EO Sterilization Validation / Revalidation per ISO 11135

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

Course Director: JOHN E. LINCOLN

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.