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May 2011

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Subject:
From:
"Lars Henrichsen (LHEDK)" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 9 May 2011 17:04:07 +0200
Content-Type:
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text/plain (192 lines)
Jennifer,

We use the direct or mathematically interpretation of a limit on a
specification, i.e. 10e2 = 100 CFU. If a result is above this limit it
is OOS and requires an investigation. If the result is within the EP/USP
interpretation (factor of 2) this would be taken into account in the
assessment of the particular OOS result.



Kind regards,


Lars Henrichsen
Chemist
ALK

T  (+45) 45 74 80 50
M  (+45) 30 22 91 44

E  [log in to unmask]



-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]] On Behalf Of Jennifer Hake
Sent: 23. januar 2010 00:04
To: [log in to unmask]
Subject: [PMFLIST] Interpretation of Results <61>

Hello -
In USP <61>, the harmonization effort has added an interpretation of
results section for TAMC and TYMC that essentially incorporates a factor
of 2 of microbial recovery - i.e., 10e2 cfu - maximum acceptable count =
200.  How is everyone implementing and/or utilizing this approach in
terms of product release specifications?  
Thanks,
Jennifer
 
Jennifer Hake

Manager - Quality Control Microbiology

Aptuit

 

10245 Hickman Mills Drive

Kansas City, MO 64137

USA

 

+1 816 767 3916 office

+1 816 767 7363 fax

 

www.aptuit.com
<file:///C:/Documents%20and%20Settings/a726325/Application%20Data/Micros
oft/Signatures/www.aptuit.com> 

[log in to unmask] <mailto:[log in to unmask]> 

 

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