Standards for Chemical and Biological Indicators in Sterilization Processes: Enhancing Occupational Health, Safety, and the Work Environment in Hospitals

Abstract

        Introduction: Ensuring the safety of patients and personnel in the Central Sterile Supply Department (CSSD) is a critical component of healthcare quality and infection prevention systems. Central to this safety assurance is the accurate monitoring and evaluation of sterilization processes through Chemical Indicators (CIs) and Biological Indicators (BIs). These indicators serve as essential mechanisms for verifying sterilization efficacy and reducing the risk of healthcare-associated infections. A comprehensive review of relevant international standards is therefore necessary to guide appropriate application within the context of Thai healthcare facilities. Methods: This study conducted a structured review, analysis, and synthesis of international standards related to the use of CIs and BIs in sterilization processes. The aim was to examine their role in ensuring sterilization quality, patient safety, and occupational health protection for CSSD personnel, particularly within the Thai healthcare context. Results: The review demonstrates that Chemical Indicators (CIs) as defined in ISO 11140-1, together with Bowie–Dick testing under ISO 11140-4/5, play a critical role in verifying air removal and steam penetration in pre-vacuum sterilization systems—conditions fundamental to effective sterilization. Concurrently, Biological Indicators (BIs) under the ISO 11138 series provide microbiological confirmation through D-values and Z-values, enhancing the precision and reliability of sterilization cycle validation. Appropriate use of CIs and BIs also contributes significantly to occupational safety by reducing unnecessary reprocessing and minimizing personnel exposure to contaminated instruments, thereby strengthening CSSD occupational health and safety (OHS) measures. However, a comparative analysis indicates several challenges in Thai healthcare facilities, including inconsistent testing practices, limited availability of advanced indicator types, and gaps in personnel competency for interpreting indicator results. These limitations affect both the quality of sterilization processes and overall safety in healthcare service delivery. Conclusion: The application of CIs and BIs in accordance with international standards is fundamental to ensuring effective and safe sterilization systems that protect both patients from infection risks and CSSD personnel from occupational hazards. This review provides a framework for the contextualized adoption of appropriate indicator systems in Thailand, supporting improvements in sterilization quality and promoting sustainable safety across healthcare settings.