The Future Of Automation For Container Closure Integrity Testing

By Oliver Stauffer and Noba Ebaid

The FDA continues to encourage the shift away from a compliance culture to one that is of a more holistic quality mindset in the manufacturing realm. The topic of quality assurance has never been more dynamic. Multiple guidance documents weave a strong fabric of quality frameworks. One topic that has garnered specific attention is container closure integrity. An integral container is the single most critical attribute to protect product quality beyond the walls of manufacturing. CCI is a critical quality attribute (CQA) for parenteral product classes, dictating a high level of risk mitigation.

In recent years, regulatory bodies and guidance documents have been prompting the industry to adopt deterministic CCIT technologies and discourage traditional, probabilistic approaches. At a foundational level, probabilistic methods do not have the measurement and control capabilities needed for modern validation requirements. For quality attributes as high risk as CCI, greater levels of control are needed. New regulatory guidance documents continue to tighten the narrative on what is expected of container closure integrity.