Certain sterile pharmaceutical products require deep cold storage, either at -80°C or even cryogenic temperatures (down to -196°C). Live viral vaccines, gene therapies, or products that contain active cells (cell therapies) often need deep cold storage to maintain stability and/or activity. Studies have shown that deep cold storage temperatures can introduce risk to the container closure integrity (CCI) of vial-rubber stopper combinations traditionally used to fill sterile pharmaceutical products. This eBook describes the risk of CCI issues during deep cold storage and transport, and a framework to minimize this risk including case study examples.
What you will learn:
- Effects of deep cold storage at -80°C on the CCI of sterile vials
- Holistic approach to ensure CCI of products needing deep cold storage
- Seal quality testing; test method development for vials