Testing Requirements for a Successful Medical Device Sterilization Validation
Today there are a range of sterilization techniques used to terminally sterilize medical devices. This webinar will provide a general overview of the requirements for planning and executing sterilization validations. Using two of the more common sterilization techniques, ethylene oxide (ISO11135) and irradiation (ISO11137), we will review in detail the testing requirements underpinning their validation process and how to optimize your testing strategy utilizing case studies.
In addition to the detailed review of these sterilization techniques, we will also discuss the importance of microbiological control, how this can be assessed throughout the production process and its impact on the sterilization outcome for devices
Who should attend?
Managers, directors, engineers and scientists responsible for research and development, product development, quality assurance and regulatory compliance.
View our Past Webinars
- Packaging Validation of Medical Devices - Impact of the Revisions of ISO 11607 & Suitable Strategies
- Chemical Characterization and Toxicological Risk Assessments: A Smart Approach to Biological Evaluation
- Sterility Validation 101: Ensuring a robust sterilization validation program from start to finish
- Biocompatibility Testing of Combination Devices - New Regulatory Guidance
- Developing a Comprehensive Tool Kit for Microbial Identification
- Chemistry and Microbiology Perspectives on Cleaning Validations and Disinfectant Efficacy Studies
- Best Practices for Extractables and Leachables Testing