Container Closure Integrity at Low Temperature
Many complex biologic drug products, such as gene and cell therapies, require storage at low temperatures (from -60oC to -180oC). This presents a challenge for containment systems when maintaining container closure integrity (CCI) – especially for glass-rubber vial systems.
Glass and rubber have substantially different coefficients of thermal expansion (CTE), i.e., as temperature decreases, they shrink at different rates. This can lead to the formation of gaps in the glass-rubber seal and concomitant loss of CCI. This phenomenon has been well documented in the literature.
An approach to the challenge of low temperature storage is the use of polymer-based vials, such as those comprising of Daikyo Crystal Zenith® cyclic olefin polymer (COP). Having a CTE much closer to that of rubber, the risk of gap formation and loss of CCI with a COP-based vial is far reduced.
West, through the Integrated Solutions platform, has the expertise and facility to evaluate CCI of vial systems from room temperature down to -180oC – using the deterministic methods called out in USP <1207> (Package Integrity Evaluation – Sterile Products), such as tracer gas leak detection (with helium), and frequency modulated spectroscopy head-space analysis (with oxygen and carbon dioxide). This support enables customers to select the components and sealing parameters needed to protect their drug products, to help ensure safe delivery to patients.
For more on West, contact an Account Manager or Technical Customer Service (TCS) representative. Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.