Section 10 | Braille

The European Union has mandated that the name of products be included in Braille on the packaging of authorized medication to aid in its identification. As part of this initiative, specific requirements have been imposed on the height and placement of Braille dots to ensure easy readability for the visually impaired.

The direct consequence of this initiative is that all companies involved in the development of packaging for pharmaceutical products need to ensure that their packaging meets compliance standards regarding Braille dots. Standardizing on best practices for Braille will help ensure that compliance is achieved and maintained.

In this section, GlobalVision describes best practices when creating Braille.

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10.1 Create a separate top layer for Braille

RISK
Braille dots may not be detected during the inspection, causing invalid translations.

ISSUES
Braille dots may be partially or completely hidden by text or artwork.

EXAMPLE

SOLUTION
Do:
✓ Create a separate layer containing the Braille dots.
✓ Ensure the Braille layer is the top-most layer.
✓ Use Adobe PDF Version 1.5 and higher.

Don’t:
✗ Place Braille dots underneath text or artwork.

TIPS
The following steps describe how to display existing layers in a PDF:

• Open a PDF in Adobe Acrobat Pro.
• Select Show/ Hide from view.
• Select Navigation Panes and click on Layers in the drop-down menu.
• View the layers in the left panel and show/ hide their contents.

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10.2 Create Braille dots with solid-filled fonts

RISK
Braille dots may not be detected during the inspection, causing invalid translations.

ISSUE
Braille dots that are not solid-filled may overlap or blend in with text, artwork, or die lines.

EXAMPLE

SOLUTION
Do:
Create an asset inventory.
✓ Create Braille dots using PharmaBraille fonts or other standard Braille fonts.
✓ Use Adobe PDF Version 1.5 and higher.

Don’t:
✗ Create Braille dots that are not solid
✗ Draw Braille dots.
✗ Outline Braille dots.

TIPS
The following options describe how to set up PharmaBraille fonts:

• Set a font size of 10 mm.
• Set the font with a leading (line spacing) of 10 mm (100%).
• See Appendix 06 Braille Cell Dimensions.

Note: 10 mm = 28.3465 pt.

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10.3 Ensure Braille dots are a unique color

RISK
Braille dots may not be detected during the inspection, causing invalid translations.

ISSUES
Braille dots in a PDF with the same color as the rest of the artwork or text may not be recognized.

EXAMPLE

SOLUTION
Do:
✓ Create a separate layer containing Braille dots.
✓ Ensure the Braille dots are a unique color.

Don’t:
✗ Create Braille dots that are the same color as the rest of the text or artwork.

TIPS
The following steps describe how to create uniquely colored Braille dots in Adobe InDesign:

• Choose a new color swatch from the Swatches panel menu.
• Choose the library file from the Color Mode list.
• Select one or more swatches from the library and click Add.
• Go to the Braille layers and apply the new color.

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10.4 Create Braille dots following the Marburg Medium
Font Standard

RISKS
Braille dots may not be detected during the inspection, causing invalid translations.

ISSUE
Braille dots that do not follow the Marburg Medium Font Standard for dot, character, word, and line spacing may not be detected.

EXAMPLE

SOLUTION
Do:
✓ Create Braille dots that adhere to the Marburg Medium Font Standard.
✓ Use PharmaBraille fonts or other standard Braille fonts.

Don’t:
✗ Create Braille dots that do not adhere to the Marburg Medium Font Standard.

TIPS
The following steps describe how to create uniquely colored Braille dots in Adobe InDesign:

• Set a font size of 10 mm.
• Set the font with a leading (line spacing) of 10 mm (100%).
• See Appendix 06 Braille Cell Dimensions.

Note: 10 mm = 28.3465 pt.

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10.5 Ensure Braille dots are created using a validated
standard font.

RISKS
Braille dots may not be detected during the inspection, causing invalid translations.

ISSUE
Braille dots in a PDF created by using a non-standard Braille font (perhaps featuring smaller spaces than are normally accepted) may cause invalid translations.>

EXAMPLE

SOLUTION
Do:
✓ Create Braille dots using PharmaBraille or other standard Braille fonts.
✓ Validate the Braille font before using it in artwork.
✓ Update marketing tools and inform the whole company.
✓ Use the Marburg Braille grid as a template to verify the dot position.

Don’t:
✗ Create Braille with a free font that does not conform to the Marburg Medium Font Standard.
✗ Create Braille using a font with an anonymous source.

TIPS
The following options describe how to set up PharmaBraille Fonts:

• Set a font size of 10 mm.
• Set the font with a leading (line spacing) of 10 mm (100%).
• See Appendix 06 Braille Cell Dimensions.

Note: 10 mm = 28.3465 pt.

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