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LIVE WEBINAR

Extractables and leachables in ophthalmic drug products – what the eye cannot see

October 15, 2020

11:00 am CET

Kathleen Lava

In absence of a ready-to-use protocol, Extractables and Leachables (E&L) testing for ophthalmic drug products (ODPs) may seem a shot in the dark. During the course of time, the industry has adopted a number of scientifically based best practices, taking into account the specific nature of containers used for the storage of ODPs. For example, it is generally accepted that the semi-permeability of low density polyethylene requires a thorough assessment of secondary (pouches, labels) and even tertiary (cardboard box, leaflet) packaging components. This webinar focusses on the implications of leaching from secondary and tertiary packaging with respect to the study design for E&L testing of ODPs.

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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.