By Gasporox AB
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Gasporox laser spectroscopy for CCIT and leak testing in pharma packaging quality control
Gasporox AB’s proprietary technologies that leverage the power of optical spectroscopy using diode lasers can be applied to a range of non-destructive testing solutions for various industries, including pharmaceuticals and healthcare.
These solutions include Leak Testing and Headspace Gas Analysis that can be applied separately or in conjunction to ensure total package or container integrity and meet the demands of current regulatory guidelines such as United States Pharmacopeia General Chapter 1207 (USP 1207) on Container Closure Integrity Testing (CCIT) and Annex 1 of the European Commission (EC) Rules governing medicinal products in the European Union.
Gasporox products are based on a laser spectroscopic technique called Tunable Diode Laser Absorption Spectroscopy (TDLAS). This technique relies on the principle that every gas molecule absorbs light in a unique way at certain wavelengths. 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.
This capability makes TDLAS particularly useful in quality control of pharma products and packaging, as well as leak testing on any type of package. 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.
The basic principle is to sense gas presence and densities by sending laser light through the sample, probing the gas content without any change of the sample.
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 is useful when measuring the porosity inside pharmaceutical substrates.
Gasporox technologies have been proven over more than a decade for the successful parenteral inspection and packaging quality control. They are embodied in a range of Gasporox GasSpect and CellSpect sensors as well as in their latest product the VialArch, that are optimized to measurement of O2, CO2, H2O, and pressure levels, as well as leak detection for integration as components into machines, systems and instruments used to do in-line quality inspection and CCIT of pharmaceutical parenteral packaging such as vials and ampoules in many packaging lines and labs worldwide.
They are also integrated into Gasporox’s own GPX1500-series of instruments for at-line or laboratory QC testing. These can be used in a range of applications:
- Package integrity testing: Headspace gas analysis (HGA) of packages ensures a sterile environment which is crucial for quality, safety and prolonged shelf life. The package can be any type of bag, bottle, vial or tray for the pharmaceutical or food industry, whether transparent or non-transparent and made of materials such as plastic, glass, foil or carton.
- 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, vial, can, tray or bottle for the pharmaceutical or food industry. The packages can be made of virtually any material, including metallic containers.
- Porosity Analysis of Pharmaceuticals: Material porosity is a relevant parameter in many production processes with dry compounds. For example, pharmaceutical production of tablets uses porosity measurement as a relevant GMP quality assurance attribute. Gasporox technology offers an alternative to destructive testing methods that require additional laboratory steps like sample weighing, have long measurement times, are material dependent, or subject to limited accuracy. By using its innovative approach with GASMAS technology in Gasporox GPX Porosity system, it allows measurement of the porosity of pharmaceutical substrates such as 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.
Gasporox solutions align very closely with the principles laid out in USP 1207, which provides an overview of common CCIT tests and categorizes them as being probabilistic testing (basically subject a batch of containers to stresses and record failure rates) or deterministic (test each container individually and confirm it passes). The most commonly deployed deterministic tests are laser-based headspace analysis, vacuum decay, pressure decay, HVLD and tracer container gas analysis.
Crucially, USP 1207 states a preference for deterministic tests because they are non-invasive and non-destructive, produce repeatable and predictable results and are suited to 100% testing. Furthermore, it produces individual data that are applicable to test/trace and serialisation environment, in contrast to the statistical quality control approach used in probabilistic methods.