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May 2006


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Sarbjit Mann <[log in to unmask]>
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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Fri, 28 Apr 2006 17:03:21 -0400
text/plain (61 lines)
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 

•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 

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


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