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May 2011

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Subject:
From:
Lagomarsino Mónica <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 23 May 2011 19:35:12 -0300
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Dear Michael
Yes, in that case (API is the only ingredient)we do the suitability on the higher concentration (worst case).
If an antimicrobial is present (according Carol has suggested), it is taken in account in order to evaluate if a worst case is possible.
Mónica  

-----Mensaje original-----
De: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] En nombre de Dr. Michael J. Miller
Enviado el: Viernes, 13 de Mayo de 2011 04:02 p.m.
Para: [log in to unmask]
Asunto: [PMFLIST] Bracketing method suitability studies for sterility testing

Has anyone bracketed their method suitability (bacteriostasis/fungistasis) testing for sterility testing? For example, if a range of products only differ in their API concentration and the API is the only ingredient in the formulation, have you performed method suitability on the highest and the lowest API concentrations instead of qualifying every concentration/formulation? I am looking for current industry practices.
Thanks, Michael

Michael J. Miller, Ph.D.
President
Microbiology Consultants, LLC
19009 St. Laurent Drive, Lutz, FL 33558
phone: 727-437-2743 (RAPID-RAPID)
email: [log in to unmask]
web: http://microbiologyconsultants.com
linkedIn: http://www.linkedin.com/in/drmichaelmiller

http://rapidmicromethods.com ­ advancing the science and implementation of rapid microbiological methods.

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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

=================================
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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