USP 62 – Microbiological examination of non-sterile products: Tests for specified microorganisms [USP62]
Published: January 30th, 2019
Revised: March 24th, 2023
This is a product safety test specified by the United States Pharmacopeia Convention (USP) to evaluate the presence or absence of specified microorganisms. These tests are necessary for cosmetic and personal care products especially products that have high potential for use around the eyes, nose and mouth. Passage of these bioload challenges is required prior to the release of these products to market. It is not only important to determine the microbial burden of a product (See USP 61), it is also important to know what types of microbes are able to grow in a product. This test method determines whether your product will support of bacterial growth of potential pathogens such as:
- Staphylococcus aureus
- Pseudomonas aeruginosa
- Escherichia coli
- Salmonella enterica
- Candida albicans
- Clostridium sporogenes
- bile-tolerant Gram-negative bacteria
- fungi
Testing for this procedure is usually conducted for cohort of organisms, typically 3 or 4. As each organism has specific requirements related to incubation medium, temperature, and duration, we generally wait until all organisms in a cohort have been tested prior to reporting the results.
Laboratory code: USP62
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Prior to performing this test, a product should undergo suitability testing to ensure the non-interference of microbial inhibitor additives (in the same manner as that required prior to the performance of USP 61).
