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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:
Wed, 30 May 2001 08:52:40 -0400
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Clare,
The standard equipment used for sterility testing in the US is Millipore Corp's Steritest System.  The system is configured for a number of packaging styles.  If it is bioburden you are interested in I would use classic membrane filtration methods.
You should go to www.millipore.com.
Tony Cundell
Wyeth-Ayerst Pharmaceuticals

>>> Clare MacLeod <[log in to unmask]> 05/30 4:35 AM >>>
I would like to benchmark bioburden (total viable count) determination
methods (specifically methodologies and equipment) used in the
pharmaceutical industry for sterile solutions and suspensions in various
containers eg bags, vials and ampoules.

Relating to the equipment I am looking for information on where this
equipment can be purchased and how rapid the bioburden results are
available as well as the accuracy of these determinations.

Thanx Clare MacLeod


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