Sizing Up Labels

As labels and inserts increase in size to accommodate FDA�s labeling changes, 
companies are exploring new ways to fold and apply them to bottles and cartons.



Kassandra Kania, Managing Editor

FDA�s 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. 

�Some companies are promoting folding cartons with package insert usage, and that�s something that�s really new right now,� 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. �I�ve 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.� 

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 increased�as much as 15�20%, says Andrew Vale, vice president and general manager, East Coast, Ampersand Label (Garden Grove, CA). 

�Companies that have a moderate amount of information on a label can get away with expanded-text and booklet labels,� says Tom Moore, president, Pharmaceutic Litho & Label Co. (Chatsworth, CA). �But 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.�

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.

It�s 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 machinery�s ability to fold them. �We�ve noticed that people are requiring larger inserts and folding is becoming more and more intricate. It�s taxing the equipment,� says Moore.

Chaplin agrees: �The larger formats of package inserts have pushed the limits of folding equipment. You�re seeing some places that are driving the requirements of folded literature and inserts to double the sizes.�

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 20�80%. �That�s where most of the people have a problem,� he says. �They�re going to expand these inserts and outserts, but they want to fold it down to the same size.� To handle such challenges, Vijuk has developed new equipment that will allow companies to increase their inserts by 50�100% and still fold it down to the same size. �We can fold up to about 120 panels, and that will vary, depending on fold configuration as well as thickness of paper,� says Mattila.

When applying ECLs to bottles, folding or curving can also be an issue as the size of the labels increases. �When 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,� says Tom Miller, MultiVision product manager for Ampersand Label. �We have a patent pending process in which we precurve the labels to the bottle prior to application. If the label wasn�t precurved, it would wrinkle, the edges would lift, and it could potentially jam the label applicator.�

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. �A lot of ethical drugs come in square bottles, and I constantly get requests from companies looking for solutions,� he relates. �The solution they have right now works, but it works once. Patients open it, and it folds out like a map that�s 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%.�
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 Ampersand�s Vale, is verification. �How do you make sure all the pages are there? That�s the question I get asked by everybody, because they�re paranoid about leaving out a sheet.� 

The outsert is folded down to the required size, explains Vale, and then three of the four sides are trimmed to make a booklet. �It starts out as one piece of paper and it never leaves the machine, so you don�t have to worry about assembling multiple pages and leaving one out,� 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. �Suddenly, companies have been told to include extra information on that package, and the initial reaction is, �Let�s put it in a folding carton.� Well, dropping everything into a folding carton increases product cost. And then you also have a problem with brand image. You�re used to seeing it in a specific bottle with a label, and now it�s in a box.� The option of using a folding carton usually doesn�t appeal to companies that haven�t 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. �After 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,� says Margaret Polt, marketing manager. �We 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.� 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. �There are companies that are dropping inserts into the cartons by hand,� says Jim Hamilton, executive vice president. �[Zip-Sert] solves insert placement problems, and it runs on high-speed equipment. Our goal is to have one unit come into a customer�s manufacturing site, so the carton would already have the directional inserts embedded into that panel.�

Arlington Press is also developing a product called CartonSert, which places the package insert inside the carton during the manufacturing process. �The customer would get the carton, pop it open on their packaging lines, and push the product in,� says Henfling. �The insert will be inside the carton, so they don�t have to worry about handling a difficult or large piece and trying to get it into the carton.�

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. 

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