By Gasporox AB
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Innovative Gasporox VialArch™ finds high pharma industry demand for 100% CCIT inline testing
Lund, Sweden: – Non-destructive testing technology specialist Gasporox AB reports enthusiastic pharma industry uptake of its innovative VialArch™ headspace analysis sensor module.
VialArch™, launched at CPhI Worldwide 2021 in Milan, has already established a leading place in the market for on-line container closure integrity testing (CCIT) solutions and was selected as a short-listed finalist in the ‘Excellence in Pharma: Manufacturing, Technology & Equipment’ category at the recent CPHI Pharma Awards 2022, whose results were announced in Frankfurt.
TDLAS Technology
The VialArch™ headspace analysis (HSA) module uses Gasporox’s Swedish-developed Tuneable Diode Laser Absorption Spectroscopy (TDLAS) technology that passes a laser beam through the gas headspace of moving vials to perform non-destructive measurements of the residual gas composition and any pressure deviations for 100% quality and CCIT inspection on a packaging line.
This is deterministic testing that complies with USP<1207>, Pharma 4.0 and GMP Annex 1 guidelines.
CCIT game-changer
“For an industry that has had to rely for too long on offline systems can only provide destructive CCIT tests with a high reliance on statistical analysis, a solution like VialArch™ is a potential game-changer, allowing genuine in-line testing,” commented Gasporox Senior Application Expert, Roland Koch.
“Furthermore, many of those non-destructive testing solutions that do already exist are relatively big and difficult to incorporate into a packaging line, in contrast to the compact form factor of VialArch™,” said Mr. Koch.
“They also suffer from the disadvantage of only being able to detect leaks that are actually present at the moment of testing, whereas VialArch™ will be able to detect whether the closure integrity has ever being compromised,” Mr. Koch added.
Industry advantages
It was advantages like these that led the CPHI Pharma Awards judges to name VialArch™ as one of the finalists for 2022. Their commendation also highlighted its small footprint, high inspection speed of up to 600 units per minute, plug & play installation, compatibility with a wide range of industry interfaces, and flexibility to accommodate ISO 2R to ISO 200R container sizes.
The addition of VialArch™ to the Gasporox product range also marks a significant milestone in the evolution of the company as a market-leading provider of industrial-scale solutions.
Move to line integration
“With our previously developed sensors, we became experienced in providing quick and accurate residual gas analysis measurement solutions to the industry. It was a natural step to optimize our products for easy line integration,” explained Gasporox CEO Dr. Märta Lewander Xu.
“We saw that we had an opportunity to greatly improve our offer on the market, recognizing that as compliant CCIT has now become a regulatory demand, there has been a growth of in-line HSA sensor demand among end-user companies in the pharmaceutical and biotechnology industry. For these customers, an inline solution that can be quickly and easily integrated into their existing production lines would certainly attract their attention, and so it has proved with VialArch™, said Dr. Lewander Xu.
Preferred end-user choice
A further significant factor in the market success of VialArch™ has been Gasporox’s creation of an international marketing and distribution network. This has selected experienced and professional resellers in important regional markets that have close relationships with OEM production platform manufacturers and play leading roles in supporting end-user installations.
“We are finding that for many projects, end-users are increasingly requesting installation of VialArch™, no matter which OEM provider installed their production line,” said Larry Li, from Gasporox Chinese reseller partner Tianjin Mican (Maxcann) Automation Technology Co., Ltd.).
“After comparing its performance with that of competitors, end-users invariably choose VialArch™ without any hesitation, despite its premium pricing,” added Mr. Li.
About Gasporox
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
Resources
Click on Gasporox on LinkedIn to see original social media announcement, video, and reaction.
Click on CPHI Pharma Awards 2022 Finalists to download brochure.
Click on Gasporox VialArch™ sensor for detailed product information.
CPHI Award finalist: Gasporox VialArch™ sensor module allows advanced Headspace Gas Analysis for non-destructive CCIT testing to USP 1204 and GMP Annex 1 standards.
The compact form factor and plug and play engineering of VialArch™ sensor makes it easy to integrate 100% CCIT testing into existing production lines.
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