Sizing Up Labels
As labels and inserts increase in size to accommodate FDAï¿½s labeling changes,
companies are exploring new ways to fold and apply them to bottles and cartons.
Kassandra Kania, Managing Editor
FDAï¿½s proposed format changes for OTC and prescription drug labeling are forcing the pharmaceutical labeling industry to face one of its biggest challenges yet—how to accommodate the increase in information without significantly increasing the size and cost of the package. According to a label study conducted by the Freedonia Group (Cleveland), a growing number of firms have turned to expanded-content labels (ECLs) to meet expanded product information requirements. In addition to providing much-needed real estate, ECLs are user-friendly and tamper-evident, and stay with the product, the study says.
Originally, the trend was to move from cartons and inserts to ECLs. However, while ECLs hold many benefits, they are not for every company. In some instances, inserts may be more practical to accommodate labeling changes.
ï¿½Some companies are promoting folding cartons with package insert usage, and thatï¿½s something thatï¿½s really new right now,ï¿½ says Ernie Chaplin, vice president of sales, marketing, and product licensing for Pharmagraphics (Greensboro, NC). The reason for this shift, he says, is that the larger package insert formats no longer fit on the bottles. ï¿½Iï¿½ve seen cases in the last month where the circular insert/outsert is larger than the bottle.
Fortunately, our efforts of internal process improvements and new folding capabilities have allowed our customers to make the regulatory changes in stride.ï¿½
Placing bulky labels on bottles can also pose a machinery challenge. However, if folded inserts are relatively small and can be incorporated into the prime label, manufacturing speeds can be increasedï¿½as much as 15ï¿½20%, says Andrew Vale, vice president and general manager, East Coast, Ampersand Label (Garden Grove, CA).
ï¿½Companies that have a moderate amount of information on a label can get away with expanded-text and booklet labels,ï¿½ says Tom Moore, president, Pharmaceutic Litho & Label Co. (Chatsworth, CA). ï¿½But when you have a lot of indications for a drug, it takes a huge insert to do that, so a lot of companies are staying with their inserts.ï¿½
Whether a company chooses an ECL or a package insert for its product labeling needs, it will likely face a similar challenge: how to successfully fold and apply a piece of paper that continues to increase in size. Here is a look at how some companies are addressing this issue.
Itï¿½s in the Fold
With the addition of a highlights section to prescription labels on the horizon, as well as the addition of patient information to the package insert, inserts are going to continue to grow in size, says Robin Henfling, president of Arlington Press (Brooklyn, NY). And with the increased size of the inserts comes an increased strain on machineryï¿½s ability to fold them. ï¿½Weï¿½ve noticed that people are requiring larger inserts and folding is becoming more and more intricate. Itï¿½s taxing the equipment,ï¿½ says Moore.
Chaplin agrees: ï¿½The larger formats of package inserts have pushed the limits of folding equipment. Youï¿½re seeing some places that are driving the requirements of folded literature and inserts to double the sizes.ï¿½
Roger B. Mattila, vice president of Vijuk Equipment (Elmhurst, IL), estimates that the labeling format changes could increase the sizes of current inserts and outserts by 20ï¿½80%. ï¿½Thatï¿½s where most of the people have a problem,ï¿½ he says. ï¿½Theyï¿½re going to expand these inserts and outserts, but they want to fold it down to the same size.ï¿½ To handle such challenges, Vijuk has developed new equipment that will allow companies to increase their inserts by 50ï¿½100% and still fold it down to the same size. ï¿½We can fold up to about 120 panels, and that will vary, depending on fold configuration as well as thickness of paper,ï¿½ says Mattila.
When applying ECLs to bottles, folding or curving can also be an issue as the size of the labels increases. ï¿½When applying a label with multiple layers to a curved surface, the diameter of the top layer should be greater than the bottom because it must travel a greater distance around the bottle,ï¿½ says Tom Miller, MultiVision product manager for Ampersand Label. ï¿½We have a patent pending process in which we precurve the labels to the bottle prior to application. If the label wasnï¿½t precurved, it would wrinkle, the edges would lift, and it could potentially jam the label applicator.ï¿½
Maps Versus Booklets
|Some companies are doing away with cartons and inserts in favor of extended content labels with booklets (photo courtesy of CCL Label).|
As regulatory information increases, placing outserts on 45- and 90-cm3 square bottles for prescription drugs is proving to be a challenge, says Miller. ï¿½A lot of ethical drugs come in square bottles, and I constantly get requests from companies looking for solutions,ï¿½ he relates. ï¿½The solution they have right now works, but it works once. Patients open it, and it folds out like a map thatï¿½s about 22 inches long. They have to be engineering geniuses to figure out how to fold it back up. Even if you can do it, the chance of the resealing mechanism working properly again is about 20%.ï¿½
Ampersand has come up with a solution using an insert bound like a book and incorporated into its EasyTab Label. The biggest concern for customers with this type of label, says Ampersandï¿½s Vale, is verification. ï¿½How do you make sure all the pages are there? Thatï¿½s the question I get asked by everybody, because theyï¿½re paranoid about leaving out a sheet.ï¿½
The outsert is folded down to the required size, explains Vale, and then three of the four sides are trimmed to make a booklet. ï¿½It starts out as one piece of paper and it never leaves the machine, so you donï¿½t have to worry about assembling multiple pages and leaving one out,ï¿½ he says.
The largest booklet the machine can accommodate is 40 pages. Vale acknowledges that in certain applications, a booklet would be too big to fit around the circumference of a bottle, in which case a folding carton and insert might be a better option.
However, there is still an incentive for companies to continue using ECLs, whether with an outsert or with a booklet. ï¿½Suddenly, companies have been told to include extra information on that package, and the initial reaction is, ï¿½Letï¿½s put it in a folding carton.ï¿½ Well, dropping everything into a folding carton increases product cost. And then you also have a problem with brand image. Youï¿½re used to seeing it in a specific bottle with a label, and now itï¿½s in a box.ï¿½ The option of using a folding carton usually doesnï¿½t appeal to companies that havenï¿½t used one in the past, says Vale.
The Challenge Printing Co. (Wallington, NJ) has noticed an increased interest in ECLs. The company recently created its MultiPly label, which is a two-layer label that increases the amount of space available for text by 300%. It is also in the process of launching its Pharmascript line of multilayer ECLs. ï¿½After conducting extensive primary research, we have concluded that ECL design will continue to gain acceptance among pharmaceutical manufacturers, albeit for specific products as opposed to entire product lines,ï¿½ says Margaret Polt, marketing manager. ï¿½We believe that the products more likely to be considered for ECL design are those that incorporate patient package inserts or have messages specifically targeted to the end-user.ï¿½ At the same time, says Polt, the company has recently seen a great deal of interest in cartons among its
customers. As a result, Challenge is entering that market.
Cartons and Inserts
For companies that decide to switch to cartons and inserts, there are products such as the Zip-Sert from Colbert Packaging (Lake Forest, IL) that can help reduce costs and increase efficiency. The Zip-Sert incorporates inserts and folding cartons into one unit, eliminating manual or automatic placement of inserts on production lines. The carton has a die-cut window that allows verification and certification of the insert in the carton while the zipper feature allows for easy access. ï¿½There are companies that are dropping inserts into the cartons by hand,ï¿½ says Jim Hamilton, executive vice president. ï¿½[Zip-Sert] solves insert placement problems, and it runs on high-speed equipment. Our goal is to have one unit come into a customerï¿½s manufacturing site, so the carton would already have the directional inserts embedded into that panel.ï¿½
Arlington Press is also developing a product called CartonSert, which places the package insert inside the carton during the manufacturing process. ï¿½The customer would get the carton, pop it open on their packaging lines, and push the product in,ï¿½ says Henfling. ï¿½The insert will be inside the carton, so they donï¿½t have to worry about handling a difficult or large piece and trying to get it into the carton.ï¿½
With products such as these and advances in labels and equipment, companies will have a variety of options to choose from when looking for the most efficient way to accommodate labeling format changes.