Container Closure Integrity (CCI) Manufacturer & Supplier
CCIT systems for vials, prefilled syringes and sterile drug packaging — deterministic pressure-decay testing per USP <1207>.
Overview
Manufacturer & U.S. supplier. MedIntegrity designs and builds the CCI / CCIT instrument in its own factory — 28 patented products, 15 years in pharmaceutical testing equipment.
Models
System-level offering — instruments and configurations available on request. Contact us.
Where Container Closure Integrity (CCI) Is Used
Vials & stoppers
Pressure-decay CCIT for stoppered glass and plastic vials — the deterministic, every-unit test that supports fill-finish release under USP <1207>.
Prefilled syringes
CCIT for the stopper and plunger interfaces that prefilled syringes add to the container — the leak paths that tend to hide.
Sterile drug release
Release-stage confirmation that each unit in the lot is sealed, with the electronic record that the audit reads.
Going Deeper
The problem you are trying to catch
You filled the vial. The stopper went in. Now it sits in a carton, rides a truck, gets stacked on a pallet, waits on a shelf. Somewhere in that journey a crimp can crack or a stopper can work loose, and you will not know unless you test. That is the whole reason CCIT exists. You prove the seal held before you release the lot, and you keep proving it through the shelf life you claim.
Which method you need
USP <1207> gives you two families to choose from. Deterministic methods — pressure decay, vacuum decay, dye ingress, laser flash — look at the actual unit and hand back a pass or a fail. Probabilistic methods, like accelerated visual inspection, sample the lot and let statistics make the call. Most release programs for vials and syringes end up on deterministic, and the reason is easy to state: the unit you test is the unit that ships.
Why syringes are the hard case
A prefilled syringe has more to inspect than a vial ever has. There is the barrel, the stopper, the plunger, and the crimp or thread at the end. The interface where the stopper meets the plunger is where the failures that matter most tend to hide, and a test built for vials would never even look there. If you run syringes, the program has to cover all of those points.
CCIT testing, unit by unit
CCIT testing means proving each individual container-closure holds its seal — not sampling a lot and letting statistics carry the risk. For a stoppered vial, pressure decay or dye ingress reads that one vial; for a prefilled syringe, the method has to reach the stopper-to-plunger interface a vial test would never even look at. The release program needs a per-unit pass or a per-unit fail with the record behind it, and that is exactly what a deterministic CCIT platform returns.
How the delivery lands
You get a system, not one box. The pressure-decay platform, fixtures matched to the containers on your line, and the IQ/OQ/PQ documentation that moves it into your validated environment. Send us the closures you run and the failures you are chasing. We come back with a configuration and the acceptance criteria to validate against.
Frequently Asked Questions
Which standard governs CCIT?
USP <1207> Container Closure Integrity Testing. It sets the framework for demonstrating that a container maintains its sealing integrity through its intended storage and use conditions, and that any failure would be detected by the test.
Is pressure decay destructive?
No. The unit you test is the unit that ships. That is why deterministic pressure decay is the workhorse for rigid containers and prefilled syringes on the release path.
Do you supply the complete CCIT system?
Yes — the testing platform, the fixtures for your container formats, and the IQ/OQ/PQ qualification documentation. Configurations and acceptance-criteria support are available on request; tell us the container-closure systems on your lines.
Need a quote or technical advice?
Tell us your application — our U.S. team responds with product selection, documentation and pricing.
Request a Quote