ISO 11135:2014 Changes – Are You Prepared?

Available On Demand until January 31, 2018

ISO 11135:2014 (Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices) was originally published in August 2014. As the end of the 3-year transition period approaches, the specifications in the previous edition will no longer apply. 

This Webinar will address the significant changes in the most recent edition, with a focus on the additional parameters that are required to be included in the routine sterilization process specification, plus the expanded guidance relating to re-qualification review.


Speakers:

Grégory Grams, Senior SteriPro Consultant EMEAA, Sterigenics

Grégory Grams joined Sterigenics in 2006 as Validation Manager for the Petit-Rechain facility in Belgium. He has managed numerous validation and R&D projects in the plant and has led the Validation Team until joining the SteriPro ® Consulting Group for EMEAA region in 2012. Grégory is responsible for leading the SteriPro projects in EMEAA regions, in the development and management of ISO- and FDA-compliant sterilization studies including Process Definition, Cycle Validations, Parametric Release and Cycle Optimization for ethylene oxide processing. Prior to joining Sterigenics, Grégory was responsible for engineering development and validation of catalytic convertors for car industry for nine years. He is graduated in Industrial Chemistry from Engineering High School of Liège, Belgium.





Mike Padilla, Manager, SteriPro Consulting, Sterigenics

Mike Padilla joined Sterigenics International in 1997 (formerly Griffith MicroScience) as Corporate Quality Engineer and in 2000 joined SteriPro® Consulting. In his current position, he is responsible for leading the SteriPro EO Consulting team in the development and management of ISO- and FDA-compliant sterilization studies including Process Definition, Cycle Validations, Parametric Release and Cycle Optimization for ethylene oxide processing. Prior to joining Sterigenics, Mike served a total of six years between Baxter Healthcare and Allegiance Healthcare where he managed various projects ranging in both product development and validations in Steam and Ethylene Oxide sterilization modalities. He is an active member of ISO/AAMI/TC 198 where he serves as a working group member of WG01, Industrial EO Sterilization, including member of the AAMI Process Equivalency Task Group which developed TIR 28, Product Adoption and Process Equivalency for Ethylene Oxide Sterilization. He holds a Bachelor of Science in Mechanical Engineering from University of Illinois at Chicago.





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