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  - 2021 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 91--99
VI  - 75
IP  - 1
4099  - http://journal.pda.org/content/75/1/91.short
4100  - http://journal.pda.org/content/75/1/91.full
SO  - PDA J Pharm Sci Technol2021 Jan 01; 75
AB  - 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.