Uniquely Positioned: Adding Serialized Codes to Packaging
Despite rule delays, pharmaceutical and medical device manufacturers may find reasons to begin employing unique identifiers.
Nutecï¿½s HP-enabled printing system utilizes inks from APS that can adhere to plastics.
When it comes to adding serialized codes to your pharmaceutical and medical device packages to support electronic pedigrees or to meet unique identifier requirements, you’ve got some time on your hands. FDA is still drafting proposals for industry standards, and in September, California Governor Arnold Schwarzenegger signed a bill by Senator Mark Ridley-Thomas that would push electronic pedigree deadlines to 2015 and beyond.
With no pressing regulatory requirement, pharmaceutical companies may be tempted to slow down. Given U.S. economic troubles and credit crunches, some companies may even consider delaying capital investments. But there may be significant advantages—even financial ones—to getting an early start.
California’s new law gives drug manufacturers until January 1, 2015, and beyond to comply with California electronic pedigree requirements. Before January 1, 2015, manufacturers will need to designate a minimum of 50% of their drug products that will be subject to the pedigree requirements. Before January 1, 2016, manufacturers shall designate the remaining 50%. Drug wholesalers have until 2016 to meet the e-pedigree requirements; pharmacies must comply no later than 2017.
FDA is still busy drafting standards for unique identifiers, for both drugs and medical devices. Work is well under way on unique device identification (UDI), which could very well guide the agency’s policies on drug identification. FDA is charged with developing standards for unique drug identifiers by March 2010, and any federal standards for unique identification and track and trace would take precedence over California law. But federal standards may take a while to be fully implemented.
In other words, manufacturers may have up to two-thousand plus days to figure out how to meet pending requirements for item serialization. Because the details are still being drafted and even debated, it may seem safer to wait for standards. Many directions have yet to be decided. For instance, if it will be acceptable to infer the contents of sealed cases along the pharmaceutical supply chain, item-level serialized bar codes will be sufficient. But if inference will not be allowed, item-level RFID tagging may be demanded to avoid having cases opened for scanning individual bar codes.
A Data Matrix code printed by Nutecï¿½s HP-enabled system can achieve an A ANSI grade.
Despite the uncertainty of the ultimate standards, technology developers advise pharmaceutical and medical device manufacturers to start applying unique codes to packages as soon as possible to overcome any challenges particular to products or plants.
“If you have only 50% of your product lines ready by 2015, you won’t get the other 50% ready in just a year, unless you’ve got only a handful for products,” says Bob Neagle, business unit manager, brand protection solutions group for Videojet Technologies Inc. (Wood Dale, IL). “Some pharmaceutical companies have said that they need seven years to roll out the e-pedigree system across the multiple production facilities and packaging lines that are affected.”
And printing a unique code on each package is a new avenue for most of the pharmaceutical industry as well as the medical device industry. “Historically, we have found that pharmaceutical manufacturers have just printed lot codes and expiration dates on packages,” says Dennis McLaughlin of Nutec Systems Inc. (Lawrenceville, NJ), an engineer who has worked for Purdue Pharma and Pfizer. “They have not been interested in becoming printers. But now, many are talking about individually serialized printing for commercial benefits, not just e-pedigree.”
Because of the potential efficiencies and visibility into the supply chain, some pharmaceutical and medical device manufacturers are starting to invest in item-level serialization, report technology providers.
Neagle of Videojet, for instance, is helping drug companies begin item-level serialized printing. “They see benefits other than meeting pedigree rules,” he says, pointing to obtaining data on charge backs and other supply-chain events.
One of Nutec’s customers, for instance, has already reaped benefits from serialized codes. Summit VetPharm LLC employs unique individual identifiers on its animal-health product ectoparasiticide Vectra 3D using track-and-trace technology from Nutec. Intended to be sold exclusively through licensed veterinarians, the product was discovered to be for sale on the Internet. Tracking those items with their serial numbers, VetPharm identified the veterinarian that was diverting products to the Internet.
McLaughlin sees more of these projects emerging now that the e-pedigree rule is delayed. “Eighty-percent of our inquiries now are for value-added identification projects to meet a particular need,” he says, referring to Summit VetPharm’s solution. Nutec currently has seven similar systems in the healthcare product industry that are printing unique codes, scanning them, creating data files, and uploading those files to a database.
Work on e-pedigree won’t come to a halt, though, says McLaughlin. “When there was the potential for regulations, companies were willing to pull the trigger on high-risk lines,” he says. “Now that FDA and the state of California have backed off for a while, companies may focus on adding serialization to some of the easier packaging lines.” Easier may mean lower volume, McLaughlin adds.
But not all pharmaceutical companies go to unique codes right away. Some may start off printing 2-D codes with date or batch codes. “If companies use lot- or batch-based business processes, this is supported by GS1 standards using a GS1 Application Identifier [the name GS1 uses for the data elements encoded in bar codes or RFID tags] that is different from a serial number,” explains Scott Gray of GS1. “It is important to note that GS1 can support all four levels of uniqueness: [Global Trade Item Number (GTIN), GTIN + date, GTIN + batch, GTIN + serial]. Our healthcare strategy basically accounts for an evolution more than a revolution in moving to serialization as printing bar codes and or writing tags are not the major factor. The main factor is business system and process reengineering in a pervasive way that establishes critical mass.”
George Wright IV, vice president of Product Identification & Processing Systems Inc. (PIPS; New York City), understands the appeal of easing into 2-D code printing without encoding a serial number. “You can move forward incrementally, and you can minimize the chance of inadvertently duplicating a serial number in your pilots, because if you do so, arguably the product may be misbranded. But companies have to realize that printing a bar code encoded with a static number in-line at a given speed is not the same as printing the same symbology with a unique code at a given speed. You may be able to prove the printing and scanning (data-capture) technologies and interfaces and to test static-data imaging throughput, but you cannot validate the system until you are actually printing, scanning, and managing the data from variable-data symbols.”
In late September, Wolke Inks and Printers LP (Tucker, GA) helped an existing pharmaceutical customer initially driven by looming e-pedigree rules add a second m600 advanced for printing unique codes. The firm will be printing lot, manufacturing date, and expiry date in a human readable code and printing a unique serial code in a 2-D Data Matrix for a track-and-trace project. These codes will be in addition to a linear bar code that represents the UPC. Wolke’s m600 advanced printer offers high-speed data processing for real-time printing and automatic security encryption of each Data Matrix code.
Nutec markets APS systems that can print on nonporous substrates such as plastics and untreated aluminum foil.
Neagle says that packaging converters are well on their way to serializing items. Despite the rule delay, they are not “pulling back,” he says. He believes that such converter involvement may be the industry’s first step into serialization, so the firm has developed IMprints for Converters, which includes an IMprints line controller that interfaces with all printers and vision equipment to manage code application and association.
In a recent converter installation, one pharmaceutical manufacturer is sending serial numbers to Videojet for application on a carton printing line using a binary-array printing system. “It is an ink-jet on steroids, printing with 256 streams at once. The system manages and prints serialized bar codes on the cartons and then reads and verifies the codes. If it cannot read a printed code, the system rejects it and keeps track of the rejected codes. The pharmaceutical company will then verify the printed codes on its own packaging line against a list of codes the converter provides.” The converter’s use of Videojet’s IMprints for Converters solution provides an opportunity for increased efficiencies should the pharmaceutical manufacturer choose to utilize Videojet’s IMprints Track & Trace Solution for its track-and-trace infrastructure in the future, Neagle adds.
Wright adds that contract packagers may also emerge as some of the leaders in item serialization right alongside some of the pharmaceutical manufacturers that have already made strides.
ON THE LINE
Mike Shaw of Nutec argues that inline printing systems may be in the best position to print codes that include batch numbers or dates. “Preserialization by label and carton converters most likely does not include lot or expiration date simply because lots and dates haven’t yet been determined,” he says.
For manufacturers that have been printing lot codes and expiration dates themselves on the packaging line, “printing serialized 2-D codes is not that much of a stretch,” continues Shaw. Software could be added to existing in-line printing systems to provide the control needed for unique item-level coding, or an entirely new software-controlled printer can be shoehorned into an existing packaging line, he says. An upgrade in printing technology may be needed to handle the finely printed 2-D bar codes usually needed to encode product codes and serialization strategies.
For instance, a Data Matrix code measuring one-quarter-inch square can include 38-character alphanumeric code and still achieve a B-level ISO/ANSI grade using HP’s thermal-ink-jet printhead, says Shaw.
Packagers are looking to serialize 2-D bar codes alongside human-readable codes. Image courtesy Videojet Technologies Inc. (Wood Dale, IL).
The controllers guiding printers through serialization can be as flexible as needed. Videojet’s IMprints system can grab codes from an SAP ERP system, it can derive codes based on rules, or it can create pseudorandom codes to support anticounterfeiting initiatives, reports Neagle. “Most drug companies are looking at straightforward serialization to comply with e-pedigree rules, but a few are working toward random serialization. We advise random if counterfeiting is an issue.”
Vision-enabled verification systems will need to be added to double check codes as they are activated and printed and to guide the controller as it assigns those uniquely coded items to specific cases. Nutec, for instance, couples vision technologies from Cognex/DVT, Systech, Siemens/Acuity, Optel, or others with its printers and software, and Videojet has been working closely with Label Vision Systems as part of its IMprints system.
Such “parent-to-child aggregation is one of the real challenges for companies,” says Neagle. To guide users away from trouble spots, Videojet’s IMprints system offers standard approaches to aggregation. “For instance, we advise that companies keep custody of items in case quantities after printing,” Neagle says. He acknowledges that when associated serialized bar coded items move along a packaging line yet are not sealed in a case, there is the chance that a QA professional could pull one out for random testing, disrupting the carefully aggregated relationships. “Companies may have to hand-scan it out, or have bar code readers at points beyond where QA folks could take out a bottle. If you want the level of precision needed for e-pedigree, companies will need extra cameras.”
RFID use, of course, would overcome the need to scan each bar code. But Neagle says that today, RFID isn’t ready for pharma in terms of readability and cost. “Readability must be well over 99% for pharma lines; RFID just isn’t there. The technology probably will evolve, though.”
MEDICAL DEVICES, TOO
The m600 advanced from Wolke Inks & Printers utilizes the latest processor and interface technology for compliance with 21 CFR Part 11.
Medical device manufacturers are also considering unique item-level identification. “We are getting requests from larger medical device companies looking to add real-time or sequential variable bar codes to their packages,” reports Tom Pugh of Bell-Mark Corp. (Pine Brook, NJ). “Most packagers are printing in-line today, so they may already be using a programmable printing system. They are looking at employing Data Matrix, GS1 DataBar Stacked, even linear bar codes.”
Upgrades may be needed for many. “The simple fact is that they will need a high-quality programmable printer appropriate for their packaging,” he says. Bell-Mark has just announced a new human-machine interface for its printer control systems for packaging machines. “It is simpler for operators, and it will be a plus for managing variable bar codes.”
Pugh says that sequential coding offers benefits beyond any pending FDA standards on unique device identification. “There is a keen advantage to identifying specific items that may have integrity or sealing problems and recalling those from the field. Recalls can be expensive, and anything you can do to identify specific items may allow you to minimize costs.”
Greg Rochon, president of Greydon (York, PA), says that serialization makes sense for certain medical devices, such as those used in the body. “For ultimate control on the supply chain, serialize these products. It may even fight tampering. But I don’t think that every medical device needs to be serialized.”
Nutec and APS have overcome the challenges with using HP’s thermal-ink-jet technology for printing on nonporous substrates often used for medical packaging. “APS has a patent issued for the ability to print on nonporous substrates such as plastics and untreated aluminum foil,” reports Shaw.
For both pharmaceuticals and medical devices, use of the GTIN is dicussed in GS1 Healthcare’s GTIN Allocation Rules for Healthcare.
Wright from PIPS says that GS1 Healthcare is helping stakeholders understand the potential of a truly global and integrated universal item and location identification system. “This is still very much a work in progress and will be for at least another decade,” he says, but tools are available for “global traceability, implementable today. There is tremendous opportunity for manufacturers to identify where products are in the supply chain and where the holes may be.”
While visibility offers some incentive for unique identification, Wright feels that FDA regulations will hold the most weight for the industry, “principally for their uniformity and standardization but also as the prime motivator. Improved supply-chain efficiency and brand protection are valuable on their own, but nothing trumps regulatory requirements in the name of patient safety. ”