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March 2020

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Subject:
From:
"Berman, Alison" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 4 Mar 2020 22:33:52 +0000
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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?

Thanks

Alison Berman, MFS
Supervisor
Quality Control - Microbiology

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