Ethylene Oxide For Industrial Sterilization: Lethality Indicators And Their Use In Cycle Development, Validation, And Routine Monitoring

Sterilization process development is a critical component in ensuring the safety and efficacy of medical devices, pharmaceuticals, and other products requiring microbial control. A well-structured development process involves designing and optimizing sterilization cycles that consistently achieve the desired sterility assurance level. Central to this effort is the use of Biological Indicators (BIs) and Process Challenge Devices (PCDs), which play a vital role in cycle development, validation, and routine monitoring. BIs provide a standardized method for assessing microbial lethality, while PCDs simulate the most challenging conditions within a load, helping to confirm that the sterilization process is robust and effective across all product configurations.

To ensure your sterilization processes are compliant, effective, and optimized for your specific products, watch how you can conduct a thorough review of your current cycle development and monitoring protocols to elevate your sterilization strategy.