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December 2003

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Subject:
From:
Gayle Shaw <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 29 Dec 2003 15:41:50 -0500
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Eileen,
In other companies I have been in we tested sterility at 10% of the lot
for liquid media .  For contact plates, regular plates and RCS strips we
tested 100% of the lot for sterility, and then performed the PH, and
growth promotion testing.   We always used 5 liquid samples for PH, 2
plated sampled for PH.   We also tested the growth promtion as specific to
the media, example TSA got duplicates testing of gram pos cocci, gram
negative rod, b. subitlis, yeast, mold etc while Mendo media was only
tested for E. Coli.

Gayle Shaw
QE Validation Microbiologist
Cryolife, Inc




"Clark, Eileen" <[log in to unmask]>
Sent by: The Pharmaceutical Microbiology Forum Email List
<[log in to unmask]>
12/29/2003 12:42 PM
Please respond to The Pharmaceutical Microbiology Forum Email List


        To:     [log in to unmask]
        cc:
        Subject:        [PMFLIST] Media Sterility and Technical Definitions


Hi all,
As a new member to the mail group, I have been very impressed by the
discussions going on.  I have 2 questions, somewhat related, to pose to
the members.

1)  We always perform quality control testing (pH, sterility, and growth
promotion) on our incoming media prior to release for use.  Thus far, we
have been testing 5% of each lot for sterility.  What are the various
companies out there doing, or is there some type of industry standard to
refer to?  I should add that this media is used for environmental
monitoring and water testing, but we may be expanding our in-house testing
to microbial limit testing.

2)  We manufacture a non-sterile product in an environment classified as
100,000.  I am writing a general SOP for environmental monitoring which
may include higher classifications in the future and am somewhat confused
as to terminology and would appreciate any help in clarifying the correct
usage of the following terms:  Classified area, Controlled area, and
Cleanroom.  I have looked at USP <1116> Microbiological Evaluation as well
as PDA Technical Report No. 13, Fundamentals of an Environmental
Monitoring Program, but have not found clear, consistent usage of these
terms.

Thank you,

Eileen Clark
Lead Microbiologist
PR Pharmaceuticals
[log in to unmask]

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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.
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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