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May 2001

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Subject:
From:
Anthony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Tue, 22 May 2001 08:53:48 -0400
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Laura,
It does not say much for aseptic techniques if you continually need to identify your positive control.  If we run a growth-promtion test why a positive control.  If we did I suggest that just as the retention time is indicative of a standard in HPLC the colony morphology would identify a positive control.
Tony Cundell
Wyeth-Ayerst

>>> <[log in to unmask]> 05/21 6:15 PM >>>

Hello Again Everyone:

I found a company in the USA that per FDA has to quantitate their positive
controls for Coliform Testing of their water.  In addition, the FDA has told
them to IDENTIFY the positives as they come up.  I certainly find this
practice quite unusual.  I am used to running a positive and a negative
control along with a few other controls for each test but enumeration of the
positive control is not typically done.  Identification of the positives is
even a more remote possibility as part of a company's SOP unless the company
has shown problems with this particular control and the extra steps will then
be justified.

I would like to know if your company enumerates the positive controls for
water testing and if positives are identified.  Any information you can relay
would be greatly appreciated.

Regards,

Laura Valdes-Mora, MS
Technical Services Director
Elite MicroSource Corporation
3166 Wood Valley Road
Panama City, FL 32405
Phone:  850-763-5453
Fax:    850-913-9735
E-mail: [log in to unmask] 
"The Pharmaceutical Microbiology Resource Center providing seminars and
technical books around the continental USA, Canada and Puerto Rico"
Visit us at www.ELITEMICROSOURCE.COM


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