By unidentified

Published in: Lighthouse

Published on: March 22, 2022

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

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