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March 2020


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"Berman, Alison" <[log in to unmask]>
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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Wed, 4 Mar 2020 22:33:52 +0000
text/plain (2093 bytes) , image001.png (21 kB)
Hello all,

I am wondering how companies are assigning their alert/action limits for pre-filtration bulk bioburden samples if data normally produces zeroes.  Testing is performed as per USP <61>.
Is there an approach of considering the limits on the active raw materials/volume of WFI used to formulate/validated filter SAL or is it simply based on trending alone?


Alison Berman, MFS
Quality Control - Microbiology

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