Injectable container closure systems are often assessed component by component, across different suppliers. This can make it difficult for drug manufacturers to build an early, complete view of assembled-system performance. As development teams make delivery-system decisions before the formulation, device and validation strategy is fully defined, late-emerging system sensitivities can lead to additional investigation, repeated work or delays.
In this live webinar, experts from Aptar Pharma and Stevanato Group will share a practical approach to building useful assembled-system evidence earlier. Drawing on their joint work with representative prefilled syringe configurations, they will show how USP <382>-aligned functional testing can help injectable development teams understand component interactions before formal, drug-specific validation begins.
Participants may submit questions throughout, with speakers addressing them during the discussion and live Q&A.
What Participants Will Learn
- Where USP <382>-aligned system-level testing fits in early injectable development.
- What functional, sealing and container closure integrity data can reveal across representative PFS configurations.
- How comparative findings can help teams prioritize next technical questions before formal product-specific studies.
Who Should Attend
Professionals responsible for injectable development, CMC, R&D, quality, regulatory affairs, device and combination product development, technical operations and procurement. The session is designed for subject matter experts as well as directors and senior leaders responsible for development risk and timelines.
Speakers
- Pavan Hemmege, Technical Product Manager Injectables, Aptar Pharma
- Sara Masucci, Product Management Syringe Platform, Stevanato Group
