Prefilled syringes (PFSs) have gained increasing preference over traditional vial-based container closure systems (CCSs) for injectable drug products, particularly in scenarios requiring facilitated or self-administered therapies. However, compared to conventional CCSs composed of vials, rubber stoppers, and crimp caps, PFSs exhibit significantly greater structural complexity. This complexity introduces unique challenges in container closure integrity (CCI) assurance and verification, primarily due to the presence of multiple critical sealing interfaces (e.g., plunger-syringe barrel, needle shield-syringe tip). To ensure robust CCI evaluation and support efficient packaging development/qualification, a thorough understanding of the CCS design, material compatibility, and failure mechanisms is essential.

Refer to test mothod of container closure integrity testing described in USP <1207>, Labthink developped a highly sensitive leak detection system for various types of liquid-filled packaging including, but not limited to pre-filled syringes, vials, cartridges and ampoules. Labthink C690 series leak detectors utilize non-destructive, non-invasive, and provides a high level of repeatability and accuracy.