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May 2020

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Subject:
From:
Robert Westney <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 5 May 2020 16:19:02 +0000
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text/plain
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Per USP <1116>: "In general, monitoring for strict anaerobes is not performed, because these organisms are unlikely to survive in ambient air. However, micro-aerophilic organisms may be observed in aseptic processing. Should anoxic conditions exist or if investigations warrant (e.g., identification of these organisms in sterility testing facilities or Sterility Tests <71> results), monitoring for micro-aerophiles and organisms that grow under low-oxygen conditions may be warranted."

Basically, you're going to need very specific reasons why you'd need to perform anaerobic EM.  Almost no company does.

Bob Westney
Director of Quality and Operations
Cryologics, Inc.
www.Cryologics.com

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Nilofar Bagban
Sent: Monday, May 4, 2020 1:23 AM
To: [log in to unmask]
Subject: [PMFLIST] Regarding anaerobic monitoring in Fill finish and sterility testing area

Hi All,

Greetings!!

Is there any guideline requirement for anaerobic monitoring in fill finish and sterility testing area?

Is there any risk assessment required for inclusion of anaerobic monitoring for routine monitoring.

Regards,
Nilofar


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The PMFList is supported by our sponsors as a service to the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



Steris - http://www.sterislifesciences.com/

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


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The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of the PMF or the sponsors of the list.

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