Alternate Approach for Defining Worst Case in Steam Sterilization Validation of Porous/Hard Goods Loads.

For steam sterilization load validation of porous/hard goods loads, regulatory guidelines state to identify and validate the worst-case challenge that is the most difficult to sterilize. The maximum load and the minimum load are usually considered as worst-case challenges, and both are validated. This article demonstrated with examples how the control strategy determined the worst-case load in the steam sterilizer. It further established with examples how a suitably designed control strategy could nullify the impact of varying load characteristics (e.g., mass, configuration, and air removal challenges) in porous/hard goods loads and make it load size independent.