🎤  John E. Lincoln        |  📅  Recording Available  |  🕒  90 Minutes


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 Affairs 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

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