A more detailed list of the new USP <61> and <62> can be found below.
Effective May 2009, the new USP <61> and <62> provide harmonization to the existing European Pharmacopeia method for testing non-sterile pharmaceuticals. This includes over-the-counter (OTC) and personal care products.
The original total mictobial limits USP <61> underwent significant changes and split into two part new parts, USP <61> and <62>.
- USP <61> Microbial Enumeration Tests such as total aerobic microbial count (TAMC), and total yeast and mold count (TYMC). The Microbial Enumeration Tests' changes include new pass/fail criteria, longer incubation durations, and the disallowing of retests. Negative control is now required every time that the product is tested. Organism validation in TSA plates have changed to Staphylococcus, Pseudomonas, and Bacillus subtilis.
- USP <62> Microbiological Examination of Non-Sterile Products: Tests for Specified Microorganisms. The modifications on microbiological medias for specific pathogens like Salmonella, Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Clostridia, bile–tolerant Gram-negative bacteria, and Candida albicans. Critical changes have been made to enrichment broth, incubation temperatures and incubation duration. Organisms such as Candida albicans, Clostridia species, and bile-tolerant Gram-negative bacteria may be required to be tested depending on product type per FDA and USP monograph. Negative control is required everytime that the product is tested.