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

Customer benefits

• Improves sensitivity, capacity and reliability of your integrity test.
• Large detection range – can replace gross leak and helium test
• Improves manufacturing productivity with equipment that is easy to use and to set up.
• Lower cost of non-quality thanks to advanced process monitoring and feedback control
• Fast return on investment