USP<62> Test for Objectionable Microorganisms
Confirm the presence or absence of potential pathogens
Leigh Labs performs USP<62> testing to confirm the presence or absence of objectionable organisms including E. coli, Pseudomonas aeruginosa, Salmonella spp., Staphylococcus aureus, and Candida albicans. Objectionable microorganisms for nonsterile products, as cited in the U.S. Code of Federal Regulations (CFR) Title 21, Part 211.113, are microorganisms whose growth or persistence in nonsterile products can cause harm to users of those products and degrade the physicochemical, functional and/or therapeutic attributes of the products.
The USP <62> Test consists of an initial enrichment of the sample in an appropriate neutralizer broth and then streaking the enriched sample onto selective media for determination of the presence or absence of the specified objectionable microorganisms. It utilizes specific elements of the USP <61> for sample preparation to include the neutralization of the product to be tested. The USP <62> requires that prior to or in concert with routine specified microorganism testing, a one-time suitability of recovery test must be performed. This suitability test demonstrates the ability of the methods used to recover and detect the defined microorganisms if they are present in the sample.
