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Pharmaceutical and Medical Packaging News Magazine
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Originally Published PMPN November 2005

Coding and Marking

Coding Matures

by David Vaczek
Senior Editor

Healthcare and revenue issues are at stake as companies jump into RFID and expand the scope of bar coding.

Microscan's Quadrus EZ inspects unit-dose RSS/Composite cpdes on a blister packaging line.

When it comes to advancing bar code and radio-frequency identification (RFID) programs, 2005 has turned into a pivotal year for pharmaceutical companies.

Companies have purchased printers to produce small machine-readable codes and variable data. Preparing for FDA’s April 2006 bar coding deadline, many are verifying and grading bar codes to standards in-line, with systems that were perceived as too costly just a year ago.

In terms of RFID, the pharmaceutical industry has transitioned from window shopper to consumer. Companies are adopting RFID solutions for selective tagging of products and launching initial pilots to investigate technology options. Purdue Pharma (Stamford, CT) has progressed from item-level tagging to solutions that integrate RFID data into legacy systems and share product pedigrees with partners for track and trace programs.

“In the past year, there has been a clear understanding that RFID can and does work,” says Rick Raber, RFID pharmaceutical product manager, Northern Apex (Fort Wayne, IN). Purdue Pharma uses Northern Apex’s Constellation software for tag scanning and verification and for sending the data to Purdue’s SAP application, at two facilities. Purdue has been shipping tagged bottles of Oxycontin and its Palladone pain medicine to H. D. Smith Wholesale and Wal-Mart.

“We are working with two other pharmaceutical companies to tag normal production items being shipped to Wal-Mart, one with an identical program to Purdue’s. The other company is also tagging at the item level,” Raber says.

RFID BUILDS STEAM

Other vendors confirm that drug firms have advanced their commitment to RFID, following the lead of companies such as Purdue and Pfizer, which is tagging Viagra at the bottle and case level. “Pharmaceutical companies have had RFID on their calendars. Now they are seriously looking at and adopting solutions,” says Joe Costa, director of marketing, Systech International (Cranbury, NJ).

The company has several implementations under way of its TIPS Serialized Product Tracking solution, which provides product mass serialization and track and trace of item-level products. It provides the backbone for anticounterfeiting, product authentication, pedigree, diversion control, and chain-of-custody applications. “With more than $30 billion worth of counterfeit and diverted drugs flooding the market annually, manufacturers are seeking to address the staggering financial, brand, and public implications,” says Costa.

Such programs are proceeding, despite uncertainty over requirements and standards.

“There are no defined standards yet on what should be included on a tag or how that information will be passed through the pedigree chain. These are still evolving within EPCglobal Inc. and other industry organizations. Numerous states have come out mandating electronic pedigrees, but many of their requirements are unique to each state,” says Raber.

Raber says that some manufacturers desire to include only mass serial numbers in tags, without a National Drug Code (NDC). “So, if somebody with a reader scans a group of cartons, they won’t know which carton is more desirable to steal. Others are saying, ‘I want item-level information in there, so those down line, such as pharmacists, can obtain the NDC when they scan the product,’ ” he says.

While FDA has promoted RFID use as an anticounterfeiting tool, the agency has been short on specifics. “I think the technology firms and the end-user community have developed a lot of tools. FDA has to put some definition on how it expects people to use those tools,” says Dan Mullen, president, AIM Global (Warrendale, PA).

Companies are not sure what tag and reader frequencies to support. Industry looked more closely at high-frequency (HF;13.56-MHz) tags after Texas Instruments (Dallas), Royal Philips Electronics of The Netherlands, and TagSys (Doylestown, PA) issued a white paper that defined the benefits of HF for item-level tagging, says Raber.

Drug firms began investigating HF as a technology that works better than ultrahigh frequency (UHF; 860–960 MHz) around liquids. This has spurred RFID adoption. Yet, companies using UHF were prompted to investigate HF, which has “slowed down the adoption process. Two years ago, 13.56 MHz was not in the picture, so people started doing pilots with 860–930 MHz. Now they are saying, ‘I want a better understanding of what 13.56 MHz can do,’ ” he says.

“All of the pharmaceutical companies are looking at HF right now. We have seen interest in the HF tags grow considerably in the past year,” says Phil Henry, manager, RFID technology, National Label Co. (Lafayette Hill, PA), a label printer and converter. “We are doing HF tag development with several companies,” says Henry.

NEW STANDARDS

EPCglobal standard setting jumped ahead with the ratification of the Applications Level Events (ALE) standard, the first EPCglobal standard for software.

ALE sets a standard interface for filtering and collecting electronic product code (EPC) data. It defines how reader data are sorted and aggregated and provides a standard way for users to request information. “This is a mechanism for an upstream user to specify what level of information they would like to see. You might say ‘just give me a list of all items, or, instead, just cases from a specific manufacturer that went through a specific dock door,” says Bryan Tracey, chief architect, GlobeRanger (Richardson, TX).

EPCglobal is working on standards such as EPCIS, which defines how data are sent between business partners, and the Reader Protocol, for communications between middleware and readers, says Russell Patrowicz, vice president, business development, Acsis (Orlando, FL).

“There are still a lot of standards that need to be defined and ratified. The expectation is that by the end of 2006, most if not all standards will be ratified,” Patrowicz says.

The ALE standard follows EPCglobal’s endorsement of the Gen 2 tag and reader protocol standard. “In the first three quarters of this year, people were holding back on purchases. Gen 2 equipment is just inching its way into availability, as manufacturing of tag and reader products starts up,” says Raber.

Among the advantages of UHF Gen 2 tags are that they have more capacity and they support keeping track of data when multiple readers are being used. “Gen 2 is an awesome specification. People just starting with Gen 1 tags might see this as a hiccup, but it will prove to be a critical enabler of full-scale RFID solutions,” says Tracey.

Drug companies are turning to label converters for preencoded RFID tags, since in-line coding of tags can slow line speeds. “Drug companies that we have integrated with to date are utilizing preencoded tags. I am not aware of anyone running production and encoding labels at line speeds, or, if they are, they are not doing it at 120 or 150 bottles a minute,” says Raber.

Converters such as National Label are supplying these tags, encoding serialized numbers when requested. “For customers supplying Wal-Mart, in one instance we programmed UHF labels with EPC numbers. For another pharmaceutical company, we developed and programmed a label that incorporates an RFID tag along with printed overt and covert anticounterfeiting technologies. We are eliminating the need to program the labels on the labeler, which can reduce line efficiencies,” Henry says.

National Label does inlay verification and tag programming. Inlays are tested before integration into the label. National Label’s Merge system inserts the tags into the preprinted labels, and the RFID labels are read at several points to validate the process. During the final inspection process, the labels can be programmed with serialized EPC numbers if requested. Programmed tags are read, and the EPC is checked against the bar code. EPC data are saved to a file for submission to the customer.

Yet drug companies have been investigating in-line tagging alternatives.

Datamax Corp. (Orlando, FL) has launched an RFID option on some models in its I-Class printer line. The company’s I-Class RFID printers and RFID Ready printers support writing to HF or UHF tags, for simultaneous tag coding and bar code printing. The RFID Ready printer features field-installable modules for the HF and UHF support. The systems can write to Class O, Class O Plus, ISO 1800-6, the Philips U code standard, and Gen 2 tags, says Sarah Schabacker, director of channel marketing.

“We are seeing a lot of interest in RFID from many industries, but particularly in the pharmaceutical industry, given Wal-Mart’s mandate for tagging Class 2 narcotics and the need to combat counterfeiting. There is demand at a high level, and we expect that to increase into actual mass product shipments in the next year or so,” says Schabacker.

Zebra Technologies’ (Vernon Hills, IL) Alchemy avoids the need to switch media for smart label and traditional label applications. Instead of using smart label media, it bonds an RFID inlay to the label only when a tag is needed.

Markem Corp. (Keene, NH) has launched the 800-series high-speed RFID encoder/ applicator for tagging cases. Gen 2 compliant and built to work with existing software, it can handle up to 100 cases per minute.

The Fast Tag encodes and applies RFID tags utilizing a Videojet label applicator and a Accu-Sort RFID reader.

Videojet Technologies Inc. (Wood Dale, IL) offers the Videojet Fast Tag applicator that encodes, applies, and reads RFID tags. It also features a patented bad tag reject component. Fast Tag has “10 RFID protocols preselected and programmed in” supporting different tag types and communication protocols. In the bad tag solution, “we are reading and rejecting bad tags at the point of application, rather than four or five labels back,” says Ian Carver, product manager, labeling systems. Fast Tag incorporates Accu-Sort Systems Inc.’s (Philadelphia) RFID reader that reads the bar code and references software to determine whether an RFID tag is required.

Accu-Sort suggests solutions such as the Fast Tag Start tag applicator and reader to companies looking to experiment with RFID manual tagging. The company’s Fast Tag DataServer and Device Manager is middleware supporting “a complete tag-to-ship solution,” says Frank LaBarbera, director of RFID product management. Accu-Sort’s historic focus has been in distribution center bar code and RFID verification in many industries. “We have been working with Schering-Plough tagging certain OTCs at the case level,” he says.

Automated Packaging Systems (Streetsboro, OH) has developed a fully integrated system for its Autobag AB 180 bagger that employs both RFID and bar code technology. In such applications as pharmaceutical mail order fulfillment, products can be identified at the item level using a preapplied and preprogrammed RFID tag. That tag provides information to the system controller, which correlates patient identification, shipping, and prescription information.

The appropriate data are then sent to the printer, which produces bar codes and human-readable shipping information directly onto the mailbag. Data are also programmed into a second RFID tag that is preapplied directly to the bag just prior to packaging. The complete printed, loaded, and sealed package and the contents can then be verified, without line of sight, using an RFID reader/verification system before shipping.

PURDUE PROVIDES A PEDIGREE

Purdue Pharma is employing electronic pedigree software from SupplyScape (Woburn, MA) on a Unisys hardware platform for sharing shipment data with the wholesaler H. D. Smith. The software is integrated with Purdue’s SAP system. When Purdue is sending a shipment, the SAP feeds the data to the pedigree software. The software provides a pedigree document and sends it to the wholesaler. H. D. Smith authenticates it with a digital signature and then scans the tags to match the pedigree serial numbers to products received. The pedigree transfer supports supply-chain visibility and authentication, because an item can be excluded from the channel if it doesn’t track back to the manufacturer.

Purdue Pharma’s integration of RFID into its business processes made the pedigree solution possible, says Michael Celentano, associate director, supply chain and RFID systems.

“We are applying the labels to the bottles on the line (reading 48 bottles in five seconds), and then we are automatically collecting that data, seamlessly integrating it into our SAP system. There we can manage it for future downstream applications,” says Celentano.

“So, we created the first step of the electronic pedigree on our end. We know the serial and lot numbers, and the date of expiry, and then, when it is shipped, who it was shipped to, when it arrived, and who signed for it,” he says.

“We are in discussion with many of our customers and expect to tag more volume in more pilot programs over time and expand the electronic pedigree pilot,” Celentano says.

The company uses Symbol Technologies 915-MHz Class O tags. “This is what Wal-Mart had asked for. If the industry were to switch to HF, we have the capability to switch out hardware appliances and support that,” he says.

Northern Apex’s Hercules stations and Galaxy software control Symbol AR400 readers to capture tag information at reader stations along the packaging line as products are packaged. The solutions are used for checking the preencoded tags, validating the tags after they have been applied, checking the serial numbers, and checking the cased bottles. It is handling inbound and outbound vault monitoring. Purdue also uses Symbol Technologies’ mobile computers for RFID and bar code reading, imaging, and Wi-Fi connectivity.

NEW BAR CODE NEEDS

FDA’s requirement that companies put bar codes onto the lowest-sized level of packaging, such as unit-dose blisters, has spurred demand for new printing solutions. In some instances, companies are using two-printer set- ups, pairing a programmable digital printer with flexographic printing for printing labels and bar codes. Others are using flexographic printing alone, making plate changes for varying lot and expiry data.

Programmable thermal-transfer and ink-jet systems can provide the precise printing of small bar codes that are often required, as well as on-the-fly variable printing.

“We are seeing demand for variable printing grow dramatically,” says Tim Lydell, director of sales and marketing, Label Vision Systems Inc. (Peachtree City, GA). Companies are typically using digital printing for lot and expiry data text printing along with codes and also to support changing bar codes when multiple products are marked in short runs, he says.

This demand is driving sales of Label Vision’s in-line bar code validation and verification systems. “In-line verification and grading to ISO standards has been adopted rather quickly. We have shipped a half-dozen systems in the last two months. Using these systems, people are catching their errors and reducing the fines that are levied when bar codes don’t scan. We are working with one vendor that was issuing $2 million in fines annually for noncompliant bar codes. People don’t want their lines grinding to a halt when bar codes don’t scan, and they are going back to suppliers and trying to educate them to do it right,” Lydell says.

“Digital printing can create bar code anomalies—arising from nozzle jam-ups, ink overspray, and toner defects in substrates—that you may not see if you are spot-checking codes off-line. Label Vision’s LVS 7000 validates the readability and content of bar codes and numbers and lot and expiry data. It also grades 1- and 2-D codes, such as Reduced Space Symbology/Composite Codes to ISO/ANSI standards in-line at line speeds,” he says.

For reading RSS Composite symbols, omnidirectional imagers can cope with the code’s small row and bar heights, says Niels Wartenberg, applications engineer, Microscan Systems Inc. (Renton, WA). The firm’s Quadrus EZ imager supports match code routines or can report all or part of the encoded data in codes, including Data Matrix and RSS/ Composite through RS232 or Ethernet connections.

“Often people just want to know whether you read the correct code. Customers are typically looking for mismatch reporting, and, after the run, counters of good, bad, and no-reads. If companies want to extract more information, we provide high-speed Ethernet connection for reporting,” he says.

Many of Systech’s customers use the company’s TIPS Sentri in-line bar code grader, says Costa.

Thermal ink-jet (TIJ) printing has gained use in the pharmaceutical industry. RSI Print Systems’ (Gaithersburg, MD) products employing Hewlett-Packard (HP) ink-jet technology are used in cartoning and in flexible packaging for printing on porous and semiporous media, such as Tyvex and paper, says Michael McKinney, vice president marketing.

“Ink-jet has not historically been used with foil. We have done some printing on foil materials where an ink-jet-receptive coating has been added to it. The industry will be hearing more in the coming year about new types of inks, including UV-curable inks, for addressing some of these nonporous substrates,” he says.

Some RSI Print Systems models print 50 inches per second at 600 dpi for various print speeds, or about twice as fast as most TIJ printers, says McKinney.

“Speed is important, because manufacturers are trying to increase their production. We are printing DataMatrix, RSS stacked composite, and all the linear codes on the fly, three times faster that you can with a thermal-transfer printer,” he says.

HP took aim at ink-jet consumable costs with its IMS (industrial manifold system) for bulk ink delivery for high-volume printing applications. The IMD docking station holds four 350-ml cartridges, each of which feeds through gravity four 42-ml print cartridges. “IMS provides the flexibility of buying larger ink supplies. We have effectively cut the cost of ink in half,” McKinney says.

FLEXIBILITY

“What has become crucial for most pharmaceutical manufacturers is flexibility in the coding. People want to be able to print as much information as possible. In many cases, that has meant applying static and programmable printing directly onto the same package,” says Glenn Breslauer, director of marketing and information technology, Bell-Mark Corp. (Pine Brook, NJ).

For static printing of labels and bar codes, Bell-Mark’s FlexPrint II offers two-color in-line flexographic printing. FlexPrint II was the first printer to feature the two-color flexo alternative to preprinted webs and two-printer solutions, says Breslauer.

Flexographic printing of labels and bar codes is feasible for many applications because of the efficiencies of in-house platemaking technology. It is most suitable for customers doing longer runs, says Greg Rochon, president of Greydon Inc. (York, PA). “Plate-making systems provide a value-added [option] to our printers. We say it makes our printer ‘semiprogrammable.’ You can make a plate at the last minute, put it in the machine, and do it cost-effectively,” Rochon says. “Most of our customers are using the same lot number for three or four hours, or a full day. Changing a plate every three hours to change the bar code and lot number is not a big deal,” says Rochon.

Greydon has built a two-station flexographic printer for two-color static printing for a major pharmaceutical manufacturer. Two-color printing has been favored for medical devices because it allows end-user practitioners to identify devices by sizes and color. “We were using the two-station flexo printing for medical devices for printing UCC/EAN Code 128, but had never considered it for the pharmaceutical industry,” Rochon says.

Concerns over patient safety and liability are driving the adoption of thermal-transfer printing, says Gary Hinthorne, sales manager, Dynic USA Corp. (Hillsboro, OR). Companies need to print very fine detailed fonts and scannable bar codes that are chemical resistant, he says. “You need a reliable transfer ribbon married to the substrate for the high-speed printing the industry requires,” he says.
Dynic offers enhanced ribbon technology for pharmaceutical and medical device companies that require high-image definition and durability in thermal transfer printing.

“Reliably sharp images ensure scanability and resistance to smearing, smudging, scratching. Dynic has focused on a full line of formulas, including high-end wax resin and resin coatings, that support this precise printing, at high-line speeds, and that hold up in autoclave sterilization,” Hinthorne says.

Dynic now has 10 Sirius brand ribbons that have Drug Master Files listed with FDA. The company has recently formulated a resin ribbon to work in medical or hospital applications requiring resistance to isopropyl alcohol and other chemicals and fluids. Also, printer manufacturers are using Dynic’s antistatic back-coated ribbons in RFID label–printing applications, he says.

Videojet’s latest printing offerings include the DataFlex Plus thermal transfer overprinter for high-resolution variable printing on flexible packaging and labels. DataFlex Plus features a 1000-meter ribbon supporting less-frequent ribbon changes, and thus production line efficiency. “Data Flex Plus can produce ANSI Grade A bar codes when printing on a white substrate. In the past, companies just wanted a readable bar code. They are starting to stipulate ANSI Grade C or better,” says Carver.

IV BAG CHALLENGES

Matthews International offers two-step digital thermal-transfer printers to manage IV bag flexibility.

Manufacturers have adopted thermal-transfer printing to supplement or replace hot stamping for IV bags. Hot stamping has been used for printing text and data, such as “use by” dates and lot codes. The method presents setup costs for changing information and prints bar codes with inconsistent quality, says Trace Bocan, product manager, contact products, Matthews International (Pittsburgh).

“Using hot stamping, you can’t get a reliable, scannable bar code onto the slightly irregular surfaces without a lot of rejects,” Bocan says. Traditional thermal transfer also has its limitations, since printhead damage and bar code voids can occur, as the printheads ride directly over the surface to be marked, he continues.

Matthews’ Coditherm digital thermal-transfer system uses two-step printing to manage the irregular surfaces of PVC IV bags. As the ribbon passes over the printhead, the code or text is burned onto the ribbon. The ribbon then moves under a heated silicone transfer roller that applies pressure and heat to the ribbon to transfer the code to the material. “We are printing reverse bar codes with the definition required for scanning onto clear PVC bags. Some processes will use hot stamp to print the text and the Coditherm for the bar code. The Coditerm could be used to print the static and variable information in one pass,” Bocan says.

“Coditherm is for applications that need high-quality printing and variable data needs, or for short batches in which the code changes frequently. People are looking to print lot and expiry data, and we are seeing pilot programs in hospitals where sequential numbers will be associated with each bag,” he says.

IMPLEMENTATION

Bar coding is filling an important role, and RFID is still in its early stages. The value of both will become more apparent when hospitals more widely adopt bedside bar code scanning and when RFID is used to build electronic drug pedigrees. RSS/Composite and other 2-D codes allow more information to be put into bar codes. As more companies explore RFID, companies such as Purdue Pharma will provide a model for RFID integration into business systems that support tracking and tracing initiatives for serialized unit-of-use drugs.

 

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