Microbial limit testing, also referred to as microbial content/bioburden testing, is conducted to analyze non-sterile pharmaceutical products, nutritional and dietary supplements for microbial content. Sterile products are tested according to USP <71> Sterility Test.
Preparatory testing is a required study that ensures results obtained are valid and reliable.
USP <61> and USP <2021> are quantitative tests that allow the client to determine the total aerobic microbial count and total combined yeast mold count of their product.
USP <62> and USP <2022> are qualitative tests for specified organisms that may be present in the product. Any recovered organisms should be considered by the client for the affect on user safety and product degradation.
Clients may refer to USP <1111> or <2023> for assistance in determining which test(s) are applicable for their product. For further guidance, please contact us
to discuss your needs.