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    SAIL is an automated inspection laboratory that brings together CCIT, AVI, and HGA technologies in a single machine for inspecting different container types, sizes, and contents. It provides ergonomic, scientific, and objective inspection of containers like vials, ampoules, and cartridges at speeds of 50-500 containers per hour. The modular structure allows flexibility across inspection technologies that comply with various quality assurance standards for non-destructive container integrity, foreign matter, and gas level testing.

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    Product_Sheet_SAIL

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    SAIL is an automated inspection laboratory that brings together CCIT, AVI, and HGA technologies in a single machine for inspecting different container types, sizes, and contents. It provides ergonomic, scientific, and objective inspection of containers like vials, ampoules, and cartridges at speeds of 50-500 containers per hour. The modular structure allows flexibility across inspection technologies that comply with various quality assurance standards for non-destructive container integrity, foreign matter, and gas level testing.

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    © All Rights Reserved
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    5 views1 page

    Highlights: Additional Plus Technical Features

    Uploaded by

    Roberto C
    SAIL is an automated inspection laboratory that brings together CCIT, AVI, and HGA technologies in a single machine for inspecting different container types, sizes, and contents. It provides ergonomic, scientific, and objective inspection of containers like vials, ampoules, and cartridges at speeds of 50-500 containers per hour. The modular structure allows flexibility across inspection technologies that comply with various quality assurance standards for non-destructive container integrity, foreign matter, and gas level testing.

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    of 1

    SAIL

    Smart Automated Inspection Laboratory


    SAIL is an automated inspection laboratory for different
    container types, sizes, and contents bringing together
    CCIT, AVI and HGA all in one machine suitable for
    in-process, clinical trials and laboratory use.

    HIGHLIGHTS
    • All in one Industry 4.0
    based laboratory
    • Ergonomic workstation
    • Scientific and objective inspection
    • 100 % traceability
    • Time & cost saving

    TECHNICAL FEATURES ADDITIONAL PLUS


    Container Application: BFS, Vials, Ampoules, PFS, • Single operator
    Cartridges
    • Single validation & qualification procedure
    Products: Lyo, Liquid, Powder
    • Multiple inspections, containers, formats
    Container Dimensions: Ø [10 - 69] mm
    • Easy & fast evaluation thanks to real time HD display
    Speed: 50 - 500 cph (depending on configuration)
    Technology: CCIT - AVI - HGA • Automatic Container Handling

    Inspection Features: A COBOT optimizes the • New user-friendly touchscreen HMI, Android-like,
    collaborative non-destructive inspection processes 22” size adjustable panel
    Inspection Capabilities: Integrity testing; foreign • Tool-less, no format change by means of automatic
    matters, cosmetic and cap defects; Oxygen/Moisture/ adjustments and regulations
    Carbon Dioxide level, Absolute Pressure value

    TECHNOLOGY QUALITY ASSURANCE

    SAIL modular structure provides adequate flexibility • Software designed to comply with FDA 21 CFR
    upon all 3 of testing technologies: Part 11 and EU Annex 11
    - AVI (Automatic Visual Inspection)/ SAVI • Visual Testing method conforms to current
    a collection of images is acquired using high pharmaceutical regulations, such as USP – United
    resolution matrix cameras under designed States Pharmacopeia – General Chapter <790> and
    illumination conditions. European Pharmacopeia § 2.9.20
    - CCIT (Container Closure Integrity Testing) • Vacuum decay Method based on the approved
    non-destructive integrity testing in packages by industry standard ASTM F2338-09, recognised by
    Vacuum Decay Method. the FDA
    • HGA Testing method in conformity with provisions of
    - HGA (Headspace Gas Analysis)
    USP General Chapter <1207>
    inspection process is based on the Tunable
    Diode Laser Absorption Spectroscopy (TDLAS) • The Machines Qualification and Validation complies
    method which accurately quantifies gaseous with requirements stated in EU Annex 15
    concentration levels. • Machine manufacturing process and materials are
    compliant with applicable GMP requirements

    www.bonfiglioliengineering.com - info@bonfiglioliengineering.com

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