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March 2020

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Subject:
From:
"Knutsen, Chris" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 6 Mar 2020 14:43:24 +0000
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For the pre-sterile filtration bioburden specification, see the EMEA "Note for Guidance on Manufacture of the Finished Dosage Form" on page 5/6.  It states that, for most situations, NMT 10 CFU/100 mL is acceptable.  You should get a copy of this guidance for your records.


Chris Knutsen, PhD
Technical Fellow| Microbiology Center of Excellence
Analytical Strategy and Operations

Office +1 732-227-5375
Mobile +7 609-751-8362

Bristol Myers Squibb
1 Squibb Drive
New Brunswick, NJ 08903

bms.com / LinkedIn / Twitter / Facebook / Instagram



-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Berman, Alison
Sent: Wednesday, March 4, 2020 5:34 PM
To: [log in to unmask]
Subject: [PMFLIST] In-Process Bioburden Limits

[Use CAUTION when opening links/attachments]

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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