Container closure integrity (CCI)

The ability of a container closure system to keep the product sterile and to keep out gases and moisture throughout its shelf life. It is tested by deterministic methods such as vacuum decay, helium leak or high-voltage leak detection, or by probabilistic methods such as dye ingress and microbial challenge, with USP <1207> as the common reference. EU GMP Annex 1 expects integrity testing of closed containers. Japanese documents also use the abbreviations CCI and, for the test, CCIT.