What Is Container Closure Integrity Testing (CCIT)?

Container Closure Integrity Testing (CCIT) is a scientific method used to evaluate whether a pharmaceutical or medical device package maintains a complete and effective seal throughout its lifecycle. CCIT verifies the integrity of the entire container closure system—including the container, closure, and sealing interface—rather than assessing individual components in isolation.

In regulated industries, CCIT is essential for confirming that sealed packages prevent the ingress of microorganisms, gases, or liquids that could compromise product sterility, stability, or performance. Even microscopic leaks, often invisible to the human eye, can lead to contamination over time. CCIT detects these defects using measurable physical principles rather than subjective visual judgment.

What Does CCIT Evaluate?

CCIT assesses whether a package can consistently maintain a sterile barrier under defined conditions. It is commonly applied to:

• Vials and ampoules
• Prefilled syringes and cartridges
• Blow-Fill-Seal (BFS) containers
• Bottles, pouches, IV bags, and blister packs

Unlike visual inspection, CCIT does not rely on operator interpretation. Instead, it uses quantitative or qualitative signals—such as pressure change, electrical conductivity, or tracer gas flow—to identify leaks.

How CCIT Works

Depending on the method used, CCIT measures package integrity by detecting air ingress, liquid egress, electrical current variation, or tracer gas movement through defects. Deterministic methods provide repeatable, physics-based results that can be validated and defended during regulatory inspections.

Why CCIT Is a Regulatory Expectation

Regulatory guidance, including USP <1207>, recognises CCIT as a critical quality attribute for sterile packaging. Agencies increasingly expect manufacturers to use deterministic, scientifically justified methods that demonstrate sensitivity, repeatability, and relevance to real-world risks.

Conclusion

CCIT is not simply a quality control check at the end of production. It is a risk-based integrity verification strategy applied across development, validation, commercial manufacturing, and distribution. PTI focuses on deterministic CCIT approaches that deliver objective, defensible evidence of package integrity throughout the product lifecycle.