How To Prove A Sterility Assurance Level Of 10⁻⁶ PART 2: The Biological Indicator/Bioburden Method

By Kurt McCauley and Laurent Berliet

Explore the Biological Indicator/Bioburden (BI/BB) method for achieving sterilization of products. The BI/BB is different from the overkill method in that it aims to deliver sufficient lethality without excess insult to the product. The BI/BB method requires extensive knowledge of the product bioburden and its resistance characteristics.

Several prerequisite studies are needed in order to develop the sterilization process. These include:

• Bioburden characterization
• Product D-value Studies
• Load Mapping
• Cycle development and validation

In summary, the BI/BB method of validation requires additional precursor studies as compared to the overkill methods; however, once these are complete, the ability to develop a cycle that truly targets the contaminating organisms can be achieved.