Automation Shifts Packaging Into High Gear If you can afford it, a form-fill-seal machine could supercharge your packing process. William Leventon The manufacturer laid out the situation for Patrick Lennon: He had 50 people at 50 hand-packing stations who took two hearing protectors, put them in a bag, sealed the bag, and dropped it onto a conveyor. The conveyor carried the bags to another worker who packed them into a box. “What can you do for me?” the manufacturer asked Lennon. What Lennon did was help him automate his packaging operation. Lennon’s company, Circle Packaging Machinery Inc. (Green Bay, WI), sold the manufacturer a form-fill-seal machine that packaged 600 sets of earplugs a minute — and cut the head count on his packaging line from 50 to about five. Stories like this aren’t unusual, according to Lennon, Circle’s product manager. “There are usually huge productivity increases when you go from manual to automatic packaging,” he says. Spurred by the prospect of such increases, many medical device manufacturers are switching to form-fill-seal. Considering the switch yourself? Despite the attractions of form-fill-seal, the decision to buy a machine isn’t a no- brainer. And if you do decide to buy, there are many things you should know that will help you avoid problems and get the most of out the technology. How It Works Instead of using pre-made packages, form-fill-seal machines create packages with rollstock materials. Film is pulled into the machine, heated, and formed into cavities. At the next station, packaging personnel or machines load products into the cavities. To complete the process, a top web is pulled over the bottom, and the two parts of the package are heat-sealed together. Machines that do this are sometimes called thermoformers. Some people expand the form-fill-seal category to include pouch machines. These machines form open bags, which are then filled and sealed. When it comes to packaging speed, form-fill-seal easily beats manual processes. “It can go like a shot,” says Earl Hackett, a research associate for DuPont Tyvek’s medical packaging group (Wilmington, DE). According to Hackett, form-fill-seal can cut packaging time by 50 percent or more. Besides speeding up the packing process, form-fill-seal reduces the number of people on the packaging line, thereby cutting per-pack labor costs. The idea of faster, less labor-intensive packaging appealed to R-Group International (Gainesville, FL), which decided to use form-fill-seal to package its medical tubing sets. “We feel we can get more product volume with fewer employees,” says Darren Kahn, R-Group’s sales manager. Form-fill-seal also offers users lower material costs. “The cost of a roll is significantly less than preformed packaging per thousand square inches of packaging material,” notes Lynn Damske, vice president of sales and marketing for Hayssen Inc. (Duncan, SC), a maker of form-fill-seal machines. By eliminating pre-made containers, form-fill-seal eliminates the complications they add to the manufacturing process. “If you’re dealing with containers of any kind, you have to buy them, store them, inventory them, track them, protect them,” says Bruce Teeling, manager of form-fill-seal products at Key International Inc. (Englishtown, NJ). “With a form- fill-seal machine, you form packs as you need them. You don’t have to warehouse 100,000 pieces of a rigid container.” What’s more, you don’t have to worry about obsolescence. “If marketing says they want to give 10 or 20 percent more of something to the consumer, you’d have to redesign and refabricate these rigid pre-made containers,” Teeling notes. With form-fill-seal, by contrast, “you just go to your packaging machine and put in a set of change parts. Then you turn a few knobs, and instead of a 4 x 8 container, you make it a 5 x 8 container.” Container size often shrinks when form-fill-seal replaces manual packaging. By forming the cavity that will hold your product, “you can minimize the size of your package,” says Wilmer Caraballo, technical manager for the medical division of Multivac Inc. (Kansas City, MO), a manufacturer of form-fill-seal machines. “So you save in cartoning and shipping space. That’s one of the main advantages of form-fill-seal.” Form-fill-seal could also save floor space if you have to expand your packaging operation. “If you need to go from a million to 10 million packs a year, you’d have to hire a lot of people to do that manually, and they’d take up a lot of space,” says Ray Johnson, president of Doyen Medipharm Inc. (Lakeland, FL), which sells packaging machines to the medical industry. But if you bought the right machine, Johnson says, the same unit that’s cranking out a million packages a year can crank out 10 million a year — without the aid of additional workers. Johnson also thinks form-fill-seal offers more consistent package quality than manual methods. “Human intervention leads to human errors,” he points out. “But if you have a machine that’s fully validated and 100-percent repeatable, you’re much less likely to have any critical package defects.” Kahn is impressed with the form-fill-seal packages he’s seen. “It’s a much cleaner, neater package for some of the products we make,” he says. Downsides But those clean, neat packages come at hefty price — $250,000 or so. Form-fill-seal machines “are very expensive pieces of hardware,” Hackett notes. As such, they make financial sense only for high-volume packaging operations, where savings in material and labor costs will allow purchasers to recoup their investment fairly quickly. According to Johnson, most manufacturers won’t buy a form-fill-seal machine unless they expect a payback in two years or less. A machine packaging millions of units a year usually pays for itself in that time, he claims. The price of a form-fill-seal machine depends on the extent to which it automates the packaging process. Some machines, for example, require manual loading, while others are well-suited for automatic loading. “All the machine types could be highly automated or highly manual,” Johnson says. “More automation drives the price up.” And the financial hit is immediate. Before the machine is even delivered, buyers usually have to put down a 50- percent deposit. To lessen the financial strain, some sellers offer leasing arrangements with an option to buy the machine at the end of the lease. There are other downsides to form-fill-seal besides high upfront costs. According to Caraballo, it can’t handle rigid films as well as processes that produce preformed trays. As a result, he says, the material distribution and overall quality of preformed trays are better than anything form-fill-seal can deliver, though new form-fill-seal technology is closing the gap. For Damske, the main disadvantage of form-fill-seal is “the limited number of packaging styles you’re stuck with.” You may be out of luck, he says “if you want  a different style of package — for shelf presence, easy reclosability, easy opening, or whatever the reason.” If for no other reason, cost alone certainly justifies caution when deciding whether to buy a form-fill-seal machine. For those who aren’t quite ready to take the plunge, there’s another option to consider: contract packaging. Sometimes, says Johnson, a small manufacturer whose budget is too tight for a form-fill-seal machine will turn to a contract packager in the hope that his production volume will eventually increase to the point where he can afford to bring his packaging operation in-house. There are other reasons to opt for contract packagers. For example, a manufacturer who’s introducing a new product might not want to take the financial risk of immediately buying an expensive machine to package it. “What if you buy all this [form-fill-seal] equipment and the product bombs? Now what do you do with this equipment?” says Teeling. “So instead, you go to a contract packager to minimize your exposure for the project.” Despite the possible advantages, Teeling says some manufacturers will never go contracting. “They want to make the product in their house, and they want to package the product in their house. They don’t want anybody outside of their approved people touching the product.” Automation Considerations For manufacturers who decide to tackle automated packaging themselves, there are many things to consider. First and foremost, they have to figure out what packaging material to use. Film that’s drawn into a machine will thin out considerably, according to Hackett. “You might start out with a 7-mil-thick polymer, but if you have a really deep draw, you might have 1½ or 2 mils left in the corner, so it really thins out,” he says. “The corners are the weakest spot. You have to make sure they’re strong enough to withstand whatever impacts and loads you put on them during shipping.” To prevent packages from being punctured in the corners, Hackett recommends three courses of action. Manufacturers can (1) use more of a less expensive material that thins out fairly quickly, (2) use less of a more expensive material that does a better job of maintaining its thickness, or (3) use a thin layer of expensive material that’ s sandwiched between two layers of less expensive material. What about the material you used in your manual packaging process? For a variety of reasons, it may not be suitable for a packaging machine. For example, if your pouch material can’t be melted, it can’t be used in a thermoformer. “That means you have to go through a whole FDA approval process again when you go to an automated machine,” Johnson says. Besides changing your materials, form-fill-seal will change your labor force. “You’re going to have fewer people handling products and more people monitoring processes,” says Lennon. “You’re going to lose head count because of the loss of manual labor. The head count that remains will be more highly skilled and better trained.” Repair and maintenance skills are crucial to the success of automated packaging operations. “Packaging machines need to be adjusted, calibrated, and maintained on a regular basis or they’re not going to produce good-quality packages,” Johnson says. “Although the machines are very intelligent, no machine is smart enough to maintain itself.” Another consideration for those switching to automated packaging is the equipment that will interact with the form-fill- seal machine. Though tempting, it may not be wise to link your new form-fill-seal machine to automated feeders and cartoners right away. “People love that when their volumes are big and it works right, but when it doesn’t work right it’s a major headache,” says Johnson, who advises manufacturers to use manual feeding and cartoning until their labor force has digested the new technology. Since they carry such a hefty price tag, form-fill-seal machines should meet your packaging needs for many years. But they may not if you don’t take a good look ahead before you buy. When Garden State Nutritionals (West Caldwell, NJ) was shopping for a form-fill-seal machine, the company’s top priority was diversity. “We had to make sure that we had something that could handle everything that was requested of us,” says Bill Howard, the company’s manager of packaging technology. Now, though, Howard gets requests that his packaging machine is having trouble handling. “If we had predicted this three years ago, perhaps we would have stepped up to a larger, more diverse machine,” he says. The lesson? “You have to roll with the punches of the industry. If your machine can’t do that, you’re going to end up getting duplicate machines. So try to plan for what you think the future may hold.” This article appeared in Pharmaceutical & Medical Packaging News.