Archived Webinar

EO Sterilization: Considerations for Neonate Products and Medical Devices & ISO 10993-7

Recorded on Wednesday, November 10, 2021

Grégory Grams, EO Technical Director

Marie-Pierre Hildebrand, RA/QA Director, EMEAA

EO sterilized items are life-saving and critical devices that are sterilized in highly regulated environment, under strict normative rules and with the greatest care. This webinar will review important considerations for EO Sterilization of neonate products and medical devices. Aspects of EO sterilization will be covered, including the consideration for EO residues that takes into account the amendment of the governing standard, ISO 10993-7. The use of risk assessment, risk/benefit evaluation, validation and application of the right method to define the most suitable limits will also be discussed during this webinar.

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Grégory Grams
EO Technical Director

Grégory is an EO Technical Director with Sterigenics. He is responsible for the development of new cycles, customer validation, and R&D projects. He is a leader in validation, development, and cycle design and improvements in the EMEAA regions. Gregory is an active trainer who enjoys sharing his knowledge with others through formal seminars at trade shows, as well as informal customer training. He has been published in Medical Design & Outsourcing and Med Device Online and holds a patent EP 638909A1: “Process for preparing sterile Brinzolamide” (European patent application, 18/09/2013, F. Porstmann, J. Ondracek, K-T, Van Van, G. Grams). Grégory is also a member of ISO TC198 – WG1 for EO sterilization representing Belgium in the ISO committee. Areas of Expertise include: Ethylene Oxide Sterilization Validation of Medical Devices, Cycle Development, Medical Device Consulting, Gas Chromatography Method Validation, Failure Investigations. Education: Master in Industrial Chemistry, Engineering High School, Liège (Belgium); Business Administration Certification, Cambridge (UK)

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Marie-Pierre Hildebrand
RA/QA Director, EMEAA

After completing her master’s in Industrial Pharmacy, Marie-Pierre started her carrier as Process Supervisor in the production of vaccines and then move to a role as a Clinical Trial Manager. After a couple of years in the Operations part of the business, she continued her education with a master’s in Management in order to take a role in Business Development. Marie-Pierre started at Sterigenics 7 years ago as the Responsible Site QA for an EO facility as well as executing the role of Qualified Person per EU regulations for Pharmaceutical products. Marie-Pierre assumed the role of RA/QA Director for EMEAA 3 years ago and ensures the QA oversight of 11 EMEAA facilities for both RADIATION and GAS technologies. Marie-Pierre is also a Pharmaceutical Quality Systems (GMP PQS) Auditor/ Lead Auditor. Expertise: Deep knowledge in both EU regulatory requirements as well as global sterilization requirements. Internal Auditor ISO 13485:2016 and Pharmaceutical GMP Auditor/Lead Auditor. Education: Master in Management Liège University; Master in Industrial Pharmacy; Master in Pharmaceutical Sciences Liège University; EU registered Qualified Person; Lead GMP and ISO 13485 auditor

For More Information, Contact:

Brooke AkinsBrooke Akins
Division Director, Life Science Programs
+1 (312) 224-1693​