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May 2011

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Subject:
From:
Christina Kerksieck <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 13 May 2011 18:13:03 -0700
Content-Type:
text/plain
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text/plain (76 lines)
Dear PMF,

 

In USP Monograph for Insulin Human (Microbial Enumeration Tests <61> and
Tests for Specified Microorganisms <62>), the requirement is the total
bacterial count does not exceed 300 cfu per gram.

 

Would you test TAMC only?

 

Test TAMC and TYMC, but subtract TYMC result from TAMC result?

 

There is a disagreement with the interpretation of "bacterial count" and
would like to hear from the forum.

 

Regards,

 

Chris Kerksieck

Microbiologist

Columbia Analytical Services, Inc.
1317 S. 13th Ave
Kelso, WA 98626
360-501-3351 (Direct Line)
360-577-7222

[log in to unmask]
http://www.caslab.com/ <http://www.caslab.com/>  


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