AMI Integrity Test System - Innovative solutions for the pharmaceutical industry
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AMI Integrity Test System - Innovative solutions for the pharmaceutical industry - 1

AMI INTEGRITY TEST SYSTEM Innovative solutions for the pharmaceutical industry

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AMI Integrity Test System - Innovative solutions for the pharmaceutical industry - 2

AMI INTEGRITY TEST SYSTEM Innovative solutions for the pharmaceutical industry 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. Thereby our customers bene­ fit from over 50 years of experience in helium leak detection. Integrity challenges Contamination such as humidity, oxygen or microbiological ingress can impact drug stability throughout the product life cycle. To prevent the...

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General customer benefits Improves sensitivity, capability 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 retur

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AMI INTEGRITY TEST SYSTEM Innovative solutions for the pharmaceutical industry 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 pharmceutical industry AMI equipments have been qualified by leading pharmaceu­ tical companies as in-process control...

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AMI INTEGRITY TEST SYSTEM Packaging types Blister packs Sensitivity Down to 2 · 10-5 mbar l/s (Equivalent to ~2 µm pin hole) Test duration Down to 20 sec per test (Depending on the pack format) Widest detection range available on the market – Higher sensitivity than conventional methods – Blue dye test no more needed Can test packs that contain tablets / capsules in multiple material / design formats Can test multiple packs per test cycle Applicable to peeling blisters QAir (mbar · l/s) = f [Hole diameter (µm)] Correspondence: Air leak rate & hole diameter Leak rate (mbar·l/s) Boundary...

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Glass vials Sensitivity Up to several hundred microns hole down to 1 · 10-7 mbar l/s (equivalent to several 1/10 µm hole) Test duration Global test Fast and easy to set up (no sample preparation, no storage time) Flexibility: Unitary test or test per batch Applicable to liquid and solid drugs Plastic bottles Sensitivity Up to several mm hole (depends on the inner volume) down to 2 · 10-5 mbar l/s (equivalent to several µm hole) Test duration What other applicable packaging types? Tool-less device Fast and easy to set up Flexibility (multi-formats) High throughput: Unitary test or test per...

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AMI INTEGRITY TEST SYSTEM Connection between hole diameter & air leak rate Leak rate versus hole diameter 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 been experimentally been determined by using orific­ es of known diameter. As a consequence tightness criteria in pharmaceutical industry are usually expressed as an equiva­ lent hole diameter in μm. However, an equivalent hole diame­ ter is not enough to define the tightness criterion of...

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AMI 121 INTEGRITY TEST SYSTEM FOR BLISTER PACKS Technical data Housing: 304L stainless steel Test chamber dimensions (l x w x h)1) Tooling change over Test type Non-destructive integral vacuum test based on optical emission spectroscopy > 1 · 10-5 mbar l/s (Equivalent to few microns hole diameter) Typically 40 sec. for 1 µm hole size on aluminum blister2) Measurement range Testing speed Operating conditions: Temperature (min./max.) Humidity (min./max.) Power supply Typical power consumption CDA pressure supply (min./max.) (1.3.1 according to ISO 8573-1) Typical CDA consumption User...

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Power Supply Themal Exhaust

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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 Headquarters · Germany T +49 6441 802-0 All data subject to change without prior notice. PA 0075 PEN (October 2016/5) Benefit from our...

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