Course Title:
Ethylene Oxide Sterilization of Medical Devices – ISO 11135:2014 Requirements
Training Duration:
2 Days (14 Hours Total)
Day 1: Foundational Understanding and Regulatory Requirements
Module 1: Introduction to Ethylene Oxide Sterilization (1 hour)
- Introduction to sterilization methods
- Characteristics of EtO and why it’s used
- Overview of ISO 11135:2014
- Key terms and definitions
Module 2: Structure of ISO 11135:2014 (0.5 hour)
- Clause-by-clause breakdown
- Key focus areas of the standard
Module 3: Roles and Responsibilities (1 hour)
- Manufacturer vs. contract sterilizer
- Legal obligations and documentation needs
- Contracts and quality agreements
Module 4: Quality Management System Requirements (1 hour)
- Documentation control and traceability
- Integration into ISO 13485
- Change control, training, and internal audit requirements
Module 5: Risk Management in EtO Sterilization (1.5 hours)
- Link to ISO 14971
- Hazard identification (EO toxicity, residuals, process risks)
- Risk control measures and justification
Module 6: EtO Process Overview and Sterilization Cycle (1 hour)
- Process flow (preconditioning, sterilization, aeration)
- Critical process parameters
- Equipment requirements
Module 7: Validation Overview and Requirements (1.5 hours)
- IQ, OQ, PQ – Introduction and overview
- Selection of validation method (Overkill vs. BI/bioburden)
- Overview of microbiological and physical validation tools
Day 1 Workshop: Interactive Group Case Study (1.5 hours)
- Scenario-based: Preparing a sterilization validation plan for a new product
- Group discussion and presentation
Day 2: Validation, Monitoring, and Operational Control
Module 8: Detailed Validation Protocols (2 hours)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Load configuration and chamber studies
Module 9: Microbiological Requirements (1.5 hours)
- Bioburden testing and its role
- Biological Indicators (BI) – placement, recovery, and analysis
- Sterility Assurance Level (SAL) and statistical concepts
Module 10: EO Residuals and Biocompatibility (1 hour)
- ISO 10993-7 requirements
- EO, ECH, EG exposure limits
- Testing and acceptance criteria
Module 11: Routine Process Control and Monitoring (1.5 hours)
- Process control charts and trends
- Batch release criteria
- Routine use of BIs and EO sensors
Module 12: Requalification and Change Control (1 hour)
- Frequency and triggers for requalification
- Managing process and product changes
- Maintaining a validated state
Module 13: Handling Deviations, Failures, and Nonconformities (1 hour)
- Investigating out-of-spec results
- CAPA process
- Documentation for regulators
Module 14: Documentation and Audit Readiness (0.5 hour)
- Validation files and recordkeeping
- Audit trail and traceability
- Preparing for MDA, FDA, NB inspections
Day 2 Workshop: Risk-Based Process Validation (1 hour)
- Group activity to evaluate change control and requalification needs
- Presentation of group solutions
Final Module: Post-Test and Wrap-Up (0.5 hour)
- 10-question multiple choice test
- Review of answers and discussion
- Participant feedback session
Deliverables:
- PowerPoint Slide Deck (Day 1 and Day 2)
- Participant Manual
- Group Case Study Worksheets
- 10-question Quiz (Pre-test and Post-test)
- Certificate Template
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