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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 17:10:52 +0200
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David,

I guess that the EP/USP interpretation of a limit using a factor of 2 is
due to the method variability.

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 deviation. 


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 David Page
Sent: 1. marts 2011 10:02
To: [log in to unmask]
Subject: [PMFLIST] Interpreting bioburden limits

Hi All,
 
The EP/USP harmonised bioburden specifications include the statement:
When an acceptance criterion for microbiological quality is prescribed
it is interpreted as follows:
-  101 CFU: maximum acceptable count = 20;
-  102 CFU: maximum acceptable count = 200;
-  103 CFU: maximum acceptable count = 2000, and so forth.
 
Can anyone explain the basis for this statement?
Also, does anyone implement this limits as stated (20, 200 etc), or do
you use 10, 100 etc?
 
Thanks,

David Page
Senior Quality Officer


Vectura Limited, a subsidiary of Vectura Group plc



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the scientific community.

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