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In-line printers continue to enhance their capabilities to meet the growing demands of medical device firms.
Erik Swain, Senior Editor
|The Micromax printer from Greydon Inc. features a removable inking system with bottle feed that allows for fast color changes.|
A lot of the package printing capabilities that medical device manufacturers have wanted for years are now a reality. But this is no time for printing suppliers to be resting on their laurels, as device firms are already raising their expectations once more.
The ability to print in-line has led to the demand to do it even faster and more efficiently. The ability to perform variable printing for lot codes and expiration dates has led to the demand to do it for foreign language instructions. The ability to do variable printing in two colors has led to the demand to do it in three or more.
"With success, people expect more success," says John Merritt, managing director of Tiromat Medical Packaging (Avon, MA). "With sophistication, people expect more sophistication. Now that the concept of in-line printing with one color has been firmly established, the next logical steps are multiple colors and faster-drying inks that won't blend those colors."
THE RISE OF IN-LINE PRINTING
Years ago, converters did all the printing before the material ever got to the device manufacturer's packaging line. But this meant there was no way to differentiate the packages for individual tracking, which became a bigger priority for the device firms.
Enter variable in-line printing, which allows the device manufacturer to print individualized lot and bar codes on each device package during the packaging process and results in significant cost and time savings. "The concept of in-line medical package printing in unsophisticated applications has been around for a while, but the ability to fine-tune it and maintain consistent quality has been a challenge," Merritt says. "In the last few years, simple but effective control systems have enabled the level of sophistication in printing to move forward and have furthered the application of in-line printing."
"It's not practical to do flexographic printing in-line for variable lot codes and bar codes; downtime would have to be increased to accomplish that," says Tom Pugh, vice president of sales at Bell-Mark Sales Co. (Pine Brook, NJ). "You need a programmable printing device to pull it off, and now there are compact thermal-transfer printers that are easily installed. If you are running a product on three or four packaging lines, you might be able to network the printers off a PC and make one change to the PC that can be sent to all the printers."
Use of a two-color in-line system is a quick and easy way for device manufacturers to differentiate between similar products. Hospital personnel have come to rely on identifying different products from the same line by color as opposed to wording. "For example, it allows a medical packager to identify a 10-cm3 syringe in yellow and a 3-cm3 syringe in green," says Pugh. "And it can do this at a cost savings over preprinted material."
With bar codes now an essential part of a medical device package, it is a challenge to get them onto the packages of very small devices. Therefore, says Tom Thatcher, president of Tharo Systems Inc. (Brunswick, OH), "there is definitely a shift going on from one-dimensional symbologies to two-dimensional (2-D) symbologies, which allow you to fit more data onto less geography." Printing systems with high resolutions, like a digital system from CSAT America LLC (Longmont, CO) that prints 600 dpi, can handle 2-D symbologies. "Micron sized–particle distribution allows for concise image production with smaller font sizes," explains Natalie Gragger, CSAT's business manager. Suppliers say that most in-line printers can handle these jobs, though some may not work well at high speeds and resolutions.
Nonetheless, in-line printers are considered to be important for device manufacturers who use bar coding to track and trace their devices, says David Vinson, director of sales for Willett America Inc. (Dallas). "Preprinted labels don't give you real-time information, and a lot of these firms need to know down to the second when and where each device came from or how it was produced."
Another factor in the popularity of in-line printing is its ease in handling the less extensible materials like paper. An in-line printer can be flexible enough to print text in the proper place without requiring precisely controlled printed repeats on the part of the converter or without trying to stretch the paper into the proper position on the packaging machine, Merritt explains. For paper, CSAT's Gragger recommends a straight path. "There is less risk of wrinkling," she says.
The variability of the in-line systems has worked well for device manufacturer C. R. Bard (Covington, GA), says Russ Riescher, senior packaging engineer at Bard's urological division. "We have used them for lot numbers and to differentiate sizes, and we see more big uses coming," he says, noting that his firm saved up front in costs because of not having to store as much label stock. "With all the multilanguage requirements we will be facing, we could see a role there for variable printing."
All of this progress raises one question: With preprinted graphics becoming less of a factor, what will the converter's role for graphics be in the future? "It used to be that the essential printing expertise rested with the converters," Merritt says. "Converters were considered essential to high-quality graphics. Now that you can apply on-site graphics with good print quality, it will make that expertise less necessary. And if you don't need to rely on a converter for sophisticated printing, will you need a converter at all if you don't have to apply coatings?" The answer may still be yes, he says.
Using preprinted rollstock from converters may still be the best route for the packager using large quantities with few copy variations or where extremely small type or fine screens are required, Merritt explains. "This is especially true if the packager is using coated materials where the converter can print in-line with his coating operation," he says. "However, the packager using small quantities of printed material with many different copy variations is probably better off with the flexibility of in-line printing."
When primitive in-line printers first came into use about 10 years ago, their leakage of ink inspired a running joke about printing the plant floor as much as the package. No more. The latest in-line printers contain their inks well and aren't prone to such mishaps.
Nonetheless, conserving ink remains a major concern for safety and economic reasons. One potential solution has come from Greydon Inc. (York, PA), which has a line of cartridges that are only as big as the length of the print (usually 4 in.) rather than the length of the web (usually 22 in.). This means that not as much ink is expended, with an 8-oz bottle being added every shift, says Gregory Rochon, Greydon's president.
"If you needed more ink, you might have to add it by the gallon, but if that gallon is open for a week, it might evaporate," he says. "And with small cartridges and 8-oz bottles, it makes it very easy to change colors in the middle of a run."
The type of ink is also a major consideration. "A major development has been the move from solvent- and water-based inks to UV-based inks," says Jim Umdenstock, president of Griffin-Rutgers Company, Inc. (Ronkonkoma, NY). "They provide a higher print quality on a wide variety of substrates."
Drying is also a significant issue with inks, says Andy Millar, marketing business and development manager for Willett. "Methanol-based inks are viewed as harmful, so you can move to alcohol-based inks, but they don't dry very fast, depending on the substrate," he says. And "alcohol-based inks may not be compatible with certain print media," adds Gragger.
"So we have an ethyl acetate ink that is similar to the methanol-based ones but are fast drying and more friendly to the operators and their environment," explains Millar. "You need something that provides clean start-up, clean shutdown, and minimum operator interface."
Flexographic printing presents another set of challenges for inks, notes Jerry Napiecek, manager of technical services for the No-Tox Products division of Colorcon (West Point, PA). "The inks have to be extremely slow drying so that they don't build up on the flexo printer, yet have to dry almost instantaneously on the substrate, many times without the use of heat or forced air," he says.
Even tougher, he says, is that with nonporous medical packages made with film rather than paper or Tyvek, "there is no absorption to help drying, and evaporation becomes more of a concern. Additionally, if either ethylene oxide or steam sterilization of the finished packages is being employed, the inks will need to have chemical resistance to these processes."
Therefore, the choice of substrate is just as important to a successful printing operation as are the choices of printer and ink. Karen H. Bean, technical paper research and development for medical paper supplier Kimberly-Clark (Roswell, GA), says uniformity, smoothness, and surface energy are characteristics to look for if paper is the choice.
"Uniformity refers to how consistent the paper's thickness and fiber density are. Variations in either property will affect the ink transfer to the web," she says. "The smoothness of a paper will determine the quality of the printed image. Naturally, a rough or uneven surface means poor contact with the printhead and poor transfer of the image. Surface energy is a measurement of how well the substrate 'wets out' or absorbs the ink. Most medical packaging papers have sufficient surface energies for printing with multiple types of inks. Inks should be selected that have lower surface energies than the paper, ensuring that the ink will be adequately transferred to the web."
One reason it is desirable for inks to dry quickly and without the aid of heat or air is that overdrying after coating can cause paper to curl, Bean says. "Curl can be managed by drying and maintaining paper to air-dry levels, between 5–15% moisture."
Tyvek, from DuPont Medical Packaging (Wilmington, DE), "can be printed in much the same way as paper, using standard commercial printing equipment," explains Stasys Rudys, senior research associate.
According to DuPont literature, due to the unique physical properties of Tyvek and the fact that medical grades of Tyvek are neither corona treated nor contain an antistatic agent, special steps must be taken to ensure optimum printing results. For example, solvent- or water-based inks formulated for printing untreated polyethylene should be used. In addition, soft (50 or less Shore A durometer), 75-mil photopolymer plates mounted with 15–20 mil of sticky-back closed-cell foam deliver the best overall print quality.
Thorough consideration of all aspects of printing is required before a substrate choice is made. For example, at Bard, "the performance of the bar code often dictates what the face stock should be," Riescher says.
In-line printers allowing for multiple colors and variable text, inks that dry quickly, and substrates that are compatible with the ink and the printing process are all major aspects of a successful and efficient medical device package printing operation. Merritt adds, "Now that printers are as good as they are, the aggravation associated with preprinted registration may be bigger than that associated with in-line printing."
Networking Creates Error-Free Printing
Paul Mills, Senior Product Manager, Markem Corp. (Keene, NH)
Networking is beginning to change the way the packaging environment operates. Already, software exists that enables one PC to control the entire package coding line from beginning to end, including dozens of different coding and labeling machines, and to create a streamlined, cost-efficient workflow.
With the significant growth of thermal-transfer printing and ink-jet marking over the last few decades, digital-to-print (DTP) technology has revolutionized package coding. Unlike older mechanical coding systems, which required type to be set by hand, DTP technology allows operators to create a legend or printed code simply by keying information into a computer. Once entered, the information can be stored, modified, or shared—networked—among multiple printing devices.
As shipping and receiving processes become increasingly automated, the use of sophisticated label printers and applicators is also rising. Networking is becoming a necessity in this environment. To manage an automated integrated operation, a company needs networking to move data and carry out diagnostic work.
Regulatory demands are also driving the networking trend for coding and labeling. For example, one company was required to place a distinct bar code on each of its 600 products. With the company's old hot-stamp plate system, which had been in use since the l960s, operators had to stamp out a plate for each product with the lot number and other variable information. The plate then was loaded on the printer and the entire process repeated for the next product or lot. Making plates for all of the items would have been very costly.
Instead, the company installed three Markem coders and networking software in June l998. Working from the network database, the operator now keys in a product code number that pulls up product-specific information, such as bar codes, lot codes, and batch numbers. To change production, operators need to change only the variable information (lot code and batch number) and don't have to reenter the product's standard information. Networking software keeps the information for each code centralized and automatically sends it to the appropriate printer at the right time. The software also manages the labels' image, style, and format, further simplifying the printing process.
Not only do manufacturers have a greater variety of products to print, they also are placing more information on each product. In the past, a bar code indicated only the product's identity. Now, companies want to include information such as expiration dates, lot numbers, and origination data. Networking maximizes efficiency in dealing with all this data by storing it centrally and dispatching it to the appropriate printers as needed.
A networked system reduces operator error. Because data are controlled at a single, central PC, there are less likelihood of misinformation or misplacement of files. Increased accuracy and reliability also translate into less downtime for the packaging line.
However, when a data problem does develop, operators of a networked system get an immediate indication and can stop the line automatically. Networking provides diagnostic capabilities from a central location. The software notifies the operator of a fault and pinpoints the problem, enabling the operator to direct a specific repair. If the operator needs further assistance, technicians at the manufacturer often can electronically diagnose the problem off-site. The operator can e-mail the entire database to the manufacturer to solve the problem. This rapid diagnosis and repair cut down the time the line is out of operation.
Manufacturers also want to reduce the time it takes to change over the printing line between batches. A networked system can potentially reduce printing changeovers to less than one minute. In addition, a networked system makes it easier for packagers to respond to the growing demands for real-time coding. From a single PC, an operator can control date and time stamps, batch codes, and other real-time data for multiple printing devices. In the event of product recall, real-time coding can help operators pinpoint defective batches.
As manufacturers look to the future and move toward high-tech coding, networking becomes more essential. Many experts predict that two-dimensional (2-D) bar codes will someday be an industry standard. Because 2-D bar codes carry much more and varied information, the printing system needs to be connected to a reliable database. With 2-D labels, there are more information, work, and changing of labels. These add up to a greater chance for error. Networking, however, manages that flow of data and decreases the risk of error.
There is continuing changeover from conventional printing to DTP technology. As companies make the investment to go digital, they open the door for networking. The shift to DTP technology also presents a challenge, however. Converting to digital is no small expense, and convincing companies to make the significant investment to go digital and to network can be difficult. For example, if a company has 20 lines of conventional machines, all of the pieces on those lines become useless in the switch to digital and go straight into the trash can.
Another challenge will be how to integrate those legacy printing systems and devices into the new networked world. Currently, there are no open systems designed to work easily with customers' existing networks. Industry recognizes the importance of that integration and is working toward it.
Networking is rapidly changing the landscape of the printing environment and speeding the way toward automation. It is probable that someday companies will no longer give special thought to networking and will consider it second nature to integrate all of the devices along the packaging line.