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.
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]
http://rapidmicromethods.com advancing the science and implementation of
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