Access all areas – braille on packaging
The needs of partially sighted and blind people are being heard. By October 2010, the majority of secondary medicinal packaging in the EU is set to become more accessible by accommodating braille. Getting the process right, however, has taken six long years. Rupal Mehta investigates
Heading up a working group requires a clear agenda and strong management to keep all parties on track. When there are over 40 people from 15 European countries, speaking different languages and coming at the issue from conflicting viewpoints, it’s hard work, requiring a firm hand with a reconciliatory approach.
The CEN (European Committee for Standardization) group that is creating a standard for braille on medicinal packaging is ‘an unusually big working group, it is extraordinary’, says its Chair, Dieter Moessner, of packaging printers Edelmann in Heidenheim, Germany. The group comprises representatives from across Europe from associations for the blind, the pharmaceutical industry, and carton and label makers.
The committee, set up in 2006, aims to help packaging and printing suppliers, and their pharmaceutical customers, comply with a European Directive passed in 2004. The Directive places responsibility on market authorisation holders of medicinal products to print the product name and strength in braille on the secondary packaging (usually a carton), or on a label affixed to the primary pack.
Some pharmaceutical companies already apply braille on their packs, and, in Italy, it has been a legal requirement since 1998. However, this is the first pan-European legislation, and, by October 2010, such products must comply.
‘The Directive said, “put braille on pharmaceutical packaging”. [But] the European Commission produced a high level guidance document, which indicated the braille requirements not the height,’ explains Tony Harper, Chairman of the British Standards Institution (BSI) Braille Panel and member of the CEN working group. ‘There was also a proposal to put out a guidance document referring to the 0.45mm dot height, as achieved for books, but this is not achievable for pharmaceutical packaging materials.’
The BSI panel and, subsequently, the CEN group have since sought a more practical solution to the dichotomy between packaging industry capabilities and the requirements of braille users. Meeting heightened consumer and legislative demand without breaking the bank is vital, but it is not an easy balancing act.
Give and take
The scientific basis for the CEN standard, which is awaiting its final vote from the committee, comes from research commissioned to the University of Birmingham, UK, into Braille dot elevation on pharmaceutical products.
‘There is a lot of will in these industries to make this happen, but working across such diverse sectors made it challenging to resolve,’ admits Dr Sarah Morley Wilkins of the UK Royal National Institute of Blind People (RNIB). A participant in both the BSI and CEN groups, she was involved in the work at Birmingham.
Morley Wilkins says, ‘I was quite surprised at the volume and speed of carton production – it is out of this world. You start to appreciate that it is not the same process as producing braille books and magazines and we have taken that into account. We cannot get carton manufacturers to achieve what we would ideally like, but equally, they also need to understand that there is no point putting braille on if no-one can read it. The end user will think that the service provider does not care about them’.
The research at Birmingham has confirmed to the packaging industry that the braille dot height does not need to be as high as 0.45mm for readability. The CEN group now stipulates that on cartons the target height should be 0.2mm, with no more than five per cent of measurements below 0.12mm and no more than one per cent under 0.1mm. This recognises that the plant cannot guarantee all dots are the same height, but should ensure the majority hit the target.
For screen-printed labels, the target height is also 0.2mm, but with no more than five per cent smaller than 0.16mm. The more stringent requirements are because the label printing process is ‘slower and more controlled’, explains Morley Wilkins.
Dot to dot
The height specifications were reached after user trials with 45 consumers, from 15 to 77 years, and with varying levels of experience of reading braille.
‘Braille users range from someone who has newly lost their sight and just learnt the alphabet, so they can read a label but not a book, to people who have used braille all their lives,’ explains Morley Wilkins.
She adds, ‘Older blind people also have less sensitivity in their fingers, especially if they are diabetic, and it’s harder for them to read “poor” braille. So we have got the whole spectrum [and] we had to protect the needs of older people too. The older population is growing exponentially and are more likely to be taking a battery of drugs’. The aim is to ensure that most braille users can read the packet.
The CEN group therefore advises that braille labels are positioned vertically down a bottle instead of around the curve. While matt labels were found to be easier to read than their glossy counterparts, and Braille on boxes is more accessible than on bottles.
‘It is to do with the friction against the finger and being able to feel the dots,’ describes Morley Wilkins. ‘You need some resistance to read braille, but you don’t need too much or too little, otherwise it is hard work for the fingers to read the dots.’
Taking the research back into business and onto the factory floor, however, is no small feat, with a capital and time investment required to review the entire work schedule and implement change cost effectively.
This involves making strategic decisions, such as choosing between embossing the braille on the carton during cut and creasing, or opting to apply it at the gluing stage using a rotary embosser. While for labels, is digital or screen-printing the best option?
Duncan Robinson, Founder of Pillbox Design, based in Sileby, UK, consults companies on implementing braille into their production line. He says, ‘People are coming to terms with what they have to do and assessing the cost and who’s paying for it. The pharma companies might say to packaging suppliers, “if you are buying [the rotary embosser] for your gluer, then we are prepared to pay for some of the costs’.
Having worked on the Birmingham investigation, Robinson notes, ‘The challenge [in cartons] is to have decent dot height while not damaging the printed text’.
This is because the height stipulated may result in some ‘burst through’, depending on the material thickness and printing controls. If the braille is placed over printed text, the cracking could affect legibility for sighted or partially sighted non-braille readers.
Ideally, designers should aim to position braille on a blank area, but as that may not be possible on small packs, the team at Birmingham has also tested the dots on different colours. A dot burst on a dark background is more obvious and aesthetically displeasing, while, on a light background, the impact is not so visible. ‘Good design and placing is key,’ says Morley Wilkins. Braille cannot be applied where there are barcodes, labels or perforations on the carton.
For cost effective results, the standard suggests that the artwork from the pharmaceutical client must place the braille in line with the supplier’s tooling, clearly indicating where it must go in a different colour for ease of use by machinery operators.
By applying a manual micrometer (until something of equal accuracy is proven), operators must then measure and validate the height of the braille at various points in production – how often this occurs can be agreed between the supplier and the customer. Robinson insists, however, that ‘if you have a validated process which can guarantee to achieve a particular braille height, you don’t need to measure the height too often. That's where the dot shape and tooling needs to develop to guarantee that 95% of dots are above 0.12mm’.
This is particularly pertinent as research has revealed that the dot heights do relax post-production. When validating the process, measurements should therefore be taken a few weeks after to ensure that the braille is still legible when the pack leaves the premises. If the braille is poor, the dots can be flicked off or get squashed.
Harper cautions, however, ‘The standard is written to refer to carton production not the subsequent use. We can only control what we can control’. Packagers, retailers and distributors have a responsibility to protect the braille further down the supply chain.
Morley Wilkins believes, ‘The pharma standard has trailblazed for other industries. The methodology and the level of engagement is a useful benchmark’.
Yet increasing environmental considerations to downsize packaging are already conflicting with consumer demand for more information on packs – space is a commodity. The European Carton Makers Association argues that extending the legislation on Braille to consumer goods is impractical and unnecessary.
Its position paper notes, ‘When considering the relatively limited proportion of braille readers amongst the blind and visually impaired, the technical development of new media solutions… and the comparably high costs for [fabricating] braille, marking braille on consumer good and food packs will bear…little or no value’.
Recognising the space constraints, the European associations for blind people are already trying to harmonise the different braille codes to make it easier to supply medicinal packs across the European market.
The RNIB also aims to increase accessibility by exploiting research into RFID, interactive packaging and embedded barcodes. Morley Wilkins says, ‘Looking to future solutions to benefit all consumers is our next big mission. We have to remember we have real people whose lives are being affected by these products – we all want the same thing, for people to buy things and be able to use them’.
Further information: RNIB