This article describes the effects of deep cold storage on the container closure integrity of sterile product vials.
Certain sterile pharmaceutical products require deep cold storage. 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.
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