Article: CCI Testing Method Development for Vials in Deep Cold Storage

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. 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..

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