RT Journal Article
SR Electronic
T1 Ridding the World of 'Rogues': Improving Vapor Phase H2O2 Sterilization and Decontamination Processes
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2021.012727
DO 10.5731/pdajpst.2021.012727
A1 Jim Agalloco
YR 2023
UL http://journal.pda.org/content/early/2023/05/15/pdajpst.2021.012727.abstract
AB This publication reviews the reported ′rogue′ behavior of biological indicators used for vapor phase hydrogen peroxide processes with attention to the aspects of BI design / configuration to identify factors which may contribute to the reported greater variance in resistance. The contributing factors are reviewed with respect to the unique circumstances of a vapor phase process that adds challenges to H2O2 delivery to the spore challenge. The numerous complexities of H2O2 vapor phase processes are described as these contribute to the difficulties encountered. The paper includes specific recommendations for changes to the biological indicator configurations in use and the vapor process to reduce the incidence of rogues.