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November 1998


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Tony & Roz Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Mon, 30 Nov 1998 11:49:25 -0500
text/plain (54 lines)

You do not state your affliation but we have formed a MetroNY-Northern NJ
SteriScreen Users group.

Details would be avaibable from Steve Richards, Schering-Ploug or Pat Booth,

Tony Cundell
[log in to unmask]

At 09:34 AM 11/25/98 -0500, you wrote:
>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
>The PMFList ( is operated from
>The Microbiology Network ( and supported by
>our sponsors ( as a service to
>the scientific community.

The PMFList ( is operated from
The Microbiology Network ( and supported by
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the scientific community.