Container Closure Integrity (CCI): A Holistic Approach

Maintaining container closure integrity (CCI) is essential for ensuring the sterility and quality of parenteral drug products throughout their lifecycle. While traditional approaches rely heavily on end-product testing, this ebook advocates for a more proactive, science- and risk-based strategy. By embedding CCI into the design and manufacturing processes—rather than relying solely on final release or stability testing—organizations can better safeguard product integrity. Explore how a holistic CCI strategy can be applied across development, validation, routine manufacturing, shipping, and ongoing monitoring. Gain insight into practical tools, including qualification checklists and analytical guidance, to support implementation.

If you're involved in drug product development or quality assurance, access the full ebook to learn more.