Article: Regulatory Guidance in Designing a Strategy for Container Closure Integrity Testing of Sterile Injectable Product

Container closure integrity (CCI) plays an important role in maintaining the sterility and stability of sterile injectable products. Recent regulatory guidance has triggered changes in industry best practices in the area of CCI testing (CCIT). This article summarizes the current state of container closure integrity testing in the pharmaceutical and biopharmaceutical industries and outlines possible approaches for developing a CCIT strategy.