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November 1998

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The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Mon, 30 Nov 1998 10:13:32 EST
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Dr. Easter:

Your opening statement is somewhat misleading. The fact remains that any rapid
alternative methodology satisfies both compendial and regulatory requirements
when properly validated. In the cases of both your system (bioluminescence)
and  systems available from Chemunex (Scan RDI and D-Count), that involves
validation of the core technology and procedural validation that verifies
equivalence of results to compendial methods.

I concur with your statement regarding the desire expressed by regulatory
agents for the industry to use  "the best available methods" and the fact that
there is a recognition  on "the limimitations of conventional methods". For
years microbiologists have had to compromise between speed to result and
recoverability as related to any and all growth based methods. In fact, this
problem is amplified in the pharmaceutical industry for the adequate recovery
of stressed an fastidious organisms, as well as spores.

Since the weaknesses of growth based methods have been and are recognized by
industry and regulators alike, alernative non-growth based methods are
currently being evaluated and validated for a number of applications. For
those who have interest in an approach that yields sensitivity to the single
cell level within a 90 minute time frame, a Stimuli for Revision will appear
in the Jan.-Feb. issue of Pharmacopoeial Forum that describes the technology
as it relates to pharmaceutical grade waters.This article highlights the
weaknesses associated with growth based methods, and describes how real-time
results may be used to improve overall quality.

Martin Tricarico
President
Chemunex, Inc.


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