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November 1998


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The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Thu, 26 Nov 1998 15:02:20 +0000
text/plain (81 lines)
ATP Bioluminescence - satifies the requirements!
The systems supplied by Celsis / Millipore are the first and only rapid microbiological method to satisfy compendial and regulatory requirements. 

The Steriscreen system is the first and only rapid method to have received regulatory approval as part of a licensed product. This was achieved by Wyeth in November 1997 being approved by the Medicines Control Agency (MCA) in UK. The process took 3 months and there were no issues or problems in granting a license variation to accommodate the change in methodology. Call Tony Cundell (USA ) or Marianne Weatherhead (UK) for more details.
ATP Bioluminescence can also be used for purified waters using the MicroCount digital system which was used to demonstrate how to validate alternative micro. methods in a Stimuli for Revision published in the Pharmacopoeial Forum Jan 1998, vol 24, 1, 5645. This has been well received by industry and the regulators alike. This method has also achieved another first for  a pharmaceutical test method by being  certified by the AOAC Research Institute Performance Tested Program that is recognised by the regulators as an independent verification of performance claims.

Celsis / Millipore products are fully supported by extensive validation and claim support documentation ( first and only DMF's for micro. methods filed since 1996). This information was the subject of a specific 3 hour seminar for regulators and has been given on 20 different occasions to a total of over 400 regulators in countries such as USA ( 15 different FDA locations), Canada (Health and Protection Board 2 locations), Spain, Switzerland, Benelux.
No problems or issues have been raised with respect to their implementation as far as the regulators are concerned , in fact want industry to use the best available methods and recognise the limitations of conventional methods.

These experiences are included in our contribution to the PDA Task Force on Methods validation that is in its final draft stage and is likely to appear as a Technical Guide. Tony Cundell and Brian Bauer are joint chairmen of this group.

So what are y'all waiting for!
I would be more than happy to share our experiences of validation and regulatory feedback. Give me a call ++ 44 1223 435 206 or email.
Martin Easter
(Celsis International, Director of Scientific & Regulatory Affairs)
From:  [log in to unmask]
Sent:  26 November 1998 13:41
To:  [log in to unmask]
Subject:  [PMFLIST] Bioluminescence Testing

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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
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
or FDA acceptance of these methods?  I know the USP states something to
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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