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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 - AMI 1000
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Innovative CCIT solution for the pharmaceutical industry based on optical emission spectroscopy - AMI 1000 - 1

AMI 1000 Innovative CCIT solution for the pharmaceutical industry based on optical emission spectroscopy

Innovative CCIT solution for the pharmaceutical industry based on optical emission spectroscopy - AMI 1000 - 2

Innovative CCIT solution for the pharmaceutical industry based on optical emission spectroscopy 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 and medical markets. Leak testing and CCIT can be performed on a large variety of drug/container combinations. Integrity...

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Innovative CCIT solution for the pharmaceutical industry based on optical emission spectroscopy - AMI 1000 - 3

Customer benefits The laptop is not provided by Pfeiffer Vacuum 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 inve

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Innovative CCIT solution for the pharmaceutical industry based on optical emission spectroscopy - AMI 1000 - 4

Innovative CCIT solution for the pharmaceutical industry based on optical emission spectroscopy 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 equipments have been qualified by leading pharmaceutical companies as...

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Innovative CCIT solution for the pharmaceutical industry based on optical emission spectroscopy - AMI 1000 - 5

Versatile and high performance technology for various applications Specific test chambers are designed according product format. Syringes & Vials IV bags Plastic bottles Sensitivity Orifice diameter3) Air/N2 Leakage Water leak Air/N2 leak 0.4 µm 2 · 10-5 mbar l/s 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 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 Test per batch to increase the troughput (high sensitivity...

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Innovative CCIT solution for the pharmaceutical industry based on optical emission spectroscopy - AMI 1000 - 6

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...

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Innovative CCIT solution for the pharmaceutical industry based on optical emission spectroscopy - AMI 1000 - 7

Technical data Power supply Typical power consumption Pressure (min./max.) Typical consumption Calibration gas supply (CDA, N2, Ar, ….) Pressure (min./max.) Venting gas (Ambient, CDA, Ar, ….) Pressure (min./max.) User interface Optional 6.3/10 bar rel. – 91/145 psig Optional 0/1.5 bar rel. – 0/22 psig Operating system Touchscreen Possibility to use a customer laptop via Ethernet or WiFi connections. 21 CFR part 11 compliance PDF GMP test and calibration reports authentication local or domain (LDAP) Remote access to data (optional) Windows 10 Network connection Interfaces (printer, bar code...

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Innovative CCIT solution for the pharmaceutical industry based on optical emission spectroscopy - AMI 1000 - 8

VACUUM SOLUTIONS FROM A SINGLE SOURCE Pfeiffer Vacuum stands for innovative and custom vacuum solutions worldwide, technological perfection, competent advice and reliable service. COMPLETE RANGE OF PRODUCTS From a single component to complex systems: We are the only supplier of vacuum technology that provides a complete product portfolio. COMPETENCE IN THEORY AND PRACTICE Are you looking for a perfect vacuum solution? Please contact us: Pfeiffer Vacuum GmbH Germany T +49 6441 802-0 All data subject to change without prior notice. PL 0024 PEN (December 2021/PoD) Benefit from our know-how and...

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