Lyophilized Vial CCIT
In partnership with Gasporox AB, Nikka Densok provides comprehensive inline and offline Container Closure Integrity Testing (CCIT) solutions, featuring specialized magnetized metal detector and headspace gas analysis systems for the pharmaceutical industry.
CCIT and Oxygen Quality Control
Headspace Gas Analysis
Headspace gas analysis is an advanced laser-based solution for package quality inspection. It enables non-destructive measurement of gas composition inside sealed packages without opening them. This approach supports fast and reliable quality control for lyophilized vials.
Oxygen Fill Quality Control
During aseptic filling of oxygen-sensitive products such as biologics, HGA can be used to efficiently monitor oxygen levels in real time, ensuring the effectiveness of nitrogen purging or the quality of vacuum stoppering.
The detection mechanism is based on Tunable Diode Laser Absorption Spectroscopy (TDLAS), which provides reliable and selective identification of target gases with high sensitivity.
Offline Solutions
Vials and ampoules
The instrument is compatible with ISO tubular vials (2R – 100R), moulded vials (16mm – 49mm), and ampoules (1-30mL).
Pouches or IV bags
This compact tabletop system provides non-destructive HGA for transparent IV bags and pharmaceutical pouches. The system supports primary and secondary flexible film bags—including multi-chamber designs—and requires a measurement area of only 10 × 30 mm.
A Novel Solution for Dual Purpose CCIT and Metal Detection
CCIT and Metal Detection for Lyophilized Parenteral Products
This combination system integrates a Magnetized Metal Detector and HGA into a single inspection platform, providing comprehensive quality control. Unlike conventional metal detectors, the magnetized metal detector can reliably detect extremely fine stainless steel contaminants even sealed with aluminum caps. After metal inspection, each container is automatically transferred to the HGA station for non-destructive headspace gas inspection. This makes the system an ideal solution for lyophilized products requiring both foreign particle inspection and headspace gas monitoring, while also supporting nitrogen-purged liquid products. By combining two critical inspection technologies in one system, manufacturers can streamline the inspection process, reduce equipment footprint, and perform comprehensive quality inspection without compromising throughput or reliability.
- 100% CCIT
- 21 CFR Part 11 compliance
- USP <1207> recommende
- 0.1μm hole size detection capability
- Tool-less, easy size parts changeover