By Gasporox AB
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Gasporox GPX1500 Film Pharma tester: a new approach to headspace gas inspection
Non-destructive testing technology specialist Gasporox AB has introduced the GPX1500 Film Pharma instrument as a unique and innovative solution for non-destructive headspace gas analysis for measurement of oxygen concentrations in pharmaceutical pouches and bags such as IV bags.
The new instrument, the latest addition to the Gasporox GPX1500 Series of non-destructive quality inspection instruments, is based on the company’s mastery of Tunable Diode Laser Absorption Spectroscopy (TDLAS) technology.
TDLAS was originally developed by research scientists at nearby Lund University and perfected by Gasporox’s own senior R&D team for quality control in HSA applications and for leak detection of gases such as oxygen, carbon dioxide and water vapor in packaging for the pharmaceutical, food and beverage industries.
TDLAS is based on the principle that every gas molecule absorbs light at certain wavelengths and that tuning the laser across different gas absorption lines will produce changes in light intensity from which gas concentrations can be calculated. This provides an innovative 21st century alternative to destructive testing methods which lead to product loss and high production costs.
In-line and laboratory quality control
The GPX1500 Film Pharma is very compact and easy to use. It is designed to operate parameter-free allowing for a reliable and efficient quality control both at-line or in a laboratory. With a testing time below 10 seconds, it allows efficient inspection of bags and pouches with high sampling frequency.
The measurement of oxygen in the headspace of the package can be performed on primary or secondary bag without the loss of the bag or its precious contents. These non-destructive measurement abilities also enable reductions in production costs.
GPX1500 Film Pharma applications
Many parenteral drugs and nutritional products are packaged in plastic IV bags, invariably requiring very low oxygen levels to ensure long shelf life. GMP procedures request statistical checks for quality assurance and close control over oxygen concentrations in order to make sure that the product and its precious content will not be destroyed. Traditional methods involving extraction of gas from the headspace are destructive, breaking the seal or puncturing the surface of the IV bag.
The effectiveness of the TDLAS technology for this application has been confirmed by a research study conducted by Gasporox in collaboration with Fresenius Kabi AB.
This focused on mono bags of an oxygen sensitive drug product that were packed inside secondary bags. The correlation of the instruments was first verified using 10 different bags, of which five were filled with air and five purged with nitrogen. A total of seven bags was used for the study, each measured 10 times with the non-destructive method and then using a destructive method. The resulting 210 measurements showed almost identical correlation between the results obtained by each method. However, the Gasporox method did not require any loss of products or waste.
Proved over a decade
Gasporox technology has been proven over more than a decade for the successful testing of parenteral drugs.
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 packaging lines and labs worldwide.
Click on GPX 1500 Film Pharma Product Sheet for product details.
Click on GPX1500 Film Pharma – Instrument for IV-bag CCIT oxygen inspection to watch video.