INTRODUCTION
This chapter provides tests for the estimation of the number of viable aerobic microorganisms present in dietary ingredients and dietary supplement products. Alternative methods may be substituted for the tests, provided that they have been properly validated as giving comparable results, General Notices 6.30. See Validation of Alternative Microbiological Methods 〈1223〉 for general guidance. In preparing for and applying the tests, observe aseptic precautions in handling the specimens.
METHOD SUITABILITY
The validity of the results of the tests set forth in this chapter rests largely upon the adequacy of a demonstration that the test specimens to which they are applied do not, of themselves, inhibit the recovery, under the test conditions, of microorganisms that may be present. Therefore, prior to conducting the tests on a regular basis and as circumstances require subsequently, inoculate diluted specimens of the material to be tested with separate viable cultures of the challenge microorganisms to demonstrate their recovery during the microbial enumeration test. The ability of the test to detect microorganisms in the presence of product to be tested must be established. Suitability must be confirmed if a change in testing performance, or a change in the product that may affect the outcome of the test, is introduced.
Use standardized stable suspensions or in-house preparations of test strains. Seed-lot culture maintenance techniques (seed-lot systems) are used so that the viable microorganisms used for inoculation are not more than five passages removed from the original master seed lot.
Source from USP and Please refer to USP for details:https://online.uspnf.com/uspnf/document/2_GUID-24417C3D-8216-4737-8FFD-92759914578B_10201_en-US?source=TOC
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