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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

Looking into the Future of Extractable testing to support Chemical Characterization: What can we learn “Non-Targeted Analysis”Approaches and Practices applied in other Industries

Published Date: August 10, 2023

It has now been more than 3 years ago since the adoption and implementation of the new ISO 10993-18 standard in Chemical Characterization for Medical Devices. With this implementation the science of E/L-testing on medical devices, which is mainly based on Non-Targeted Analysis (NTA), has improved substantially. However, there is a clear consensus from both the Industry as well as from the Regulators that more guidance and harmonization is needed and necessary.

Aspects in Quantification and Identification will need to be better defined if the outcome of E/L-studies should be comparable between different labs. While the outcome of a structure elucidation (identification) exercise for detected compounds is binary – it is either true or false – for quantitation based upon the existing quantification practices lead to a broad range of reported concentrations for compounds? An idea on how to harmonize on the quantitative aspect of an E/L study is to introduce the concept of “protective concentrations” versus accurate concentrations. The presentation will also explore what consequence this would have on the currently existing and accepted AET calculations.

Presenter: Piet Christiaens PhD, Scientific Director Nelson Labs Europe

This presentation, by Piet Christiaens, was recorded at the Open House seminar, in Leuven, in April 2023 and is part of a series of videos.

Piet Christiaens, PhD

Piet Christiaens, PhD

Scientific Director, E&L Expert

Piet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Belgium) in 1991. From 1992 to 1997, he was Lab Manager in two CROs. From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, Texas (US), working on hydrogenated triblock co-polymers. Since 2001, Piet...

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