Regulatory Guidance: Designing A Strategy For Container Closure Integrity Testing Of Sterile Injectable Product

By Derek Duncan, Ph.D., Director at Lighthouse Instruments

Container closure integrity (CCI) plays an important role in maintaining the sterility and stability of sterile injectable products. The defects which cause a sterile vial to leak are not necessarily defects that will be detected by a visual inspection process. Examples of such defects are defects that are hidden by the crimp, microscopic cracks & scratches in the glass, or temporary defects such as stopper pop-up that result in temporary container leakage. 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.