With the advent of more advanced drug development for a wide variety of injectable compounds and an increasing preference for self-administration, prefilled syringes are the largest parenteral package growth sector. In many ways, the prefilled syringe is more complex and intricate in comparison to a traditional vial, a sealed ampoule, or bottles with screw top closures. They have multiple sealing sites that require integrity, but there is also a functionality piece associated: the syringe plunger must be able to deliver a dose, and thus, is movable. Prefilled syringes have the additional consideration of plunger movement during air transit, etc. For these reasons, amongst others, CCI evaluations of prefilled syringes are both more complex, but even more critical to ensure total system integrity.
Helium leak detection as performed with the SIMS 1915+ is an ideal tool to address these complex integrity considerations. Custom tooling can be designed to isolate and deterministically and quantitatively measure the different seal points, down to individual sealing ribs, or to test systems as a whole, enabling companies to build a robust level of seal quality into their package systems.