Container Closure Integrity Testing

Preservation of container closure integrity (CCI) of a parenteral drug product is critical over the shelf-life of a product. Use of CCI testing is a viable alternative to sterility testing, and, according to FDA guidance, may be more useful than sterility testing in demonstrating the potential for product contamination over the shelf-life or dating period.

This important topic is examined by Louis Brasten, Barbara Jacobs, and Alicia Brydzinski for Controlled Environments magazine.

In the article, the authors note that there are many advantages to using CCI testing in lieu of sterility testing, including conservation of samples, fast results, and sensitivity that can pinpoint a leak in a vial or syringe system. It must be noted, however, that container and closure system integrity tests cannot demonstrate a product’s initial sterility.

The article can be accessed here.

Posted by Tim Sandle