Medical Device Link.

Pharmaceutical and Medical Packaging News Magazine
PMPN Article Index

Originally Published September 1999

MEDICAL

In-Line Printing Increases Flexibility

Is adding a printer to a form-fill-seal machine beneficial for your company?

by Annie Gorton, Managing Editor

The increasing pressure on medical device manufacturers to lower costs causes them to look closely at their production lines and forms of packaging. As a result, many companies have brought the packaging process in-house by installing form-fill-seal lines. The next step toward further savings may be to bring printing in-house as well, by printing in-line rather than using preprinted materials.

A 460-SI ink-jet printer from Willett America Inc. (Fort Worth, TX) mounted on the MT2500 thermoformer from Doyen Medipharm (Lakeland, FL) allows the machine to print lid stock in-line cost-effectively.The FlexPrint flexographic printer from Bell-Mark (Pine Brook, NJ) prints lid stock in-line on Multivac's (Kansas City, MO) R330 form-fill-seal machine.

Each situation must be evaluated individually to determine whether adding a printing system to a form-fill-seal machine is cost-effective. In addition, once a company decides to print in-house, its packaging department must decide which printing system is best for the company.

There are no quick ways to make these decisions, especially because, when it comes to in-line printing on form-fill-seal machines, customization is the name of the game. Every medical device company has different needs, which means every system is different.

Ray Johnson, president of Doyen Medipharm (Lakeland, FL), says: "No two machines look the same in the medical industry. Each application is very much customized. The typical medical device company buys one machine at a time and keeps it for 15 years or more. It needs to be a very flexible machine that can be adapted to changes in product and packaging over the life of the machine."

Form-fill-seal machines and the printers that work with them have evolved as printing needs have changed over time. "In the 1980s, some companies brought all printing in-house for off-line production of printed materials. However, they often found that they could not be as efficient as outside print shops, so they began buying preprinted materials again," says Johnson. "Now, with the progressive development of on-line printer technology for high-quality print with rapid changeover, on-line printing can be very efficient and cost justifiable." With that in mind, manufacturers of form-fill-seal machines can install printers that are especially designed for a particular application and that are easy to use.

"A preprinted top web is acceptable when lines are dedicated and there are no print label or product changes," says Tom Pugh, vice president of Bell-Mark (Pine Brook, NJ). "Anytime there is more than one product changeover, having an in-line printer is good."

CONSIDERING THE CHANGE

Many companies, especially smaller ones, can save money by bringing a printing system in-house, especially when a company has already brought its package-forming operations in-house.

When considering whether to choose in-line printing, most medical device manufacturers want to know how a printing system will work with the form-fill-seal machine. "While most packagers tend to address technical issues first, they should think economically first," says Joe Martin, general manager, medical division, at Multivac (Kansas City, MO). After all, cost savings is the primary reason manufacturers consider switching to in-line printing. "Companies need to decide whether it's better to buy preprinted lid stock or to purchase a printer on a form-fill-seal machine in terms of return on investment," Martin adds. "Technical issues can be complex and time-consuming to resolve, but the economic decision can be reached in a few days. Once you justify the investment, then go on to the technical issues."

One thing to keep in mind, says Pugh, is that "most printers pay for themselves in a year."

Also, consider what your needs are, not only now, but "5 to 10 years in the future," says John Soporowski, pharmaceutical sales manager at Klöckner Medipak (Clearwater, FL).

More than anything else, the cost of preprinted materials may be the determining factor in making the decision. For some manufacturers, the cost of using preprinted materials may be prohibitive when setup charges and minimums apply. "The decision to print in-house is driven by cost savings," says Fran Ventura, medical product manager at Tiromat Medical Packaging Inc. (Avon, MA). "If a company has been using preprinted rollstock and product sales increase to the point where the company has to inventory several kinds of printed rollstock, that situation may no longer be cost-effective. By printing in-house, the company can stock one blank type of lidding material and print in-line."

ADVANTAGES

The main advantage of printing in-line over using preprinted lid stock is that it costs less. "There can be tremendous savings," says John Rochon, vice president of Greydon Inc. (York, PA).

Bruce Teeling, product manager at Key International Inc. (Englishtown, NJ), agrees. "You must buy a lot of material to get a good price from a printing company," he says.

Another advantage of printing in-line is flexibility, which allows a device manufacturer to respond to its customers' needs swiftly. For example, if a company needs to add directions, a warning, a phone number, or a new language to the package, it can do so quickly with a programmable in-line printer. Also, today's printers can be servo driven, which means that if the package size changes, then the frequency, length, and profile of the printing operation can be changed quickly and easily, according to Johnson. "You have more control," says Teeling.

Also, it can be difficult to keep preprinted paper in register, says Martin. "Paper is susceptible to moisture," he explains. "Depending on the humidity, it can get longer or shorter, and it is extremely difficult to stretch, so it's hard to register." Rochon adds, "Materials registration is no longer an issue with in-line printing because you're printing as the machine moves."

Adding a printer to a form-fill-seal machine can also reduce the amount of warehouse space and material-handling personnel necessary for preprinted rollstock. "There can be a great reduction in preprinted inventory," says Rochon. And, says Teeling, "Materials can become damaged or obsolete while in storage." However, companies will need to keep track of printing supplies as well as unprinted stock.

An in-line printer shortens the turnaround time for printed materials, because there is no waiting for the preprinted lid stock to come in. "You can create it just in time," says Teeling. "If you need it now, you can get it. If you are printing in-line, you can make any changes to the package immediately; you don't have to wait for approvals or new mats or rollers."

CHALLENGES

Every system has its drawbacks, and printing is no exception. The biggest challenge to adding a printing system to a form-fill-seal line is the added responsibility.

"Printing is an industry in itself," says Soporowski. By taking on in-line printing, a company is adding another technology to packaging. Therefore, it's important to simplify the process as much as possible.

"It's also important to remember that the operators are packaging people, not printing people," says Rochon. "You don't want printing to be the sore spot of the operation."

If a company has never printed in-line before, it's important to keep the operators' level of expertise in mind. "For example," Rochon says, "we had a customer in Malaysia to whom we gave a proposal for a flexographic printer combined with an ink-jet printer. They said they did not want an ink jet because they had had difficulty with them in the past and their employees had little expertise with printing. So we came up with a dot matrix. It's user-friendly and still programmable but more mechanical."

Another issue is that when adding a printer or printers, "it's one more device on the machine that is already carrying devices," says Martin. Space may become cramped. Also, it's one more device that can break down.

"If the printer is damaged, you have to stop the entire form-fill-seal machine," says Teeling. "You can run into more headaches by installing a printer. There's always a risk when you bring another system and the responsibility in-house."

A smaller issue is choice of color. "In-house printing limits you to one or two colors," says Teeling. Some printers offer companies a greater choice of colors than others.

Fortunately, most of these limitations are fairly easy to overcome. "Today's printers are designed for pharmaceutical and medical use," says Johnson. "They're simple to use, yet meet GMP requirements."

TECHNICAL ISSUES

Once a medical device company has determined that printing in-line is cost-effective, the next step is to figure out the best printing system for its form-fill-seal line. From a technical standpoint, this decision is based on the packaging machinery, cycle speed, and die configuration. The size, type, and number of products also determine the printing method.

Because every medical device company has different requirements, different solutions will emerge. Some companies may wish to print a company logo, others may need to print only lot and date codes, and still others want to print different languages. Two or more types of printers may be used on one line to print all the necessary information on a package. Some companies may choose to buy preprinted stock and use an in-house printer only for lot codes.

Angelo Schepis, executive vice president of Marchesini Packaging Machinery (West Caldwell, NJ), says: "We offer the option of having a printer with our deep-draw thermoformer. Our form-fill-seal machine is standard, but we have different degrees of customization. The customer can define the level of automation and the type of printer based on the data to be printed."

Space. Space is one of the first issues to be considered when attaching a printer to an existing form-fill-seal machine. Is there room for it? Can operators easily gain access to it? "Space is usually precious on a packaging line," says Johnson. "If the addition of multiple printers to a packaging machine is not well thought out, either access will be compromised, or the machine footprint will grow, eating up expensive cleanroom space. Operators should be able to accomplish changeovers easily without having to climb ladders, squeeze themselves into a small space, or risk spilling ink and contaminating the products."

"Generally, printers don't affect space as much as they used to," says Pugh. "Printers have become more compact and therefore require little bed space."

Aesthetics. Some data, such as company names, logos, and directions, need to be printed clearly and consistently on each package. These are usually permanent data that change only rarely. Variable data, such as dates and lot codes, may change daily. There may be more emphasis placed on aesthetics for permanent information than for variable information.

Aesthetics is always subjective. The level of acceptable quality differs for every person, and the higher the quality, the higher the price of the printer. However, Martin points out, "Most medical device packaging is part of industrial packaging and doesn't require aesthetics." But printing must be clear enough to be read by automated inspection systems.

Kent Gladish, market manager for Videojet Systems International Inc. (Wood Dale, IL), says, "Codes are not usually for the user—they are often for traceability." Data such as lot codes do not necessarily need to be aesthetically pleasing because they serve a functional, rather than decorative, purpose.

"The most commonly used combination of printers is flexographic for more permanent information plus an ink jet for variable information," says Soporowski. "The key is versatility, so you see combinations of printers."

Some types of printers can produce better quality type than others; however, the materials used in form-fill-seal packaging must also be taken into consideration because they may determine the type of printer and ink required.

Materials. "All printers today have different ribbons or ink to match the materials," says Soporowski. But there are different considerations for different materials.

Tyvek and paper, absorbent materials, work well with flexographic printers, which use ink. Films and foils, which are not absorbent, can take ink when the proper solvents or drying methods are employed. "You need to have hot air to dry the ink and drive off the water," Martin says. "It's difficult to design a film path where the printed side of the film won't go over a roller. If the ink isn't dry, it will offset onto the roller and print again on the film."

Soporowski points out that UV flexographic printers work well for foils, but foils must then be given a lacquer coating.

Most plastics require an ink that contains a solvent so that the characters can be etched into the plastic. However, volatile solvents such as methylethylketones can present a problem for some medical device companies because a venting system is required. Ink-jet printers often use volatile solvents. There are quite a variety of inks, many that will satisfy both adhesion and environmental requirements. However, Gladish points out: "A water-based ink can take 20 seconds to dry. You have to make sure you have that much time allowed on the line."

Cleanliness. Cleanliness is another issue. "The most potentially messy printers are flexographic," says Martin, "because they use a live inking system. However, there have been real strides made to resolve that issue in flexographic printing." Some flexographic printers have an enclosed ink system, ensuring that the ink is exposed only during the process of inking the printing plate.

In other printing systems, the ink is contained on a ribbon so the transfer of ink is well controlled. The only place the ink is exposed is at the point where it is being printed, so the chances of mess or spill are very small.

Validation. "Validation is a growing issue in the medical industry," says Johnson. "For example, if the printer ribbon breaks or ink runs out and the operator doesn't notice, you may have 200 products without the printed warning information. Then you may have an FDA recall. The best printers can catch errors or double-check themselves. The form-fill-seal machine and the printer must be validated together."

Safety. Some safety issues include changing the safety guards on the form-fill-seal machine. When a printer is attached, it is usually placed in-line just before the sealing die. With the addition of the printer, the company may have to change the safety system. "There are two issues here: personal safety and liability issues for the company operating the machine," says Martin. "You have to be careful about the safety system when you're installing the printer."

Stretching and dragging. Stretching and dragging are other considerations. "Film suppliers have done a good job of developing lighter gauge, more cost-effective films," says Martin. "The problem is there may be a complicated film path through various rollers to the seal station. As the film is pulled through its path, it is possible to get drag on the film and stretch it. Then the package may be sealed with the film in a stressed situation." The best way to solve this problem, he says, is to drive the film through the printer using a servo motor. This eliminates stretching and dragging. "Flexographic printing puts a lot of drag on film, but a servo-driven flexographic printer eliminates most of the drag," Martin says. "You get a better seal and better registration."

Product cost. The cost of the product may determine what type of printer is chosen. A company may not be able to justify using a more expensive printer to record data on a product that costs less than a dollar. By contrast, the company may purchase an expensive printer for a device that costs $10 or more.

EMPHASIS ON VERSATILITY

Many printers are available to perform a variety of tasks in a cost-effective manner. Because device companies will purchase one form-fill-seal machine approximately once a decade, the machine and its printer must adapt to any changes through the years.

"There is an increasing demand to build a machine that is highly flexible, whether it's small or large," says Johnson. "You can change the widths, lengths, and ink colors easily."

The future of in-line printing looks promising. Printers will become easier to use and offer more options. "A long-term goal is to eliminate flexographic and other methods of printing by using a PC," says Pugh.

In the meantime, device companies are increasingly looking into in-line printing. "Our business has grown tremendously because more and more customers are deciding to save money by printing in-line," says Rochon. "Also, with the many mergers occurring today and the globalization of the market, the information on a package may change weekly. A simple phone number change, for example, may have a major impact on a company's packaging operation. It's better to change a print plate than to throw out hundreds or even thousands of rolls of stock." A versatile in-line printing system can help a medical device company keep up with the times and help create an up-to-the-minute, cost-effective packaging operation.

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