Abstract
For steam sterilization load validation of porous/ hard goods loads, regulatory guidelines state to identify and validate the worst-case challenge which is most difficult to sterilize. The maximum load and the minimum load are usually considered as worst-case challenge, and both are validated. This paper demonstrates with example how the control strategy determines the worst-case load in the steam sterilizer. It further establishes with examples how a suitably designed control strategy can 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.
- Received November 26, 2019.
- Accepted August 3, 2020.
- Copyright © 2020, Parenteral Drug Association
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