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Container Closure Integrity at Cryogenic Temperatures
How the AT-Closed Vial® ensures safe cryopreservation of novel therapies
Cryopreservation techniques are implemented at multiple points of the manufacturing process of cell and gene therapy products. The choice of the container system for cryopreservation of these products has an impact on the manufacturing, logistics and clinical strategy.
Container Closure Integrity (CCI) in cryogenic temperatures is identified as critical parameter for successful long-term storage of the cell and gene therapy products.
This article outlines the regulatory perspective on the CCI and overviews how the AT-Closed Vial® Technology, the fill and finish technology developed by Aseptic Technologies, provides a holistic approach to the CCI in cryogenic temperatures.
The authors analyze the design, manufacturing and processing factors, ensuring resistance of the AT-Closed Vial® to ultra-cold temperature storage.
The following validation methods of AT-Closed Vial® resistance to cryogenic storage are described: dye ingress test made after storage of vials at ultra-low temperature, closure integrity of AT-Closed Vials® stored at different temperature and humidity conditions, closure integrity using a laser-head space analyzer on AT-Closed Vials stored in vpLN2, analysis of the chemical bonding of the stopper and vial body.
The article findings indicate the importance of the CCI and its impact on the process development and manufacturing of cell and gene therapy products.