Procedures for Pharmaceutical Braille

Set procedures at the start to save costs and achieve efficient production. The aim is to set clear criteria and guidelines for :

• Standardisation of fonts
• Proper forming of Braille characters
• Standardisation of positioning
• Testing and controlling

Standard for Braille fonts

Braille Cell Dimensions

It is recommended that the Marburg Medium font specification is used for pharmaceutical packaging and labels. Marburg Medium details the size, spacing and positioning of the Braille dots. PharmaBraille fonts follow this specification.

Braille Character Sets

Braille character sets consist of letters, numbers, punctuation, symbols and special characters. Some parts of character sets are common between countries whereas other parts differ, e.g. Latin versus other alphabets and accented letters.

In the artwork creation process, the Braille character set to be used should be verified as appropriate for the country in which the medicinal product is to be supplied. The Marketing Authorization Holder (MAH) and packaging supplier must check all Braille artwork for current accuracy and relevance.

If multi-market, multilingual packs are being produced with Braille text, the correct character sets should be included and clearly identified in the artwork.

Capitalization should be avoided other than where required for trademark purposes. Trademark symbols, e.g. © ® ™, should be omitted unless required for legal purposes.

Technical standards of the Braille form

Braille legibility

It is important that the Braille dots are produced strongly enough for the blind person to identify the product. Compliance with the Braille cell dot height limits is evidence of compliance with the text legibility requirement. If the MAH does not specify compliance with the Braille cell dot height requirements then legibility testing shall be carried out in accordance with.

Braille cell dot height

In order to ensure that Braille readers can identify the name of the medicinal product, the Braille cell dot height of production samples when measured in accordance with the guidelines below at the packaging (e.g. carton or label) manufacturer's site shall be:

1. for embossed materials the target Braille cell dot height shall be 0,20 mm with not more than 5 % of Braille cell dot height measurements lower than 0,12 mm and not more than 1 % of Braille cell dot height measurements lower than 0,10 mm;
2. for other Braille production methods, e.g. screen-printed labels, the target Braille cell dot height shall be 0,20 mm, with not more than 5 % of Braille cell dot height measurements lower than 0,16 mm.

NOTE 1 The MAH and packaging manufacturer are encouraged to aim for a higher cell dot height in line with the packaging manufacturer's processes. After embossing, the formed dot is exposed to mechanical and climatic influences in the subsequent manufacturing and delivery processes. It is important to always calculate a slight back-formation.
NOTE 2 Braille dots should not compromise any printed text whether the dots are intact or are formed with a burst- through.

Braille cell dot height measurement

The number of samples and the method of measurement should be agreed between the customer and supplier before production begins. The Braille cell dot height should be measured along the Braille text in at least three places. It is recommended that random checks are carried out across all stations. Checks should also be made to ensure the readability of underlying printed text.

The Braille cell dot height can be measured using a calibrated, spring-loaded (spring-force not less than 0,5 N) micrometer with an anvil that covers at least three Braille dots in a cell. Measurement of the Braille cell dot height shall use cells containing at least three dots. Alternative methods may be used provided that they are of at least equivalent precision and accuracy.

Measurements can be performed with two decimal places and results reported to two decimal places.

standard Layout Specifications

It is necessary for the MAH and the packaging supplier to agree the Braille text to be applied, and its placement on the packaging material.

Braille can be placed on any main side of a folding carton. The ideal position from a production point of view is to have the embossing on the side next to the glue flap. However, production set-ups vary, so you should check with your manufacturer before positioning your Braille artwork.

The positioning of the Braille needs to be defined in relation to the edges of the panel on which the information will appear. It is important to clearly establish the "Braille register point"

The distance between the place for embossing and the middle of cutting an creasing lines should be 8mm from the end of the dot. The Braille must avoid areas containing barcodes or where labels/Bollini and perforations are applied.

Control of Artwork Files and Print Approvals

It is important that the print artwork and the Braille content are clearly communicated on the packaging artwork. This needs to be agreed between the MAH (or their contractor) and the packaging supplier. Once approved the artwork should not be amended unless agreed by all parties. Formats for submission of artwork containing Braille can vary in each regulatory authority.

There might be several layers of artwork to define the packaging (e.g. text and graphics, Braille, die-line, varnish, anti-counterfeiting measures). For clarity and verification, the colour used to represent the Braille text should not be used in any other place in the artwork.

The approval of the proof should confirm the Braille characters are correct. A translation of the Braille text may be reproduced outside the die-line for quality assurance purposes.

It is recommended that digital approved artwork for Braille packaging is established with separate layers in particular for separating the Braille text from the printed graphics and text.
It is recommended that a printed hardcopy for Braille packaging is established with separate pages in particular for separating the Braille text from the printed graphics and text.

In case of printed paper proofs it is recommended that the approved artwork proof should be set up as follows:

• on the first page all texts, graphic elements and die-line except for the Braille text should be presented
• on the second page only the Braille text and the die-line should be presented

Sources:

"Braille Cell Dimensions", Tiresias - Scientific and Technological Reports
"Braille on folding Cartons", European Carton Makers Association, Sept 2005
EN 15823:2010 "Packaging. Braille on packaging for medicinal products"