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October 2005

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Subject:
From:
Lisa Gray <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 30 Sep 2005 08:52:31 -0700
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Hi All!  I have another question for the forum.  My company makes solid oral dosage tablets.  Currently, we do cleaning validation on our equipment using TOC analysis to check for chemical residues.  I've been told that we also need to do microbial cleaning validation on the equipment along with developing an environmental monitoring program.  I'm finding conflicting information about when to take microbial samples, I've found one reference that says I need to take samples before cleaning, and one that says take the sample after cleaning and sanitizing.  Also, the previous microbiology staff performed a microbial recovery study, where they inoculated stainless steel and cast iron plates with organisms and used rodac plates to validate that Rodac plates effectively recovered microorganisms from the surface of our equipment, but they did not complete the study, is this something that actully needs to be done?  I have found no references to this type of procedure for microbes.  We have
 done several recovery studies by TOC analysis for the chemical components of our products to verify that our method (TOC) can recover chemical residues from the equipment..
 
All information will be greatly appreciated.  Also, would microbial cleaning validation be considered part of our cleaning validation program or our soon to exist environmental monitoring program?
 
Thanks
 
Lisa Gray, PMP
Microbiologist II

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