Optical Emission Spectroscopy
Our patented O.E.S. (Optical Emission Spectroscopy) method does not require any specific tracer gas. Instead, the gas mixture present in the container headspace of the primary packaging is used to perform high sensitivity tests with high throughput. A multi-gas sensor is used to independently track the different gases (i.e. argon, nitrogen, CO2, humidity,…) escaping from a leaky container exposed to vacuum. Our method is non-destructive, deterministic, easy to use and to set up, faster and has higher sensitivity than other conventional methods. O.E.S. is able to detect down to 0.2µm defect size on glass containers which corresponds to the sterility barrier defined as the MALL (Maximum Allowable Leak Limit) in the USP<1207> guidelines.
AMI 1000: Optical emission spectroscopy, an innovative CCIT solution for the pharmaceutical industry
With the AMI 1000, the products can be sampled directly from the production line and loaded in the test chamber without any specific conditioning. At the end of the test sequence, the result is clearly displayed and a PDF report is automatically generated at the batch closure. Full automation of the test cycle including loading/unloading of the samples can be easily implemented for in-line tests.
Dedicated to the pharmaceutical industry
AMI 1000 equipment has been qualified by leading pharmaceutical companies as in-process control (IPC) leak testing for blister packs. Our software is CFR21 part 111) compliant.
Large detection range
Different detection methods can be combined in order to cover the complete detection range. Massive leak and fine leak tests are performed within a single test sequence, any additional gross leak test (e.g. blue dye ingress) can be omitted.
Deterministic test method
As no operator intervention is required, the measurement results are totally objective. High accuracy measurements can be achieved thanks to a calibration-validation sequence of the equipment based on certified calibrated leaks.
High sensitivity, high throughput
High sensitivity tests combined with high throughput enables trend analysis to early indicate production issues. In high sensitivity mode, O.E.S is able to detect 0.2 μm defect size on glass containers which corresponds to the sterility barrier defined as the MALL (Maximum Allowable Leakage Limit) in the USP2) <1207> guidelines.
1) Code of Federal Regulations by the United States Food and Drug Administration (FDA)
2) United State Pharmacopeia