RT Journal Article
SR Electronic
T1 Alternate Approach for Defining Worst Case in Steam Sterilization Validation of Porous/Hard Goods Loads
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 91
OP 99
DO 10.5731/pdajpst.2019.011304
VO 75
IS 1
A1 Subrata Chakraborty
A1 Vaidehi Soman
A1 Vinayak Dhumal
YR 2021
UL http://journal.pda.org/content/75/1/91.abstract
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.