Gasporox Tuneable Diode Laser Absorption Spectroscopy (TDLAS)

Gasporox AB’s non-destructive testing solutions are based on laser absorption spectroscopy, which is optical spectroscopy, leveraged by using low-power diode lasers.

This technology is very powerful for non-destructive and non-intrusive pharma package leak detection and integrity testing, being  able to quantify headspace gasses in a variety of primary and parenteral packaging formats, including bottles, vials, ampules, and flexible plastic intravenous IV bags, infusion bags or pouches .

TDLAS technology principles and applications

Gasporox’s laser spectroscopic Tuneable Diode Laser Absorption Spectroscopy (TDLAS) technology platform is based on the principle 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.

TDLAS can sense gas presence and densities by sending laser light through the sample, probing the gas content in the headspace of a package without any effect on contents. Laser absorption technology can be applied both to leak testing and container closure integrity testing (CCIT) inspection.

Gasporox also uses another technology originally developed at Lund University in Sweden, called GASMAS (Gas in Scattering Media Absorption Spectroscopy). Uniquely, GASMAS applies optical spectroscopy 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.

Laser absorption spectroscopy applications

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

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 pharmaceutical packaging lines and labs worldwide.

TDLAS-based Gasporox sensors are available as GPX1500 stand-alone testing stations or as CellSpect or GasSpect modular sensors that can be integrated into machines or production lines.

Specific applications include:

• Package integrity for long shelf life: Measuring gas concentrations inside the headspace of packages ensures a sterile production environment crucial for quality control, safety and prolonged shelf life. The packages can include bags, bottles, vials, and ampoules for the pharmaceutical industry..
• Package leak detection: Gasporox laser sensors can determine whether a package is leaking or not, even detecting the most minute leaks in packages that include any type of bag, bottle, can, tray or vial for the food or pharmaceutical industry. The packages can be made of virtually any material, including metallic containers and flexible plastic IV bags, infusion bags and pouches .
• Porosity Analysis of Pharmaceuticals: Material porosity is a relevant parameter in many production process with dry compounds. For example, pharmaceutical production of tablets uses porosity measurement as a relevant GMP quality control attribute. 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 is fast, accurate and easy to use.

GPX1500 Vial and Film testing

Gasporox offers GPX1500 Film Pharma and GPX1500 Vial instruments for standalone package integrity inspection of pharma IV and infusion bags or vials and ampoules respectively.

Both measure residual headspace oxygen in the package to verify the effectiveness of aseptic filling, for example, as required by  GMP (Good Manufacturing Practice) regulations.

With GPX1500 Vial testing. rigid containers, which can include ampoules, are placed on the sample holder and a button pressed to trigger the measurement by passing a laser beam through the headspace, with oxygen level displayed a few seconds later. Flexible containers (bags and pouches) do not require any holder. These are placed on the top of the GPX1500 Film Pharma and the measuring head is adjusted on the upper side of the container before the button is pressed to start the measurement.

This technique has several advantages, most important that it leaves the container intact, in contrast with traditional measurement practice that involves piercing the package to extract a physical sample of the headspace gas. With IV bag or infusion bag testing, the headspace of the primary bag can be measured without removing it from secondary bag.

Resources

Click on Innovative Laser Technology for further information.
Click on GPX1500 Vial testing  for further information.
Click on GPX1500 lyophilized vial testing  for further information.
Click on GPX1500 Film Pharma testing of IV-bags and pouches for further information.