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October 1998

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Subject:
From:
Holly Erickson <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Mon, 26 Oct 1998 10:19:27 -0800
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   Colleagues
   I have had several lots of Biological Indicators fail spore count
   verification, (ampules and strips). This constitutes an OOS trend that I
   am now required to investigate further.
   While I am investigating our method, I also understand that this is an
   industry wide problem.
   I am looking for some documentation of this as an industry problem.
   If you have had a similar experience, would you please relay this back
   to me?

   Additionally, do you have any insight on the cause of the problem?
   Are the USP specifications are too tight, considering the variability of
   method?

   I'd appreciate any input you could give me.
   Holly Erickson
   QA Microbiology
   Chiron Corporation


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