The container closure system for a drug product provides critical protection for stability and sterility. It consists of all components intended to seal and protect the package/delivery system and its contents. Container-closure integrity (CCI) is the ability of the system to keep contents in, and to keep harmful environmental contaminants out.
CCI testing (CCIT) detects leaks in the container closure system. A passing test result indicates the packaging system can maintain sterility and relevant physicochemical specifications. Three types of leaks that can be detected during CCIT include:
- entry of microorganisms
- escape of the product dosage form or entry of liquids or solids
- escape of nitrogen gas or entry of oxygen, water vapor, or air gases
In February 2008, the Food and Drug Administration (FDA) introduced CCIT in lieu of sterility testing as a component of a stability written testing program for sterile products. A stability study measures the extent to which a product retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics it possessed at the time of compounding. Sterility is a stability characteristic that should be conducted throughout a stability study to confirm a product's shelf life.