PT - JOURNAL ARTICLE AU - Agalloco, James TI - Biological Indicators, Process Lethality and Vapor Phase Hydrogen Peroxide Processes AID - 10.5731/pdajpst.2024-003033.1 DP - 2025 Jan 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - pdajpst.2024-003033.1 4099 - http://journal.pda.org/content/early/2025/06/16/pdajpst.2024-003033.1.short 4100 - http://journal.pda.org/content/early/2025/06/16/pdajpst.2024-003033.1.full AB - This manuscript reviews the similarities between death curves associated with ‘rogue’ biological indicator results in vapor phase hydrogen peroxide decontamination / sterilization processes and those expected from varying process conditions. The manuscript considers whether the perceived ‘rogue’ behavior of some biological indicators in these process may be the result of the phase differences. Consideration of ‘wet’ vs ‘dry’ processes are discussed and recommendations for process improvement to reduce failures are provided.