Intertek Testing Service,Ltd - Comment

Document ID: FDA-2008-N-0397-0002
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: July 29 2008, at 09:57 PM Eastern Daylight Time
Date Posted: August 8 2008, at 12:00 AM Eastern Standard Time
Comment Start Date: July 18 2008, at 12:00 AM Eastern Standard Time
Comment Due Date: September 16 2008, at 11:59 PM Eastern Standard Time
Tracking Number: 8069e2d6
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Dear Sir: We are third party testing and certification agency and our company name is INTERTEK Testing Service., LTD. Now we have some puzzlement during providing testing services for our client (General Electric). We did melting point testing of polypropylene according to FDA CFR Title21. § 177.1520. In this part of regulation, there have the descriptions, as “The melting point shall be determined by ASTM method D2117–82, “Standard Test Method for Melting Point of Semicrystalline Polymers by the Hot Stage Microscopy Method”. But as we known, ASTM had withdrawn the method ASTM D2117-82 in 1994. Check the ASTM web site for verification. This ASTM method is called the HSC (Hot stage microscopy). So we want to know if there has replacing method or exclusive method for this test item. Thanks.

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Intertek Testing Service,Ltd - Comment
Public Submission    Posted: 08/08/2008     ID: FDA-2008-N-0397-0002

Sep 16,2008 11:59 PM ET