Tender

1F，building A ,No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717 F: 021 54306718

Page 3 / Total 19

1.2. Power of attorney from legal representative

Power of attorney from legal representative

Shenyang Sunshine Pharmaceutical Company Limited:

This power of attorney declares: I, Wang Wei, the legal representative of ShangHai MacroProcess Technology Co.,Ltd, 1F，building A ,No.168 LuoYang Rd, Shanghai, now sign on behalf of the company to authorize the sales Manager Zhang Song acting as the legal agent who will attend the tender of Compressed Air and Process Gas System project organized by Shenyang Sunshine Pharmaceutical Company Limited. Out company will bear all responsibilities on the signature of the agent upon all documents and actions.

The agent shall be not allowed to transfer the authorization.

This authorization has come into force since 15th January 2009.

Agent: Zhang Song, Gender: Male, Age: 35

Unit: ShangHai MacroProcess Technology Co.,Ltd  Title: Sales Manager

Address: 1F，building A ,No.168 LuoYang Rd, Shanghai

Bidder: (common seal) ShangHai MacroProcess Technology Co.,Ltd

Legal representative: (seal)

15th January 2009

Shenyang Sunshine Pharmaceutical Company Limited

Compressed Air and Process Gas System

Bidding Documents

Tender

1F，building A ,No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717 F: 021 54306718

Page 4 / Total 19

1.3. ID Card copy of legal representative

Shenyang Sunshine Pharmaceutical Company Limited

Compressed Air and Process Gas System

Bidding Documents

Tender

1F，building A ,No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717 F: 021 54306718

Page 5 / Total 19

1.4. Tender

Tender

To Shenyang Sunshine Pharmaceutical Company Limited:

We have received your tender documents regarding to Compressed Air and Process Gas System, and we decided to attend the tender. The Sales Manager Zhang Song is authorized to submit the following documents, 1 original and 2 copy on behalf of our company. Meanwhile, we are willing to abide by the following requirement:

1、Acknowledge and be willing to supply, install, debug and maintain the Compressed Air and Process Gas System according the rules and requirements in various tender documents.

2、The total quotation is 1,322,028.71 Yuan, and the promised supply period is 50 calendar days, installation period 60 calendar days, and the installation quality should live up to GMP requirement.

3、Be willing to fulfill the responsibility and obligation according to the law of contract and Law of the People's Republic of China on Tenders and Bids.

4、In the event we win the tender, we will perform all requirements in the tender document and finish the task with proper time, quality and quantity.

5、We are willing to provide all information required in the tender document.

6、We understand that the lowest quotation is not the only condition to win.

7、We agree to pay tender bond according the tender document and observe all regulations regarding to tender.

8、We tender is effective with 60 days after bid opening.

9、Please send all correspondences to the following address:

Address: 1F，building A ,No.168 LuoYang Rd, Shanghai

Tele: 021-54306717/ 13901375676 fax: 021-54306718

Bidder: (common seal) ShangHai MacroProcess Technology Co.,Ltd

Legal representative: (seal)

Date：__

Translation of other English bidding documents refers to the PDF. The part not being translated could be: Price Breakdown for PRO Distributiong System.

EX-4.7.14

EX 4.7.14 - Supplemental Translation to Bidding Document 3

Part 1

Tender

ShangHai MacroProcess Technology Co.,Ltd

Shenyang Sunshine Pharmaceutical Company Limited

Purified water、water for Injection、Pharmceutical Steam

storage and Distributions System

Bidding Documents

Tender

1F，building A ,No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717 F: 021 54306718

Page 1 / Total 60

Content

1. Quotation document	3
1.1. Qualification of legal representative	3
1.2. Power of attorney from legal representative	4
1.3. ID Card copy of legal representative	5
1.4. Tender	6
2.Proposal 1 pipes and fitness are ALFA LAVAL	7
2.1. Quotation list	7
2.2. Item quotation list	9
2.2.1. Purified water system material list and quotation	9
2.2.2. Water for Injection system material list and quotation	14
2.2.3. Pharmceutical Steamstorage and Distributions System list and quotation	21
2.2.4. Quotation for purified water and water for injection system	24
2.2.5. Storage tank configuration list	26
2.2.6. Cost of welding spot	30
2.2.7. Piping insulation price list	31
2.2.8. Quantity list of accessories for system	32
2.2.9. Quotation for authentication service	33
3.Proposal 2  pipes and fitness are NEUMO	34
3.1. Price list	34
3.2. Item quotation list	35
3.2.1. Purified water system material list and quotation	36
3.2.2. Water for Injection system material list and quotation	41
3.2.3. Pharmceutical Steamstorage and Distributions System list and quotation	48
3.2.4. Quotation for purified water and water for injection system	51

Shenyang Sunshine Pharmaceutical Company Limited

Purified water、water for Injection、Pharmceutical Steam

storage and Distributions System

Bidding Documents

Tender

1F，building A ,No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717 F: 021 54306718

Page 2 / Total 60

3.2.5. Tank body list instruction	53
3.2.6. Cost of welding spot	57
3.2.7. Piping insulation price list	58
3.2.8. Quantity list of accessories for system	59
3.2.9. Quotation for authentication service	60

Shenyang Sunshine Pharmaceutical Company Limited

Purified water、water for Injection、Pharmceutical Steam

storage and Distributions System

Bidding Documents

Tender

1F，building A ,No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717 F: 021 54306718

Page 3 / Total 60

1. Quotation document

1.1. Qualification of legal representative

Qualification of legal representative

Name of organization: ShangHai MacroProcess Technology Co.,Ltd

Address: 1F，building A ,No.168 LuoYang Rd, Shanghai

Operating period: 26th July 2007 -25th July 2017

Name: Wang Wei

Gender: Male

Name: 36

Title: Legal representative

Here by prove that Mr. Wang Wei, the legal representative of ShangHai MacroProcess Technology Co.,Ltd, is entitled to sign the tender document regarding to this tender, negotiate the contract and deal with all matters therein.

Tender unit (stamp): ShangHai MacroProcess Technology Co.,Ltd

Date: 15th January 2009

Shenyang Sunshine Pharmaceutical Company Limited

Purified water、water for Injection、Pharmceutical Steam

storage and Distributions System

Bidding Documents

Tender

1F，building A ,No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717 F: 021 54306718

Page 4 / Total 60

1.2. Power of attorney from legal representative

Power of attorney from legal representative

Shenyang Sunshine Pharmaceutical Company Limited:

This power of attorney declares: I, Wang Wei, the legal representative of ShangHai MacroProcess Technology Co.,Ltd, 1F，building A ,No.168 LuoYang Rd, Shanghai, now sign on behalf of the company to authorize the sales Manager Zhang Song acting as the legal agent who will attend the tender of Purified water、water for Injection、Pharmceutical Steam storage and Distributions System project organized by Shenyang Sunshine Pharmaceutical Company Limited. Out company will bear all responsibilities on the signature of the agent upon all documents and actions.

The agent shall be not allowed to transfer the authorization.

This authorization has come into force since 15th January 2009.

Agent: Zhang Song, Gender: Male, Age: 35

Unit: ShangHai MacroProcess Technology Co.,Ltd  Title: Sales Manager

Address: 1F，building A ,No.168 LuoYang Rd, Shanghai

Bidder: (common seal) ShangHai MacroProcess Technology Co.,Ltd

Legal representative: (seal)

15th January 2009

Shenyang Sunshine Pharmaceutical Company Limited

Purified water、water for Injection、Pharmceutical Steam

storage and Distributions System

Bidding Documents

Tender

1F，building A ,No.168 LuoYang Rd, Shanghai, China 201100

T:021 54306717 F: 021 54306718

Page 5 / Total 60

1.3. ID Card copy of legal representative

Shenyang Sunshine Pharmaceutical Company Limited

Purified water、water for Injection、Pharmceutical Steam

storage and Distributions System

Bidding Documents

Tender

1.4. Tender

Tender

To Shenyang Sunshine Pharmaceutical Company Limited:

We have received your tender documents regarding to Purified water、water for Injection、Pharmceutical Steam storage and Distributions System, and we decided to attend the tender. The Sales Manager Zhang Song is authorized to submit the following documents, 1 original and 2 copy on behalf of our company. Meanwhile, we are willing to abide by the following requirement:

1、Acknowledge and be willing to supply, install, debug and maintain the Purified water、water for Injection、Pharmceutical Steam storage and Distributions System according the rules and requirements in various tender documents.

2、The quotation for proposal 1 is 6,707,782.17 Yuan (pipes and fitness are ALFA LAVAL), for proposal 2 is 6,512,069.68 Yuan（pipes and fitness are NEUMO）; the promised supply period is 120 calendar days, installation period 90 calendar days, and the installation quality should live up to GMP requirement.

3、Be willing to fulfill the responsibility and obligation according to the law of contract and Law of the People's Republic of China on Tenders and Bids.

4、In the event we win the tender, we will perform all requirements in the tender document and finish the task with proper time, quality and quantity.

5、We are willing to provide all information required in the tender document.

6、We understand that the lowest quotation is not the only condition to win.

7、We agree to pay tender bond according the tender document and observe all regulations regarding to tender.

8、We tender is effective with 60 days after bid opening.

9、Please send all correspondences to the following address:

Address: 1F，building A ,No.168 LuoYang Rd, Shanghai

Tele: 021-54306717/ 13901375676 fax: 021-54306718

Bidder: (common seal) ShangHai MacroProcess Technology Co.,Ltd

Legal representative: (seal)

Date：__

Translation of other English bidding documents refers to the PDF. The part not being translated could be: Price Breakdown for PRO Distributiong System.

EX-12.3

Exhibit 12.3

Certification by the Chief Executive Officer

Of 3SBio Inc.

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Jing Lou, certify that:

1. I have reviewed this annual report on Form 20-F of 3SBio Inc. for the fiscal year ended December 31, 2009, as amended hereby;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

Date: November 3, 2011

By:	/s/    DR. JING LOU
Name:	Dr. Jing Lou
Title:	Chief Executive Officer

EX-12.4

Exhibit 12.4

Certification by the Chief Financial Officer

Of 3SBio Inc.

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Bo Tan, certify that:

1. I have reviewed this annual report on Form 20-F of 3SBio Inc. for the fiscal year ended December 31, 2009, as amended hereby;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

Date: November 3, 2011

By:	/s/Bo Tan
Name:	Bo Tan
Title:	Chief Financial Officer

EX-13.3

Exhibit 13.3

Certification by the Chief Executive Officer

Of 3SBio Inc.

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

In connection with the Annual Report of 3SBio Inc. (the “Company”) on Form 20-F for the fiscal year ended December 31, 2009, as amended and filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Jing Lou, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934.

Date: November 3, 2011

By:	/s/    DR. JING LOU
Name:	Dr. Jing Lou
Title:	Chief Executive Officer

The foregoing certification is being furnished solely pursuant to 18 U.S.C. Section 1350 and is not being filed with the Securities and Exchange Commission as part of the Report or as a separate disclosure document.

EX-13.4

Exhibit 13.4

Certification by the Chief Financial Officer

Of 3SBio Inc.

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

In connection with the Annual Report of 3SBio Inc. (the “Company”) on Form 20-F for the fiscal year ended December 31, 2009 as amended and filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Bo Tan, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934.

Date: November 3, 2011

By:	/s/    Bo Tan
Name:	Bo Tan
Title:	Chief Financial Officer

The foregoing certification is being furnished solely pursuant to 18 U.S.C. Section 1350 and is not being filed with the Securities and Exchange Commission as part of the Report or as a separate disclosure document.