I've always written Sterility test procedures to include at least one daily
positive control for the media lots used.
I picked up this practice from an FDA observation back in 1991...

Paul Phillips
Quality Operations
Pfizer Inc
100 Pfizer Drive
Terre Haute, IN 47802
Phone: (812) 299-2121 EXT 269
Fax: (812) 299-6014
Email [log in to unmask]



-----Original Message-----
From: JAMES DONNELL [mailto:[log in to unmask]]
Sent: Wednesday, December 10, 2003 10:32 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] media fill using thioglycollate medium


Kuel and forum,

I have a question too:  Has anyone ever read a sterility test procedure
which directs a perpetual positive control (ala growth promotion w/ <100cfu)
which is incubated along with the article under test AND if the positive
controls don't indicate positive, the sterility test is invalid?

Please reply,


JD

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