Bioburden

The number and type of viable micro-organisms on or in a product, component or material before sterilisation. Bioburden is tested to set and justify sterilisation cycles, especially for heat-sensitive products using a bioburden-based approach, and to monitor the cleanliness of the manufacturing process. For aseptically filtered products, the bioburden of the bulk solution before filtration has a limit, often 10 CFU/100 mL, and is tested by membrane filtration.