Bioburden
Bioburden is normally defined as the number of bacteria living on a surface that has not been sterilized. The term is most often used in the context of bioburden testing, also known as microbial limit testing, which is performed on pharmaceutical products and medical products for quality control purposes. Products or components used in the pharmaceutical or medical field require control of microbial levels during processing and handling. Bioburden or microbial limit testing on these products proves that these requirements have been met. 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. The aim of bioburden testing is to measure the total number of viable micro-organisms (total microbial count) on a medical device prior to its final sterilization before implantation or use. 21 C.F.R. 211.110 (a)(6) states that bioburden in-process testing must be conducted pursuant to written procedures during the manufacturing process of drug products. The United States Pharmacopeia (USP) outlines several tests that can be done to quantitatively determine the bioburden of non-sterile drug products. It is important when conducting these tests to ensure that the testing method does not either