Braille and 'braille-ing' pharmaceutical packages

  by  greenbird_ontree 

History

Braille is a 'tactile' writing system used by the blind and visually impaired.
'Tactile' means - 'Of or relating to or proceeding from the sense of touch' - so the braille is read by the visually challenged people by touching the relief portions on a medium. This can be found in books, menu cards, signs, elevator buttons and currency.

The event that would truly transform lives of many in the future 

Braille is named after its creator, Frenchman Louis Braille, who went blind following a childhood accident in his father's workshop. Being very intelligent and diligent by nature and along with the support of his parents and teachers - he was determined to fashion a system of reading and writing that could bridge the critical gap in communication between the sighted and blind.

In 1821, Braille learned of a communication system devised by captain Charles Barbier of the French Army. Barbier had invented the system called NIGHT WRITING which was a code of dots and dashes impressed into thick paper. These impressions could be interpreted entirely by the fingers, letting soldiers share information on the battlefield without having light or needing to speak.This inspired Braille to develop a system of his own and the first edition of this was published in 1829.

His words

"We do not need pity, nor do we need to be reminded we are vulnerable. We must be treated as equals – and communication is the way this can be brought about."

BRAILLE ALPHABETS

A single braille cell

• The basic grid of a Braille alphabet character consists of six dots, in two parallel vertical lines of three dots each. From the six dots that make up the basic grid, 64 different signs can be created. 
• Reading direction of Braille is the same as for regular type and the rules for hyphenation that apply for regular fonts also apply in Braille. 
• An un-contracted Braille is one in which each individual letter of the alphabet, punctuation mark etc. is represented by its own Braille character(s).

Note 1: In order to indicate a number, the braille numbers are preceded by the braille Number Sign - this is to differentiate them from the braille alphabets A to J which share the same scripting.
For instance, if  50 mg is to be indicated, it would be as follows:

Note 2: In order to continue without space, alphabets after the numbers - the letter sign has to be included after the numbers.
For instance, if 150g is to be indicated, it would be as follows:

Sample Text:

I am Balaji and 27 years old; Daughter's name is Madhu.

Braille Conversion

(Courtesy - Translator tool of Mathisfun.com)

BRAILLE REQUIREMENTS FOR PHARMACEUTICAL LABELING AND PACKAGING

There are currently 2 global standards that lay out the regulations for including braille text on pharmaceutical packaging.

1. In EU, European Committee for Standardization (CEN) created a new standard EN 15823 'Packaging - Braille on packaging for medicinal products'. From October 2005, the 25 member states of the European Union are required to have legislation in place in conformance with the EU Directive 2001/83/EC: this requires that all products authorized after October 30 2005 carry Braille identification.
2. In North America and Canada, International Association of Diecutting and Diemaking (IADD) has created “Can-Am Braille” - a set of guidelines and recommendations for the use of Braille on pharmaceutical packaging. This is still a voluntary standard with no legislation. The standard is very similar to the European Braille standard.

Braille Compliant Font Specification:

The ECMA standard (European Carton Makers Association) ECMA Euro Braille is based upon 'The Marburg Medium format'.

ECMA Euro braille Specification

• The diameter at the base of the dot is 1.6 mm, this is also the diameter on the female matrix and the diameter of dots shown in the artwork file.
• The dot spacing is exactly 2.5 mm (from dot center to dot center).
• The character spacing amounts to 6.0 mm (from center to center).
• The line spacing is 10.0 mm with a tolerance of +0.0 mm/-0.1 mm.
• With regard to the height of the embossing on the surface of a folding carton, it is recommended that this is determined visually, since the deformed carton board is likely to recover slightly over time. The upper tolerance level is reached when the surface of the folding carton starts to burst.

• An un-contracted Braille grade should be used - here every individual letter of the alphabet, punctuation mark etc. is represented by its own Braille character(s).
• There is no capitalisation in Braille text on folding cartons.

Positioning of Braille 

• The distance between the chosen Braille embossing location and the center of the cutting and creasing lines must be 8 mm - measured from the edge of the dot. 
• Braille texts cannot be applied to locations on the carton where there are bar codes or perforations.

Amount of Braille Text

The number of available characters and lines for Braille text embossing are determined by the dimensions of the folding carton.

Based on Height (H) - the total number of braille characters are decided.
Based on A(Length) / B (Breadth) - to whichever panel it is attached to - the total number of braille lines are decided. 

Number of braille lines on the main panel

• If Dimension A/ B value is greater than 22.6 mm - Number of Braille Lines on the panel should be 1.
• If Dimension A/ B value is greater than 32.6 mm - Number of Braille Lines on the panel should be 2.
• If Dimension A/ B value is greater than 42.6 mm - Number of Braille Lines on the panel should be 3.
• If Dimension A/ B value is greater than 52.6 mm - Number of Braille Lines on the panel should be 4.

Number of braille characters per braille line

• If Dimension H value is greater than 50.1 mm - Number of Braille characters per line should be 6.
• If Dimension H value is greater than 56.1 mm - Number of Braille characters per line should be 7.
• If Dimension H value is greater than 62.1 mm - Number of Braille characters per line should be 8.
• If Dimension H value is greater than 68.1 mm - Number of Braille characters per line should be 9.
• If Dimension H value is greater than 74.1 mm - Number of Braille characters per line should be 10.
• If Dimension H value is greater than 80.1 mm - Number of Braille characters per line should be 11.
• If Dimension H value is greater than 86.1 mm - Number of Braille characters per line should be 12.
• If Dimension H value is greater than 92.1 mm - Number of Braille characters per line should be 13.
• If Dimension H value is greater than 98.1 mm - Number of Braille characters per line should be 14.
• If Dimension H value is greater than 104.1 mm - Number of Braille characters per line should be 15.
• If Dimension H value is greater than 110.1 mm - Number of Braille characters per line should be 16.
• If Dimension H value is greater than 116.1 mm - Number of Braille characters per line should be 17.
• If Dimension H value is greater than 122.1 mm - Number of Braille characters per line should be 18.
• If Dimension H value is greater than 128.1 mm - Number of Braille characters per line should be 19.
• If Dimension H value is greater than 134.1 mm - Number of Braille characters per line should be 20.

Braille Dot Height

For embossed materials, the target Braille cell dot height shall be 0.20 mm.

Conclusion

Braille has deeply influenced the lives of visually challenged people - letting them being treated with dignity in a society and empowering them. With the advent of having braille on medical packages, it becomes a life saver that can help the blind even at emergency situations. 

India is home to about one fifth of the world’s blind people, according to the World Health Organization. As European and American communities have embraced the concept of braille-enabling the pharmaceutical packages - I wish our Indian pharmacos and package design / converting community join hands together and implement the process. 

Guidelines on the labelling of pharmaceutical products

  by  Ano Lobb. @healthyrx 

This is a post that's related to my field of packaging. I have now been interacting with a company called KAROMI, who develop enterprise solutions for a variety of domain. They have now ventured into packaging domain in which they help the clients - the pharmaceutical companies - to manage their artwork and establish seamless communication channels with the graphic artwork development process for the medical products - (Here is the link to their website)

As I began to interact with these guys, I became curious in studying about what this drug - compliant artwork labelling meant. So, I have researched some common day to day pharma products and have tried presenting these data in a 'lay-man-digestible' image.

I also wish to convey here that the material below is not collected from Karomi and hence is not their endorsed opinion. It is just my 'blind' capturing of details for research storage.  


I have used a free application called XMind, to generate a mindmap (a visual representation in a map format), exported it as an image and then used the services of a free image hosting website service - FreeImageHosting.net to put up this image.

Click Here to open a detailed description about the general guidelines 

Click Here to open a detailed description about the individual drug based labeling guidelines

If there is any other pharma labeling guidelines I have missed out. feel free to add them in the comments section. It would be helpful to the community.