A touch quicker

EC Directive 2004/27/CE requires Braille labelling and information to be provided with pharmaceutical products for human use, and EC firms are scrambling to implement it.

The Braille system enables blind or partially sighted people to read using the sense of touch, providing a valuable tool for independent living. The embossed dots represent letters and numbers. The basic Braille unit is composed of six dots, two columns across and three rows down. Letters are represented by certain dots that are embossed and the others left blank. Braille characters require a fairly large, defined area on the packaging so descriptions are typically very brief. From a design perspective, Braille characters should not detract from the packaging visuals that are seen by sighted consumers or alter established corporate design guidelines.

Taming regulatory technicalities

The new Braille requirements are just ‘the tip of the iceberg’ in terms of the complex regulatory requirements that pharmaceutical firms, packaging firms and print suppliers must contend with. “There are very tight constraints governing the use and description of pharmaceuticals. Examination by regulatory groups requires packaging to conform to stringent requirements,” explains Jan De Roeck, Marketing Director Software Packaging at Esko-Graphics. “Correct copy placement – and text itself – is only the start. And all of these rules differ from one country to the next.”

These demanding criteria require that pharmaceutical brand owners go beyond setting deadlines, cost and quality targets: they must actively participate in the project management, revision and approval processes.

In this context, the real challenge of adding Braille text isn’t the mechanics of adding relief dots. It is having a flexible and efficient workflow in place to streamline the internal processes in order to quickly and effectively comply with this new regulation. “With its integrated CAD and Graphics workflow, Esko-Graphics Scope workflow environment leads the way for trade shops and converters to rapidly and cost-effectively meet this EC directive,” states Jan De Roeck.

Scope covers a wide range of functions, from job and product specification, through graphic and structural design and expert pre-production operations. The Scope architecture decisively builds onto broadly accepted industry data standards, such as PDF for graphics. Scope’s workflow and asset management servers are fully JDF-enabled for flexible integration with other pre-production and business systems.

Working smarter

Having the right distributed collaborative workflow in places enables products to be supplied faster and cost-effectively. When there is a new packaging requirement, such as the case with Braille, it can be easily integrated into the existing workflow process. A streamlined and flexible process also significantly reduces costs by organising the packaging and labelling for multiple markets.

Scope offers solid support to ensure that pharmaceutical products meet regulatory compliance for packaging. Scope’s SmartMarks and DesignWizard drive the risk for human error out of the process by linking the graphic design with crucial job information.

SmartMarks, for example, prints control strips, automatically adjusted to changes in the job. SmartNames allows Scope production software to link to a database using SQL queries. With DesignWizard, label design templates tie content to a location in a secure database. Information may include brand logos, product variations such as languages, legal notifications and safety warnings and barcodes.

Only the persons responsible enter information. No one spends time searching for files, because the required information is automatically tagged in a database. There are no out-of-date instructions, because information is polled in real time, each and every time the package design artwork is developed.

Cost-efficient (re-)use of dies

Does Braille increase the overall packaging cost? Not if it is implemented into the existing workflow, and the Braille is added at the same time that the carton blanks are cut and scored. Re-using dies is also a useful cost-saver.

Jan De Roeck further elaborates: “Adding Braille is technically not difficult, it’s just another element in the set of die-shapes. The die is probably the most expensive ‘consumable’ in carton production. Converters will try to re-use die-shapes for multiple products. The various cartons may have different graphics, but for the structural part, they are identical. Re-using dies for multiple cartons is very cost efficient.”

However one consideration when re-using dies for Braille is that the embossing elements specific to the Braille text need to be stripped off the die when it is used for another carton with a different product name.

By using Scope’s integrated ArtiosCAD plug-in for Adobe Illustrator, the Braille text can be copied directly in register into the die-shape. Whatever changes the structural designer makes, the graphic designer is always sure to work with the correct version of the die. The graphic designer can also use the rich content of the die-shape to get a 3D preview of the work, eliminating communication errors and reducing design review cycles.

Error reduction for overall savings

Scope’s workflow automation capabilities offer important savings via error reduction. Esko-Graphics views automation as a way to create data once, and transfer it to workflow applications throughout the supply chain from a common database. Thus, Scope reduces the risk for costly operator errors throughout the workflow.

For example, Scope can import ‘work slip’ information about the Braille text from a Management Information System (MIS) and automatically create a related job folder on the pre-production server. Scope uses JDF as the communication protocol for this type of system interface. (Esko-Graphics is an active developer of JDF. It holds the chair in the packaging and labels subcommittee, as well as the co-chair in the prepress subcommittee of CIP4). The MIS system feeds production critical parameters such as the ingredients or ‘use’ Braille copy to the pre-press server database. Operators no longer need to re-key important job specifications, thus effectively reducing the risk for human error in the workflow.

Every graphical task that the Scope BackStage server executes can be driven with a JDF ticket. For example, MIS could request a ‘PDF preview’ of a package that contains the new Braille text for a customer.

Ensuring efficiency and peace of mind

What is the potential cost of incorrect Braille instructions on a drug product? This is every pharmaceutical firm’s worst nightmare. Scope increases efficiency while reducing risks due to error, miscommunication or inaccurate information. Jan De Roeck concludes: “The modularity and open architecture of Scope configurations, guaranteed by the use of broadly accepted industry data standards, ensure problem-free compliance with the Braille requirement. Scope is well-positioned to grow with the ever-evolving packaging needs in the pharmaceutical sector.”