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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 16 May 2011 19:32:07 -0500
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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
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Carol Lampe <[log in to unmask]>
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Michael,
I have seen concentration bracketing done in the past and it works well if
you have a good understanding of the effects increasing concentration has on
your panel of organisms.  As a basic example, if you were covering varying
concentrations of ethanol, and you tested the 90% and the 10%, you would
miss the most bacteriostatic concentration - 70%.  The 10% is too dilute to
be as effective as the  70%; and the 90% does not have the water activity
needed to be as effective bacteriostatic agent as the 70%.

You might try running some screening studies at each concentration, like a
mini sterility test, to determine which concentration poses the greatest
challenge to the bacterial panel you are using, and use that as the
justification for you choice of validation.  You will however, then be
forced to perform the most stringent neutralization on every product in that
line.  If that would not be cost or time prohibitive, then I think you would
have a logical approach for streamlining your validation.  Of course your
initial validation plan, with acceptance criteria, would need to be outlined
in a protocol or procedure prior to starting any formal studies.

Carol Lampe
Sr. Consultant, JMHAI

On Fri, May 13, 2011 at 2:01 PM, Dr. Michael J. Miller <
[log in to unmask]> wrote:

> 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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-- 
Carol
"Life is not about waiting for the storms to pass - it is about learning to
dance in the rain."

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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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