Application Note: CCI of Product Requiring Deep Cold Storage

Live viral vaccines and gene and cell-based therapies sometimes require deep cold storage temperatures (-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. In particular, studies have shown that the low storage temperatures can introduce risk to the container closure integrity (CCI) of vial/rubber stopper combinations traditionally used to fill sterile pharmaceutical product. 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.