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November 1998

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Subject:
From:
"Brien C. David" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Wed, 25 Nov 1998 09:34:48 -0500
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Hello Y'all!
I just got onto the PMF list today and thought I'd start off with a
question immediately.
We would like to start using Millipore's Bioluminescence technology in the
micro lab wherever applicable to speed up efficiency, turnaround times,
etc. Specifically, we are looking to use the Steriscreen system as an
alternate test method to the USP Microbial Limits testing for relatively
"clean" products and raw materials.  Additionally, we would like to use the
Microstar system for testing our purified waters.

Does anyone have any experience using any of these?  Any tips on
validation, dealing with regulatory submissions, the USP or EP perspective,
or FDA acceptance of these methods?  I know the USP states something to the
effect that "automated procedures may be substituted if validation shows
them to be equivalent or better", but is anyone using these routinely now?
Any help would be greatly appreciated.
Thank you.

Brien David


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