Ethylene Oxide Sterilisation Training - The Process
Ethylene Oxide Sterilization Training - The Components
Part 1 – Introduction
- Overview of why Ethylene Oxide (EO) is used.
- Brief History on EO and sterilisation.
- 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 – EO Sterilisation Cycle Appreciation
- Achieving sterility.
- Sterilisation 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 6 – Process Qualification
- Regulatory Standards.
- Validation Overview.
- Validation Life Cycle.
- Implications of 21CFR Part 11.
Part 7(a) – Mechanical and Electrical Components and Installation
- ATEX Review.
- Local and National Requirements.
- Insurance Requirements.
- ATEX / Ex electrical equipment.
- Intrinsic Safety.
- Explosion / flame protection.
Part 7(b) – Mechanical and Electrical Components and Installation
- 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
- Sterilisation 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.
For Further Information & all other enquiries, get in touch with us today
For more information on these or any of our services, our highly experienced team of consultants are here to answer your questions.