clean room monitoring system / environmental
for clean rooms, environmental
The AMI 120 is the perfect in-line integrity test solution for pharmaceutical blister packs. High sensitivity and quantitative measurements are performed in real-time without using any specific tracer gas.
High sensitivity combined with high throughput
Contaminants such as humidity, oxygen or microbiological ingress can impact drug quality throughout the product life cycle. Even the smallest leaks corresponding to holes with a diameter smaller than 1 µm may impact the stability of the drug. This innovative solution can measure the leak rate down to
1/10 µm within a cycle time of less than 45 seconds.
Reliable analysis of the blister packaging integrity
In order to guarantee its performance, the CFR21 part 11 compliant AMI 120 is equipped with an automatic calibration sequence based on traceable calibrated leaks. This method is a patented In-line Process Control (IPC) for blister packaging leak testing qualified by leading pharmaceutical companies