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October 2009

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From:
Kuhne_Wes <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 14 Oct 2009 09:43:43 -0700
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text/plain
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A few years ago, to address a question from an auditor, I initiated a
test with my BI supplier for hold time for sublethal processing.  The
tests validated a 5 day wait before the damaged spores started to die
off as well.  You should discuss this with your BI manufacturer.

Wes P. Kuhne, MSc, RM/AAM
Staff Microbiologist, QA/QC Operations
ALLERGAN Medical
Office:  805/961-5841
Fax:  805/571-0170
 

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]] On Behalf Of Stewart, Jon
Sent: Tuesday, October 13, 2009 12:03 PM
To: [log in to unmask]
Subject: [PMFLIST] Processed Biological Indicator Hold Time

 

Dear Forum,

Is there a defined hold time for processed biological indicators (paper
carriers)?  USP <55> lists a 4 hour maximum hold time of processed
samples for D-value determination.  Does this hold true for equipment
validation samples.

Thank You
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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

Applied Biosystems, MicroSeq Microbial ID System - http://www.microseq.com/

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

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

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

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

Millipore - http://www.millipore.com

MODA Technology Partners - http://www.modatp.com

Pall - http://www.pall.com

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

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

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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