Is EU pharma ready for Braille embossing?

November 1, 2009

Pharmaceutical Technology Europe

In 2010, Braille embossing will be required on all European pharmaceutical packages. Is the industry ready?

Craig Jasper, Director of Sales for the paperboard converting equipment at Roberts PolyPro, a division of Pro Mach, discusses the obstacles facing Braille embossing on pharmaceutical packages.

Q1: In 2010, Braille embossing will be required on all European pharmaceutical packages. Can you tell us more about this?
It is a very noble cause. Yes, the number of blind people is less than 2% — and older people that become blind late in life cannot read Braille — but, try to imagine an elevator or an ATM without Braille. It has become part of the fabric of our lives in so many places and it is the right thing to do for those that need some assistance in everyday functions. Also coming up next year it is the 200th birthday anniversary of Louis Braille.

It has been mandatory since 2005 in the European Union to include Braille text on the pack of every newly approved medicine, including uncontracted forms of the drug name and its strength if more than one is made available. The regulation was expanded in 2007 and by 30 October 2010 the requirement will be applied to all products, regardless of when they were approved.

Q2: Do you think most pharmaceutical companies are prepared for this?
It's really the pharmaceutical packaging companies that need the preparation and no, most are not ready. To be fair, up until now pharmaceutical packaging suppliers have not seen a universal solution that was quick, affordable and easy to use. Most of these solutions meant either buying a full specialty gluer with a Braille embosser or integrating a third party solution into the existing gluer line.

Q3: What obstacles do pharmaceutical companies face with regards to incorporating Braille embossing on packages?
One of the biggest obstacles is the embossed characters themselves. Paperboard packages by design are flat throughout the printing and die cutting process. Most companies have begun embossing on the platen die cutter, which is a logistical mess: it is hard to keep up with all the various pieces of tooling; it is difficult to monitor the quality of the Braille dots; and, most difficult of all, the cartons have to be dispensed in the folder gluer. Dispensing in folder gluer causes serious concerns over dot quality because of scuffing and the cartons also no longer lay perfectly flat because they curl up a bit due to the extra thickness where the embossing is located. This is a huge quality concern.

Furthermore, the set-up time for Braille in the die cutter ranges from 60– 120 minutes, and the average run for most of companies is less than an hour. If you are spending most of your time setting up the Braille, then your time is not used wisely.

Additionally, many suppliers in Europe use an injection molded plastic male plate to emboss the cartons; however, one of these male dots could break off during production. Fortunately, there are now several vision detection options available to read and check every package.

Q4: How competitive is the market for suppliers of Braille embossing systems to the pharma industry?
There are about five or six Braille producing solutions that I am aware of. Of course, the Braille can be conducted prior to the gluer or off-line, but these solutions add cost. For this QA session, let's focus on in-line solutions with the gluer solutions, which are the most economically viable. In the gluer, the cartons are single stream and can be easily and continuously checked for quality. Most of the larger gluer companies offer a kit that can be purchased and added either to a new machine or a recently purchased machine. The problem, however, is that most companies already have ample gluer capacity and it seems a bit much to ask them to buy new gluers just to add Braille. feature. In addition, most of these gluer solutions offer a limited area in which Braille can be placed.

Another solution is a module that drops into the gluer just downstream of the feeder. This solution provides more flexibility on where you apply the Braille and is certainly a step in the right direction, but it is not portable and depending on what type of gluer you are integrating it can be just as expensive as a new gluer.

The solutions offered by Roberts PolyPro solution is a portable feeding system that fits in front of existing gluer lines. Embossing can be conducted anywhere on the package, and the system can be easily moved if needed elsewhere.

Q5: With different systems available for Braille embossing, what features should pharma companies be on the lookout for in particular?
Flexibility is a key feature. Forecasting the future is difficult so buy something that allows you to put the embossing anywhere on the package. You should also look for built in quality control; there are devices that can measure the dots, read the patterns and let you know when the product is either not matching the master or is out of specification.

Also, look for something that does not add labour or time to the process. Most Braille systems should be able to run as fast as your current gluers so don't buy something that will limit your production if you can avoid it.

Q6: Roberts PolyPro has recently launched its Rapid Braille Module. Can you tell us more about this system?
The Rapid Braille Module is a feeding system similar to the hundreds of feeding systems we have built in the last 30 years. It is very small and portable, and although it is vacuum based it is not as noisy as other vacuum systems. The air is moved by a simple fan, which is built into the machine to reduce noise and eliminate the need for filters. It also means that you don’t need upper belts to carry the cartons, which keeps it simple and safe.

The Braille embossing head is a servo driven rotary pair of wheels that rotate once for each carton. It embosses up to 4 lines of Braille text and 20 characters per line. The accepted Marburg Medium is used for the Braille characters and each Braille plate is made from a very simple brass or thin aluminium plate. The depth of the Braille dot can be changed easily by simply moving a lever left or right.

Next year, we plan to unveil a method of incorporating the Braille tooling plates into our machine; so if a plate breaks in the middle of the night, the operator can simply make another one [QA: Do you mean replace?].

Q7: How are traditional hurdles associated with Braille embossing overcome with the new machine?
Braille systems can often be very complicated, but our Rapid Braille Module is very simple to use; most operators know how to set up a feeder and the embossing tooling is very intuitive. Beyond that, the single stream flow of cartons in a folder gluer is just a much more controllable method of producing and checking quality than the traditional stacks of cartons coming from the die cutter. I think the system solves most of the problems described in Q4.

Q8: Will the regulation have any effect on packages imported into the EU?
Yes, absolutely — it will affect all packages even imports. Quite a few American, South American, Asian and Australian companies have already been to our plant to run and test our machine. Most are now placing orders.

Q9: Do you think the regulation will encourage countries outside of the EU to adopt a similar mandate regarding Braille embossing?
I expect it will — our customers in South America are expecting it to happen there very soon. I see it this way; if we can offer Braille now to help our blind customers, then we will be way ahead of the curve when it becomes mandatory.