In this interview, Edouard Pagnoud, Product Line Manager for Vial Stoppers at Aptar Pharma, discusses the importance of evaluating elastomeric closures as part of the container closure system. The article explores how worst-case and lifecycle testing can generate data that can help pharmaceutical manufacturers better understand system performance and inform risk-based approaches that consider USP <382> requirements.
In this interview, Edouard Pagnoud, Product Line Manager for Vial Stoppers at Aptar Pharma, discusses the evolving expectations for elastomeric closures under USP <382>. He explains the importance of evaluating closures as part of the complete Container Closure System (CCS) and how system-level performance data can help pharmaceutical manufacturers develop robust, risk-informed qualification strategies for sterile injectable products.
Drawing on Aptar Pharma's approach to worst-case scenario testing, Edouard Pagnoud explores how material hardness, stopper geometry, sterilisation methods and access conditions influence closure performance throughout the product lifecycle. The discussion highlights how lifecycle-based evaluation can contribute to evidence-based qualification activities and informed packaging decisions.