Employ Data-Driven Methods To Ensure Container Closure Integrity Across The Product Lifecyle

En route to patients, CGT manufacturers must uphold strict quality control and risk management protocols across every stage of development, manufacturing, storage, and transport. One critical aspect of this is container closure integrity testing (CCIT), which tests whether a drug’s container is securely sealed to prevent contamination or degradation. EMA and FDA guidance now recommend a holistic approach to CCIT in which container closure integrity (CCI) data is gathered across the full product life cycle. To achieve this, manufacturers are on the hunt for CCIT technologies that accommodate a variety of container closures across different stages.

In a recent webinar on CCIT, Derek Duncan, PhD, Director of Product Line at Lighthouse Instruments, highlighted the evolving regulatory landscape as well as a series of case studies on the benefits of using headspace analysis to build a lifecycle approach to CCI assurance. Following the webinar, Josine Wilmer, MSc, Analytical Services Product Manager at Lighthouse Instruments, shared her insights on the impact of container material and the advantages of headspace analysis in a Q&A session.