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 :
Who Should Attend: