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October 1998

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Subject:
From:
Ayo Ogunsanlu <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Tue, 27 Oct 1998 17:27:00 +0000
Content-Type:
TEXT/PLAIN
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TEXT/PLAIN (58 lines)
>>>>>>>>>>>>>>>
   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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<<<<<<<<<<<<<<<
Holly,

I am glad you raised this issue because I had similar problems with several batches
of BI's last year. 
We found we could not reproduce the spore counts claimed by the label. After
several attempts, we contacted the suppliers and asked for their test method. Their
method was different from that specified in the USP and ..... it worked. The main
difference being the use of a phosphate buffer for the serial dilution prior to plating.
While it was great to be able to confirm their results, we still had a dilemma.  To
implement their results would mean deviating from the pharmacopoeial method. We
finally got around the problem by drastically reducing the shelf life to a month of
purchasing, ,and we specified to the suppliers that we only wanted BI's with a
minimum of 1 years shelf life by the time we got them. We have not had a problem
since, but I would be interested in what others have to say about this.

Ayo Ogunsanlu
Microbiology QC (Biotechnology)
British Biotech


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