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 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 challenges...

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 retu

Ease of use 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 pharma- AMI 1000 equipments have been qualified by leading pharmaceutical industry ceutical companies as in-process control (IPC) leak testing for blister packs. Our software is CFR21 part...

Syringes & Vials IV bags Plastic bottles 0.4 |jm 2 ■ 10-5 mbar l/s 0.4 jm 2 ■ 10-5 mbar l/s 0.2 jm 6 ■ 10-6 mbar l/s 0.4 jm 2 ■ 10-5 mbar l/s 0.5 jm 4 ■ 10-5 mbar l/s > 20-30 sec > 15 sec ~45 sec. (high sensitivity mode) > 20 sec > 20 sec 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 MALL level can be achieved in high sensitivity mode Air and water detected simultaneously Test per batch (up to 50 or 100) to increase...

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 of...

Technical data Features AMI 1000 Operating system Network connection Interfaces (printer, bar code reader, data export) Software 90-250 V AC / 50-60 Hz 1,200 W Required for operation (1.3.1 according to ISO 8573-1) 4.5/10 bar rel. - 65/145 psig 2 Nl/cycle Optional 6.3/10 bar rel. - 91/145 psig Optional 0/1.5 bar rel. - 0/22 psig iPad mini 4 (WIFI remote connection) Possibility to use a customer laptop via Ethernet or wifi connections. 21 CFR part 11 compliance PDF GMP test and calibration reports LDAP compatible OPC (optional) MES connection (optional) Windows 7 1 x LAN 2 x USB 3.0 (ext.) 1 x...

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 Benefit from our know-how and our portfolio of training opportunities! We support you with your plant layout and provide first-class on-site service worldwide. Are you looking for a Pfeiffer Vacuum GmbH perfect vacuum solution?...