Assessing And Navigating Testing For Parenteral Packaging And Delivery Systems: Container Closure Integrity

By Jennifer Riter

Container Closure Integrity (CCI) is a key area that needs to be evaluated in the development phase of drug products. CCI is defined as the ability of a package to prevent product loss, to block the ingress of microorganisms, and to limit entry of detrimental gases or other substances over the shelf life – ensuring that the drug product meets all necessary safety and quality standards. This article discusses the chapters in USP <1207> Package Integrity Evaluation – Sterile Products, which covers CCI and different methods of selection and validation.