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May 2011


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"Dr. Michael J. Miller" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Fri, 13 May 2011 15:01:50 -0400
text/plain (55 lines)
Has anyone bracketed their method suitability (bacteriostasis/fungistasis)
testing for sterility testing? For example, if a range of products only
differ in their API concentration and the API is the only ingredient in
the formulation, have you performed method suitability on the highest and
the lowest API concentrations instead of qualifying every
concentration/formulation? I am looking for current industry practices.
Thanks, Michael

Michael J. Miller, Ph.D.
Microbiology Consultants, LLC
19009 St. Laurent Drive, Lutz, FL 33558
phone: 727-437-2743 (RAPID-RAPID)
email: [log in to unmask]
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