USP <61> and <62>
Professional microbiology testing services by Nova Biologicals, Inc.
The USP Chapter 61/62 test utilizes the Compendial Method, as set forth by USP, for the testing of non‐sterile pharmaceutical products and other non‐sterile article for bacterial load and pathogenic organisms. USP 61 testing includes a plate count and suitability testing, which validates the plate count. USP 62 testing evaluates the presence or absence of objectionable organism. This test method has defined procedures for the detection of Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Salmonella species, fungal organisms, and a quantitative MPN for Bile Tolerant Gram Negative bacteria. USP 61/62 testing is recommended on all pharmaceutical raw materials, non‐sterile products, such as liquids and powders, transdermal patches, and dietary supplements.
The USP <61> and <62> tests are designed to validate and determine the quantitation of organisms present and screen for the presence or absence of objectionable organisms in non‐sterile pharmaceutical products.
The validation and suitability testing are performed once for each product. The testing verifies the validity of the testing method by demonstrating any antimicrobial properties of the product do not inhibit possible recovery of growth. Both validation and suitability are performed with inoculation of the product with <100 CFU of the defined organisms. USP <61> describes the validation of the plate count preparation and plating method by demonstrating recovery of Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans, and Aspergillus brasillensus on the appropriate media. USP <62> suitability testing verifies the validity of the testing method by demonstrating the recovery of Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, bile‐tolerant Gram‐negative bacteria, Clostridia species, Salmonella species and Candida albicans.
USP <61> routine analysis is performed to determine the total aerobic microbial and total yeasts and molds counts. The plating of the sample can be performed by membrane filtration, pour plating, or the spread plate method. The sample is diluted in an appropriate medium, generally Phosphate Buffer Solution, than it is plated on Soybean Casien Digest Agar (SCDA) for total aerobic microbial count (TAMC) and Sabaroud Dextrose Agar (SDEX) for total yeasts and molds count (TYMC). Incubation is for 3‐5 days at 30‐35°C for TAMC and 5‐7 at 20‐25°C days for TYMC.
USP <62> routine the test for the determination of the presence of specified microorganisms; Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, bile‐tolerant Gram‐negative bacteria, Clostridia species, Salmonella species and/or Candida albicans. The test involves an initial enrichment of the sample in Soybean Casien Digest Broth (SCDA), or other appropriate neutralizing media, and then streaking the enriched sample onto selective agars for determination of the presence of the defined objectionable organisms.