EO Sterilization of Medical Devices, Equipment and Instruments
Treatment with ethylene oxide (EO or EtO) is one of the most common methods for sterilizing medical devices, equipment, and instruments. In EO sterilization, the products are exposed to ethylene oxide in a sealed vacuum chamber. EO sterilization is a safe method that ensures products available on the market always meet the required sterility level.
Ethylene oxide is particularly suitable for sterilizing a wide variety of materials that are otherwise incompatible with other sterilization methods, as ethylene oxide penetrates multiple layers of air-permeable packaging.
Deepen your knowledge of the ethylene oxide sterilization process, how it is carried out, and how to successfully implement the various requirements in your company. You will learn the necessary steps for pretreatment, sterilization, and ventilation during the process.
- Content
- Regulatory and legal requirements for EO sterilization of medical devices (ISO 11135, ISO 10993-7, etc.)
- Implementation of EO sterilization for medical devices
- Validation of the sterilization process
- Microorganisms, D-value, residues
- Selection of PCDs, worst-case products, product families, indicators
- Routines and monitoring
- Evaluation of changes
- Your Benefits
- You will learn about the various requirements for EO sterilization of medical devices.
- You will understand the different phases of sterilization.
- You will know how to implement the requirements for the validation and qualification of EO sterilization processes.
- You will receive practical tips for your company.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Medical device manufacturers
- Manufacturers of sterile products
- Product management professionals
- Quality assurance and quality management professionals
- Research and development
- Regulatory affairs managers
