Air Transport Validation of PFSs and Auto-injectors
For these kinds of validations, 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.
This is followed by 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 result in 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 extractables and leachables, ISO 11040, ISO 11608, migration studies, particle analysis.and bespoke tests that can be uniquely designed for your particular needs.