Optical emission spectroscopy
Contamination such as humidity, oxygen or microbiological ingress can impact drug stability throughout the product life cycle. To prevent the risks of stability failure of highly moisture-sensitive drugs (e.g. dry powder for inhalation), or the risk of biological ingress of parenteral drugs, integrity tests with a high sensitivity are required. Most test methods are very challenging in regard to time effort, complexity or the limitation of sensitivity and detection range.
AMI integrity test system – an innovative solution
Our patented 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 over a large detection range. Therefore, our method is non-destructive, easy to use and to set up, and has higher sensitivity than other conventional methods. AMI equipment has been qualified by leading pharmaceutical companies as in-process control (IPC) leak testing for blister packs. Our software is 21 CFR part 11 compliant.
Large detection range
Different detection methods can be combined in order to cover the complete detection range. Gross 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.
Therefore, high sensitivity tests combined with high throughput enables trend analysis to early indicate production issues and to avoid the loss of valuable pharmaceuticals.
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