Clean room monitoring system AMI 121

environmental

Integrity testing for high demanding pharmaceutical packages and advanced sealed devices Optical emission spectroscopy for high sensitivity testing The Pfeiffer Vacuum AMI, with its optical emission spectroscopy is perfectly suited for pharmaceutical applications. Especially the stability of the primary packaging integrity to assure sterility and to protect the pharmaceuticals against microbiological, oxygen or moisture ingress is very critical. The patented method does not require any specific tracer gas. Instead the gas mixture present in the container head space of the packaging is used to perform high sensitivity testing over a large detection range. The test method is applicable for different kinds of packaging like blisters, pouches, vials and plastic bottles and can also be used to test sealed devices like battery cases. Core strengths Thanks to its large detection range, the AMI can replace helium leak testing and gross leak test with one system. It delivers a user-independent, deterministic go / no go result and also enables quantification of the leak test result. Therefore, the calibration validation is based on certified calibrated leaks and offers high reliability and accuracy according to USP 1207.1.