Instrument for Lyophilized vial
Residual Headspace Oxygen in Vial
Gasporox offers GPX1500 Vial for headspace oxygen measurements of pharmaceutical vials.
Many parenteral drugs are filled in glass containers like vials. Oxygen sensitive drugs need to be produced and filled with a low residual oxygen in the headspace of the container. Often a nitrogen overlay is used during the aseptic filling process. Multiple vacuum / nitrogen cycles are used for even lower residual oxygen levels. The GMP (Good Manufacturing Practice) regulations requesting a verification of the effectiveness of the process. The instrument GPX1500 Vial enables an accurate and fast non-destructive measurement of the residual oxygen in the headspace of the vial.
Application description
The specific vial holder is installed without using any tools. With installing the vial holder all parameters are set. No parameter settings are required for the operator. The vial is placed in the vial holder. The measure button in pressed to start the measurement. The laser beam is passing the headspace of the vial to perform TDLAS based, non-destructive and precise measurement of the residual oxygen in the headspace.
Performance
The vial was removed for each measurement and re-inserted in the vial holder. This shows the instrument performance including the influence of the vial itself. All values are within a band of +/-0.03% O2.
| Parameters | |
|---|---|
| Product: | 10 R Vial |
| Gas: | Residual O2 in N2 |
| Measurement time: | 2 seconds |
| Sample handling: | No vial movement and no gas flushing |
Technology
The GPX1500 Vial optical gas measurement instrument is based on 25 years of development and refinement of industrial laser gas sensors. The product 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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Measurement on vials
An application example of lyophilized vial measurements with the GPX1500 Vial instrument.