In response to the growing emphasis on sustainable EO sterilization practices, this course navigates the evolving landscape by exploring alternative validation methods beyond the traditional half cycle overkill approach. The industry shift towards more efficient sterilization processes has led to the prominence of methods like the overkill cycle calculation and the BI/bioburden approach.

A notable development is the revised AAMI TIR16:2023, which now offers comprehensive guidance on these contemporary sterilization validation approaches. This is a departure from historical standards and Technical Information Reports (TIR) such as ISO 11135 and pre-revision AAMI TIR16, which predominantly centered around the half cycle overkill method.

Key advantages associated with the overkill cycle calculation and BI/bioburden methods include a streamlined sterilization cycle, enabling quicker product release turnaround times, and a concurrent reduction in residual EO levels.

This course covers essential aspects of EO sterilization, encompassing process definition and performance qualification. Participants will gain insights into the significant updates in AAMI TIR16:2023, with a specific focus on the application of ISO 11138-7 in industrial EO sterilization. The curriculum is enriched with practical case studies illustrating the implementation of either the overkill cycle calculation method or the BI/bioburden approach for EO sterilization validations.

Over the course of (4) hours, the attendee will be able to:

• Gain a basic understanding of EO sterilization including process definition and performance qualification,
• Understand the principals of process lethality and how they apply to the Overkill Cycle Calculation Method and BI/Bioburden Approach to EO sterilization, 
• Apply best practices from the revised edition of TIR16 to establish an optimized EO sterilization process.

Medical device professionals with experience in Sterility Assurance, EO sterilization and Microbiology.