Functional principle of the AMI Integrity Test System
The packaging to be tested is put into a test chamber that also provides a viewport and mechanical support for the package. The test chamber can be customized according to the needs of the product dimensions and the quantity of products tested simultaneously.
After loading the sample, the chamber is evacuated. At pressures lower than 10 mbar, a plasma is ignited and its optical emission analyzed with an optical emission spectrometer. The lowest detectable signal corresponds to an orifice diameter of roughly 0.1 μm (according to USP 1207.1). Since the gas amount is restricted by the available headspace volume of the packaging, the maximum detectable pore size is limited in regards to the free headspace respectively the outgassing of the drug itself.
Functional principle of the AMI
For further coarse leak tests, the AMI sensor technology can be complemented with a second dedicated leak sensor integrated into the same test equipment to extend the upper detection limit up to a few holes. Please contact us for more information.