This program is designed to help attendees to:
- Gain an understanding of the differences between Ethylene Oxide and Irradiation sterilization processes, their mode of action and their factors of influence.
- Acquire methodology as well as the technical and documentary tools required to validate, implement, control and audit the sterilization process by ethylene oxide or irradiation.
- Manage and control contract sterilization activities and satisfy regulatory requirements.
Sterilization Validation (EtO and Irradiation)
- Overview of the Sterilization Process
- Microbiological Tests Used to Validate the Sterilization Process
- Sterilization Process: Radiation Sterilization
- Ethylene Oxide Sterilization
- Innocuousness Testing
Cleaning, Decontamination, and Disinfecting Medical Devices
- Regulatory and Standard Context, Environment
- Equipment Identification and Qualification
- Cleaning Process
- Analysis methods and techniques
- Managing changes and modifications
- Risk Analysis