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December 2003

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Subject:
From:
Michelle Stevens <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 18 Dec 2003 15:22:45 -0500
Content-Type:
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We use PCA and incubate at 30 - 35C for 3 to 5 days.  We did a very
extensive study about 3 years ago where we compared PCA to R2A, incubating
both at 20 - 25C for 5 to 7 days and 30 - 35C for 3 to 5 days and found no
significant difference in recovery on either agar.  We ultimately chose PCA
and have been very pleased with its performance.  We have been audited by
clients and the FDA without any negative findings.

In regard to coliform testing....While it is true that Water for
Pharmaceutical Purposes has no compendial requirement for coliform use, you
do need to confirm that your incoming raw feed water (in our case, city
water) meets EPA standards.  So, we test our incoming raw feed water on a
weekly basis for total counts (on PCA) and for coliforms using mColiBlue
from Millipore.  It works really well and is pretty easy.

Hope this helps,
Michelle Stevens
Metrics, Inc.

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]]On Behalf Of Anthony Cundell
Sent: Thursday, December 18, 2003 10:54 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] question on media used for Water Bioburden
testing


Please note that there is no compendial requirement for coliform and
specified microorganism monitoring of water for pharmaceutical use.

I would refer you to USP General Informational chapter <1231> Water for
Pharmaceutical Purposes.

Tony Cundell
Wyeth Pharmaceuticals

>>> [log in to unmask] 12/17/03 11:49PM >>>
We are using TSA for Total Heterotrophic Count, M-Endo for Coliform and
P.
cepacia for B. cepacia

Nicola Skeet
Unigene Laboratories
[log in to unmask]

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The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
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the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for
their support of this service.
AAI - http://www.aaiintl.com/Micro.htm
Accugenix - http://www.accugenix.com/
Becton Dickinson Microbiology Systems - http://www.bd.com/industrial
Microcheck - http://www.microcheck.com/
MIDI, Inc. - http://www.midi-inc.com/
Microbial ID, Inc. - http://www.microbialid.com/
MicroTest World Class Services - http://www.microtestlabs.com/
MIDI Labs, Inc. - http://www.midilabs.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 PMFList (http://microbiol.org/PMFList_info.htm) is operated from
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the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
AAI - http://www.aaiintl.com/Micro.htm
Accugenix - http://www.accugenix.com/
Becton Dickinson Microbiology Systems - http://www.bd.com/industrial
Microcheck - http://www.microcheck.com/
MIDI, Inc. - http://www.midi-inc.com/
Microbial ID, Inc. - http://www.microbialid.com/
MicroTest World Class Services - http://www.microtestlabs.com/
MIDI Labs, Inc. - http://www.midilabs.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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