Medical Device Ethylene Oxide (EtO) Sterilization Validation Masterclass

Everything That Matters in Medical Device EtO Sterilization Validation

This practical two-day masterclass provides teams with the knowledge needed to understand, control and justify Ethylene Oxide (EtO) sterilization throughout the lifecycle of a sterile medical device.

The course provides a practical understanding of ISO 11135 requirements for EO sterilization validation. It examines the factors that affect sterility, including product design, raw materials, bioburden, packaging, load configuration, BI and PCD selection, EO residuals, routine monitoring, release criteria, deviations and change management.

Participants will learn what to ask, what to verify, how to interpret validation and cycle records, and how to manage the EO sterilization process with confidence—even when sterilization is performed by an external supplier.

Course Details

Duration: 2 days
Dates: 21.12.2026 and 22.12.2026
Hours: 09:30–15:00
Format: Online

What You Will Learn

• EO process principles, chemistry, hazards and key parameters, including gas concentration, temperature, humidity and exposure time
• Why sterilization is considered a Special Process and cannot be demonstrated through final product testing alone
• ISO 11135 requirements for EO sterilization validation
• IQ, OQ, microbiological and physical PQ, routine monitoring and product release
• BI, PCD, bioburden, SAL, D-value, worst-case selection and justification of the most difficult-to-sterilize location
• The impact of product and packaging characteristics, including lumens, mated surfaces, materials, packaging layers, Tyvek, cartons and pallet configuration
• PQ using the overkill half-cycle approach, including MPQ/PPQ, load configuration, fractional cycles, half cycles, full cycles, sensor and PCD placement, and acceptance criteria
• Supporting tests, including EO residuals, sterility testing, pyrogen testing and packaging considerations
• The impact of changes to the product, packaging, raw materials, suppliers, manufacturing process, load configuration, manufacturing environment or site
• When a change requires assessment, requalification or full revalidation
• Routine cycle records, release criteria, nonconformance handling, annual review, requalification triggers and requalification options
• How to interpret validation reports, cycle records and monitoring data
• How to support and defend EO validation decisions during audits, Notified Body reviews and regulatory inspections

Who Should Attend?

This course is designed for:

• QA and RA professionals
• Process engineers
• R&D, Manufacturing and NPI teams
• Packaging teams
• Project managers
• Startup teams
• Manufacturers of sterile medical devices
• Professionals involved in the development, manufacturing, validation or release of sterile medical devices

The course is especially relevant for teams:

• Developing a new sterile medical device using EO sterilization
• Preparing for their first EO sterilization validation
• Transferring a product from development or NPI to routine manufacturing
• Working with an external sterilization supplier
• Making changes to packaging, raw materials, load configuration, suppliers or manufacturing sites
• Preparing for an ISO 13485, FDA or Notified Body audit
• Defending BI and PCD selection, worst-case rationale, product family grouping or revalidation decisions
• Reviewing or approving validation reports, routine cycle records, release criteria or revalidation decisions