Rapid CO₂-Based CCIT of Vials at 10% Tracer
Summary
This case study explores how CO₂-based tracer gas and Headspace Analysis can be used to detect integrity issues in pharmaceutical vials under realistic testing conditions. It highlights how low tracer concentrations and short exposure times can still provide clear differentiation between intact and defective containers. The findings indicate a strong relationship between defect characteristics and measurable gas changes, enabling objective and quantitative evaluation. The results point toward a simplified and efficient approach to CCIT without compromising reliability.
Technology
The Gasporox sensors and instruments are built on more than 25 years of development and refinement in industrial laser-based gas measurement. The system uses Tunable Diode Laser Absorption Spectroscopy (TDLAS), a highly reliable and precise method for non-destructive headspace gas analysis.
Developed by Gasporox in collaboration with its technology partners, this laser sensor technology is widely used in demanding industries such as pharmaceuticals, petrochemicals, and energy.
Gasporox’s laser-based headspace analysis has been successfully deployed for over a decade in pharmaceutical manufacturing. It is integrated into fully automated inspection systems and benchtop instruments for 100% in-line and laboratory testing of vials, ampoules, and other parenteral packaging formats. The performance and robustness of the system have been validated through extensive real-world use.
