FDA is developing standards for automatically identifying lots or serialized products. Product manufacturers are looking at bar codes to help them uniquely identify pharmaceuticals and medical devices, which leads them to some level of variable coding technology use.
|Bell-Mark recently had its EasyPrint MLP (Thermal Transfer Printer) and its FlexPrint mini (Flexographic Printer) installed on a Multivac packaging form-fill-seal machine for printing static and dynamic codes. Photo courtesy of Bell-Mark Corp.
Could the days of relying solely on static bar code printing be over? Recent word from FDA shows that the agency is interested in having drug and medical device packaging carry unique identification. For instance, at FDA’s “Unique Device Identification Public Workshop,” held on February 12, FDA’s senior advisor for patient safety Jay Crowley spoke about the potential use of a production code for automatically identifying particular lots or even specific items of medical devices. This variable code would join an existing static product code.
Further, FDA is interested in autoID for drugs. In January, FDA introduced draft guidance suggesting the voluntary use of a standardized numerical identifier (SNI) on prescription drug packages. It proposes that the SNI for most prescription drug packages be a serialized National Drug Code (sNDC) composed of the NDC and a unique eight-digit numerical serial number generated by the manufacturer or repackager for each package.
FDA is sorting through comments, both from the UDI meeting as well as from its proposed guidance. The exact path forward is just now being plotted. In fact, FDA may not specify a particular bar code symbology or even that a bar code must be used. RFID is still a potentially acceptable data carrier. Many companies, however, are pursuing the use of bar coding.
To prepare for unique bar coding, you should be reviewing your packaging and printing line capabilities as well as those of your contract partners to be sure you can transition to some degree of variable printing. And if you want to use RFID, you will need to bring several systems online and inline. And don’t forget inspection—you will want to equip your lines to be able to handle the increased code verification duties. Finally, you will also want to evaluate your data capabilities. Will you need software upgrades for creating variable codes and handling the data?
TIME TO CHANGE OVER
When it comes to bar coding, the challenge for pharmaceutical and medical device companies may not be finding capable coding technology. “Technologically speaking, adding variable bar codes to packages is a piece of cake,” says Ralph Dillon, managing director of Compliance Surety Associates. He says that some forward-thinking pharmaceutical companies were successfully printing serialized bar codes online at line speed in the late 1990s, but at that time, the vision systems couldn’t quite keep up. Now, “with computer clock speed advances,” that’s no longer the case, he says.
The key tools companies need in place for variable printing are “a capable programmable printer—like an ink-jet or laser—a vision system that can verify codes as you print them, and space on your label or package,” says Dillon. “With those in place, whatever FDA tells you to print, you’ll be able to do so. If you need to change it, you’ll be able to upgrade software to do so.”
So, you may be more ready than you think. Tom Pugh, vice president of Bell-Mark Corp. (Pine Brook, NJ), says that most of his customers are already asking for some sort of variable-printing capabilities. “Over the last five years, we have seen that anyone who has a printer on a packaging line is equipping that printer with a programmable device. They are adding one or two different printers.” Pugh adds that the technologies his team is often adding to lines already running flexographic printers are thermal-transfer and ink-jet printers.
Steve DiAngelis, director of Hapa, North America (Rockaway, NJ), says that “in most cases, it is less expensive for the end-user to print the product-related information, which repeats every cycle, with flexo, which also provides the best online printing quality, and the variable information with noncontact digital printing technology. This provides the best of both worlds for the customer.” He adds that Hapa has “had requests to serialize and bar code down to the blister tablet.”
The larger, multinational medical device companies have already been printing variable codes for some time, adds Pugh. “They have been dealing with country-specific codes,” he says.
Perhaps the struggle may be in the process change itself. “In most cases, the challenge is a shift from printing fixed human-readable data, such as a lot code, to continuously variable data in a bar code that has to be reliably read by camera and scanning systems,” explains Bob Neagle, business unit manager for Videojet Technologies Inc.’s Brand Protection Solutions Group (Wood Dale, IL). “This introduces a variable that could affect the throughput of the packaging line either through downtime [e.g., having to stop the line because of unreadable codes] or running speed [e.g., printing system can’t process and print as fast as the packaging line can run]. Choosing the right supplier who can assist by putting in place the appropriate printing technology can mitigate this risk.”
QUESTIONING THE DATA—AND THE CODES
|Medical device manufacturers are considering the use of DataMatrix codes to add automatically identified lot codes or other unique information. Packages courtesy of Bell-Mark Corp.
“Item serialization for anticounterfeiting or any other reason is not a simple process,” explains Jim Umbdenstock, president of Griffin-Rutgers Company, Inc. (Ronkonkoma, NY). “Printers with capable software packages exist to create high-quality 2-D codes. The larger issue is, what do you do with it after it is printed? You have to read and track the serialized package and associate it with a carton, case, pallet, or so on. How do you ensure that are you getting all the correct data?”
Pugh says the most-common questions he hears theses days pertain to the data behind the codes: “Can you import data? Can you network the printer?” His answer is an affirmative one, and he often points toward Bell-Mark’s Versa-Style label-creation software for generating the bar codes.
Software and hardware must be robust, however. “With a data change for every package, there could potentially be a much bigger demand on the printer’s internal processing controller than there would be for static printing systems,” explains George Wright, vice president of Production Identification & Processing Systems (New York City). Reliability in printer control is of utmost importance when serializing products, because any duplication could require a product recall.
As Wright explained in a past PMP News article, “If you inadvertently duplicate a serial number, arguably you have a misbranded product.” You simply don’t have this risk with static product coding, so you need to institute safeguards to prevent duplication.
And no serialized package is an island. Neagle adds that “coding individual items is only a starting point for drug traceability. Prior to shipment, individual items often get put into bundles, which get put into cases, which get put onto pallets. It is necessary to create parent/child relationships between these packaging hierarchies. Again it’s important to choose a vendor that has the experience and the resources to ensure their product offering can be adapted into the particular use-cases related to how that plant packages and ships products.”
And then you have to store that data, says Umbdenstock. “How large a memory bank do you build? How long do you hold onto the data—for the shelf life of the product? Or beyond? The challenge is understanding what the investments and ongoing costs will be.”
THE ULTIMATE GOAL
FDA’s Web page states that the new UDI system will require “the unique identifier to be able to identify the device through distribution and use,” and “the unique identifier to include the lot or serial number if specified by FDA.”
Lot-based identification isn’t a stretch for most of the medical device industry, says Crowley. But “encoding a lot number in a code” will be a challenge, he says. It essentially turns a static bar code into a dynamic one, requiring printing on the fly, he explains.
And by using sNDCs, FDA believes such identification can “facilitate authentication and tracking and tracing of prescription drugs.”
But even if FDA does not require serialization down to the lowest saleable unit, manufacturers may end up having to anyway. “With initiatives aiming for bedside delivery of drugs utilizing automatic identification [e.g., Computers on Wheels], manufacturers may eventually need to code at the item level,” says Umbdenstock.
Concludes Ralph Dillon: “Now that we have slain the major technical impediments to serialized bar code and the political imperative rises, we must race to put it in place as quickly as possible. In difficult financial times, where even local coffee shops are sneaking in nondairy creamer powder as an unannounced substitute into your carry-out coffee, one must expect nefarious, highly profitable counterfeiting and diversion will increasingly attack legitimate supply chains. Bar coding as a tracking tool is a first line defense for the company and patient suffering the consequences of illegitimate drugs.”