USP <61> and USP <62> are tests primarily used to evaluate raw materials, non-sterile pharmaceuticals, OTC finished products, personal care/cosmetic products and nutritional supplements. USP <61> involves quantitative testing for enumeration of total bacteria, yeast or mold present while USP <62> screens for the presence/absence of specified objectionable microorganisms. These methods are harmonized with the European Pharmacopoeia EP 2.6.12 and 2.6.13. CPT℠ also performs suitability and screening for Burkolderia cepacia complex according to USP <60>.
USP <61> is a quantitative test (plate count) to enumerate bacteria and fungi that may be present in non-sterile products. The tests performed are Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC).
USP <62> shows qualitative tests which determine the presence or absence of specified objectionable microorganisms or potential pathogenic microorganisms in non-sterile products. The organisms that can be tested for in this chapter include the following:
Prior to performing MLT testing on any specific product or material type, USP requires that method suitability be conducted. This is to ensure that the product/material does not inhibit recovery of organisms which may be present and could result in ‘false negative’ test results. Any antimicrobial properties present in the product/material can be eliminated by dilution, filtration, neutralization or inactivation before testing that product or material. This determines the valid dilution to be used for testing that product or material on a routine basis.
This general information chapter offers recommendations for microbiological specifications based on the nature of the product and its route of administration. This information should be provided to the testing laboratory when submitting samples for test method suitability by these chapters.
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