Studies confirm effectiveness of new laser-based headspace testing

Lund, Sweden: – Non-destructive testing technology specialist Gasporox AB has introduced and tested new laser absorption spectroscopy based solutions for more reliable and consistent HSA headspace analysis testing of containers.

The new technology allows enhanced HSA measurements for total pressure & oxygen content with reduced differences between in-line and benchtop testing.

Gasporox teams headed by CEO Märta Lewander Xu, and including Engineers Rikard Heimsten and Jennifer Wong, Development Manager Mikael Sebesta, and Sales Director Roland Koch, carried out two studies.

Benchtop v. In-Line

The first study, ‘Enhanced Pressure Measurement in Vials with HSA’ assessed the reliability of laser-based HSA for measuring oxygen content and total pressure in vials to ensure Container Closure Integrity (CCI) in parenteral packaging, focusing on the effect of high pressures  above 800 mbar and low humidity typical in lyophilized (freeze-dried) vials.

Traditionally, conducting HSA at high pressures has been challenging due to signal broadening and noise interference. The study confirms that recent advancements in Tunable Diode Laser Absorption Spectroscopy (TDLAS) technology now enable accurate pressure measurements up to 1000 mbar, even in dry or low-moisture environments.

The Gasporox team used a GPX 1500 Vial H₂O Total Pressure instrument to measure headspace pressures across three sets of vials featuring pressure increments of 50 mbar ranging from 700 mbar to ambient pressure, as well as different humidity levels.  Each vial was measured ten times with repositioning. The measurements showed greater signal variation in vials with lower humidity levels, as expected due to smaller absolute signal to evaluate. Deviations varied from below 3 mbar for the humid and wet conditions to about 21 mbar for dry conditions at ambient pressure.

However, the system provided clear resolution and accurate differentiation of pressures across the full range from 800 to 1000 mbar for all three levels of humidity, proving laser-based HSA to be an effective tool for precise pressure detection through H₂O measurements, with an enhanced capability to accurately measure pressures up to 1000 mbar, even in low-humidity vials, that makes it particularly valuable for CCIT in lyophilized products packaged at 800 mbar.

Benchtop v. In-Line

The second study, ‘In-Line vs Benchtop HSA O₂ Testing’ examined the variations in oxygen content readings in container headspace obtained from Gasporox GPX 1500 vial benchtop testing instrument and those inspected by its VialArch™ high speed in line testing sensors, again vital in Container Closure Integrity Testing (CCIT) and inspection of oxygen-sensitive products.

The study compared the Limit of Detection (LOD) for each system, calculated as three times the standard deviation of repeated measurements for 0% O₂ vials, as measured across a wide range of vial sizes and types.

The LOD comparison confirmed the tradeoff between sensitivity and throughput in benchtop and in-line systems, with the benchtop system consistently achieving better LOD values due to its longer measurement time, but the inline system maintaining acceptable sensitivity while significantly improving throughput. An interesting insight was that molded vials exhibited lower performance compared to tubular vials in both systems, with the effect less pronounced in in-line testing.

The study confirmed that while in-line HSA testing is slightly less precise than benchtop inspection, it remains within ranges needed for pharmaceutical applications, with the huge advantage of the significantly higher throughput making in-line HSA systems ideal for largescale production environments.

About Gasporox

Gasporox, based in Lund in southern Sweden, develops and manufactures laser-based sensors for integration into in-line inspection and production lines for Headspace Analysis and Leak Detection. Gasporox sensors are also available in various instruments ideal for quality control and at-line inspection of packaging and support many different package formats as highly effective tools for more efficient sample testing and greener production.

The VialArch™ is a unique laser-based solution for vials to be installed on the production line for 100% quality inspection for residual oxygen and container closure integrity testing. The laser beam is passing the headspace of the moving vials to perform laser-based headspace analysis (HSA), non-destructive and with precise measurements of the residual oxygen in the headspace.

The GPX1500 Film Pharma is a compact and easy to use instrument to measure accurate the headspace of pharmaceutical bags and pouches. It’s designed to operate parameter free to have a reliable and accurate use in the pharmaceutical production and lab. The GPX1500 Vial is the Film Pharma’s sibling for rigid containers, like vials and ampoules.

The available Headspace Analysis sensors work with many types of containers like vials, ampoules, bottles, bags and trays and are available for measuring O2, CO2, H2O, or the pressure inside the inspected container and are suitable for Leak Detection on packages like trays, bags. These sensors can be integrated into production machines or form the basis for stand-alone instruments.

Gasporox technology has been proven for performance and robustness over more than a decade in the pharmaceutical industry in the testing of parenteral drugs. It is integrated and used in machines, systems and instruments for total lab and production testing of vials and ampoules in many parenteral packaging lines.

Gasporox testing technologies are non-destructive and deterministic and recommended by <USP1207>.

Learn more at: www.gasporox.com

Resources

Click on GPX1500 Vial for product information.
Click on GPX1500 Film Pharma for product information.
Click on VialArch™ to learn more about in-line testing.