Regulatory Open Forum

 View Only

  • 1.  Barcode Verification

    Posted 15-Feb-2016 11:14

    We are implementing a 2D barcode on our labels for UDI compliance.  I would like to do a barcode verification to ensure we meet minimum print quality standards.  I'm having a hard time finding information on this.  A lot of sites are telling me what barcode verification is, what it measures, and that I should do it, but not really about the equipment or process.  It looks like I can purchase machines to do this, but I was kinda looking at it like a one-time thing.  Can I rent one from some place, or is there a company that comes in-house to do barcode verification?

    Thanks!

    ------------------------------
    Rene' Hardee
    Regulatory Affairs Specialist
    Sun Nuclear Corporation
    Melbourne FL
    United States
    ------------------------------


  • 2.  RE: Barcode Verification

    Posted 15-Feb-2016 16:39

    Hi Renee,

    I would suggest that you perform a simple process verification by scanning your barcodes printed at the desired size with your production printer. If you manage to read the barcode, and the output is correct, then you're good to go.

    You only need to perform the verification once for each barcode (unless you modify the barcode or change the printer during product's lifetime), thus achieving your goal of "one-time testing".

    Regards,

    ------------------------------
    Stephane Mazet
    Capsule Technologie
    Paris
    France

    Original Message


  • 3.  RE: Barcode Verification

    Posted 16-Feb-2016 08:49

    Thanks for the reply Stephane.  However, I do not wish to perform verification with only our scanners.  Barcodes have a print quality requirement that needs to be met.  HIBCC is our issuing agency for UDI, and in their Guidelines it says,

    The bar code symbol quality for an Aztec Code, Data Matrix or QR Code symbol in its final configuration shall be no lower than a C/06/660 when measured according to ISO/IEC 15415 Information technology -- Automatic identification and data capture techniques -- Bar code print quality test specification -- Two-dimensional symbols. Labelers should attempt to reach B/06/660 or better at the time of printing. Labelers should use an X-dimension of 0.015 inches (0.37 mm). Any X-dimension greater than 0.010 (0.25mm) inches is allowable if the print quality requirement is met.

    I need to know our print quality "score" to know if we can use an X-dimension less than 0.015 inches.  I am looking for a recommended service to perform this verification scoring. Do you have any recommendations?

    Thanks!

    ------------------------------
    Rene' Hardee
    Regulatory Affairs Specialist
    Sun Nuclear Corporation
    Melbourne FL
    United States

    Original Message


  • 4.  RE: Barcode Verification

    Posted 16-Feb-2016 10:43

    Where are you located? 

    I have had great experience with ValSource.

    www.valsource.com/Contact-Us

     P: 610.269.2808 | F: 610.269.4069. 918A Horseshoe Pike, Downingtown, PA 19335. 

    Hollie

    ------------------------------
    Hollie Johnson
    Director of Quality and Regulatory
    Nephros, Inc.
    River Edge, NJ
    USA
    hollie@nephros.com
    732-403-4681

    Original Message