How the GPX1500 Vial and CO₂ bombing provide a modern alternative to dye ingress testing.

 

Summary

The GPX1500 Vial CO₂ offers pharmaceutical manufacturers and developers a deterministic alternative to dye ingress testing by bombing with CO₂ and using it as a tracer gas to reveal microleaks with precision. Unlike traditional methods that are destructive and operator dependent, this approach provides quantitative, repeatable, and non destructive verification that aligns with Annex 1 and USP 1207 expectations. The case demonstrates how QC teams can strengthen compliance and improve efficiency by replacing subjective tests with a sensitive, data driven solution that detects leak paths through CO₂ ingress during controlled exposure.

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.