Bioburden is that dirty little topic nobody wants to talk about in mixed company (operations and QA). Bioburden is a contamination that can get into our products at several entry points. Our fundamental responsibility is to eradicate it, but since it is invisible, we often make believe it doesn’t exist.
According to Wikipedia, “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.”
Read more on Pharmaceutical Online here: https://www.pharmaceuticalonline.com/doc/cleaning-sanitizing-sterilizing-or-wishing-it-away-what-are-we-doing-to-control-bioburden-0001
