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May 2001

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Subject:
From:
Anthony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Tue, 22 May 2001 09:03:14 -0400
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text/plain
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Pat,
Asked by whom?
Based on the discussions at last years PDA Special Technical Forum on Aseptic Processing I believe the FDA position is there is no absolute requirement to monitor sterilized and aseptically assembled product contact parts like syringes.

As for gloves and gowns, I believe most pharma companies have audited their suppliers and accept the sterility of these components based on Certificate of Analysis. 

These garments are subject to personnel monitoring with a very high frequency of no isolations so I see no added value conducting sterility tests on these materials.

Tony Cundell
Wyeth-Ayerst

>>> Patricia Parish <[log in to unmask]> 05/21 6:12 PM >>>
We are now being asked to check all product contact components for
sterility.  This includes syringes, gloves,  and many other odd items.  We
are wondering how others are testing this type of component.  Are you
simply validating the vendor using audits, or qualifying them through
sterility testing of random items?  I've been asked to survey the group.

Patricia Parish
Berlex Biosciences
Richmond, CA


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