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Originally Published PMPN April 2001

SPECIAL

A Horse of a Different Color: Animal Healthcare Packaging

The diversity of animal healthcare packaging calls for automated, flexible, and cost-efficient solutions.

Jenevieve Blair Polin, Contributing Editor

Worth about $12 billion annually worldwide not including nutritional products, the animal healthcare market represents a growth opportunity for major pharmaceutical companies. London-based Merial Ltd., the world's largest animal health product manufacturer, which was formed by the merger of the animal health businesses of Merck and Company, Inc., and Aventis S.A., has an annual R&D budget of more than $135 million. As animal health products become more diverse, the challenges of packaging them multiply.

Animal health products are not just human pharmaceuticals given to a different species of patient. The diversity of sizes in the animal kingdom, as well as the unique medical problems of various species, call for the utmost flexibility and creativity from designers of animal healthcare products and packaging.

INNOVATIVE PACKAGING

Animal health products must be administered to the most unwilling of patients. In response to this challenge, product designers have conceived unique routes of administration. For instance, Fort Dodge Animal Health (Overland Park, KS), a division of American Home Products Corp., has products for intramammary infusion or intrarumen injection in cattle, as well as products for intranasal administration via cannula or oral administration via syringe in horses and dogs. Packaging is complicated by the need to include the devices for product administration along with the product.

Quest Equine Gel (moxidectin), a Fort Dodge oral antiparasitic gel for horses, comes in prefilled oral syringes. Larry Brobst, Fort Dodge's manager of package development, was instrumental in the evolution of a second-generation package, the Sure Dial, which consists of a rotating dial attached to the syringe that meters the desired dose. Even though field testing was performed during development of the applicator, the original design of the syringe for administering Quest Equine Gel created challenges both in the production mode during filling and packaging, as well as in the field during actual usage of the product. "The self-zeroing concept that was designed into the applicator was an excellent idea, but the market was not ready for it," he adds.

Figure 1. Wellmark International's packaging path for Zodiac Fleatrol.

To fill the Sure Dial syringes, Fort Dodge installed a custom labeler and filling machine in January 2000. The syringe is labeled and fed into a bottom-up filler, where product is metered into the syringe, then cycled to the next station, where the end cap is placed on automatically. At the next station the adjustment nut is screwed down to the barrel. The syringe is then inserted in the final sales carton with a product leaflet.

Pinnacle and Bronchoshield are intranasal products for horses and dogs, respectively. Fort Dodge asked its suppliers to engineer, mold, and manufacture unique nasal cannulae for administration of these products. A company should strive to develop a user-friendly applicator that is suitable for drug delivery, Brobst says. "The veterinary pharmaceutical business is very competitive. Companies do not want competitors to use their devices or developed processes to administer their products," says Brobst.

INNOVATIVE LABELING

Pharmagraphics LLC (Itasca, IL) worked with Fort Dodge to develop a product, called the Info-Vax-ID label. Fort Dodge uses these labels on single-use vaccine vials.

The Info-Vax is a one-ply label with a portion that can be peeled away from a glass vial. The peelable portion contains the lot number, the expiration date, and the product name. "The main advantage," Brobst says, "is that the veterinarian can just peel off that portion and attach it to the patient's record. All he has to write down is the date."

"We knew the characteristics of the face stock material, which is a Primax from Fasson," says Glen Grosskopf, Pharmagraphics's vice president of product development. "And we knew that if you cut the material in the linear direction it would tear straight across. So we designed a label with the knowledge that the adhesives used could be pulled cleanly away yet still give the anchorage needed in shipping and storing."

With this development, animal healthcare products are actually ahead of human pharmaceuticals. Ernest Chaplin, Pharmagraphics's vice president of sales and marketing, says makers of human vaccines are considering similar label innovations.

COMPLIANCE PACKAGING

Another way in which animal health products packagers lead the way for human pharmaceutical packagers is compliance packaging. "Novartis was probably eight years ahead of the human side of compliance packaging," says Paul Alvater, president of PCI Contract Services Div. (Philadelphia), in reference to the packaging for Program and Sentinel flea control products.

The folding cartons for these products contain directions for use, the product on perforated blister cards, and stickers for the consumer to put on a calendar as a reminder to administer the product once a month. "Every time that a drug is not taken it is a lost sale of that item for that dosage for the pharmaceutical company," explains Don Huggins, PCI's senior vice president of sales and marketing. It is also a loss for the veterinarian, since these products are sold only through veterinarians' offices.

Capstar (Nitenpyram) tablets for flea control from Novartis Animal Health are contained in individually packaged blister packs.

The Novartis products compete aggressively with Pfizer's Revolution flea control product, but all are packaged in the same building—PCI's Philadelphia contract-packaging facility. The Novartis products are oral dosage forms, while the Pfizer products are topical solutions in tubes. Pfizer fills the tubes at its Lee Summit, KS, plant, then ships them to PCI. Uhlmann Packaging Systems Inc.'s (Towaco, NJ) three highly automated cold-form blister lines dedicated to these products incorporate robotic pick-and-place units, as well as vision systems to detect product for quality assurance. On the Pfizer line, 400 tubes per minute are sealed in blisters. The blisters are then glued onto a card, the card is inserted into a carton, and literature and date sticker cards are added.

STREAMLINE AND SIMPLIFY

Wellmark International (Schaumburg, IL) manufactures a competitive flea control product that is sold at a lower price by mass market and pet specialty stores, rather than veterinarians. Searching for a way to cut packaging costs, they developed a completely new packaging line, which came on-line in January 2001, says Roy Brown, Wellmark's manager of engineering and maintenance. Wellmark's original Zodiac Fleatrol packaging consisted of three tubes, which were sealed in a blister card and placed in a carton. The company eliminated the tubes and now forms three cavities, fills and seals them, perforates between cavities, and drops the product into the carton (see Figure 1), all in one continuous process.

The manufacturing path is reduced considerably, as well as the supply chain. Wellmark cut lead times in half, says Brown, "because we've completely removed at least two packaging components, and we've also removed several different steps in the process of getting our tubes from the vendor to us. It's an incredible savings over what we used to do."

Packaging discrete components, for instance, taking three tubes and putting them in a blister card, is labor intensive, Brown adds, "so we've achieved a tremendous labor savings as well." Furthermore, Wellmark's purchasing agents have fewer components to outsource; the warehouse has fewer parts to store and retrieve; the quality control staff is relieved of inspecting additional parts; and its reliance on vendors has been reduced.

Making this change required a leap of faith and a considerable capital investment. Wellmark purchased a custom form-fill-seal machine from Klöckner Medipak (Clearwater, FL) and a CSAT (Longmont, CO) in-line printer. The polymer forming web from Klöckner Pentaplast (Gordonsville, VA) and foil lid stock from Reynolds Metals Co. (Richmond, VA) were both new materials for Wellmark as well.

Brown credits Wellmark's suppliers—Klöckner Pentaplast, Klöckner Medipak, and Reynolds Metals—with easing the transition by doing much of the groundwork. "This is new technology for us, and we had to learn everything that we needed to know in our project window, which started a little over a year ago."

Sometimes, says Fort Dodge's Brobst, it is not cost-effective to make this technological equipment capital investment. "If you have a packaging concept that requires a unique piece of equipment, which is not already present in-house, it makes sense to look into using a contract packager to perform the operation for you. Quite often, you can get the product into the market much quicker using the contract packager," explains Brobst. Fort Dodge uses Sharp Packaging (Conshohocken, PA) for the packaging of a blister pack presentation.

One lesson Wellmark learned as they became acquainted with their new system was the importance of the shrinkage properties of the web. "Knowing how that affects registration, both the print registration as well as the sealing registration, is important, especially when you scale up from a smaller machine," Brown says. Wellmark used a smaller-format machine for much of the initial testing of the package and then scaled up to the larger Klöckner machine. "If I had it to do over again, I probably would have gone ahead and spent the money to have the tooling cut for the larger machine. Doing so would have made our start-up and validation simpler and faster. I just didn't have that luxury," says Brown.

Because the web is formable, Wellmark took the opportunity to add text features. The Zodiac brand is embossed on each individual cavity. First month, second month, and third month are also embossed on the three cavities in turn. This embossing was a challenge. "We had a fixed footprint, and getting anything to be embossed in there was a real struggle. We wanted the package to be solid and rigid, so we didn't toy around with the thickness of our package. Our options were therefore limited to experimenting with the dimensions of the characters and the fonts, which gets expensive." The depth and width of each individual character must match up to the formability of the polymer, which is affected not only by the thickness but also by the forming temperature, air pressures, and other variables. The company had to cut several different tools before it was satisfied.

Another improvement of the new line is the ability to print directly onto the foil lid stock with the in-line CSAT printer. "With an Environmental Protection Agency (EPA)–regulated product, we've got a tremendous amount of information that we need to put onto the package," Brown explains. Wellmark wanted to print everything the EPA required, including certain cautionary statements, EPA registration numbers, net contents, and directions for use, on each individual cavity, in case it was separated from the pack. "One of our main concerns was whether or not we were going to be able to hold registration printwise to the package and keep out of the perforation areas. This printer gave us the capability to print all the information very small and keep it in a tight registration window," he adds.

Wellmark's new packaging line has ample capacity to handle growing demand. The Klöckner machine can run up to 50 strokes per minute, with a web width of 200 mm. Furthermore, Brown points out, "the machine is incredibly versatile in terms of index length and draw depth. You can create cavities that are shallow like ours, about 8 mm, all the way down to 40 mm, so there are opportunities for different packaging configurations."

FLEXIBILITY

This flexibility is an essential characteristic of each piece of equipment on a line for packaging veterinary products, says Eder Bortoleto, production manager of Merial's facility in Paulinia, Brazil. "With veterinary products," he explains, "you have a lot of products, but the batches are often small." Many such products fill small market niches or are in demand only seasonally or regionally.

Bortoleto has just purchased a Moduline horizontal roller ramp labeling system from Quadrel Labeling Systems (Mentor, OH), which he will use for labeling vials of avian vaccine and some pharmaceutical products. It can label 2-, 5-, 20-, 30-, and 100-ml vials with minimal changeover.

Merial intends to reduce the size of its vials, Bortoleto reveals. "Today we have a 5-ml vial for avian vaccines. We are developing a production system with which we can have the same quantity of doses of vaccine in 1 or 1.5 ml, so that means we can decrease the size of the vials to 2 ml. When we bought this Quadrel machine, we bought all the hardware for the small vials also, so setup will be very quick and the system will be very flexible for us."

Furthermore, with the Quadrel labeler, speed will increase by 20%. "The most important thing is not the speed but rather the quality of the final product," Bortoleto explains.

Bortoleto's old labeling machine uses precut paper labels, fixed to the vials with cold glue. The Quadrel machine will not only affix labels from a roll but also includes an in-line hot-stamp printer. In the old system, a machine puts the batch number and the date of production on the labels, and then the cut, coded labels are picked up and used in the label machine. With the Quadrel machine, they will program the batch number and the production date into the in-line printer.

CONCLUSION

The mention of animal healthcare products might have once conjured up images of generic-looking pills in unmarked tiny envelopes handed out by veterinarians, or farmers hosing down their herds with industrial-strength disinfectant. Today, the animal health market encompasses a wide range of sophisticated products requiring automated, flexible, and cost-effective packaging solutions.

Copyright ©2001 Pharmaceutical & Medical Packaging News