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      PK-VIS In-line Automatic Visual Inspection Tester

      Pharmaceuticals

      In-line and Off-line Non-Invasive, Non-Destructive Automatic Visual Inspection (AVI) System of containers with pharmaceutical product at high production speed

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      Ampoules

      BFS

      Bottles

      Carpoules

      Vials

      Tech specifications
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      Highlights

      • High inspection solutions flexibility
      • High stability of application system and validation principles
      • Hardware and Software optimization according to customer URS
      • AVI no limited visual defects detection
      • CFR part 11 compliance and 4.0 full integration
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      PK-VIS | In-line Automatic Visual Inspection Tester Contact Us
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      Technical Features

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      • Container Application: Ampoules, BFS, Carpoules, Vials, Bottles
      • Products: Powder, Lyo, Liquid
      • Container Dimensions: Diam. 14 - 54 mm
      • Fill level: [1 - 100] ml
      • Speed: Up to 600 Cpm
      • Technology: AVI (Automatic Visual Inspection)
      • Inspection Features: Non-Invasive, Non-Destructive
      • Inspection Capabilities: Visual inspection: - Presence of Foreign Particulate Matters, - Cosmetic Defects,- False Fill Level and Product Color.
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      Additional Benefits

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      • Computer-based automated measurement system: image acquisition, processing, and decision making.
      • High resolution cameras coupled with illuminators automatically positioned so to magnify regions of interest and designed according to defect type.
      • Maximum accessibility of electrical and mechanical component for easy maintenance.
      • Connections to Active Directory and VPN router for machine remote access.
      • Validation package guarantees complete and efficient regulatory compliance.
      • Full batch control testing: fast, reliable and repeatable.
      • Testing of all nominal production line speed.
      • MES (Manufacturing Execution System connection) allows remote machine data exchange & download
      • Real time display of statistical raw data
      • Easy, quick and safe remote access
      • Easy cleaning
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      Technology

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      • It is an automated camera based measurement technology detecting visual defects, such as:
        • Presence of Foreign Particulate Matters
        • Cosmetic Defects
        • False Fill Level and Product Color
      • For each inspected container, a collection of images is acquired using high resolution video cameras under designed illumination conditions. Defects on the package are identified and/or measured by dedicated image processing algorithms and the package is classified as conforming or non-conforming with given standards.
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      Quality Assurance

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      • Equipment test method refers to:
        • United States Pharmacopeia:
          • USP General Chapter <1>: “Injections”
          • USP Gen. Chap. <790>: “Visible Particulates In Injections”
          • USP Gen. Chap. <1790>: “Visual Inspection of Injections”
        • European Pharmacopeia § 2.9.20:
          • “Particulate Contamination: Visible Particles”
          • Machines Qualification and Validation requirements stated in EU Annex 15
      • All computerized systems are designed according to ISPE GAMP 5 guidelines and to comply with FDA 21 CFR Part 11 and EU Annex 11