Medical And Combination Device Testing News

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Sep 16, 2016 |
MET News,  |
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Air Transport Validation of PFSs and Auto-injectors

The pens and syringes are mounted in a transparent chamber. The inside of the chamber is then subjected to simulated air transit whilst the air bubble and stopper positions are monitored geometrically.

Testing of dose stability after reduced atmospheric pressure exposure in air transit.
Pre-filled syringes, auto-injectors and injector pens are frequently transported by air. During their time at altitude they will be subjected to reduced air pressures. This can lead to an expansion of any air bubbles in the syringe barrel and in turn movement of the piston and stopper. MET have developed a testing regime to measure the effects of this process on the use of the device and its dose accuracy, particularly the total inject-able volume.

The pens and syringes are mounted in a transparent chamber. The inside of the chamber is then subjected to simulated air transit whilst the air bubble and stopper positions are monitored geometrically.

Following a simulated flight programme, dose accuracy testing assessment may be applied according to ISO 11608.

This programme forms part of a complete prefilled syringe test programme available from MET. This programme includes: bespoke tests, extractables and leachables, ISO 11040, ISO 11608, migration studies and particle analysis.