Ethylene Oxide Sterilization Training Components
Part 1 – Introduction
- Overview of why Ethylene Oxide (EO) is used
- Brief History on EO and sterilization
- Implications of using EO
- What can we sterilize with EO
Part 2 – Ethylene Oxide Gas Appreciation
- Properties of EO
- How EO is handled
- Process In Built Safety
- EO monitoring
- Explosion triangle appreciation
- Different gas mixtures
Part 3 – EtO Sterilization Cycle Appreciation
- Achieving sterility
- Sterilization cycle stages
- Methods of preconditioning
- Methods of degassing
Part 4 – Meeting the Standards
- Control and Monitoring
- System control architecture
- Design and Installation Requirements
- 21CFR Part 11
Part 5 – Notes on Steam and Humidity
- Steam Under Vacuum
- Dew Point and Humidity
Part 6 – Process Qualification
- Regulatory Standards
- Validation Overview
- Validation Life Cycle
- Implications of 21CFR Part 11
Part 7 – Mechanical and Electrical Components and Installation
- ATEX Review
- Local and National Requirements
- Insurance Requirements
- ATEX / Ex electrical equipment
- Intrinsic Safety
- Explosion / flame protection
- Electrical Installation requirements
- Mechanical equipment with Ethylene Oxide
- Mechanical Installation requirements
- Typical process safety interlocks
- Maintaining the process
Part 8 – Cycle / Product Qualification
- Regulatory Standards
- Key Sterility components
- Qualification methods
- Maintaining cycle / product qualification
Part 9 – Process Key Components
- Sterilization Chamber
- Doors and interlocks
- Vacuum System
- Preconditioning Equipment
- Degassing Equipment
- Service Equipment
- Deluge
- Safety monitoring
Part 10 – Process Summary and Installation
- Summarizing the Process
- Typical Installation Costs
- Typical Running Costs
- Typical personnel levels
- Installation time schedules
- Operation Time Schedules
- Typical Operating Procedures
