Achieving Container Closure Integrity During Cryogenic Storage Conditions Using An Optimized Vial Stopper Combination

By Derek Duncan, PhD, Lighthouse Instruments

The recent increase in the development of therapies requiring ultracold storage and transport has presented challenges to the traditional pharmaceutical primary packaging solutions. To bring such therapies to market requires the generation of robust analytical data demonstrating that the primary package is able to maintain CCI at the ultracold temperatures. Validation of CCI during the ultracold transport chain is also a requirement. A prerequisite for the generation of such robust CCI data is the development of an appropriate CCI test method. The laser-based headspace method, such as the one described here, is the only rapid non-destructive analytical technique available for this application as it can measure the temporary CCI failures that occur at these ultracold conditions.

The case study here describes results from ongoing work being done to investigate possible primary packaging solutions for therapies requiring even colder storage temperatures down to cryogenic levels (-150°C to -180°C).