Current and Emerging Regulations for the Sterilization of Medical Devices

Available On Demand until October 10, 2018

Specific to Ethylene Oxide, ISO11135:2014 (Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices) transition period has expired and is now fully in effect.  In this Webinar, consultants will address the upcoming Amendment to Annex E, the methodology for Single Batch Release.  Also reviewed will be relevant ISO committee activities and the status of ISO10993/7 (Biological evaluation of medical devices -- Ethylene oxide sterilization residuals), and emerging regulations relating to personnel exposure to EO.

Specific to Radiation, subject matter experts will discuss the changes for ISO 11137-3:2017 (Sterilization of health care products – Radiation – Part3: Guidance on dosimetric aspects of development, validation and routine control), present a high-level overview of the much anticipated draft ISO/WD 11137 Part 4 (Guidance on control of the irradiation process) and review the increased security requirements for Irradiators (10CFR37 in U.S.).                   



Tim Bollnow, Consultant, Sterigenics

Tim Bollnow joined Sterigenics International in 1997 as a chemist for the Itasca, IL laboratory.  Throughout his Sterigenics tenure, he has held various positions throughout the laboratory including Chemist and Microbiology Supervisor of Non-Sterile Testing before specializing in Gamma Sterilization as a consultant, focusing on minimum dose setting and coordination of dose audits.  In 2007, Tim transitioned to the Ethylene Oxide (EO) Consulting group.  As an EO consultant, Tim works on various ethylene oxide sterilization projects including cycle development, validation, product adoption, equivalency, and parametric release.  Tim is also a presenter for the Annual SteriPro Sterilization Seminar given to Customers.

Kevin O’Hara, Director of Radiation Physics, Sterigenics

Kevin is a Radiation Physicist with corporate responsibility for measurement and calculation of absorbed dose associated with the radiation treatment of product, such as sterilization of healthcare instruments.  I am highly motivated, and enjoy working with customers.  I am an applied computational physicist with almost 30 years of experience in radiation physics and radiation dosimetry within a highly technical industry.   Kevin is actively involved in industry committees, task forces and working groups. As a Working Group member, Kevin represents Canada on ISO TC 198 WG 2 Radiation Sterilization.

John Schlecht, VP Radiation Technical Services, Sterigenics

John Schlecht has served in the field of Sterilization of Medical Devices and Pharmaceuticals/biologics Sterility Assurance for 30 years. John joined Sterigenics in 1988 and has held management positions in operations as well as technical services. John currently has Global Responsibility for Radiation Safety, Security, Licensing, Irradiator Operational and Process Qualification and Dosimetry programs for over 20 irradiation facilities worldwide.


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