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 pdajpst.2019.011304
DO 10.5731/pdajpst.2019.011304
A1 Subrata Chakraborty
A1 Vaidehi Soman
A1 Vinayak Dhumal
YR 2020
UL http://journal.pda.org/content/early/2020/08/14/pdajpst.2019.011304.abstract
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.