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December 2003

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Subject:
From:
Anthony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 18 Dec 2003 16:15:15 -0500
Content-Type:
text/plain
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Michelle,
The regulations do not require coliform monitoring of incoming potable
water if it is obtained from a water authority that meets the national
regulatory requirements, US Federal EPA regulations. Many companies
review the quarterly EPA-mandated quality reports from their water
authorities and do some level of monitoring for TVMC and absence of
coliforms.
Tony Cundell

>>> [log in to unmask] 12/18/03 03:22PM >>>
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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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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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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