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December 2003

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Subject:
From:
"Clark, Eileen" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 29 Dec 2003 10:42:28 -0700
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Hi all,
As a new member to the mail group, I have been very impressed by the discussions going on.  I have 2 questions, somewhat related, to pose to the members.

1)  We always perform quality control testing (pH, sterility, and growth promotion) on our incoming media prior to release for use.  Thus far, we have been testing 5% of each lot for sterility.  What are the various companies out there doing, or is there some type of industry standard to refer to?  I should add that this media is used for environmental monitoring and water testing, but we may be expanding our in-house testing to microbial limit testing.

2)  We manufacture a non-sterile product in an environment classified as 100,000.  I am writing a general SOP for environmental monitoring which may include higher classifications in the future and am somewhat confused as to terminology and would appreciate any help in clarifying the correct usage of the following terms:  Classified area, Controlled area, and Cleanroom.  I have looked at USP <1116> Microbiological Evaluation as well as PDA Technical Report No. 13, Fundamentals of an Environmental Monitoring Program, but have not found clear, consistent usage of these terms.

Thank you,

Eileen Clark
Lead Microbiologist
PR Pharmaceuticals
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