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November 1998

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Subject:
From:
Jeff Werner <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Thu, 12 Nov 1998 15:51:01 -0500
Content-Type:
text/plain
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Members:

I am interested in any information you have on sterility testing of
virology seed stocks that are used as assay positive controls or for viral
clearance studies. Do you perform direct inoculation or membrane filtration
testing? How many vials of a lot do you use? Are there any regulatory
guidance documents on the subject?

We are thinking of testing the square root of N+1 units from the lot and
and using existing virology facilities for the sterility testing to limit
the chance for viral contamination of the sterility testing suite. We are
also concerned with incubating the sterility test media in the microbiology
laboratory (non-pathogenic mammalian cell viruses which are unlikely to
affect bacterial/fungal growth or humans).

Thank you for your response.


Jeff _Werner @ biogen.com


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