Bioburden is defined as the number of bacteria living on a surface that has not been sterilized. A bioburden test determines the total number of viable microorganisms in or on a medical device.
According to USP, “bioburden is a potential risk to the patient not only because the sterilization process might not be completely effective, but also post-processing because of the possible presence of residual materials such as allergens, endotoxins, and exotoxins. It may also have adverse impact on product quality and stability.”
