Abstract
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.
- Received December 17, 2021.
- Accepted April 20, 2023.
- Copyright © 2023, Parenteral Drug Association
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