Container Closure Integrity Testing Strategy for Drug-led Combination Products

This technical report outlines a container closure integrity (CCI) testing strategy for drug-led combination products, focusing on the challenges associated with ensuring CCI in fully assembled devices such as autoinjectors and pen injectors. It discusses the regulatory requirements for demonstrating CCI throughout the product life cycle and presents a step-wise approach to testing. The report includes a historical overview of autoinjectors and pen injectors, detailing their evolution and significance in modern medicine. It emphasizes the importance of CCI in maintaining the safety, effectiveness, and sterility of drug products. The document also describes various CCI testing methods applicable during different phases of product development, manufacturing, and commercial stability, highlighting the complexities involved in testing fully assembled devices compared to individual components. The report serves as a guide for manufacturers to implement robust CCI testing protocols to ensure product integrity and compliance with regulatory standards.