Maintaining container closure integrity (CCI) is challenging for vials that are packaged at
room temperature and stored and/or transported at a colder temperature, such as− 80° C …

As the complexities of the pharmaceuticals needed to prevail over serious diseases
continue to grow, the need for technologies to enable their efficient storage and delivery are …

Sometimes, drug product for parenteral administration is stored in a frozen state (eg,–20° C
or–80° C), particularly during early stages of development of some biotech molecules in …

The assurance of sterility of a parenteral drug product, prior to any human use, is a
regulatory requirement. Hence, all strategies related to container closure integrity (CCI) must …

Frozen-state storage and cold-chain transport are key operations in the development and
commercialization of biopharmaceuticals. Today, several marketed drug products are stored …

It was recently found that after storage of a live viral vaccine at− 80° C in glass vials closed
with rubber stoppers, a phenomenon was revealed which had not been observed before …

The sterility of drug products intended for parenteral administration is a critical quality
attribute (CQA) because it serves to ensure patient safety and is thus a key requirement by …

The regulatory expectations introduced by the US Food and Drug Administration in 1999,
ICH Q5C, the revised draft of Annex 1, Eudralex volume 4 for consultation, and the recent …

Capping completes the closure of parenteral drug products in the final packaging container
and is critical in maintaining an integral seal to ensure product quality. Residual seal force …

Container closure integrity (CCI) is a critical factor to ensure that product sterility is
maintained over its entire shelf life. Assuring the CCI during container closure (C/C) system …