Effects Of Deep Cold Storage At -80°C On The Container Closure Integrity Of Sterile Product Vials

By Derek Duncan, Ph.D., Director at Lighthouse Instruments

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. It is therefore critical that robust development work is done to understand the CCI performance of any primary packaging components used for a product needing deep cold storage and transport temperatures.