Evaluating Biological Indicator Performance in Saturated Steam Sterilization for Central Sterile Supply Department Monitoring

By Dr. Emerson Aparecido Miguel

This article examines how to evaluate biological indicator (BI) performance during saturated steam sterilization in Central Sterile Supply Departments. It explores methods for assessing BI quality using sublethal sterilization cycles, manufacturer survival times, temperature dataloggers, and F₀ lethality calculations. The article also addresses practical challenges associated with sterilizer characteristics, thermal inertia, and cycle interruption. Finally, it compares rapid-read fluorescence technology with traditional pH-based growth detection and explains how combining these approaches can improve interpretation of BI results, reduce diagnostic errors, and strengthen sterilization monitoring and infection prevention practices.

Learning Objectives

1. Discuss how biological indicator (BI) performance can be evaluated during routine steam sterilization cycles.
2. Identify practical considerations for assessing BIs based on sterilizer characteristics and monitoring practices.
3. Compare rapid incubation results with pH-based growth detection and their impact on interpreting BI results in daily use.

About the Author

Dr. Emerson Aparecido Miguel is a chemical engineering professional with more than 20 years of experience in process validation, sterilization, and equipment qualification across the pharmaceutical, healthcare, medical device, and related industries. He holds a PhD in Pharmaceutical Sciences from the University of São Paulo (USP) and actively contributes to the development of International Organization for Standardization (ISO) and Brazilian Association of Technical Standards (ABNT) for healthcare product sterilization. He is also a guest lecturer and frequent speaker on validation, sterilization, and regulatory compliance.