Earlier this year, PMP News held the Webcast, “Understanding Braille Packaging Requirements. ” Speaking on current Braille standards around the world were Nosco’s Braille Implementation Advisor, Rachel Greiner, and Director of Quality, Dick Leach. Greiner and Leach examined how pharmaceutical companies can adopt quality standards that adhere to global Braille requirements.
Greiner and Leach addressed several questions during a live Q&A, and we excerpt and condense some of their answers below. To hear the entire event, please register  to view the archived event.
Q: Do Braille requirements apply to clinical supplies?
Leach: In the directive, there really is no discussion of investigational products.
Q: In terms of producing Braille on cartons, are there other technologies that do not use a die?
Greiner: Our presentation focused on an offset method with flat-bed die-cutting, which is one of the most common and economical. We also do provide on-demand digital printing for short runs that can be coupled with die-cutting in a smaller configuration number-up for cost effectiveness.
Q:What is your current method to measure Braille height?
Leach: There are several methods used in the industry. A special caliper can take actual measurements during the process as well as vision systems that can capture height and presence. As Braille becomes more readily used and potentially moves into North America, you will see more new technologies methods emerge to make it easier and quicker.
Q: Is there one type of paperboard that is better for Braille?
Leach: One type of board is not necessarily better than others. The key is to do sufficient testing to avoid breaking the surface. This involves coating considerations as well as the amount of print on the carton. Pharmaceutical manufacturers and printed packaging suppliers can get paperboard manufacturers involved to get experimentation going in support of IADD (International Association of Diecutting and Diemaking) and BANA (Braille Authority of North America) standards to maximize a paperboard’s capability for Braille.
Greiner: The method the printed packaging supplier uses to implement Braille has an effect on the performance of the dot, and it can vary.
Q:Should you use Braille to overprint lot codes over printed text?
Leach: It is not necessary to add lot codes to pharmaceutical packaging under the directive.
Q:Will emerging requirements for serialization evolve into requirements for including serial numbers in Braille?
Leach: There is nothing specific that says that will happen, but time will tell.
Q:Do you think an ISO standard will include any carton performance requirements?
Leach: I would say yes. Current guidelines are already providing information on surface breakage and advising that it may not always be a rejectable defect. You have to strike the right balance between Braille height and surface breaking. Standards will help provide a baseline for acceptance criteria. We do believe that an ISO standard could be developed to eventually satisfy all country requirements. If every country had its own requirements, it would just add cost and complexity.
Q: Is Braille required on package labels?
Leach: Folding cartons have been the primary focus.
Greiner: In the EU, if there is no outer packaging such as a carton, the Braille must be on the primary label.
Q: Could Braille become a U.S. requirement?
Greiner: There is no U.S. proposal to date. FDA did undertake a review of its policy on the needs of the visually impaired as part of the Medicare Prescription Drug Improvement and Modernization Act of 2003. A report to Congress acknowledged that changes were needed, but no action has been taken yet. Fortunately, the IADD has been proactive so we do not end up with standards in addition to those in the EU.
Q: Is rub resistance used to test Braille cracking and height?
Leach: Rub resistance tests are conducted to evaluate printing quality, and Braille is typically applied after printing. With Braille dots, raised surfaces will rub against each other. Instead of rub tests, we suggest doing line trials on the process to understand how far you can go without breaking the surface. Work with printed packaging suppliers that perform in-process testing and document those tests in-house so you can certify incoming materials.
Q: How does Nosco control registration?
Leach: Suppliers can use high-end, high-quality tooling to control registration. Nosco has gone through a lot of tooling testing to ensure proper registration.
Greiner: You could implement an overlay on the proof that aligns with copy, or you could invest in a high-end vision system. Our customers often prefer the overlay process, which provides an inspection tool for incoming materials.
Leach: Treat it like copy. Missing Braille dots, misoriented Braille, or the wrong Braille should all be considered critical defects. It puts responsibility on the printed packaging supplier to build these Acceptance Criteria and requirements into their Quality System. A supplier like Nosco can certify materials with Braille so customers do not need to create a lot of internal processes for acceptance.