Bioburden testing for medical devices made or used in the USA is governed by Title 21 of the Code of Federal Regulations and worldwide by ISO 11737.
211.110 (a)(6) states that bioburden in-process testing must be conducted pursuant to written procedures during the manufacturing process of drug products.
[3] The United States Pharmacopeia (USP) outlines several tests that can be done to quantitatively determine the bioburden of non-sterile drug products.
[4] The membrane filter is then placed onto Soybean-Casein Digest Agar and incubated in order to be able to determine the total aerobic microbial count (TAMC).
[4] In the Plate Count Method, the sample of drug product to be tested and Soybean-Casein Digest Broth is poured into a Petri dish.
The most probable number method (MPN) can also be performed for products considered to have a low bioburden[clarification needed].