Effective Bar Code Printing
Industry explores coding and printing options to meet proposed FDA bar code rule.
If it becomes finalized, FDA’s proposed rule requiring bar codes on all prescription drugs and biologics and some over-the-counter (OTC) drugs will not only have a profound effect on the design and dispensation of pharmaceutical packaging, but on the technologies used to print them as well.
Firms will demand that their printing suppliers be able to print any and all codes accepted in the rule, at resolutions high enough to ensure proper scanning every time. They may also demand more variable-data capabilities from their printing technologies if they decide to print lot codes and expiration dates along with the National Drug Code (NDC) number. (The proposed rule requires the NDC number, but lot codes and expiration dates are optional.) And they are likely to seek the most efficient solutions, meaning they could be on the lookout for technologies that are cost-effective and require little changeover and maintenance.
There could be an impact on medical device printing, too. While medical devices are not covered under the proposed rule, FDA has stated that it will consider whether to include them in the final rule or create a separate rule for them covering bar coding issues. Even if neither happens, medical device manufacturers may decide to follow in the footsteps of their pharmaceutical brethren and take advantage of bar coding solutions that can enhance patient safety and product tracking. Either way, hospitals will need to consider what products they are going to be reading before investing in any technology.
The rule as proposed calls for the NDC number to be encoded in any linear format and in symbology approved by the Uniform Code Council (UCC; Lawrenceville, NJ). These include UPC-E, UPC-A, EAN-13, ITF-14, UCC/EAN-128, and RSS, which stands for Reduced Space Symbology. Linear stacked and composite codes are also acceptable. Nonlinear codes such as Datamatrix and non–bar code technologies such as radio-frequency identification (RFID) are not specified in the proposed rule, though the agency may decide to include them at a later date.
Printing all of these quickly and clearly has become the mission of many suppliers, and many are scrambling to offer RSS capabilities if they aren’t already.
Whether using printing plates or in-line technologies, there are a number of available solutions that can print the necessary bar codes to approved specifications, says Richard Davis, president of Quint Co. (Philadelphia). Davis shared this with attendees at the Bar Code Implementation Strategies conference, held March 27–28 in Washington, DC, and sponsored by the Institute for International Research (New York City). The key, Davis said during his speech, is to find a supplier with the proper quality control procedures who can do rigorous verification.
“The quality of the bar code must be verified at each step of the process,” he said. “Tests have shown that the current-technology in-line printers can produce RSS/CCA bar codes with ANSI/ISO grades of B and even A when under proper control. But printers must be in optimal mechanical condition and each component controlled. Which printer technology will consistently yield the best print quality, with the least maintenance, over time, is yet to be proven.”
For traditional printing, hot stamping and embossing work best for bar codes, while thermal transfer works best for digital printing, said James O’Hagan, director of technology transfer for Zebra Technologies (Vernon Hills, IL). O’Hagan also spoke at Bar Code Implementation Strategies.
Hot stamping and embossing offer excellent settings control and good contrast, whereas pad printing and screen printing tend to have poor contrast, he said. With digital technologies, laser presents a trade-off between image size and speed. Ink-jet is fast but requires a lot of verification to ensure precision, while thermal transfer is inexpensive and offers high-quality images.
Steve DiAngelis says he has noticed that digital printing systems are becoming more in demand. DiAngelis is division manager, printing and security systems, for Romaco Inc. (Pompton Plains, NJ).
“Print quality and resolution are a major issue with digital printers. It is not quite as good as flexo, but it is very close,” he says. “Our digital UV printer can print at 600 dpi, and the minimum specified for RSS is 300 dpi. So digital technology can print RSS code verifiably. We have a digital printing technology that provides the highest resolution on foils. It is the best technology for unit-dose blisters. It can print on anything with a flat surface and the proper adhesion qualities for UV inks. Utilizing UV inks means no toners on packaging floors, and you can formulate any color in the Pantone chart. Digital UV printing technology also has the benefit of low running costs.”
A reason for the increased popularity of digital printers is ease of use, says Tom Pugh, vice president, Bell-Mark Sales Co. (Pine Brook, NJ).
“Thermal transfer gives you a very scannable and verifiable print,” he says. “Traditional platen printers will find it difficult to compete because of the small size of the new bar codes, in addition to the changing of printing plates and the downtime associated with that. Thermal transfer requires no printing plates, maintenance, setup, or downtime associated with managing ink. All those things make it difficult to get a scannable bar code. Programmable printing devices will be preferred in the long run because pharmaceutical companies are looking for quick changeover.”
Adolph Gottscho Inc. (Union, NJ) has added features to its platen printers to better address the variable-data needs that the regulation should bring, says Arthur Haas, general manager.
“The life of your product will be limited if you can’t do variable data,” he says. “So we put a module on to add variable data. Continuous ink-jet technology is messy, so we are using an HP [Hewlett-Packard] ink-jet technology that we’re taking in two directions. One is for the complete web printing; totally digital, continuous, or intermittent. There is no line between heads, and you could print a photograph. Our software also allows the printing of bar codes, bitmaps, and PDF files at 600 5 600 dpi. There is no ink handling, and every time you change a cartridge, you get a new printhead. There are very little clearance or maintenance issues at all. Gottscho has used the same technology for spot printing, carton coders, and label printers.”
SCANNERS AND SOFTWARE
A major concern about the regulation is whether scanning technologies will emerge that can read all available codes. Right now, the less-expensive scanners that read linear codes cannot read nonlinear ones, which was the main reason FDA specified only linear codes.
End-users must pay attention to scanner technology as they design their packages to fit the new requirements, Delmar R. Mineard Jr. told the Bar Coding Implementation Strategies audience. Mineard is the manager, package engineering, for Boeringer Ingelheim–Roxane Laboratories Inc. (Columbus, OH).
“Most bar code scanners over two years old can’t be updated to scan RSS,” he said. “Confirm if they can scan [RSS] or have been upgraded. You must also identify the capabilities of your existing vision systems [to scan RSS].”
It remains to be seen whether FDA will change any aspect of the rule based on scanning issues. “They need to start giving guidance on what types of codes should be used,” DiAngelis says. “Right now, you can’t have one scanner that will scan all codes on any product. There has to be some structure for it to make sense all the way through the hospital supply chain.”
While much has been made about whether scanning technologies will be able to accommodate all the bar code symbologies, the software behind the scanners and readers may be even more important in the long run.
“We’ve spent a lot of time talking about scanning technology. That’s important. But think about what has to happen. The cost of a scanner is a small component of the overall system cost,” says Debbie Murphy, life sciences market development manager for Zebra. “People understand printers and scanners. They do not always understand the application software with the necessary data, and that is a big piece of it. That needs to be looked at a little more closely. The cost difference between a $300 scanner and a $500 one, as a piece of a system, is minimal.”
Pugh says software has played a major role in the advancement of printing and coding technologies. “Our biggest challenge as vendors was to design software and firmware that will allow our printers to print both linear and two-dimensional symbologies, such as RSS and Datamatrix,” he says. “We have written software that can read the code and take a step ahead in being able to address the needs for RSS bar coding.”
Though much debate is taking place now about what the regulation should say, suppliers and users with forethought are thinking about how to address the issue in the future.
For example, though RFID is not specified in the proposal, Sato America Inc. (Charlotte, NC) has introduced an RFID kit for two of its thermal-transfer bar code printers that enables them to print on the label and program the chip inside the label simultaneously. Healthcare is one of the markets that the company has targeted for the technology. Sato recently announced a partnership agreement with CCL Label Inc. (Memphis, TN) to manufacture all RFID tags and labels for the company and resell its RFID-enabled printers.
Industry is also aware that even the best technologies won’t be adopted if there is no incentive for hospitals to purchase them. “The proposal is a good first step and will be helpful to patients, but the key will be how industry can leverage the data to drive operational efficiency as well as the social benefits,” says Murphy.
One possible innovation, DiAngelis says, is a movement to on-line printing of the entire text of labels, not just lot code, expiration date, and NDC. “Why not print the whole label as well as the RSS code, which will also lower the cost of packaging materials and have the added benefit of minimizing packaging waste and inventory levels of packaging materials?” he asks. “The issue arises that if you print only the NDC on-line on a preprinted package, who’s to say you didn’t put the wrong NDC on the package? If you’re going to print the whole label, you won’t know you have the right NDC on the correct package.”
Whatever lies ahead, it will take a lot of effort to get there.
“It’s a big mandate,” Murphy says. “There is a lot of work ahead for pharmaceutical companies and hospitals to reach full compliance, but the benefits to the supply chain—including returns management and recalls—and to patients are clearly documented.”