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May 2006

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Subject:
From:
Ravi Talluri <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 1 May 2006 14:14:08 -0500
Content-Type:
text/plain
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You do not have to do it three times. B/F test need to 
Derenne,

You do not have to do it three times. B/F test need to be done only once
per product, unless there is a change in the product formulation or any
other changes to the product. Some companies recommend you do it every
year or occasionally, just so you know if your product is acting
different.
Hope that helps.

Ravi Talluri
Sr. Scientist, Microbiology
PPD Inc. 8551 Research Way
Middleton, WI 53562-3581
 
Phone: 608-203-4393
Fax: 608-827-8807
 

-----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 10:34 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 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

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

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