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May 2006

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From:
Victor Mencarelli <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 17 May 2006 08:55:16 -0400
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Curt,

You raise an interesting question.  My "knee-jerk" reaction to the 
question is that if you can show recovery to a level that allows you to 
make a decision regarding the pass/fail criteria you should be OK. 
Therefore, your dilution at 10^-3 should be acceptable.  HOWEVER, since 
there is that silly little phrase in the test method about "no increase 
between 14 and 28 days" that might change your situation.  In addition, 
you also need to account for the variation in the test method itself (I 
have heard of the method being up to 0.5 log variable either way) and 
therefore you should really be validating at least to the 10^-2 level to 
account for this variation because it is reasonably foreseeable that if 
you are only recoverable at 10^-3 you could miss either a basic fail (not 
REALLY meeting your 1 log reduction requirement at 14 days) or an 
"extended fail" (unrecognized increase in 14-28 days).

All that said, what the regulator is really going to look at is your data. 
 If your data is defensible, your product result is defensible.  Is that 
defense air-tight?  NO CHANCE.  But then again, very little of what we do 
in microbiology is truly air-tight because of the inherent variation 
involved in working with living, metabolizing, reproducing organisms.

Vic Mencarelli
Regulatory Affairs Specialist
Engelhard Corp.
50 Health Sciences Dr.
Stony Brook, NY 11790
P: 631-380-2482
F: 631-689-6880
E-mail: [log in to unmask]

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"merideth, curtis" <[log in to unmask]> 
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Subject
[PMFLIST] USP AET Validation






After inoculating our samples we serial dilute and plate each dilution
out to 10^-5.  For a category 3 product, that requires 1 log reduction
from initial for bacteria, do I need to show microbial recovery at the
first dilution for a "validation"?  Or if I can just demonstrate
recovery at the 10^-3 dilution would that be acceptable, since that
would show if the 1 log reduction was met?  Would that still meet the
second criteria of no increase from 14 to 28 days, assuming there isn't
any recovery at all in the actual testing?  Thanks for your help.
 
Curt Merideth
Microbiologist
Fleming & Company

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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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