Freeze Your Device Design With An Integrated, Verified PFA System For Biologics

Developing a combination product traditionally requires managing disparate components and complex verification data from multiple vendors. This fragmented approach often leads to regulatory hurdles and extended timelines. A harmonized prefillable syringe (PFS) system simplifies this process by providing a fully verified, integrated platform from a single source. By utilizing a single verification data package that covers all drug-independent system requirements, development teams can bypass redundant testing and "freeze" their device design earlier.

This integrated model ensures consistent system-level performance—including particle levels, silicone oil distribution, and glide force—while streamlining the regulatory submission process. With smaller minimum order quantities and a single point of accountability, operations teams can more effectively manage inventory and respond to shifting market demands.