Containter Closure Integrity Testing (CCIT) Service
Your packaging carries the full weight of your product’s sterility claim. A container closure integrity test tells you, with numbers, whether that barrier actually holds. CDM Lavoisier runs CCIT for pharmaceutical and medical device manufacturers who need results a regulator won’t push back on and a stability study won’t outgrow. This is a standard service offered as part of our CDMO services offering. Our test methods, deterministic and quantitative by default, cover vials, bottles, ampoules, and cold-chain formats. We build every protocol around your specific container.
What we test, and why the method matters
Container closure integrity, CCI, is your package’s ability to keep contaminants out and product stable for the full length of its shelf life. We measure that ability directly rather than inferring it from a dye stain or a microbial count. Since USP’s <1207> 2016 guidance, as well as GMP Annex 1, pushed the industry toward deterministic methods, we’ve built our offering around exactly that shift : real numbers, not pass/fail guesses.
| Method | Detection limit | Sample impact |
|---|---|---|
| HVLD | ~1 microns | Non-destructive |
| Vacuum decay | ~5 microns | Non-destructive |
| Pressure decay | ~5 microns | Non-destructive |
| Dye ingress | Visual, variable | Destructive |
High-voltage leak detection (HVLD) passes an electrical current through the liquid-filled container via a set of external electrodes, and any crack, pinhole, or seal defect creates a measurable spike in current flow as it offers a lower-resistance path through the package wall.
Vacuum decay pulls the sample down to vacuum inside a sealed chamber, then watches the pressure climb back up. A defect lets internal gas leak out and push that reading higher.
Pressure decay works the other way around, applying positive pressure to or around the sample and tracking how fast it drops, since an abnormal drop points straight to a leak.
Dye ingress submerges the sample in a dye bath and any dye found inside the container once opened or viewed through the wall confirms a breach, without giving a measurable leak rate.
Note : the detection limit applicable to your product will depend on multiple factors that we will carefully evaluate as part as of the qualification process.
Built for your container, not a generic protocol
Every container geometry gets its own custom test fixture before testing starts, because a mold built for one package shape rarely seals correctly on another. Rigid, liquid-filled vials run cleanly through vacuum decay once we’ve built a mold matched to that vial’s neck and cap profile, since a properly sealed chamber is what makes the seal geometry repeatable across batches.
Flexible bags and pouches need a fixture shaped around their flat-seal profile, which rules out vacuum-based testing altogether, so we move to pressure decay or dye ingress depending on your validation history.
From method development to regulatory filing
We take a project through three stages, and we scope all three before work starts.
Method development and validation
We qualify the method against your specific product-package combination under USP <1207.1> and <1207.2>, covering repeatability, specificity, and a defined limit of detection. Validation runs on calibrated defects created directly on your own containers rather than generic reference samples, so the detection limit we report reflects how the method behaves on the exact package you’ll ship, not a stand-in. We don’t reuse a generic vacuum decay parameter set across different stopper types or fill volumes.
Routine and stability testing
Once validated, we run your batch release testing, stability program timepoints, and production lot screening on the same qualified method, so results stay comparable across the full study.
Regulatory documentation
Every report ships with the data package your submission needs: repeatability data, specificity, detection limit, and a validation summary suited for regulatory filings. Our QC lab operates under cGMP.
Turnaround that matches your study, not our queue
Stability studies run on fixed pull dates. We schedule your testing against those dates from the start of the project. We flag capacity constraints before we accept a timeline we can’t hold.
Frequently asked questions
Does a passing result guarantee sterility for the full shelf life?
A passing result confirms your package met the acceptance criteria under tested conditions, at that time point. That’s why we build repeat testing into your stability protocol at multiple intervals rather than relying on a single release test.
How small a defect can you actually find?
Our vacuum/pressure decay methods reach sensitivity, down to roughly 5 microns. HVLD can go down to 1 micron. Having said that, the detectable pinhole size really depends on the method used and the type of container / product.
Do you ever recommend a probabilistic method?
Occasionally, for legacy comparability data or when no deterministic method fits an unusual package geometry. When that happens, we document the justification up front. Regulators expect a documented rationale whenever a probabilistic method gets chosen over an available deterministic one.
