“The bioburden assay should be performed on each batch for both aseptically filled product and terminally sterilized products and the results considered as part of the final batch review. There should be defined limits for bioburden immediately before the sterilizing filter or the terminal sterilization process, which are related to the efficiency of the method to be used. Samples should be taken to be representative of the worst case scenario (e.g. at the end of hold time). Where overkill sterilization parameters are set for terminally sterilized products, bioburden should be monitored at suitable scheduled intervals.”