Packaging Leak & Seal Inspection Solution
why choose our products
Non-destructive container closure integrity testing covering vacuum decay, high-voltage leak detection, and pressure decay methods for vials, syringes, blister packs, and flexible pouches.
Container closure integrity (CCI) failures - a hairline crack in a vial, an incompletely seated stopper, a pinhole in a blister seal - are often invisible to visual inspection yet can compromise sterility or shelf-life stability. As regulators shift preference toward deterministic, non-destructive methods over traditional dye-ingress or microbial challenge testing, manufacturers need CCIT platforms that can validate a wide range of container formats without destroying the sample.
Regulatory Basis
USP General Chapter <1207> (Package Integrity Evaluation - Sterile Products) categorizes CCIT methods into deterministic (physical, e.g., vacuum decay, high-voltage leak detection, CO2 headspace) and probabilistic (e.g., dye ingress, microbial ingress) approaches, and recommends deterministic methods for routine use due to their higher sensitivity and reproducibility. ASTM F2338 (vacuum decay) and ASTM F2191/F3287-family standards for electrical leak detection provide the underlying test methodologies.
Our Solutions
Our CCIT platform combines vacuum decay and HVLD dual testing modules in a single system, validated for vials, pre-filled syringes, blister packs, IV soft bags and BFS containers. The instrument is designed to detect micron-scale defects without sample destruction, supporting non-destructive full inline inspection and lab sampling. As a factory-direct manufacturer, we provide 10-day fast custom fixture delivery, cost-effective factory pricing and round-the-clock global technical support, along with dedicated CCIT method development to fit your unique packaging system.
Products
Success Case
All-in-one vacuum decay & high voltage leak detection unit, compatible with vials, pre-filled syringes, blister packs, IV soft bags and BFS containers. Fully compliant with USP <1207>, 21 CFR Part 11 and GMP data integrity requirements
FAQ
Q1: What is the difference between deterministic and probabilistic CCIT methods?
A1: Deterministic methods (vacuum decay, high-voltage leak detection, CO2 headspace) produce a physical measurement tied directly to a leak's size, while probabilistic methods (dye or microbial ingress) infer a pass/fail result statistically and are generally less sensitive and reproducible.
Q2: Can CCIT replace sterility testing entirely?
A2: CCIT verifies the physical barrier of the container-closure system; it is typically used alongside, not as a full replacement for, a validated sterility assurance program.
Q3: Which CCIT method suits flexible pouches versus rigid vials?
A3: Rigid containers like vials and syringes are commonly tested with vacuum decay or high-voltage leak detection, while flexible pouches often require pressure decay or headspace-gas methods due to their non-rigid geometry.
Q4: Is CCIT destructive to the tested unit?
A4: Deterministic physical methods such as vacuum decay and high-voltage leak detection are generally non-destructive, allowing the tested unit to remain part of saleable stock where permitted by SOP.