This Radiation sterilization training will discuss how radiation sterilization works, the equipment involved, major issues with product sterilization via radiation, and the validation requirements. Routine process control and monitoring will be reviewed along with requirements to maintain the process effectiveness.
Why Should You Attend: Radiation sterilization validation is a topic that results in many audit observations from the FDA and international regulatory bodies. Both Gamma and E-Beam radiation methods are validated following the same principles and standards. Proper understanding of the principles and requirements of the related standards is crucial to proper compliance and integrating them early in the product design can lead to quicker time to market.
Areas Covered in the Seminar:
- Introduction.
- Terminology / Definitions.
- Radiation characterization / effectiveness.
- Process Equipment.
- Product and Material Issues.
- Process Definition.
- Validation IQ/OQ/PQ.
- Documentation, review and approval of validation.
- Routine Monitoring.
- Product Release.
- Maintenance of process effectiveness.
