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  • Product Sheet PK-VG 0719 Hires

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    Roberto C
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    This document describes a non-invasive, non-destructive in-line integrity inspection system that tests flexible food and pharmaceutical packaging at high production speeds. The system uses container closure integrity testing (CCIT) based on vacuum decay methods to detect microleaks without damaging containers. It can test various types and sizes of non-standing food packaging as well as all pharmaceutical containers placed in dedicated pucks, and operates at speeds up to 220 containers per minute. The system offers features such as automatic drying of pucks to prevent contamination, batch control testing, and integration with manufacturing execution systems.

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    Product Sheet Pk-Vg 0719 Hires

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    This document describes a non-invasive, non-destructive in-line integrity inspection system that tests flexible food and pharmaceutical packaging at high production speeds. The system uses container closure integrity testing (CCIT) based on vacuum decay methods to detect microleaks without damaging containers. It can test various types and sizes of non-standing food packaging as well as all pharmaceutical containers placed in dedicated pucks, and operates at speeds up to 220 containers per minute. The system offers features such as automatic drying of pucks to prevent contamination, batch control testing, and integration with manufacturing execution systems.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    9 views1 page

    Product Sheet PK-VG 0719 Hires

    Uploaded by

    Roberto C
    This document describes a non-invasive, non-destructive in-line integrity inspection system that tests flexible food and pharmaceutical packaging at high production speeds. The system uses container closure integrity testing (CCIT) based on vacuum decay methods to detect microleaks without damaging containers. It can test various types and sizes of non-standing food packaging as well as all pharmaceutical containers placed in dedicated pucks, and operates at speeds up to 220 containers per minute. The system offers features such as automatic drying of pucks to prevent contamination, batch control testing, and integration with manufacturing execution systems.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 1

    PK-VG

    In-line not-standing F&B containers and


    Pharmaceutical on-pucks Tester
    Non-Invasive, Non-Destructive, 100 % in-Line Integrity Inspection
    System Testing at high production speed for not standing F&B
    containers (such as Bags , Pouches, Doypack, Flow packs) and for
    all pharmaceutical containers, tested into dedicated Pucks.

    HIGHLIGHTS
    • Autotest in real time
    • Easy to validate
    • CFR 21 part 11 compliance and
    4.0 full integration
    • Quick format changeover
    • High flexibility of containers to be tested
    • Automatic Drying System, no pucks
    contamination (for pharmaceutical
    containers only)

    TECHNICAL FEATURES ADDITIONAL PLUS


    Container Application: Not standing F&B containers • Full batch control testing: fast, reliable and repeatable
    (such as Bags, Pouches, Doypack, Flow Packs) and all • Testing of all nominal production line speed
    pharmaceutical containers tested into dedicated pucks
    • MES (Manufacturing Execution System connection)
    Products: Semi-solid, Powder, Lyo, Liquid allows remote machine data exchange & download
    Container Dimensions: Up to 50 x 80 x 120 mm • Statistical Process Control reduces deviations for a
    better yield control
    Speed: Up to 220 cpm
    • Real time display of testing cycle diagrams,
    Technology: CCIT statistical raw data
    Inspection Features: Non-Invasive, Non-Destructive • Easy, quick and safe remote access
    CCIT based on Vacuum Decay Method • AHE (Automatic Head Exclusion)
    Inspection Capabilities: Microleaks detection • Easy cleaning

    TECHNOLOGY QUALITY ASSURANCE

    Container Closure Integrity Testing is a non- Equipment test method refers to:
    destructive measurement technology based on
    • Approved industry standard “ASTM F2338-09”:
    Vacuum Decay Method.
    “Standard Test Method for Non-Destructive
    Measurement system comprises applying a pressure Detection of Leaks in Packages”
    differential into an airtight testing group enclosing
    • FDA 21 CFR part 11 as well as EMA Annex 11
    the container.
    For pharmaceutical containers only:
    The test objective is to detect container leakages by
    measuring the reached vacuum level as well as the • United States Pharmacopoeia – USP General
    vacuum change over test time. 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”

    www.bonfiglioliengineering.com - info@bonfiglioliengineering.com

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