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Gas Identification Unit

Efficient identification solution for pharmaceutical and biopharmaceutical gases, easier said than done. Thermal conductivity measurement can help to identify gases reliably and easily.

The  Concept

The Gas Identification Unit (patent pending) is a user-friendly,  innovative system to identify process gases based on their thermal conductivity. This unit has been developed by Air Liquide in response to the recently updated GMP regulations regarding the identification of incoming materials. The European Union (EU) GMP guidelines specify in  Volume 4 / Part 1 / Chapter 5 that “All incoming materials should be checked to ensure that the consignment corresponds to the order” and that “there should be appropriate procedures or measures to assure the identity of the contents of each container.” 

The measurement method is based on the thermal conductivity property of gases (built-in Thermal Conductivity Detector, TCD). At a given temperature, this physical property is specific to each gas molecule, and can therefore be used for identification. The method is validated following current guidelines, including  ICH Q2 (R1) Validation of Analytical Procedures. Once installed, the unit is also qualified following a standard protocol that needs to be independently approved by the respective Quality departments of the customer and Air Liquide.


The Gas Identification Unit is proposed by Air Liquide on a rental basis. Therefore, there is no need to invest in separate, gas-specific analyzers, which not only result in added instrumentation costs, but also require qualified and trained personnel to operate. Maintenance of the unit is also under Air Liquide’s responsibility.

 

Advantages

  • Suitable for process gases used in the pharma industry (e.g. N2, O2, CO2)
  • Only one device for all gases
  • Short measurement time (~ 5 min)
  • User-friendly, no need for a highly qualified operator
  • No safety risk since no intermediate sampling from the trailer of from the cylinders needed
  • No calibration needed
  • Report generated and transferable to printer/laptop
  • GMP compliant operation
  • Easy, simple and cost-saving solution to comply with the GMP identification testing requirement

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