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May 2006

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Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 30 May 2006 23:09:09 -0400
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Jill,

It is a compendial requirement, and it make good scientific practice, to 
adjust the pH into the range 6 to 8. If the pH adjustment is found not 
necessaary during the suitability testing or it can be achieved consistently 
then you can forgo the pH check

Tony Cundell
Scarsdale, NY




>From: Jill Blythe <[log in to unmask]>
>Reply-To: The Pharmaceutical Microbiology Forum Email List              
><[log in to unmask]>
>To: [log in to unmask]
>Subject: [PMFLIST] pH Adjustments
>Date: Tue, 30 May 2006 10:27:25 -0500
>
>In light of the harmonized microbial methods that I believe were signed off 
>on in November, 2005, what are the thoughts out there on pH adjustments of 
>the sample dilution to between 6-8?  Is it necessary to make the pH 
>adjustment if we can show by dilution or neutralization, recovery of all 
>the challenge microorganisms?
>
>Also, if during validation, a pH adjustment is necessary, how close to the 
>pH obtained during validation would one have to be for routine testing? 
>Plus or minus 0.2 pH units or just between 6-8?
>
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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

ATS Laboratories - http://www.ats-labs.com

Biolog - http://www.biolog.com

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

Dupont Qualicon - http://www.qualicon.com

EMD Chemicals - http://www.emdchemicals.com

EMSL Analytical, Inc. - http://www.emsl.com

Genomic Profiling Systems, Inc. - http://www.genprosys.com

MIDI, Inc. - http://www.midi-inc.com

Millipore - http://www.millipore.com

Pall - http://www.pall.com

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

Raven Biological Labs - http://www.ravenlabs.com

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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