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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, 1 May 2001 08:42:38 -0400
Content-Type:
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text/plain (68 lines)
Warren,

I assume that you agree that the inocula, antimicrobial neutralization and culture conditions are critical in terms of the reproducibility of the test.  However, I take it you do not support the presence of an internal control of a standard preservative/disinfectant that would be run periodically as an attempt to standardize the test.

I recommend the book edited by Michael Brown and Peter Gilbert "Microbiological Quality Assurance - A Guide Towards Relevance and Reproducibility of Inocula. CRC Press 1995 for two excellent chapters on the preservative effectiveness test.

Tony Cundell
Wyeth-Ayerst Pharmaceutical
>>> "Casey, Warren M" <[log in to unmask]> 05/01 8:05 AM >>>
Tony,

I believe that culture conditions and test methodology are more realistic
sources of  apparent "resistance".  We should focus on standardizing these
aspects of the test rather than opening the Pandora's box of "phenol
resistance".  The five passage rule was put in place to ensure that cultures
remain genetically and physiologically pure (I'm sure than an extensive
scientific effort was undertaken to come up with 5, as oppose to 6 or 7
passages).

Warren

> -----Original Message-----
> From: Anthony Cundell [SMTP:[log in to unmask]] 
> Sent: Monday, April 30, 2001 4:54 PM
> To:   [log in to unmask] 
> Subject:      [PMFLIST] Alternate to the Phenol Resistance Test
>
> The EPA is actively reviewing the elimination or modification of the
> Phenol Resistance Test as a requirement for the registration of
> disinfectants.
>
> The purpose of the test is control or verify the resistance of test
> organisms.
>
> The USP attempted to add such as test to the Antimicrobial Effectiveness
> test as a method of controlling the inherent variability of the test.
>
> Does anyone have an opinion as to the direction we should go with this
> issue?
>
> Tony Cundell
> Wyeth-Ayerst Pharmaceuticals
>
>
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