Pharmetric Laboratory performs Method Suitability testing, per our clients’ directions, for each new compound we receive to eliminate the chance that some ingredient in the product has an inhibiting factor. We test Method Suitability following USP <71> with the six separate Bio-burdens described therein. This only needs to be done once for the compound and is done just as our Sterility Testing, using ATP Bioluminescence as in the actual test.
“The design of the Method Suitability study for a quantitative microbial assay must mirror the actual test and be robust. To be applicable to the test, the Method Suitability must use the same microorganisms, prepared in the same manner, and recovered using the same method (plated, filtered, or MPN). The recovery conditions must be appropriate to the test as well, using the same media, same incubation temperatures, and the minimal duration of incubation anticipated. Acceptance criteria for the Method Suitability test must be sufficiently stringent to be meaningful.” Dr. Scott Sutton, (PhD. Microbiologist)
