Product Qualification in E-beam and X-ray – Part 1

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Upcoming Webinar

Product Qualification in E-beam and X-ray – Part 1

Florent Kuntz, Project Manager Radiation Dosimetry, Aerial

Nicolas Ludwig, Research Scientist, Aerial

François Vander Stappen, Product and Research Program Manager, IBA Industrial

Recorded on December 14, 2020

During sterilization by radiation, products are exposed to a dose that must remain between a minimum and a maximum value. The minimum, namely D_ster is the dose necessary to achieve the desired sterility assurance level (SAL). The maximum, D_maxAcc, corresponds to the maximum acceptable dose for which the product has been proven compatible, while preserving its quality and functionality over its shelf-life.

This webinar will present in detail how D_maxAcc is defined. We will take you on a scientific journey at the molecular scale to study the effects of radiation on materials. You will understand the origin of the various levels of radio-compatibility for the most commonly used polymers in medical devices.

After an overview of regulatory aspects, we will explain the practical process of determining D_maxAcc for a medical device and conclude with a summary of the radiation impacts on typical products and how to limit or avoid them.

PRICING
This webinar is complimentary.

TARGETED AUDIENCES
Sterilization
Sterility Assurance
Microbiology
Quality
Manufacturing

INDUSTRIES REPRESENTED
Medical Device

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Presenters:

Florent Kuntz, Project Manager Radiation Dosimetry
Aerial

Florent Kuntz received his Physics Engineer Diploma in the field of nuclear science from University of Strasbourg-France. His involvement in Radiation Processing began during his Ph.D. in which he conducted research on new developments in electron beam dosimetry. (University of Strasbourg-France)

Florent is working with Aerial, a Technological Resource Centre, as project manager in radiation processing and dosimetry.

In the field of radiation processing, he performs trainings on industrial irradiation dosimetry, helps the industry in IQ/OQ/PQ, in dosimetry system selection and calibration. He has also developed the famous AerODE, AerEDE and DoseASAP customized optical and EPR dosimetry equipments.

As dosimetry expert, he conducted several missions with the International Atomic Energy Agency and is member of ASTM and CEN/ISO committee.

Nicolas Ludwig, Research Scientist
Aerial

Nicolas has a background in material science and completed a Ph.D. in radiation chemistry at the University of Strasbourg – France.

Since almost 2 years, he has joined Aerial-CRT, an excellence center for industrial radiation processing and associated dosimetry, as research scientist.

He started a comprehensive work on electron beams and X-rays induced modifications in polymers. Recently Aerial-CRT has been involved in the American Nablo initiative in its 3rd phase. The latter aims investigating combination irradiation factors such as dose rate and temperature effect on commercial polymers.

As dosimetry expert, he conducted several missions with the International Atomic Energy Agency and is member of ASTM and CEN/ISO committee.

François Vander Stappen, Product and Research Program Manager
IBA Industrial

IBA Industrial logo

With a background in electronic engineering and in medical physics, François started working for IBA 12 years ago, in Proton Therapy. After getting a deep experience on the field, he worked in R&D and led several research programs, aimed at improving the treatment accuracy.

Early 2020, he joined the IBA Industrial business unit in the Product Management team. He works at developing a research program in collaboration with Aerial, bringing his experience of medical irradiations to the industrial domain.

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