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May 2006

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Subject:
From:
"Gotham, Amy" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 3 May 2006 23:04:29 -0400
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Hi Beth,
As chapter <1227> is an information chapter, the guidance is suggested, but
not required.  In general, either way is "correct", as the sterility testing
chapter <71> only requires B/F testing to be performed.  Using three lots of
product (rather than 3 times on the same lot) is the most conservative
approach chosen by many.  Sincerely, AMY

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]]On Behalf Of Derenne, Elizabeth M.
Sent: Monday, May 01, 2006 11:34 AM
To: [log in to unmask]
Subject: [PMFLIST] test validations


Forum,

 

Is it required to perform Bacteriostasis and Fungistasis testing ONE
time on a product or THREE times?  I was under the impression it was
three times, per USP chapter 1227, however I have noticed several
contract research orgs websites that state this test only needs to be
done once.  Which is correct?

 

 

Beth Derenne

 


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------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) 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.

Accugenix - http://www.accugenix.com

American Type Culture Collection - http://www.atcc.org

ATS Laboratories - http://www.ats-labs.com

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

Dupont Qualicon - http://www.qualicon.com

EMD Chemicals - http://www.emdchemicals.com

EMSL Analytical, Inc. - http://www.emsl.com

Genomic Profiling Systems, Inc. - http://www.genprosys.com

MIDI, Inc. - http://www.midi-inc.com

Millipore - http://www.millipore.com

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Raven Biological Labs - http://www.ravenlabs.com

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

=================================
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 Microbiology Network, Inc., the PMF, or the sponsors of the list.

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