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October 2005

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From:
Larrimore_Daniel <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 31 Oct 2005 08:49:07 -0800
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Richard,
We used to perform annual monitoring of the WFI system at my previous
company in response to an audit observation from European inspectors,
though no isolates were recovered in the testing (as TC correctly states
in his message).  This was a case of compliance vs. science.  

If you find yourself in a position where you feel that this could be a
potential issue, then simply check your first and last point of use on
the WFI system once or twice per year for thermophiles.  Summarize the
results, and present it if asked.  It is always better to be in a
position to get an observation for not liking the way that testing is
performed instead of not doing it at all.  

Dan Larrimore

Allergan, Inc.

Worldwide Quality Assurance Manager

Aseptic Processing

Office: 714-246-3902

Fax:  714-246-6758


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]] On Behalf Of Soli PharmaSolutions
Sent: Saturday, October 29, 2005 8:38 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] Screening of thermophiles

Hopefully FDA, who seem to have a track record of enforcing statements
found
in USP informational chapters, will read the latest version (official in
USP
28, Sup 2) of USP's informational chapter <1231> Water for
Pharmaceutical
Purposes.  In it is categorically stated that "...it is generally
considered
pointless to search for thermophiles from hot pharmaceutical water
systems
owing to their inability to grow there."  The prior discussion in this
same
paragraph (under the section entitled "The Classical Culture Approach")
explains in nutritional terms why thermophiles don't grow in pure hot
water.

The only reason I can think of why firms might currently screen for them
in
hot WFI is because of the well-intentioned but misguided expectation
some
FDA investigators may have that firms do so.  There is no science behind
it.

Regards,

--T.C.

Teri C. ("T.C.") Soli, Ph.D.
Soli Pharma Solutions, Inc.
(252) 795-4779 (Ofc Line 1 & Fax)
(252) 795-5363 (Ofc Line 2)
(252) 902-5097 (Mobile)
www.SoliPharmaSol.com

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]] On Behalf Of Prince, Richard
Sent: Friday, October 28, 2005 1:55 PM
To: [log in to unmask]
Subject: [PMFLIST] Screening of thermophiles

Does anyone screen for thermophiles in WFI or clean steam and, if so,
why?

Richard Prince, Ph.D.
Associate Director, Quality Services
Mayne Pharma (USA) Inc. 
Mack-Cali Centre II
650 From Road
Paramus, NJ 07652
201-225-5631 - Phone
201-887-2174 - Cellular
201-225-5556 - Fax
Web Site: www.maynepharma.com/us

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the scientific community.

Please take a second to visit our sponsors' web sites and say thank you
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ATS Laboratories - http://www.ats-labs.com
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Dupont Qualicon - http://www.qualicon.com
EMSL Analytical, Inc. - http://www.emsl.com
Genomic Profiling Systems, Inc. - http://www.genprosys.com
Microcheck Inc,  Microbial Analysis Laboratory -
http://www.microcheck.com
MicroTest World Class Services - http://www.microtestlabs.com/
MIDI, Inc. - http://www.midi-inc.com/
Millipore - http://www.millipore.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.

------------------
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/
ATS Laboratories - http://www.ats-labs.com
Biolog - http://www.biolog.com
Biomerieux - http://industry.biomerieux-usa.com/
Dupont Qualicon - http://www.qualicon.com
EMSL Analytical, Inc. - http://www.emsl.com
Genomic Profiling Systems, Inc. - http://www.genprosys.com
Microcheck Inc,  Microbial Analysis Laboratory - http://www.microcheck.com
MicroTest World Class Services - http://www.microtestlabs.com/
MIDI, Inc. - http://www.midi-inc.com/
Millipore - http://www.millipore.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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