Correlating Vial Seal Tightness to Container Closure Integrity at Various Storage Temperatures

There is risk for CCI failure at storage temperatures below the Tg of the rubber stopper formulation, because deep cold storage (-80 ˚C to cryo) is colder than the Tg of most rubber stopper formulations (-50 to -70 ˚C), there is an increased risk of losing CCI.

1. What happens to CCI during deep cold storage?
2. How does vial seal tightness correlate to maintaining CCI?
3. What should you do if you have product requiring deep cold storage? (live viral vaccines, gene/cell therapy)