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Joining up the dots. Braille implementation in the pharmaceutical industry

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.

Posted by Mark Wilkinson

Filed in Braille,

1 comments

Packaging error driven product recalls in the pharma industry

Product Recalls
packaging errors remain the largest cause of product recallsIt is well known that product packaging errors remain a significant cause of product recalls through non compliant implementation or labelling errors. Poor labelling design also contributes to a large number of prescribing errors by pharmacists. Both these problems can have a detrimental effect on your company’s reputation, your bottom line and indeed the patient.

Meeting the challenge
Addressing these issues along with the full gamut of associated requirements and challenges in the most efficient and compliant manner is paramount to most companies. Unfortunately, packaging design and artwork management are not natural skill sets found in the pharmaceutical & life sciences industries, which is the reason why more and more companies turn to industry experts for the design and artwork management of their product packaging.

Experience
Understanding and meeting the pack management needs of the pharmaceutical sector and reducing labelling driven product recalls has always been Pinnaculum’s mission. Pinnaculum are specialists in this area with over 20 years experience in assisting global top five through to small pharmaceutical companies in creating and managing their printed packaging components.

Best in class solutions
We seek best in class solutions in terms of economy, speed and quality. Our disciplined approach and expertise helps bring new products to market quicker and labelling change implementation compliance. Our quality driven processes and methodologies prevent labelling driven product recalls and the impact they can bring to pharmaceutical companies and their reputation.

CALL US TODAY +44 (0)1438 791113We can help
Whether you are looking for assistance in improving your own internal systems or are looking for a full third-party service, talk to us today to see how Pinnaculum could become your partner of choice and deliver financial and quality benefits, giving you peace of mind in this specialist area whilst allowing you to focus on your core business.

Posted by Mark Wilkinson

Filed in product recalls, labelling design, packaging errors,

2 comments