Establishing an Ethylene Oxide (EO) sterilization process involves navigating a complex path, as multiple factors influence the design of a successful validation. This webinar will provide a detailed exploration of the essential elements required to create an effective EO sterilization process, from product characterization to process parameter definition and validation activities.
In this two-part series, attendees will gain a foundational understanding of the key components involved in EO sterilization cycle validation and the associated activities. This knowledge is crucial for ensuring that the sterilization process is robust, efficient, and compliant with regulatory standards.
Key topics covered will include:
- Cycle Validation Basics: A comprehensive introduction to EO sterilization cycle validation, including the critical steps and considerations needed to establish a reliable process. Attendees will learn how to adequately characterize products to determine appropriate monitor devices and define process parameters that are suitable for the product and sterilization load.
- BIO/Bioburden and Cycle Calculation Approaches: An expanded view of different validation approaches, focusing on BIO/Bioburden and cycle calculations. This section will provide insights into selecting the right validation approach to minimize the need for future cycle optimizations, such as reducing EO usage, lowering product residuals, shortening cycle times, and developing a process for parametric release.
- Annual Review Activities: A clear definition of the necessary annual review activities to maintain the validity of the sterilization process. This will include guidance on process review and requalification, ensuring ongoing compliance and efficiency.
- Cycle Optimization Steps: Practical first steps to cycle optimization, offering strategies to refine the sterilization process and enhance its performance. This will help attendees identify opportunities for improvement and implement changes effectively.
By the end of this webinar, participants will have a thorough understanding of how to establish and optimize an EO sterilization process. This session is designed for professionals involved in sterilization validation, quality assurance, and regulatory compliance, providing them with the tools and insights needed to design, validate, and maintain a successful EO sterilization process. Attendees will be better prepared to tackle the complexities of EO sterilization and ensure their processes are efficient, safe, and compliant.