AMI 1000 Innovative CCIT solution for the pharmaceutical industry based on Optical Emission Spectroscopy

AMI 1000 Innovative CCIT solution for the pharmaceutical industry based on Optical Emission Spectroscopy Improves sensitivity, capacity and reliability of your integrity test Your added value Large detection range Our know-how Pfeiffer Vacuum is one of the world´s leading providers of vacuum and testing solutions. The product portfolio comprises vacuum pumps, measurement and analysis devices, components, as well as vacuum chambers and high performance detection systems. Furthermore, we offer a unique portfolio of equipments based on three technologies that are dedicated to the pharmaceutical...

Improves manufacturing productivity Data storage and traceability Non-destructive and deterministic test methods Fast return on investment escaping from a leaky container exposed to vacuum. Our method is non-destructive, deterministic, easy to use and to set up, and has higher sensitivity than other conventional methods. Furthermore, as sensitivity of the O.E.S. technology doesn‘t depend on the free volume inside the test chamber, several samples can be tested simultaneously. Ease of use The products can be sampled directly from the production line and loaded in the test chamber without any specific...

AMI 1000 Innovative CCIT solution for the pharmaceutical industry based on Optical Emission Spectroscopy 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...

l5 Versatile and high performance technology for various applications Specific test chambers are designed according product format. Sensitivity Orifice diameter3) Air/N2 Leakage Test duration Syringes & Vials IV bags Plastic bottles 3) Water leak 0.4 µm 2 · 10-5 mbar 0.2 µm 6 · 10-6 mbar 0.4 µm 2 · 10-5 mbar 0.5 µm 4 · 10-5 mbar Sharp edge orifice as defined in USP <1207> guidelines ~45 sec. (high sensitivity mode) Highest sensitivity test method available on the market Outgazing of the drug itself can be used for gross leak detection Applicable to peeling blisters Air and water detected simultaneously...

AMI 1000 Equivalence between defect size & air leak rate Leak rate versus defect size Historically, dye ingress testing has been the container closure integrity test of choice. The detection limit of this method is around 20 μm. Since the test is strictly visual, the detection limit has experimentally been determined by using orifices of known diameter. As a consequence, tightness criteria in pharmaceutical industry are usually expressed as an equivalent hole diameter in μm. However, an equivalent hole diameter is not enough to define the tightness criterion of a packaging. Depending on the diameter...

Dimensions in mm Technical data AMI 1000 Power supply Typical power consumption Sensitivity CDA supply Quality Pressure (min./max.) Typical consumption Calibration gas supply (CDA, N2, Ar, ….) Pressure (min./max.) Venting gas (Ambient, CDA, Ar, ….) Pressure (min./max.) User interface Software Operating system Network connection Interfaces (printer, bar code reader, data export) 90-250 V AC / 50-60 Hz 1,200 W Down to 0.4 μm 2·10-5 mbar·l/s Required for operation (1.3.1 according to ISO 8573-1) 6.3/10 bar rel. – 91/145 psig 2 Nl/cycle Optional 6.3/10 bar rel. – 91/145 psig Optional 0/1.5 bar rel....

Errors excepted. All data subject to change without prior notice. PL 0024 PEN (March 2022/PoD) Are you looking for an optimal vacuum solution? Please contact us: Pfeiffer Vacuum GmbH Germany Phone +49 6441 802-0