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May 2011

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Subject:
From:
Lou Fraser <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 20 May 2011 14:05:40 -0700
Content-Type:
text/plain
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Tom -

Look in USP 34 chapter <1227>, "Validation of Microbial Recovery",
specifically described in the "validation of neutralization method -
recovery comparisons" section, page 784. Check it out.

Lou Fraser

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]] On Behalf Of [log in to unmask]
Sent: Wednesday, May 18, 2011 1:33 PM
To: [log in to unmask]
Subject: [?? Probable Spam] [PMFLIST] Recovery specification for USP 61
Prep Test

Hello all,

It has been a while since I was in pharmaceutical micro testing so I
need 
a little help.  I am writing a method for performing a prep test based
on 
the USP61 enumeration test.  In the past I remember having a spec of
>75% 
organism recovery when comparing the product sample to the control
sample 
when using the filtration method.  How is this spec set?  I thought this

was in the USP 61, but it is not and the section pertaining to this
simply 
states that a comparison is made with the product sample to control 
sample. 

thank you in advance,
Tom







 
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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

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

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

Biotest - http://www.BiotestUSA.com/micro

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

MODA Technology Partners: now a LONZA company http://lonza.com/moda

Pall - http://www.pall.com

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

Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)

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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