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Container Closure Integrity Testing Now Available
Vacuum Decay Leak CCIT Testing per USP<1207> validated and now available to our customers
Contributors
Cameron Bravo
Research Scientist
Media Contact
pr@saphobio.com
Sapho Bio now offers validated Container Closure Integrity Testing (CCIT) per USP <1207> using vacuum decay. It is a core requirement for stability studies, and our service is built to satisfy it with minimal samples and a one-week turnaround on method suitability.
Method
Vacuum decay is a deterministic, nondestructive leak test. The sealed vial is placed in an evacuated, tightly fitted chamber that is then isolated. A pressure transducer monitors the chamber: a leak path allows headspace gas to escape into the chamber, producing a measurable pressure rise. Rise rate and magnitude correlate to leak size.
Because the signal is a direct physical measurement, results are quantitative, repeatable, and analyst-independent. The method is nondestructive, so qualified vials remain intact.
Standard: USP <1207>, deterministic leak detection
Limit of detection: ≤ 2.55 µm
Output: quantitative pass/fail with recorded pressure data
Formats
Validated out of the box for the most common parenteral presentations:
2R
6R
10R
Non-standard geometry? Send dimensioned drawings. Fixturing is geometry-dependent, so we confirm fit and feasibility before samples ship.
Sample requirements
Activity | Vials | Timeline |
|---|---|---|
Method suitability (per format) | 10 sealed | ~1 week |
Per investigation | 10 sealed | — |
Method suitability confirms vacuum decay performs reliably for your specific container, fill, and headspace. Established once per format; reused for all subsequent testing.
Where it fits
Stability studies evaluate product degradation over time; CCIT confirms the package still protects it. A vial can pass assay and appearance while a marginal seal compromises sterility and headspace. Include integrity testing at stability pulls to close that gap — also applicable to closure/process qualification and deviation investigations.
Contact us (or reach out directly to your rep) to scope your CCIT testing now!
