Long-Term Container Closure Integrity Testing Of Vial-Stopper-Seal Combinations Comprising Daikyo Crystal Zenith® Vials At Ultra-Low And Cryogenic Temperatures

Gene and cell therapies necessitate storage at extremely low temperatures: -80°C (ultra-low) and below -130°C (cryogenic). To ensure the integrity of these valuable products, the vial-stopper-seal combinations must maintain their seal at these frigid temperatures.

This study focuses on evaluating the container closure integrity (CCI) of NovaPure® and Daikyo elastomer stoppers (13 mm Serum NovaPure® RP ART 1358 4023/50G, 13 mm Lyo NovaPure® RP ART 1356 4023/50G, 13 mm Serum Daikyo S2-F451 D21-7S RB2-40 RUV, and 13 mm Lyo Daikyo V2-F451W D21-7S RB2-TR RUV) paired with gamma-sterilized Flip-Off® CCS seals (13 mm CCS Seal 5922-1120) and Daikyo Crystal Zenith® (CZ) vials (2 mL). These components are offered as part of West's Ready Pack™ containment solution.