At the 2020 PharmTech Bio/Pharma Virtual Congress, Dr. Derek Duncan presented 'A science based approach for ensuring Container Closure Integrity (CCI)'.
Recent regulatory guidance has triggered changes in industry best practices in the area of CCI testing. The increasing implementation of deterministic analytical methods for CCI testing has enabled deeper insight into the performance of primary packaging with respect to container closure integrity. However, assuring good CCI of sterile injectable product goes beyond CCI testing. A more science-based holistic approach that includes robust design &
qualification of the process and the implementation of appropriate process controls is required.