Gasporox Headspace Gas Analysis

Gasporox AB has developed a pharma industry-leading approach to analysis of headspace gases in packaging and containers as innovative non-intrusive solutions to the challenges of ensuring product quality and container closure integrity testing (CCIT).

Gasporox now offers a range of solution that can be applied for rapid benchtop testing or integrated into production and packaging lines to allow automated testing at industrial scale for industries such as pharma and food production where headspace gases provide a trusted metric for product quality, as specified in Annex 1 and similar regulatory regimes.

Non-destructive headspace testing

What sets Gasporox headspace analysis apart from other methods is that these technologies are based on the Swedish-developed tunable diode laser absorption spectroscopy (TDLAS) that allows the testing instrument to ‘see inside’ the package and measure the gas composition without having to open or damage it.

In addition to being non-intrusive and non-destructive, with less wastage, Gasporox TDLAS headspace analysis solutions also deliver other end-user benefits, such as:

• High accuracy and precision
• Adaptability to a wide range of packaging formats including vials and flexible bags or pouches
• Production cost savings
• Rapid testing in under two seconds per vial and under five seconds for flexible packaging
• Increased environmental sustainability with lower waste
• Scope for real time studies

TDLAS technology

The basic Gasporox headspace analysis method is to sense gas presence and densities by sending laser light through the sample, probing the gas content without any change of the sample. These gases can be found in the headspace of a package, inside porous materials or in gas cavities inside the human body. The Gasporox technology can also be used for leak testing.

The TDLAS system is based on understanding that every gas molecule absorbs light in a unique way at a certain wavelength. As the laser is tuned across a particular gas absorption line, there will be a change in intensity of the light after some distance of travel through the monitored gas. From this, concentrations of Oxygen (O₂), Carbon Dioxide (CO₂) or Water vapor (H₂O) can be isolated and quantified.

Gasporox also uses a unique version of the TDLAS technology, developed by researchers at Lund University in Sweden, called GASMAS (Gas in Scattering Media Absorption Spectroscopy). The GASMAS technique is unique in that it applies TDLAS principles to determine presence and concentration of gases inside pores, cavities and packages surrounded by light-scattering media.

This capability makes GASMAS particularly useful in inspection of food and pharmaceutical packaging, both transparent and opaque, as well as leak testing on any package material. The package material can range from totally transparent to materials that only allow for a minor fraction of the light to pass and be detected.

Headspace and Gas analysis applications

Gasporox technology has been proven over more than a decade for the successful testing of parenteral drugs.

Gasporox sensors form the basis for benchtop testing solutions such as the GPX15000™ series of instruments or packaged as easy-to-mount modules such as VialArch™ for incorporation into an existing production line.

Its products are now integrated and used in many machines, systems and instruments used to do all lab testing of vials and ampoules in many packaging lines and labs worldwide.

Specific applications include:

• Package integrity: Measuring gas concentrations inside the headspace of packages ensures a sterile environment crucial for quality, safety and prolonged shelf life. The packages can be any transparent or opaque bag, bottle, vial or tray formed from plastic, glass, foil, carton or paper.
• Leak detection: Gasporox laser sensors can detect the smallest leaks across the whole range of package formats, including metallic containers.
• Porosity Analysis: Material porosity is a relevant parameter in many production processes with dry compounds such as tablet production. Combining GASMAS with TOF (Time of Flight) sensors allows measuring the optical porosity of ribbons produced by a roller compactor in the process of the tablet production in a non-destructive process that provides a faster and more accurate alternative to destructive testing methods that require additional laboratory steps like sample weighing.
• Free gas measurement: Gasporox instruments can also measure free gases seated inside organic products. This technique can also be used for material analysis with parameters like porosity, dampness and gas diffusion. In the GPX-series Gasporox has developed several instruments for measuring products within the pharmaceutical and food industry.

Resources

Click on Gasporox VialArch  to learn more about production line applications.
Click on GPX1500 Vial  to learn more about benchtop vial and ampoule quality testing.
Click on Residual Vial Headspace Oxygen for GPX 1500 Vial application notes.
Click on GPX1500 Film Pharma  to more information about flexible bag and pouch oxygen headspace testing.
Click on GPX Material and Porosity Analysis for further information.