By Gasporox AB
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Gasporox bringing non-destructive pharma testing solutions to Pharma 4.0 and Annex 1 event
Lund, Sweden: – Non-destructive testing technology specialist Gasporox AB will be a prominent presence at the upcoming ISPE Pharma 4.0 and Annex 1 conference in Vienna, showing how its advanced pharmaceutical inspection solutions fit into the emerging real time monitoring and sterile manufacturing regulatory environments.
Gasporox will be an exhibitor at the event with a table top exhibition at booth 21 in the exhibition zone at the Vienna Marriott conference venue.
Its display will highlight use of the benchtop GPX1500 Vial instrument that uses advanced Tuneable Diode Laser Absorption Spectroscopy (TDLAS) technology for non-destructive container closure integrity testing (CCIT) and residual oxygen headspace testing in containers or parenteral packaging such as vials or ampoules.
The Gasporox conference team headed by Senior Application and Sales Manager Roland Koch will stage live demonstrations of the instrument.
Challenges and opportunities
“Our non-intrusive inspection technologies such as GPX1500 Film Pharma, VialArch™ headspace analysis sensor module, CellSpect leak detection module and GasSpect Flex non-destructive headspace gas analyzer module, are all very relevant to the emerging Pharma 4.0 and Annex 1 compliant regulatory environments,” commented Mr. Koch.
“We’re delighted to be present at this valuable event that places all those challenges and opportunities front and centre,” he commented.
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, and cans. These sensors can be integrated into production machines and also 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
About ISPE Pharma 4.0 & Annex 1
ISPE, the International Society for Pharmaceutical Engineering, is one of the world’s largest not-for-profit associations, committed to the advancement of the efficiency of its members through exchange of ideas and practical experience. Founded in 1980, the Society now numbers more than 20,000 members in 90 countries.
The 2022 ISPE Pharma 4.0™ and Annex 1 Conference will bring together leading pharmaceutical and biopharmaceutical manufacturers, technology providers, academic scientists, and international regulators to network, share insights and provide an outlook on the evolving landscape and future of Pharma 4.0™ supported Aseptic Manufacturing. The conference will also focus on how Pharma 4.0 concepts can help implement the revisions of the EU GMP Annex 1, Manufacture of Sterile Medicinal Products regulations, due to come into force in 2023.
ISPE Pharma 4.0™ and Annex 1 Conference is two-day event opening December 7 at the Vienna Marriott Hotel. and also hosted online as a virtual event. The conference will provide a leading interdisciplinary platform for all stakeholders of the pharmaceutical chain, showcasing recent innovations and trends, reviewing practical challenges and solutions.
The event is organized by ISPE with further information at: https://ispe.org/conferences/2022-pharma-40-annex-1-conference
Click on Gasporox GPX1500 Vial Instrument for detailed product information.
Click on Residual Vial Headspace Oxygen Testing to download application note.
Click on Ampoule Headspace Oxygen Testing to download application note.
Click on GPX1500 Vial CO2 Product Data Sheet for further information.
Click on Gasporox GPX1500 Vial video to view on YouTube.
Click on Video: GPX1500 Vial Ampoule Format to view on YouTube.