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March 2012

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Subject:
From:
Chennupalli7 <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 28 Mar 2012 10:12:15 -0400
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Hi Karthik,


Your assumption is correct, during method validation the product is challenged with the test organism and incubated for not more than 5days which indicates the maximum incubation period which indicates the durg was totally eliminated and the method is complied, In GPT we check ability of the medium against the organism.


Gangesh Chennupalli



-----Original Message-----
From: Karthi keyan <[log in to unmask]>
To: PMFLIST <[log in to unmask]>
Sent: Tue, Mar 27, 2012 10:22 pm
Subject: [PMFLIST] sterility test method validation


Dear forum,

I have a query in sterility test method validation,
following is the statement given in USP &lt;71&gt; 

“In
both cases use the same microorganisms as those described above under growth
promotion test of aerobes, anaerobes, and fungi.
Perform a growth promotion test as a positive control. Incubate all the
containers containing medium for not more than 5 days” under the heading of 
method suitability test. 

Whereas in
the growth promotion test of aerobes, anaerobes, and fungi,
USP recommends as “Incubate for not more than 3 days in the case of
bacteria and not more than 5 days in the case of fungi”

What is the reason behind the two different
acceptance criteria? 

My assumption is, during the method suitability
test (test method validation study), we are checking the sensitivity of the
media &amp; the test method against the test organism in the presence of the
drug product, therefore the incubation period is extended to 5 days to grow-up
the injured (if the product possesses antimicrobial action) organisms. Whereas
during GPT, we are demonstrating the sensitivity of the media against the test
organism without test sample.

Is it true or what is the actual reason please
share your thoughts. Regards G Karthikeyan



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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

Lonza Rapid Testing Solutions - http://www.lonza.com/rts

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

Pall - http://www.pall.com

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

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

Steris - http://www.sterislifesciences.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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