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May 2001

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From:
Alex Mello <[log in to unmask]>
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Date:
Fri, 4 May 2001 08:41:34 -0400
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Cathy;

We run negative system controls on every test we perform to verify the test
system and media sterilization of the media used in the analysis.  It is
critical in regulatory microbiology to be able to determine contamination of
a test system to effectively evaluate any potential OOS results.

For microbial limits and AET testing, we perform negative system controls of
our agar media, agar plates and apparatus.  We understand that the growth
promotion testing will monitor that the media has growth promotion
properties and monitor the sterility of the load.  This, however, does not
take into account the negative system control which assesses the analyst
aseptic technique during the test and monitors the apparatus utilized in the
test system (vessels, utensils, etc.)

I hope this information helps.  Please feel free to give us a call at
1-800-631-1680.  My direct extension is 23.

Regards,

Alexander Mello
Laboratory Director
MicroTest World Class Testing Services

-----Original Message-----
From: The Pharmaceutical Microbiology Mail List
[mailto:[log in to unmask]]On Behalf Of Hill, Katherine E.
Sent: Thursday, May 03, 2001 11:16 AM
To: [log in to unmask]
Subject: [PMFLIST] negative controls and growth promotion

Hello All-

        I was wondering what the industry practice is for performing
negative controls (time of use sterility check for media) for microbial
limits and preservative effectiveness testing (and any other kinds of
testing)?  Would performing negative controls, after doing the growth
promotion and sterility testing of the media, bring into question your
initial results for the media sterility check?  I've heard that in the
clinical area, conducting negative controls is common, but I would like to
know what other labs outside the clinical area are doing.  Any comments you
have would be greatly appreciated.

Thanks very much,
Cathy Hill
Part Three Microbiologist


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