Establishing an EO (ethylene oxide) sterilization process can be a complicated path as multiple factors play a role in the design of a successful validation. Adequate product characterization is crucial to determine an appropriate monitor device, as it helps in understanding the product’s response to the sterilization process. Defining process parameters that are adequate for both the product and the sterilization load is essential to ensure effective sterilization while maintaining product integrity. Additionally, defining the validation activities to verify adequacy is a critical step in the process.
Selecting the right validation approach can significantly reduce the need for future cycle optimization. This includes addressing issues such as the reduction of EO usage, minimizing product residuals, reducing cycle times, or developing an appropriate process for parametric release. The chosen validation approach can also impact the ease or complexity of annual validation and process review and/or requalification, making it a pivotal decision in the overall sterilization strategy.
By attending this webinar, professionals involved in medical device sterilization will learn essential techniques and strategies for establishing a successful EO sterilization process. This knowledge will help ensure that their sterilization protocols are efficient, compliant, and capable of maintaining product safety and efficacy throughout the product’s lifecycle.