Contamination control program

Monitoring of Bioburden

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. USP <1229.3>, Monitoring of Bioburden, sets up the requirement to monitor bioburden as part of your contamination-control program for sterilization processes. When…