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A risk-based approach towards the assessment of process-equipment related leachables (PERLs) – Case study

Published Date: February 2, 2024

Join this on-demand webinar to learn more about the possible risks of process-equipment related leachables (PERLs).

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Manufacturing processes are composed of a complex set of plastic materials that may introduce process-equipment related leachables (PERLs) into the final product, thereby potentially compromising its biocompatibility, safety or quality. At the same time, not all manufacturing components have the same likelihood to contribute to PERLs. A risk-based approach in which process conditions, type of process material and composition of the process solution are evaluated, allows to define relevant test requirements with respect to extractables and leachables. In this presentation the main principles of such a risk-based evaluation are highlighted by means of a case study.


This presentation, by Kathleen Lava, was recorded at Pharmapack , in Paris, in January 2024.


Kathleen Lava

Study Director for Extractables and Leachables

Kathleen Lava successfully completed her Ph.D. in Chemistry at the University of Leuven (Belgium) in 2012. Afterwards she performed postdoctoral research in the team of Prof. Richard Hoogenboom at Ghent University. In 2016, she started at Nelson Labs Europe as a Study Director for Extractables and Leachables. She is part of the team that is specialized in E&L testing of Large Volume Parenterals, Ophthalmics and Disposables, with focus on ophthalmic drug products.

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