Joining up the dots. Braille implementation in the pharmaceutical industry

Published on 15 November 2010

For a few years now, medicines legislators have sought to address the needs of the partially sighted in aiding the identification of pharmaceutical products and the communication of their contents, warnings and contra-indications. Having completed an exercise myself under blindfolded conditions it is easy to understand the  importance of the issue and the difficulties experienced by visually impaired patients – the risks of taking the wrong medicine or of not being aware of contra-indications are significant. A European Union Directive 2004/27/EC, encompassed three core requirements;

  • The availability of Patient Information Leaflets in audio form
  • The provision of Braille Patient Information Leaflets
  • Braille on outer packaging

Service providers have been established to provide PILs in audio and Braille form and Pinnaculum can manage the supply of these items for their clients. However it is in the implementation of Braille characters onto artwork and printed packaging components that we can significantly assist our clients.

Recent initiatives at National levels have sought to standardise what was a plethora of national requirements into a standard specification for Braille.  More specifically, a French labelling decree (Decree 2008-435, Article R5121-138,  6 May 2008) set the implementation pace in Europe alongside Germany and Austria, requiring that all French products (with the exception of hospital only products) should include Braille on the outer packaging with an implementation deadline of May 2009. The French market had an additional requirement, namely the use of Antoine Braille, a variant with specific ways of describing numbers.

More recently the MHRA in the UK set a deadline of October 2010 for the implementation of Braille on outer packaging marketed in the UK, again with the exception of hospital only products. Across European markets, exactly what wording should appear on the packaging in Braille varies, making knowledge of individual country requirements paramount.

The creation of artwork with Braille requires early communication with manufacturing sites and their printed component suppliers. The Braille itself is typically produced by embossing where a male Braille plate is created to the individual pack’s requirements that is ‘pushed’ into a standard female Braille plate set into the carton’s cutter guide form. Correct artwork in terms of Braille size and positioning is therefore critical in ensuring Braille characters are correct and in the right place. Braille plates are expensive so good checking procedures can prevent unforeseen costs and time delays from occurring.

Other implementation technologies are available, including Braille ‘stickers’ that create a Braille patch out of resin or another light substrate that is then stuck onto the component. The embossing of cartons though is the most typical implementation route.

Once the original artwork has been created and reviewed and having printed the carton component with the Braille characters, the final step in the quality control process is to verify that the Braille is correct. This can be achieved most effectively using Braille verification technology.

Pinnaculum have been ensuring the correct implementation of Braille in all its forms on components for a number of years. Our artwork studio is proficient in all its vagaries and our technological knowledge can assist and advise both component printers and quality functions in manufacturing sites as to the most effective solutions for ensuring the compliant implementation of Braille on a wide variety of components. If you are struggling to implement Braille on your product packaging or need an experienced voice to talk to, give us a call or post a question/comment below. We’d be only too happy to help.

Mark Wilkinson

Pinnaculum is a an end to end artwork management service provider, incorporating technology, outsourcing, consulting and creative services. We are devoted to delivering effective solutions and compliance in the pharmaceutical and life science sectors in the areas of artwork creation, design, control, and implementation. Our services address the needs of Supply Chain/QA/Regulatory Affairs and Commercial Sales and Marketing departments.

Failure to implement changes or demonstrate effective artwork control remains a major cause of product recalls and reworks for packaging and/or errors and complaints on the commercial sales and marketing side. Good artwork management practice and control & implementation systems mitigate against such outcomes. With knowledge in this field not always naturally available in many pharmaceutical and life science companies, Pinnaculum provide a range of process driven and creative services to assist clients in this specialist area.


On the 11 January at 14:38 Andy Williams said...

Great blog

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