Ana Kuschel
Principal Scientific Affairs
As Principal Scientific Affairs Europe, Ana is providing technical support relating to West’s packaging components and delivery systems for injectable drugs and healthcare products. As well as bridging scientific information through industry outreach. This is complementing her previous role as Manager Material Development, where she worked on both existing and new rubber formulations. Ana holds a PhD in macromolecular chemistry and is the ISO TC 76 WG4 convenor and one of the co-leads of the PDA Packaging Science group.
DAY 2: March 6th, 2026
SESSION: Designing a formulation with the reduction of E&L in mind
◆ Will give an overview of the raw materials used in butyl rubber manufacturing, and explain how the selection of raw materials affects the extractables of the manufactured component.
◆ Leachables data of the new formulation will be presented alongside data of other formulations.
◆ How will the new ICH Q3E guideline affect the data needed to perform a good risk assessment, and how might suppliers help?
DAY 2: February 28th, 2025
SESSION: Testing for E&L in packaging materials
◆ Reviewing USP packaging criteria.
◆ Relating chemical characterisation of components.
◆ E&L examination of glass, plastic and elastomer components.
DAY 2: March 8th, 2024
SESSION: Elastomer closures materials (TBC)
◆ Composition of elastomers used for pharmaceutical applications.
◆ Material composition and extractables.
◆ How to minimize extractables/leachables from elastomeric closures.
