Industry Survey: Best Practices In Container Closure Integrity Testing

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. New regulatory guidance has recently triggered changes in industry best practices in the area of CCI testing (CCIT). This article summarizes the answers to polling questions that were presented to representatives of pharmaceutical companies involved in CCIT activities. The polls were conducted in the time period March 2019 – March 2020 and the results therefore give a snapshot of industry best practices in this particular time period.