Which Test Is Appropriate For Container Closure Integrity?

By Paul Larocque, Acerna

Container closure integrity (CCI) testing is receiving more attention these days. In fact, the recently revised USP< 1> Injections and Implanted Drug Products (Parenterals)-Product Quality Tests, specifies that “the packaging system should be closed or sealed in such a manner as to prevent contamination or loss of contents. Validation of container integrity must demonstrate no penetration of microbial contamination or gain or loss of any chemical or physical parameter deemed necessary to protect the product.” This revision offers new insight into CCI testing (1), in spite of well established methods available, such as U.S. FDA guidance and PDA technical reports (2–6).