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      LT-Pro Leak Tester Flexible CCIT benchtop leak tester

      Pharmaceuticals

      Non-invasive, non-destructive leak tester for laboratory and in-process control applications. Provides accurate and reliable closed container integrity testing (CCIT) for rigid and flexible packaging.

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      BFS

      Bottles

      Carpoules

      Cartridges

      FFS

      Pouches

      Prefilled Syringes

      Vials

      Flowpacks

      Cups

      Tech specifications
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      Highlights

      • Enhanced flexibility
      • Interchangeable tooling for testing a wide variety of containers
      • Multiple test methods: vacuum and pressure decay
      • Available with either 5μm or 1μm test accuracy
      • Non-invasive, non-destructive testing of personalized medicine
      • Small-batch testing
      • Ergonomic design: lightweight, compact, easy to operate, clean, and move.
      • Simple Ewon connection makes it easy to store, analyze, and document test results.
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      Technical Features

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      • Container Application: Vials, ampoules, BFS, FFS, bottles, prefilled syringes, carpoules, cartridges, trays, pouches, sachets, flowpacks, cups, and other flexible and semiflexible filled-and sealed packaging
      • Products: Lyo, liquid, powder, pastes, solid, semi-solid
      • Container Dimensions: From 0.1 mL to 1 L
      • Testing time: From a few seconds to approximately 1 minute depending on container size
      • Technology: CCIT
      • Inspection Feature: Non-invasive, non-destructive CCIT based on vacuum & pressure decay test method
      • Inspection Capabilities: Weak seals, channel leaks, and pinholes, leaking cracks, inappropriate welds, improper sealing, tears.

      Available with either 5μm or 1μm accuracy, select the LT-Pro Leak Tester that best meets your container testing needs using the comparison chart.

       

       

       

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      Additional Benefits

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      • Feasibility testing of new products and concepts
      • Random batch certainty testing, and even higher sensitivity testing given longer test times.
      • Customizable and intuitive HMI
      • Customizable test types, data requirements, preferred unit of measure, and test time
      • Screen layout is common across all test types, reducing the need for training and documentation
      • Fingerprint-resistant touchscreen is latex glove compatible
      • Easy Ewon connection to OPC UA/DA for remote support, assistance and troubleshooting in real-time
      • Integrated WLAN connectivity (in addition to the classic LAN connection)
      • Housing and one-piece cover designed to prevent contamination
      • Suitable for limited lab space or portable for temporary in-line or next-to-line use
      • Calibration kit included with easy-to-use instructions
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      Technology

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      • Container Closure Integrity Testing is a non-destructive measurement technology based on the following testing methods:
      • Vacuum Decay Test Method
      • Pressure Decay Test Method
      • Measurement is achieved by applying a pressure differential into an airtight testing chamber enclosing the container.
      • The test objective is to detect container leakages by measuring the reached pressure level as well as the pressure change over test time.
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      Quality Assurance

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      • Equipment test method refers to:
        • Approved industry standard "ASTM F2338-09": "Standard Test Method for Non-Destructive Detection of Leafs in Packages"
        • United States Pharmacopoeia – USP General Chapter «1207» “Packaging Integrity Evaluation”
        • EU Guidelines to GMP Medicinal Products for Human and Veterinary Use – Annex 1 “Manufacture of Sterile Medicinal Products”
        • PDA Technical Report No. 27 “Pharmaceutical Package Integrity”
        • FDA 21 CFR part 11 as well as EMA Annex 11
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