This webinar will outline the required elements of a successful ethylene oxide (EO) sterilization validation process for medical devices as required by ISO 11135:2014. Hardware / chamber and software considerations and required documentation. Temperature and humidity mapping, BIs / PCDs and their placement. Basic system. A brief discussion of the lethal rate BI / bioburden approach, and a more detailed discussion of the more commonly used Overkill approach descriptions, IQ, OQ, PQ – MPQ / PPQ.
Why You Should Attend:
Basic information of the EO sterilization process for successful medical device sterilization to meet ISO 11135 / U.S. FDA and EU MDR requirements. Discussion of the purpose and methodology for the various partial and full cycles, IQ, OQ, PQs, acceptance criteria, and a suggested report format. Useful whether a company will do the validation, contract for it, hire a consultant to assist, or review existing sterilization documentation of a vendor.
Areas Covered in the Session :
Key parts of ISO 11135:2014, and its implementation
Control software description and suggested documentation (11 elements)
Temperature and humidity mapping
BI and PCD number and placement considerations
Contract Lab Resources, B&F, BIs, residuals, sterility testing
Fractional, Half-Cycle and Full Cycle runs
IQ, OQ, PQs (MPQs and PPQs) test cases
Pre- and Post (Aeration)- Conditioning
Putting it all together – the Sterilization V&V Test Report.
Revalidation frequency, considerations, and alternatives
Who Should Attend:
Quality Assurance Departments
QAE Personnel
Regulatory Affiars Departments
Research and Development Departments
Engineering Departments
Manufacturing Departments
Operations Departments
Production Departments
Software Engineers
Sterilization Personnel
Marketing Departments
Purchasing Departments
Consultants
Everyone tasked with product development, and sterilization / product sterility