New Braille Tools Emerge
Cortegra offers cartons embossed using an uncontracted Braille system.
Two new Braille technologies help packagers comply with impending European Union legislation. One creates code, while the other makes sure it meets quality standards. According to European Directive 2001/83/EC Article 56a, drugs will be required to repeat label information in Braille for sight-impaired customers.
Cortegra (Parsippany, NJ) has met customer demand for Braille labeling compliance by creating embossed cartons. “Inquiries have been driven by the increasing awareness in the EU and the standards and regulations developed for Braille requiring packaging products to have product names in Braille in October 2010,” says Narendra Srivatsa, business development manager. These questions spurred Cortegra to begin manufacturing cartons with an uncontracted Braille system, which refers to Braille printed or embossed individually, instead of in a chain.
“Because the EU requires drug names to be spelled out, the uncontracted system becomes a natural fit,” Srivatsa explains. In an uncontracted system the word “and,” for example, would be spelled out using three sets of characters, but in a contracted system, one character.
Cortegra uses special tooling to emboss the cartons. “It is a high-precision operation because without the precise application, you could end up either ripping the cartons, creating unwanted rejects, or end up with the Braille characters being ineffective—creating a product that the customer has no value for,” says Srivatsa. “Carton positioning, pressure, and other factors play an important role here.”
Mandated labeling laws have led another company to create a quality control solution specifically designed for measuring Braille dot height. Global Vision (Montreal) will soon introduce BraillePoint, a measurement tool to accurately measure Braille dot height and ensure readability.
Braille height is a concern, but there is no consensus on a target height. According to standardization body Euro Braille Standard of the European Computer Manufacturers Association (ECMA; Geneva): “The Braille dot height was, is, and will be one of the key issues in the discussions about the Braille standard.”
Because Braille heights are typically under one millimeter, they are difficult to manually inspect for accuracy.
Says Global Vision COO David Perlis: “It is difficult to ensure the complete accuracy of all Braille on packaging.” BraillePoint will provide a correct, consistent measurement of tactility, Perlis says.
The Global Vision system facilitates proper compliance by detecting expected dot heights and tolerance levels based on specific quality standards set by users. BraillePoint can alert users, via a computer interface, to any dots outside this range and guarantee accurate Braille readability. The system also meets EMEA and FDA 21 CFR Part 11 requirements.
Braille wording for the medicine name, formulation, and strength must be included in addition to printed words. After drug approval, a three- to six-month period is all that stands before the text must be added on the package. Medicine created prior to the rule, and all imports have until October 30, 2010, to comply with the Braille law.
Braille cannot interfere with any mechanism that would read the packaging. The code must be on the secondary packaging, but is not required on primary packages.