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    Videojet - UDI printers

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    Videojet - UDI Printers

    Uploaded by

    SACHIN KUMAR

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    of 2

    Application Note

    Pharma & Medical Devices


    Technology Solutions for UDI
    Compliance

    The Challenge Unique Device Identification


    In 2013, the Federal Drug Administration Prior to UDI legislation, variable coding standards for medical device packaging had
    passed legislation mandating a Unique been largely inconsistent across the industry. This made adverse event reporting and
    Device Identification (UDI) code on most device tracking inaccurate, cumbersome, and time-consuming. A pressing concern for
    medical devices distributed in the United public health and safety, insufficient traceability could potentially cause dangerous
    States. Compliance requirements began consequences for consumers. In an effort to improve medical device traceability, the
    in September 2014. Supported by the FDA passed legislation stipulating a common set of information be conveyed throughout
    International Medical Device Regulators the supply chain. In the United States, this standard went into effect for packaging and
    Forum (IMDRF), the EU and other countries labeling of Class III (life-saving) medical devices on September 24, 2014, with a staged
    are considering similar legislation. roll-out planned for other classes of medical devices through 2018. Similar legislation is
    being considered around the world.
    The Videojet Advantage Under UDI legislation, each medical device must carry a unique device identification
    Videojet offers a range of solutions that number and production data (typically batch code, lot number, expiration date or date
    enable compliance with UDI legislation. The of manufacture). This information must be presented in two formats: human readable
    Videojet Wolke line of inkjet printers has and machine-readable. Automatic Identification & Data Capture (AIDC) typically
    been the standard for applying high quality takes the form of a linear bar code or 2D DataMatrix. Although not specified within the
    codes on medical device packaging for over legislation, the GS1 2D DataMatrix is frequently selected due to its recognition as an
    a decade. Moreover, Videojet has the largest industry standard and the space efficiency it offers on already crowded device packages.
    installed base of thermal inkjet (TIJ) printers In the example below, three GS1 Application Identifiers (AI) comprise the unique device
    in the pharmaceutical industry globally. identity: (01) Global Trade Item Number (GTIN), (10) batch code, and (17) expiry date.
    Videojet TIJ printers allow medical device
    packaging to be coded with a range of GS1-
    compliant bar codes which also comply with
    UDI legislation.

    Example of a code produced by a Wolke industrial printer


    Integrating into thermoformers
    Videojet TIJ printers are designed with integration in mind, as demonstrated by the
    numerous tested integrations with thermoformer packaging equipment. Ideally, the
    printer is positioned to print the code on the lidding web before it is heat sealed. The
    Videojet compact printer design helps enable printer placement in small footprints
    commonly afforded by most packaging equipment. A common approach is to have
    the printhead traverse across the web, coding multiple products in a single pass during
    the dwell (in between machine indexes when the web is stationary). This solution can
    drive up to four individual high-speed printheads which is ideal in that production is not
    compromised when spaced across individual rows of products to match the index rate.
    Medical Device package with Tyvek® lidding
    Benefits of a Wolke solution
    Wolke TIJ technology performs extremely well on common lidding substrates for medical
    devices, such as medical grade paper or DuPontTM 1059B and 1073B Tyvek®. Additionally, The bottom line
    the Wolke user interface provides myriad connectivity options, to support job information Preparing your line and equipment for
    from an external database as well as a hand-held bar code scanner. UDI coding requires thoughtful planning.
    TIJ printers are capable of printing at high production speeds without compromising Videojet can help you identify the ideal
    print resolution. With quick and easy cartridge changes in 15 seconds or less, as well as solution for your production line. Videojet
    maintenance requirements consisting of a simple wipe of the cartridge print array and works closely with the major OEMs to
    printhead, TIJ printers can provide extreme simplicity. Uptime is maximized through a help ensure our printers will integrate
    new print array with each cartridge change to help ensure peak performance. No wear seamlessly with your existing lines and
    parts or maintenance consumables and no calibration procedures help reduce set up and that your UDI coding process is perfectly
    maintenance time as well. suited to your business.
    Ask your Videojet representative for
    more guidance, a production line audit or
    sample testing on your substrate.

    Blue Wolke printheads


    mounted on the web of
    a thermoformer. The
    printheads move from
    right to left, coding
    multiple packages in a
    single pass.
    Job data can be sent to the printer via
    Example of a Wolke m600 advanced printer installed on a a hand-held scanner
    Multivac R145 thermoformer

    Call 800 843 3610 ©2016 Videojet Technologies Inc. — All rights reserved.
    Videojet Technologies Inc.’s policy is one of continued product improvement.
    Email [email protected] We reserve the right to alter design and/or specifications without notice.
    Du Pont is a trademark and Tyvek is a registered trademark of E.I. du Pont de Nemours and
    or visit www.videojet.com company.

    Videojet Technologies Inc. 1500 Mittel Blvd.


    Wood Dale IL 60191 / USA

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