Package Coding and Printing
Improvements in printing technologies offer users an easier, cleaner, more flexible process.
|Mounted on a form-fill-seal machine from Multivac, Bell-Markï¿½s EasyPrint MLP brings variable printing to the packaging line.|
F or years, pharmaceutical and medical device manufacturers have been trying to accomplish more in-line, and printing is no exception. In-house printing is getting easier, cleaner, and more flexible. Some of the latest advances are also allowing product manufacturers to change text and other, previously static, information while printing in higher resolutions. Given FDAï¿½s new rules for bar coding and the ever-growing list of required languages, manufacturers should welcome such news.
ï¿½More and more packagers are moving toward on-line printing. This is being driven by a desire to put lot and expiry date information into bar codes,ï¿½ explains Steve DiAngelis, director of sales, packaging, print, and security for Romaco USA. ï¿½Although not part of FDAï¿½s recent regulation, some packagers are doing this as a benefit to their hospital customers.ï¿½
EASIER AND CLEANER
Moving from preprinted to in-line printed materials has helped product manufacturers eliminate most of the worry associated with maintaining print-to-package registration. Flexographic printing, for instance, has worked well with form-fill-seal (FFS) equipment, in both its platen and rotary versions for intermittent-motion and continuous-motion machines. ï¿½In-line flexo has been reliable,ï¿½ reports a staff packaging engineer at a major medical product manufacturer. ï¿½It has been wonderful in terms of print quality, especially on Tyvek.ï¿½
But this same packaging engineer says that flexo maintenance has always been a challenge. ï¿½It is messy, and you have to deal with ink spills. That brings up the issue of worker exposure.ï¿½ This manufacturer hasnï¿½t switched to other printing methods, however, because flexo has still been the most cost-effective.
Jared Kraeling, senior packaging engineer at Medtronic Xomed, agrees that flexo requires a lot of maintenance. ï¿½The floors around our Multivac [FFS machine] were blue,ï¿½ he says.
About three years ago, Medtronic Xomed switched to thermal-transfer printing. The firm purchased an EasyPrint MLP traversing thermal-transfer printer from Bell-Mark (Pine Brook, NJ) to replace a Multivac P100 flexographic printer. ï¿½Increased maintenance for an aging piece of equipment pushed us to find a solution that would require less maintenance, while increasing productivity,ï¿½ he says.
The investment has been worth it for Medtronic Xomed. ï¿½Our actual operating costs have increased, due to ribbon costs,ï¿½ admits Kraeling. He reports that they print between 8000 and 10,000 packages per day on one line, and they go through about 3000 feet of ribbon per day. ï¿½But reductions in maintenance costs and changeover times have offset the increase,ï¿½ he says. Medtronic Xomed currently prints in blue, and they may add another color for new products. The firm is now adding another MLP to its other Multivac FFS line.
Joe Smith, products and services manager for DNP IMS America Corp., a large manufacturer of thermal-transfer ribbon, reports that users often find thermal-transfer technology easy to operate. ï¿½The simplicity of thermal-transfer printing reduces the amount of time required during manufacturing setup, which ultimately reduces costs and improves operating efficiencies,ï¿½ he says. ï¿½Material costs can be controlled through the selection process of the ribbon grade. All thermal-transfer ribbon options include wax, wax/resin and resin formulations. The biggest challenge will be finding the appropriate ribbon/substrate combination to meet the needs of the specific application.ï¿½
To remain competitive with thermal-transfer printing and other, cleaner, methods, the newest flexographic printers have cleaned up their act. ï¿½Older flexo technology that uses solvent- or water-based inks can be messy,ï¿½ says Jim Umbdenstock of Griffin-Rutgers Company, Inc. (Ronkonkoma, NY), which offers printing and labeling equipment. ï¿½Water is water and sloshes around as such, and solvents flash off, so the ratio of ink-to-solvent changes frequently. You therefore need to constantly remix formulations and clean ink wells.ï¿½
Charles Geraldi, director of sales and marketing for Adolph Gottscho Inc. (Union, NJ), agrees that flexographic printers using solvent-based inks can be messy. ï¿½Water-based inks can be messy, too, but they clean up easily with water,ï¿½ he says. ï¿½There are also no safety issues because solvents have been eliminated.ï¿½ Gottscho is moving its platen printers toward water-based ink use, he reports.
Newer systems that use UV-light-curable inks are cleaner and more stable, Umbdenstock says. ï¿½The inks have a pastelike viscosity and are supplied in tubes, so they donï¿½t spill, and there are no solvents to flash off, so maintenance is minimal. Clean-up is reduced to every few weeks.ï¿½ Griffin-Rutgers currently offers the Metronic inPrint rotary systems with UV-
curable inks, and Gottscho may offer its platen printers with UV-curable ink soon, too.
Thermal ink-jet (TIJ) printing also offers packagers a cleaner alternative. Hewlett-Packard (HP) entered the pharmaceutical and medical device packaging market recently with technology that incorporates the ink and the printhead in one cartridge. The cartridges can be replaced by snapping them in and out of their carriers. ï¿½TIJ technology is very clean,ï¿½ says Mike Shaw, vice president of sales for Nutec Systems Inc. (Lawrenceville, NJ), an HP partner offering the technology to pharmaceutical and medical companies. ï¿½Everything is in one unit, so you donï¿½t have to deal with the ink bottle and the make-up fluid to control ink viscosity that are typically used for other ink-jet technologies.ï¿½ Bell-Mark, Gottscho, and Greydon Inc. (York, PA) are other HP partners, part of a growing list.
Flexo offers some of the highest resolutions possible in in-line printing. Umbdenstock reports that resolutions are dependent on the output device for manufacturing print mats, and some devices now produce images in up to 3600 dpi.
HPï¿½s TIJ printers are raising ink-jetï¿½s resolutions. According to HP technical specifications, the resolution is 600 dpi. For instance, Bell-Mark offers the InteliJet R system with a resolution of 600 ï¿½ 600 dpi at 25 in./sec. Adds Greg Rochon, president of Greydon: ï¿½TIJ offers a higher dpi than other ink-jet printers. Some firms are looking at the technology for printing their entire top paper webs,ï¿½ he says.
The real debate, however, concerns the emerging need for variable print. Bar codes are now required for most levels of drug packaging supplied to hospitals. Some believe the same rule is coming for medical devices. Group purchasing organizations, like Premier Inc., are even encouraging FDA to issue similar regulations for hospital-administered devices.
Even though FDA is only requiring bar codes that encode a drugï¿½s National Drug Code, some manufacturers are also opting to print lot codes and expiration dates. Premier even urged FDA to take its regulation one step further and require lot and expiry codes.
Multiple-language requirements are also popping up, especially as the European Union expands to include 11 new countries in May.
With so much to print and update, manufacturers are finding that they need a better means of changing copy. Industry is looking toward what some call programmable printing, and others call digital printing.
ï¿½There is definite movement in the industry toward digital printing,ï¿½ says Geraldi. ï¿½You can make changes much more easily with digital printing.ï¿½ Adds Shaw: ï¿½Digital allows firms to print in real time, producing variable information like lot and expiration dates.ï¿½
Medtronic Xomed was interested in such printing flexibility to make changes quickly, says Kraeling. ï¿½We print packaging in three different configurations, some with five languages, others with 11 and 14. And the numbers keep changing. We wanted to be able to make changes quickly,ï¿½ he says.
The firmï¿½s adoption of Bell-Markï¿½s thermal-transfer printer has eased changeover. ï¿½Now it is just a programming changeï¿½we just go into our database, select the new format, and change over,ï¿½ Kraeling says. ï¿½Additionally, variable information can be added to the labeling without having to use a secondary ink-jet printer.ï¿½
ONE PRINTER OR TWO?
|Nutec Systemsï¿½ HP thermal ink-jet system helps firms print variable information.|
But not everyone is steering away from two printers. In fact, Rochon of Greydon says that he sees the industry at a ï¿½two-printer setup.ï¿½ Interest in flexography is still strong, he says, because it offers ï¿½state-of-the-art printing in terms of color and image quality at the least cost.ï¿½ But because changing flexo type requires a print mat change, firms are turning to ink-jet and thermal-transfer for producing variable print, he explains. Greydon recently helped Becton Dickinson switch from the use of preprinted materials to its MicroMax platen flexographic printer for logos and text and an HP printer for lot and expiry dates.
Bell-Mark, which offers HP technology, thermal-transfer printing, and in-line flexography, says that each printing method has its own strength and purpose on a packaging line, sometimes the same line. At the EastPack exhibition in New York City this June, for instance, Bell-Mark will be demonstrating the different technologies mounted on the same machine, a 10-ft-long Multivac R230. ï¿½Each technology will be printing in a different color, so you can see what method produces the text, the logo, the lot codes, etc,ï¿½ says Glenn Breslauer, Bell-Markï¿½s director of IT Marketing.
Printing the entire web with a digital method is also a strong possibility, as Medtronic Xomed is demonstrating with thermal-transfer printing. Adolph Gottscho offers web printing up to 40 in. across with its GottJet Wing series, which consists of multiple HP printheads mounted together above the web. And Nutec is also expanding its HP capabilities from 0.5-in. print heights to full-web printing.
But consumable costs for full digital printing may be too high for some customers. ï¿½You can get a million and a half square inches from just a $75 gallon of flexo ink,ï¿½ Rochon says. ï¿½But the same amount of ink for a digital system could cost you 10 times more.ï¿½
Umbdenstock believes that it is more cost-effective to use flexography to print a full web. ï¿½To print just 8 inches across a continuously moving web, you would need 16 digital printheads. You then have to stop the line to change those heads when they get low on ink,ï¿½ he says. ï¿½I still recommend that firms use flexo and use a new print mat for each batch. Spread across the run, the per-package cost of a new mat is minimal. And you can get mats the next day from local print-mat suppliers such as The Quint Co. (Philadelphia), Paraprint (Ivyland, PA), and Flexi Print Plate Co. (Moonachie, NJ).ï¿½
In-house print-mat production is also an option. Greydon offers a system to produce print mats in-house. To the same end, Romaco offers a laser print-mat engraver.
Some companies, though, want to be fully digital, Rochon adds. ï¿½They may have a real good reason to be fully digital. If they change over 30 or 40 times per day, thatï¿½s a good reason. It would be crazy to change print mats 30 or 40 times per day.ï¿½ In addition, he adds, with digital printers like HP you can add and change colors easily.
Kraeling adds that thermal-transfer printing offers the same benefit simply by changing ribbon. ï¿½It is a nice feature to thermal transfer,ï¿½ he says.
|UV flexo and digital UV printing processes that provide 600-dpi resolution and|
above are popular, according to Romaco.
While bar coding and variable-text printing will influence printer selections, other forces will come into play. ï¿½Thereï¿½s a blurring of lines between pharmaceutical and medical products these days, especially when it comes to prefilled syringes,ï¿½ says Shaw. Nutec also recently worked with a firm that is packaging an implantable drug-delivery device. Substrates typically used for medical packages are now being used for drug packages, and vice versa. A careful study of which printers work best with particular substrates will therefore be in order.
Downgauging packaging materials is also raising issues. Greydon recently helped Baxter Healthcareï¿½s Costa Rica and Puerto Rico facilities install in-line corona treatment to its packaging printing lines. The installation was necessary so that it could print successfully on a less-expensive LDPE film that otherwise would not be possible in such an application, says Rochon. ï¿½Corona treatment is necessary to obtain adequate adhesion of water-based ink to the smooth surface of such films,ï¿½ he adds. Corona treatment is usually performed by a converter, but the surface tensionï¿½ reducing effect of the treatment doesnï¿½t last long, he says.
Sterilization methods also affect printing choices. DNPï¿½s Smith says that his firm worked with a large manufacturer of healthcare products that had recently switched from hot-stamp printing to near-edge thermal transfer printing. ï¿½Due to the harsh sterilization process, the ink was not performing to the companyï¿½s specifications. The ink was delaminating from the substrate, causing scanning failures during manufacturing, ultimately stopping their production line. Working with their engineers, we developed a resin-based product that withstood this stringent environment and met their application's requirements.ï¿½
Anticounterfeiting efforts will also be an issue. ï¿½Digital printing is helping firms combat counterfeiting,ï¿½ says Gottschoï¿½s Geraldi. ï¿½We have come up with a UV-light-readable ink that can be printed right over black ink on blistersï¿½ for covert text. The UV ink is applied after the blisters are sealed but before die-cutting so the print can be kept in register.
Radio-frequency identification (RFID) has also been identified as a possible weapon against counterfeiting. ï¿½There is incredible excitement over RFID, with interest from the U.S. Department of Defense, Wal-Mart and Target stores, and FDA with its anticounterfeiting report,ï¿½ says Debra Murphy, life sciences market development manager for Zebra Technologies Corp. (Vernon Hills, IL), a provider of thermal-transfer printers. ï¿½We are pleased that FDA recommended a combination of technologies.ï¿½ To help firms implement RFID, Zebra offers a print-and-apply labeler that also encodes an RFID tag embedded in the labelstock.
|The Hapa 230 from Romaco can be used to print foil, leaflets, labels, cartons, and infusion bags.|
Finally, Umbdenstock is seeing an increase in the need for in-line print inspection. ï¿½There is an increase in the conversations about in-line vision systems,ï¿½ he says. Firms are scanning bar codes in-line, but no one is verifying them in-line according to ANSI/ISO standards yet, he says.
Bottom line for end-users: review all your options in light of your printing needs before making a decision. ï¿½There is no perfect printing systemï¿½they all have their pluses and minuses,ï¿½ says Umbdenstock.
George Wright IV, vice president of Product Identification & Processing Systems Inc. (New York City), warns end-users to beware of charlatans. ï¿½FDAï¿½s two-year deadline for printing bar codesï¿½and only 60 days for new drugsï¿½has caught everyone off guard, so the need for education and implementation has been substantially compressed.ï¿½ To ensure that you donï¿½t select the wrong print technology or partner, investigate as much as you can, he says. ï¿½Attend industry forums that bring a number of users and providers together for education.ï¿½ He recommends two upcoming conferences: Pharmaceutical Bar Coding by Barnett International, to be held June 7ï¿½8 in Philadelphia; and the Institute for International Researchï¿½s TRAX 2004, the Pharmaceutical Supply Chain Summit, where more than 100 speakers will gather July 20ï¿½22 in Washington, DC. For more information, visit www.barnettinternational.com and www.iirusa.com/trax2004/.