Pharmaceutical and Medical Packaging News Magazine
PMPN Article Index

Originally Published October 1998

PHARMACEUTICAL

Tracking and Protecting Drugs with Coding and Marking

There are a variety of coding and marking systems drug makers can use to track their products and to fight counterfeiting and drug diversion.

To track pharmaceuticals thoroughly from the manufacturing plant to the warehouse to the end-user, manufacturers have turned to a variety of coding and marking technologies. These include using bar codes, lot numbers, and expiration dates. But the codes and marks are more than just tracking mechanisms for shipping, storage, and recalls. They are also being used to address other, more complex problems such as counterfeiting and diversion.

2-D codes can be printed with Videojet's small-character ink-jet printers. Photo by Roni Ramos.

To meet such challenges, codes must be legible and durable. "The appearance of a legible production code is much more critical to the pharmaceutical industry than to other industries," says Scott Mastricola, manager of market development at Videojet Systems International Inc. (Wood Dale, IL). "There is a continued emphasis on high print quality, high reliability, and accuracy."

It is no surprise, then, that dozens of new printers are introduced each year, with all of their manufacturers claiming advances over older models. "There has been an increase in customers wanting real-time dates and sequential numbers for product tracking and security purposes," says Warwick Hirst, marketing and sales manager, Allen Coding Systems Ltd. (Chicago and Welwyn Garden City, England). "Also, they want to print bar codes on-line rather than preprint them."

Also, with the pharmaceutical industry's increasing use of vision systems, it is imperative that codes be printed well enough to be read and verified by machines, says Gary L. Parish, president of GSMA Parish Automation's packaging division (Palm Bay, FL). "You have to select the correct font style," he says, noting that OCR-A and OCR-B are often appropriate. "If you use the character '8' in the same position as character 'B,' how different do they actually look?"

But it isn't easy to pick the right printer for your specific coding and marking needs. There are new units available in several product categories, from thermal transfer to ink jet to laser to flexographic. The right choice depends upon your company's top priorities, whether they be legibility, cost, speed, ease of use, cleanliness, or security.

THERMAL TRANSFER

Thermal-transfer printers, which print onto a label or other paper, have a high quality of print and are increasingly being used to print bar codes and other types of codes where legibility and clarity is essential. Their main drawback is lack of printing speed, but they can be set up quickly.

Because ink is not involved, "there is never any quality degradation during the process," says Tom Pugh, vice president of sales and marketing at Bell-Mark Sales Co. (Pine Brook, NJ). "And it is virtually maintenance free. The only thing you replace is the printhead."

Thermal-transfer printers are particularly suited for printing in small type. Says Hirst of Allen Coding, "If you want very small letters, you get much clearer definition with thermal. The figures are filled in."

James Butcher, product manager for Markem Corp.'s (Keene, NH, and Nottingham, England) SmartDate line of coders, says the pharmaceutical industry has showed an increased interest in thermal-transfer printers in the past year. "The new technology gives all kinds of digital and electronic flexibility, with a price not different from a good hot-stamp coder. It has the ability to do more things like automatic time and date coding" and can be connected to a software network for recordkeeping purposes, which helps with validation.

Such user interest has encouraged many suppliers to enter the market. "Come next year, I think there will be twice as many competitors," Butcher says.

INK JET

Ink-jet printers are generally the fastest, and often the least expensive, coders on the market. But there are limitations to what they can print, and some models require frequent maintenance or are messy.

The technology is rapidly improving, however, and newer models are often software based. "It enables you to print codes that are aesthetically pleasing, instead of looking like a matrix of ink droplets," says Ken W. Stephenson, manager of corporate communications at Domino Amjet Inc. (Gurnee, IL). "The early ink jets were notorious for being labor-intensive devices, but we have led the way in aiming for a maintenance-free ink jet, which you don't have to nursemaid or ruin products to try to get a decent code." In fact, he says, the company has a machine that, if a software chip is inserted, becomes a stand-alone 2-D bar code printer. The 2-D codes, which can also be printed with thermal-transfer technology, can hold more information than a regular bar code and maintain it all even if the code itself is torn or damaged.

Food-grade fluid from Videojet is ink-jet printed on these tablets.

A common complaint about ink-jet technology is that the print fades after successive use, but newer machines "don't need frequent ink changes, and the ink maintains its characteristics and stability for longer periods of time," says Mastricola of Videojet.

LASER

Laser coders are flexible and convenient because they can be mounted almost anywhere on a line and can print on many surfaces. Their uptime is around 95%, and they can be adjusted quickly, reducing changeover time. But the printing surface must be able to be burned away in order to change color. Some materials work only with certain kinds of lasers, such as carbon dioxide or YAG. Their main drawback has been cost, but certain kinds are comparable in price to ink jet, and others may come down in price in the near future.

A new technology, vector-steered lasers, has improved print quality. "It's a continuous wave of laser [light], and a machine steers the beam like it's drawing a picture or using a plotter on a CAD system," says Gary Smith, market sales manager for Lumonics' North American Coding Group (Kanata, ON, Canada). "It can create a solid character for you, as opposed to a dot matrix laser." It does, however, take longer, at least for now, he says.

Featuring package-by-package verification, the Lasetec uses two-axis vector-steered technology.

Fred L. Calhoun, president and chief executive officer of Industrial Dynamics Co. Ltd. (Torrance, CA), explains that his firm has found a way to make two-axis vector-steered lasers work faster. According to Calhoun, the company was the first to apply the technology, once used only in the automotive industry, to the beverage and pharmaceutical markets. "The two-axis laser allows you to create lettering that looks engraved," he says.

FLEXOGRAPHIC

The high print quality of flexographic printers makes them a favorite for printing small characters. Because they often use plates that require changing each time there is a coding change, they can be costly to use and maintain, but improved models continue to emerge.

"We have a platen printer that allows the pharmaceutical customer to print in-line on a blister machine and reduce problems with inventory control," says William Pulda, manager of engineering at Adolph Gottscho (Union, NJ), which also makes thermal-transfer and rotary printers. According to Pulda, the platen printer contains a microprocessor, which makes the operator's job easier.

FIGHTING COUNTERFEITING AND DIVERSION

Many pharmaceutical companies use coding and marking technologies to combat counterfeiting and diversion. As much as 5% of the world's drugs could be counterfeit, according to the World Health Organization. The unauthorized manufacture and distribution of drugs are devastating to pharmaceutical companies, not only economically but also legally. If a company's drugs are counterfeited and sold and then cause adverse reactions, the company can be held liable if it cannot prove that the drugs were duplicated. And if authentic drugs are diverted to markets for which the manufacturer has no regulatory approval, the drug manufacturer can also be held responsible. Manufacturers are therefore turning to sophisticated coding and marking methods that not only immediately identify their products, but also are difficult to duplicate.

Invisible inks are one solution. They can be printed with an ink-jet printer into the bar code, and are visible only under an ultraviolet lamp. "There are some unique inks out there," says Dave Hawkes, product manager at Videojet.

With lasers, Calhoun of Industrial Dynamics says, a packager can put an invisible code on the bottom of the inside of a bottle.

There are also digital coding techniques that can print encrypted information within the code. They can even be programmed so that printer suppliers don't know how they work, says Butcher of Markem. That method is sometimes used in conjunction with holograms, which are often included in a seal. The best path is to use a unique holographic design implemented by a hologram supplier with security expertise.

Because of the threat of counterfeiting and diversion, every code, every label, and every package has to be accounted for, lest they fall into the wrong hands. Gene Fuchs, vice president of Genesis Machinery Products Inc. (Exton, PA), says his company has a device that attaches to a vial capper. It marks each vial with regular or invisible ink right after capping and before passing by a verification camera, enabling users to keep track of all vials.

CONCLUSION

Before shopping for a coding and marking system, prioritize your company's needs for quality, cost, and speed. Next, investigate every product category, from thermal-transfer printers to lasers. Finally, when you think you've found the right technology, make sure the supplier is familiar with the unique concerns of the pharmaceutical industry. If so, chances are that the supplier already has a plan to protect your products from counterfeiting and diversion.