PMFLIST Archives

May 2011

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
Madupa papaiah <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Sun, 22 May 2011 22:50:46 +0530
Content-Type:
text/plain
Parts/Attachments:
text/plain (101 lines)
Yes, when only the API differs in concentration, we do follow the bracketing
approach for suitability studies. Rgds, Madupa

On Sat, May 14, 2011 at 12:31 AM, 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.
>
> ------------------
> 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<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.
>

------------------
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.

ATOM RSS1 RSS2