While deterministic analytical container closure integrity (CCI) test methods have revolutionized our ability to detect leaks and assess closure performance, true CCI assurance goes far beyond final product testing. This groundbreaking paper reveals how leading pharmaceutical companies are moving from final product testing to proactive CCI assurance through a holistic, science-based approach.

Through a detailed case study of a vaccine stored at ultra-low temperatures—a challenging environment for maintaining CCI—the authors demonstrate how to identify and mitigate risks before those become problems and implement process controls that ensure consistent performance.

With regulators increasingly demanding science-based approaches to CCI, this paper provides the roadmap for building a strategy that is both scientifically robust and regulator-accepted, offering practical insights you can apply to your own parenteral products.