CCI Testing Method Development For Vials Stored At -80C, Using Headspace Gas Ingress

By Allison Alix, Application Scientist, Lighthouse Instruments

Sterile pharmaceutical products such as live viral vaccines, gene therapies, and products that contain active cells often require deep cold storage, either at -80°C or cryogenic temperatures (-196°C) to maintain stability and/or activity. These storage conditions pose a challenge to the packaging components; in particular to the sealing performance of the vial/rubber stopper combinations traditionally used to package these products. It is therefore essential to generate robust data that demonstrates the maintenance of seal integrity during deep cold storage and/or transport which, in turn, requires a robust container closure integrity (CCI) test method. This article describes the development of such a test method for vials stored at -80°C.