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IV-bag inspection

iv-bag headspace inspection of O2

Gasporox offers GPX1500 Film Pharma for headspace oxygen measurements of pharmaceutical IV-bags and pouches.

IV-bags are frequently used in the pharmaceutical packaging. Some products require low oxygen levels to keep the shelf life. Therefore, the oxygen is removed during packaging by purging the bag with nitrogen to displace the residual air in the IV-bag. A statistical check is a part of the GMP procedures to assure the
quality. Traditional methods require a gas sample to be extracted from the IV-bag’s headspace. Such methods are destructive, and the product needs to be rejected. This process generates relevant cost and a risk of operator errors.

Application description

The headspace of the primary bag is measured without removing the secondary bag. The IV-bag is placed in the sample position, the measurement is triggered using the touch screen and after a few seconds the headspace oxygen is displayed. The IV-bag is removed and measured again. 20 measurements are performed, and the values are recorded. The IV-bag is not damaged or altered and can be returned to the production.

Parameters  
Product: IV-bag, 250 ml
Gas: Residual O2 in N2
Measurement time: 4 seconds
Sample handling:

Placing the IV bag manually on the instrument

Supported Packages

  • Large and small volume parenteral
  • Flexible film containers
  • Multi-chamber, primary and secondary bags can be measured
  • Transparent measurement window >10×30 mm needed
  • Content examples: Lactated ringers, Saline solutions, dextrose, colloid fluids and more.

Technology

The Gasporox products are based on 25 years of development and refinement of industrial laser gas sensors. The products 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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Other products

 

GPX1500 Film Pharma

Instrument for measuring headspace oxygen gas content in pharmaceutical bags and pouches.

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GasSpect Flex Sensor

An OEM-sensor for integration in in-line machine or lab-units designated for packaging and quality control.