Application Note: CCI of Product Requiring Deep Cold Storage

Live viral vaccines and gene and cell-based therapies often require deep cold storage (-80°C down to cryogenic, -196°C) to maintain the activity and efficacy of the formulations. Studies have shown that these deep cold storage temperatures can introduce risk to the sealing performance of the packaging components and therefore introduce risk to the container closure integrity (CCI) of vial/rubber stopper combinations traditionally used to fill sterile pharmaceutical products. It is therefore critical that robust development work is done in a holistic framework to choose the appropriate packaging components and to qualify the sealing process such that the risk of CCI issues during deep cold storage and transport is minimized.