Drawing from West’s deep elastomer formulation expertise and using QbD principles, the development of the 4040/40 elastomer formulation was focused on raw material selection to make significant progress in mitigating the risk of particulates, extractables & leachables (E&L), and fragmentation & coring.

4040 LyoTec® components provide confidence that you have chosen a high-performing primary packaging product, de-risking your new drug from development through patient administration.

4040 LyoTec® components start with a Quality-by-Design (QbD) approach to deliver:

• Ultra-low extractables & leachables 
• Well-characterized extractables profile 
• Low level of particulates
• Formula optimized for low moisture content 
• Optimized drying properties
• Compatibility with steam sterilization or gamma irradiation 
• Risk-mediated supply 
• Platform portfolio and global supply network strategy