PT  - JOURNAL ARTICLE
AU  - Subrata Chakraborty
AU  - Vaidehi Soman
AU  - Vinayak Dhumal
TI  - Alternate approach for defining worst case in Steam Sterilization Validation of porous/hard goods loads
AID  - 10.5731/pdajpst.2019.011304
DP  - 2020 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2019.011304
4099  - http://journal.pda.org/content/early/2020/08/14/pdajpst.2019.011304.short
4100  - http://journal.pda.org/content/early/2020/08/14/pdajpst.2019.011304.full
AB  - 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.