EX-10 15 exh10d3.htm EXH 10D SPEC 2104-1005 ISSUE 2

Page: 1 of 4


Issue: 2

Date: March 7, 2004

Replaces: Original

Date: December 8, 2000

 

 

 

RAW MATERIAL PURCHASING SPECIFICATION

 

Specification #: 2104-1005

 

 

 

 

1.

Description

 

 

*

TradeMark Name: Natsyn [* *]

 

*

West Code Number: 2104-1005

 

*

Chemical Name: [* *] polyisoprene

 

2.

Source

 

 

*

Manufacturer: The Goodyear Tire and Rubber Company

 

*

Production Site: Houston, Texas

 

*

Supplier: The Goodyear Tire and Rubber Company

 

3.

Safety Data, Shelf Life and Recommended Storage Conditions

 

 

*

Safety Data: MSDS (Current Revision)

 

*

Shelf Life: Retesting after 18 months for Mooney is recommended

 

*

Storage Conditions:

Store in original container in ventilated warehouse, away

 

from heat and ultraviolet light and in clean, dry conditions. Preferred storage

 

 

temperature is 60 to 70 degrees F. Storage in the range of 40 to 100 degrees

 

 

F is recommended.

 

 

4.

Change Requirements

 

 

*

The supplier agrees to notify West Pharmaceutical Services at least six months in advance of any changes with manufacturing, chemical composition, raw material sources, site of manufacture, contract processing or testing, and testing methods which may affect the composition or specified properties of the product. If requested, a new qualification sample will be submitted for approval prior to production shipments to West Pharmaceutical Services.

 

 

 

 

PD-001 7/04

 

Page: 2 of 4


Issue: 2

Date: March 7, 2004

Replaces: Original

Date: December 8, 2000

 

 

 

RAW MATERIAL PURCHASING SPECIFICATION

 

Specification #: 2104-1005

 

 

 

 

 

5.

Acceptance and Reject Requirements

 

 

*

Acceptance: Received material must be without damage and free of any contamination. The material must meet all specification requirements as specified in Section 6, and be equal chemically, physically and functionally as determined for the original qualifying sample.

 

 

*

Reject: If the material does not meet specified acceptance requirements, the supplier will be notified through the Supplier Corrective Action Program requesting response for cause and corrective action. If the material is found to be unacceptable through evaluation and mutual agreement, the supplier is responsible for return authorization, cost of return, and credit for returned material

 

6.

West Pharmaceutical Services and Supplier Testing Specifications

 

 

*

West Pharmaceutical Services: Not Tested

 

Property

Specification

 

 

*

Supplier: These tests are listed on Goodyear’s Certificate of Analysis

 

Property

Specification

 

Appearance

White [* *]

 

 

Volatile Matter

0.5% Maximum

 

Extractables

3.0% Maximum

 

Ash Content

0.6% Maximum

 

Polymer Viscosity, ML-4 at 100°C

[* *]

 

 

BHT, ppm

[* *] Maximum

 

 

 

Typical Vulcanizates Properties

Specifications

 

ML, dNM

[* *] ± 1.5

 

 

MH, dNM

[* *] ± 2.6

 

 

Ts1, minutes

[* *] ± 0.8

 

 

t’25, minutes

[* *] ± 1.2

 

 

t’c50 minutes

[* *] ± 1.2

 

 

t’c90 minutes

[* *] ± 1.2

 

 

 

 

 

PD-001

7/04

 

 

Page: 3 of 4


Issue: 2

Date: March 7, 2004

Replaces: Original

Date: December 8, 2000

 

 

 

RAW MATERIAL PURCHASING SPECIFICATION

 

Specification #: 2104-1005

 

 

 

 

 

7.

Labeling and Documentation Requirements

 

 

*

Labeling: Each shipment must be identified with the supplier name, supplier product code or name, supplier lot number, West raw material code, shipping weights and where applicable a West Pharmaceutical Services Raw Material lot number.

 

 

*

Documentation: Each shipment must be accompanied with a packing slip and Certificate of Analysis. Additionally, a Certificate of Analysis must be mailed or faxed to West Pharmaceutical Services Corporate Facility.

 

8.

Other Requirements

 

 

*

Supplier Lots: Each shipment must contain one supplier lot, however, when this is not possible a maximum of two supplier lots.

 

*

Opaque white [* *] having strippable bale wrap, 75 pound bales packaged in approximately 2025 pound corrugated boxes on 50” X 32” 4 way entry pallet.

                

 

West Approval - Purchasing

West Approval – Quality Assurance

 

Name:

Linda Curtis, C.P.M.

    

Name: ___Minneva Taltoan______

 

Title:

Director of Purchasing

Title: ___QA Engineer__________

 


Date: _14 March 2005______________

Date: __14 March 2005_________

 

Signature: ___/s/ Linda Curtis ________

Signature: __/s/ Minneva Taltoan _

 

Supplier Approval

 

Name: _____John R. Bixler_________________________

 

Title:

_____Manager Benumont Site Technology Team__

 

Date:

_____April 25, 2005_________________________

 

 

 

PD-001

7/04

 

 

Page: 4 of 4


Issue: 2

Date: March 7, 2004

Replaces: Original

Date: December 8, 2000

 

 

 

RAW MATERIAL PURCHASING SPECIFICATION

 

Specification #: 2104-1005

 

 

 

 

 

Signature: __/s/ John R. Bixler______________________

 

Date

Issue

Details of Change

December 8, 2000

1

Original Issue

 

 

March 7, 2005

2

Added manufacturing site and deleted

 

 

West tests (none required since this is a

 

clean-up polymer). Revised shelf life,

 

 

storage and Section 5 – Reject Criteria

 

 

per Goodyear’s request.

 

 

 

 

 

PD-001

7/04