PT  - JOURNAL ARTICLE
AU  - Jim Agalloco
TI  - Ridding the World of 'Rogues': Improving Vapor Phase H2O2 Sterilization and Decontamination Processes
AID  - 10.5731/pdajpst.2021.012727
DP  - 2023 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2021.012727
4099  - http://journal.pda.org/content/early/2023/05/15/pdajpst.2021.012727.short
4100  - http://journal.pda.org/content/early/2023/05/15/pdajpst.2021.012727.full
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.