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May 2006

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Subject:
From:
Sarbjit Mann <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 28 Apr 2006 17:03:21 -0400
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Hi All

During our effort to validate the manufacturing facility autoclave, one of
the BI in 3rd run of a cycle has come up with positive result. The plan was
to validate the load configuration with autoclaving at half the time
routinely used for the sterilization of the load (to show 12 log
reductions).

•Can we perform additional run(s) of the load to show that this was an
isolated case? This will not happen in routine use because the routine run
time is double than the time used during the validation.

•OR we are bound to increase the exposure time and adjust our routine time
accordingly?

Can some one please explain from their experiences how they dealt with the
situation? Thanks

Sarbjit

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