Validating, Optimizing and Monitoring EO Sterilization Processes, Day 1

Establishing an EO sterilization process can be a complicated path as multiple factors play a role in the design of a successful validation: adequate product characterization to determine an appropriate monitor device, definition of process parameters that are adequate for the product and sterilization load, and the definition of the validation activities to verify adequacy. Selecting the right validation approach would reduce the need for future cycle optimization to address things like the reduction of EO usage, reduction in product residuals, reduction in cycle times or the development of an appropriate process for parametric release. The validation approach selected can also facilitate (or complicate) annual validation and process review and/or requalification.

During the two days attendees will learn:
- A 101 approach to cycle validation and ancillary activities
- An expanded view of BIO/Bioburden and Cycle Calculation validation approaches
- A definition of annual review activities
- The first steps to cycle optimization

Day 1: Validation design for an optimal process

A.) PCD selection (least resistance option)
B.) Adequate validation approach: Cycle enumeration, BI/Bioburden, overkill
C.) Packaging/loading configuration/ Density
D.) Cycle parameters and benefits of possible adjustments to EO concentration and other parameters