CCIT Myths

Container Closure Integrity Testing (CCIT) is often misunderstood due to legacy practices, outdated assumptions, and oversimplified comparisons. These misconceptions can lead to poor method selection, false confidence, and regulatory risk. Addressing common CCIT myths helps manufacturers make informed, science-based decisions.

Myth 1: If a package passes visual inspection, it is intact

While physical defects can be visually apparent, one does not define the other (imagine a Venn Diagram). Visual inspection can identify visual anomalies, but most integrity failures are not visually apparent. Many packages that appear perfect can still harbour integrity failures. Sterility failures linked to undetected micro-leaks are well documented, making visual inspection insufficient for integrity assurance.

Myth 2: Dye ingress proves sterility

Dye ingress testing does not prove sterility. In fact, dye ingress is a test method that has been proven to be significantly inadequate at assuring integrity. Under the most ideal test circumstances dye ingress may indicate a leak in the range of 15 microns, but this requires absolute optimal package, product, and test conditions. Results are probabilistic, subjective, and highly dependent on test variables. A “no dye observed” result does not confirm the absence of a clinically relevant leak.

Myth 3: Higher sensitivity always means better CCIT

Sensitivity without repeatability, robustness, and relevance can increase risk. Without a reliable test method it is difficult to assert confidence in the test results. A method must reliably detect target leak sizes aligned with the QRM risk profile for that stage of the package development or production. Chasing extreme sensitivity without statistical confidence can lead to false failures and unnecessary rejects.

Myth 4: One CCIT method works for all packages

No single CCIT method is universally suitable. Package material, format, fill type, and product sensitivity all influence method selection. Deterministic CCIT requires a risk-based approach rather than a one-size-fits-all mindset.

Myth 5: CCIT is only needed at the end of production

CCIT is most effective when applied across the product lifecycle. Limiting CCIT to final release testing ignores integrity risks introduced during development, validation, and distribution. Common ways to further improve quality include anchoring production level CCI back to inherent integrity test levels to observe any measurable drift before an integrity failure causes real risk to patient safety.

Conclusion

CCIT myths persist because probabilistic thinking still influences packaging decisions. Deterministic CCIT replaces assumption with evidence. PTI emphasizes data-driven integrity verification to support sterility assurance, validation, and regulatory confidence.