Case Study: Achieving Container Closure Integrity During Cryogenic Storage Conditions Using an Optimized Vial Stopper Combination

Lighthouse’s ongoing work in Container Closure Integrity (CCI) testing has shown that ultracold temperatures pose challenges for the traditional primary packaging solutions typically used for sterile pharmaceutical products. In particular, there is a risk that CCI is temporarily lost at the ultracold temperature but regained when the vial is brought back to room temperature.

Headspace analysis methods have proven to be the optimum approach for performing CCI testing of deep cold storage product. Download this Case Study to learn how headspace analysis is used to investigate a primary packaging solution for maintaining CCI at temperatures between -150°C and -180°C.