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Subject:
From:
Timothy Cser <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 5 Mar 2020 16:07:32 +0000
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Hi Alison.  Search "Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective".  This BPOG working group talks about this very topic.

Sincerely,

Tim Cser
916-759-1401
MilliporeSigma

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Berman, Alison
Sent: Wednesday, March 4, 2020 2:34 PM
To: [log in to unmask]
Subject: [PMFLIST] In-Process Bioburden Limits

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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