The ability of a package system, including its container and closure or seal interfaces, to maintain its intended protective barrier under defined conditions.
Also called: CCIT; blister integrity; package integrity; Container-closure integrity testing.
CCI, CCIT and the blister package boundary
Container closure integrity (CCI) describes a package property. Container closure integrity testing (CCIT) is the assessment used to investigate it. A test result is evidence about that property within the stated method and conditions, rather than a synonym for the property itself.
The package system includes the formed cavity, lidding material and sealed interface. A leak path can occur through the material or through a seal defect. Examining only the seal’s mechanical strength leaves a different question unanswered: whether the package has a communicating path.
A pinhole and a channel leak name different defect geometries. They are useful for describing where a concern lies; neither name alone specifies a leak rate or the ability of a test to detect it.
Name the package system covered by the claim: its materials, formed cavities and sealed interfaces. Identify whether the specimen is one cavity, a multi-cavity card or another package, and retain relevant features such as available headspace.
Report the method and conditions with the integrity claim, including the defects it can detect. A negative result excludes only what that assessment was capable of finding.