Barcode Considerations for Medical Device Labeling

Barcode Considerations for Medical Device Labeling

Barcodes labeling and packing are a critical part of the life sciences and medical devices products. However, how do you know that your barcode and packaging design surrounding it makes the grade?

The two main data carriers for barcodes are GS1 (www.gs1.org) and HIBCC (www.hibcc.org). Both not-for-profit organizations develop electronic data standards, enabling you to identify, capture and share information using consistent unique data for your products now and in the future.

AIDC (Automatic Identification and Data Capture) refers to the methods of automatically identifying objects, collecting data about them, and entering them directly into computer systems. This data can be included as machine readable formats in multiple ways including 1D (one-dimensional), 2D (two-dimensional) or contained within an RFID and each of these types of carrier can have a significant influence on the space used, readability and usability.

Barcode Quality
But once you can produce a barcode, how do you know if they’re good enough? A barcodes quality depends on Data Conformity and Print Quality. It is necessary to ensure that any barcode added to a design on any part of a product label or package meets certain quality guideline grading (from 0 to 4 or A to F depending on the standard (fig.1)).

Barcode QualityFig.1

The print quality must be 1.5 or better and is determined using:

  • ISO/IEC 15415 Bar code symbol print quality test specification – 2D Symbols
  • ISO/IEC 15416 Bar code print quality test specification – Linear Symbols
  • ISO/TR 29158 Direct Part Mark (DPM) Quality Guideline

As part of the print quality you must also consider how it is being printed. Printing barcodes on different printers and materials may influence size and quality (fig.2).

Print Quality

Fig.2

To ensure that your barcodes are of an adequate quality, here are some useful guidelines that you should bear in mind:

  • Do not print the same size barcode on printers that have different dot sizes. This is normally given as a DPI (Dots Per Inch) or DPMM (Dots Per Millimetre).
  • Printing a barcode at 300 DPI or 600 DPI is not a problem, you just use 2 dots rather than 1.
  • Printing a barcode at 300 DPI or 12 DPMM though will produce differences in the size of the barcode. If the barcode size is printed the same, then the dots or bars will be printed with inconsistent sizes which will have a detrimental effect on the barcode quality.
  • Consider the material you are printing onto (Tyvek, cardboard, Thermal Transfer, Inkjet) as this will affect print bleed. For instance, when using thermal transfer printers, you may see bleed as the head heats up and cools down at the start and end of a dot or bar and on inkjet printers the dots may shrink or swell depending on the surface it is applied to.
  • To achieve a suitable quality of print you may need to increase or decrease the bar or dot sizes based on both the printer and label.

In addition, it is no longer enough to check that a barcode is readable. The ability to read a barcode in a clean production environment with a well-maintained scanner is a very different situation to reading the barcode on a box in a busy distribution center. For this you require a Barcode Verifier rather than just a Barcode Reader. This will not only read the barcode but also give you a grading to determine whether it meets the quality required by the regulation. Some manufacturers verify the quality as part of the design and approval process then ensure that the printers produce the equivalent quality of print by following a regular maintenance and calibration plan for each printer. Other include a verification within the production process.

Whatever method you decide to take, it is recommended that verification should be built into different parts of the label design, approval and production process.

Barcode Configuration and Data Capture
The quantity of data now required to be captured for the medical device labeling means that the design will need more than one barcode. This has a significant impact when creating the packaging as there are additional requirements issued by regulating agencies that affect the ‘real-estate’ available on your label. So, what’s the best way to configure your design?

Best Practices:

  • Consider how many barcodes you use and concatenate barcodes where possible.
  • Contemplate using 2D barcode if linear barcodes are too big. Using 2D barcodes is becoming more the norm.
  • Use label design software that can easily design GS1 and HIBCC barcodes.
  • Make clear the purpose of each barcode to all users and which should be scanned.
  • Understand the full requirements dependent on agencies and regulators.

Determining the optimum size of barcode is essential. Different issuing agencies have their own specific requirements. For example, GS1’s size guide recommends for the GS1-128 barcode that the width of the symbol’s thinnest or narrow bar is 0.0485mm as well as the recommended height of 31.75mm. Whereas for the GS1-DataMatrix barcode, there are recommendations for the size of the smallest dot 0.300mm and 0.2mm for direct marking of small medical devices.

Where possible use the smallest number of barcodes. The less barcodes on the label the less confusion there is when trying to decide which one you need to scan.

Making the Grade
Finally, to help make sure that you barcode labeling and packaging makes the grade, we’ve listed these 5 simple rules:

  1. Standardize on printers/printer resolution
  2. Verify the print quality using all resolutions (DPI) used for production
  3. Integrate barcode or label verification into approval/production processes
  4. Implement a maintenance plan for all production printers
  5. Avoid using universal Label Design Software that hides resolution effects.

Contact us to discuss more about your barcode labeling needs

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Mark Cusworth

About the author

Mark Cusworth, VP Research and Development, PRISYM ID

Mark has over 15 years of experience heading up a team providing off the shelf and tailored solutions to Life Science companies. During this time, he has seen many changes to the industry including significant tightening of regulations and challenges of globalization. His primary objectives are to target the ongoing investment in research, development and quality effectively and to lead the company in-house research and development.