System for Porosity Analysis of Pharmaceuticals
New possibilities for Porosity analysis of pharmaceuticals
The Gasporox GPX Porosity technology represents a new approach to porosity analysis of pharmaceutical substrates such as ribbons and tablets. Gasporox is now developing GPX Porosity to the first at-line version with this technology and is working with the users to bring this to their needs.
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Material porosity is a relevant parameter in many production processes with dry compounds. Actual porosity measurement technologies are using destructive methods. Several disadvantages are connected with the determination of the porosity. They require a lab to do additional steps like sample weighing, have a long measurement time, take a long time to be performed, are costly, are material dependent, have limited accuracy, can require handling of poisonous liquids etc.
The pharmaceutical production of tablets uses the porosity measurement as a relevant quality attribute. The routine measurement to comply with the GMP process, the scale process as well as the validation of equipment and process are demanding a faster, easier and more reliable measurement technology.
Gasporox is highly specialize in the development and application of optical spectroscopy. The combination of TDLAS technology and GASMAS (GAs in Scattering Media Absorption Spectroscopy) and TOF (Time Of Flight) sensors allows measuring the optical porosity of ribbons produced by a roller compactor in the process of the tablet production as well as pharmaceutical tablets. The non-destructive at line instrument is fast, accurate and easy to use. No special sample preparation is required. No lab with additional instruments needs to be available and the measurement can be done at line by an normal line operator.
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How it works
A typical sample to be measured is a ribbon used for the production of a pharmaceutical tablet. The sample is placed in the holder of the instrument. The automated process of the instrument moves the sample to the GASMAS (GAs in Scattering Media Absorption Spectroscopy) and TOF (Time Of Flight) sensors. The algorithm is calculating the optical porosity. The integrated calibration curve converts it to the physical porosity. The sample is unchanged available for further use.
The full cycle takes less than a minute. Additional functionality allows a spatial porosity mapping over a larger scale ribbon. The measurement can be done at line by a normal line operator.
The Gasporox products are based on 25 years of development and refinement of industrial laser gas sensors. The product utilizes Tunable Diode Laser Absorption Spectroscopy (TDLAS).
The laser sensor technology has been developed by Gasporox and Gasporox’s technology partner/supplier, and is used in many other industrial settings, including the petro-chemical, pharmaceutical, and energy industries.
The Gasporox technology is already used more than 10 years very successful for the testing of parenteral drugs. It is integrated and used in machines, systems and instruments to do 100% and lab testing of vials and ampoules in many parenteral packaging lines and labs. The great performance and robustness of the measurement is well proofed in the industry.
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