Medical Device Link.

BAR CODING SUPPLEMENT

The ThermalPak Model-4000 multiple-head thermal-transfer printer from Norwood Marking Systems provides a cost-effective solution for multilane marking.

Industry has advanced rapidly in the bar coding of pharmaceuticals in the two years since FDA required the codes for most prescription drugs and OTC drugs used in the hospital arena. Using preprinted bar coded labels, or printing codes directly onto packaging in-line, many firms have adopted the robust Reduced Space Symbology (RSS) for encoding National Drug Code (NDC) numbers in a linear format on the lowest-sized level of packaging.

Pfizer, Bristol Myers Squibb, and Roxanne led in the coding of unit-dose blisters, printing RSS along with a composite 2-D stacked linear symbology for coding variable data such as expiration date and lot code. Abbott Hospital Products has put RSS and Code 128 on all its hospital injectable drugs and IV solutions. More recently, Eli Lilly extended its bar coding of insulin packaging by putting bar codes directly onto individual insulin vials. Since the vials are often removed from outer packaging, the coding is critical. Hospital error rates in the product’s administration can be high, as there are many insulin types with different durations of activity.

With FDA’s April 26, 2006, deadline for compliance with the bar code rule just around the corner, most major companies seem prepared to meet it. One concern, however, is that FDA has yet to clarify whether the deadline refers to the date by which products must be packaged with a compliant bar code or whether products shipped by the manufacturer must be compliant by this date. The latter interpretation could have a significant negative effect on a manufacturer’s ability to ship current inventory that does not contain the required bar code, says George Wright IV, vice president, Product Identification & Processing Systems Inc. (PIPS; New York City).

“We think there is going to be a high degree of compliance, especially among many of the Rx pharmaceutical companies, even if FDA says that the deadline applies to products shipped on or after April 26. But other companies are still working just to be able to comply with the packaged-on-or-after interpretation,” says Wright. “Among smaller firms, and among manufacturers of OTC products in particular, it is an open question as to whether many of them are going to be able to meet either interpretation. Based on the comments we have heard, they seem to be lagging.”

Some firms are using RSS only, in either the RSS-14 Stacked or RSS Limited formats, while others are pairing it with the 2-D composite component symbology. “The RSS portion represents the minimum for compliance under the FDA rule. You are identifying the drug and its strength with the 14-digit GTIN (global trade identification number). Where production processes allow, manufacturers are using the 2-D composite component for coding lot and expiry data to provide the added information for the benefit of their customers and patients,” says Wright.

Device makers can mark individual pouches, blister cards, and Tyvek sheets using Bell-Mark’s Easy Print off-line thermal-transfer printer paired with a high-speed conveyor.

RSS has been the predominant choice for printing a bar code on packages that have previously not had one, says Wright. “Although Code 128 is a permitted symbology under the FDA rule, most companies that understand its limitations are migrating from Code 128 to RSS on packages not intended to be scanned at retail, where UPC is still required. As flexible as Code 128 is, the same information encoded in RSS results in a much smaller symbol and one that, despite its small size, can withstand more printing defects by a considerable margin than can Code 128,” Wright says.

Richard Davis, president of Quint Co. (Philadelphia), says that some companies have avoided using the composite portion to simplify printing requirements. “Hospitals are asking for encoded lot and expiry data. We have tried to convince customers that the RSS composite symbol is very easy to print and that in fact the composite prints even better than the RSS part of the symbology,” Davis says.

“Package redesign to accommodate FDA’s bar coding ruling has been an expensive, time-consuming exercise for the pharmaceutical industry. We have advised companies to not only leave room for the linear code, but also to create space for the composite code. Then, should FDA revisit the ruling and request that human-readable data be in a machine-readable format, a company could add the code without the large cost and time of a complete label redesign,” says Jim Umbdenstock, president of Griffin-Rutgers Inc. (Ronkonkoma, NY).

For now, UPC, RSS, and Code 128 meet FDA’s requirement that companies encode the NDC number in a standardized data structure and a linear symbology specified by GS1 (formerly The Uniform Code Council Inc.) or the Health Industry Business Communications Council (HIBCC).

SERIALIZING WITH DATA MATRIX

In its pilot project RFID-tagging and bar coding Viagra bottles, Pfizer uses Data Matrix for coding serialized product numbers and as a backup to serialized numbers in the EPC-coded chips. Bottles also feature a UPC linear code that addresses the FDA mandate.

CCL Label preprints the linear code on smart labels incorporating RFID tags from Tagsys (Doylestown, PA). The tags include black boxes onto which a Domino Amjet printer laser ablades the Data Matrix code in-line at line speeds. On cases and pallets, a Zebra printer in-line encodes the EPC and prints the Code 128 bar code and human-readable EPC data.

Packaging line devices, the writing and recording of EPCs to the tags, and redundant bar codes are managed by the TIPS Serialized Product Tracking (SPT) software from Systech International (Cranbury, NJ). TIPS SPT tracks and traces process flow data collection and storage and establishes parent-to-child links with items, cases, and pallets. The Pfizer solution integrates Tagsys HF and UHF tags, with item-level HF tags coded at line speeds of 120 bottles per minute. The solution includes the RXAuthentication Service from SupplyScape Corp. (Woburn, MA), supporting electronic pedigree and drug ID.

The Data Matrix code is composed of 22 characters, including “the EPC header information and the most significant digits of the serialized portion of the EPC number. We remove the padded zeros,” says David Dejean, director of global PPM sales, Systech International.

Systech is engaged in several pilots of the TIPS SPT solution with other drug makers, including one European blister manufacturer. “These are not massive rollouts. Manufacturers at this point are looking for results. Programs require significant investment and training, so they want to establish that the technology is working. We are working with companies on pilot programs, involving one product, one line,” says Joe Costa, director of marketing, Systech International.
“Pfizer is taking a leadership position in the use of Data Matrix in a complementary fashion with an FDA-compliant linear code. From their perspective, in using the dual coding, they fill up the pipeline with labeling that is compliant today and useful tomorrow in a more-advanced setting,” Wright says.

SUPPORTING RFID

Greg Metcalf, industry market manager, Nosco Security Protection, Nosco Inc. (Gurnee, IL), says that other companies have begun to use bar codes and bar code data storage and management systems as a bridge to RFID. “Pfizer is spending $4 million or $5 million to set up its RFID pilots. That is a significant expense, particularly for a smaller company. Bar code technology is an easier way to begin serializing and tracking product, since distribution networks are already set up for reading bar codes. So you can begin to develop a formula for tracking product, setting up criteria you would use with an RFID system,” says Metcalf.

Even as RFID is established as an authentication and tracking technology, bar codes will be used as a critical secondary system. “People are going to try to bar code as many products as humanly possible. Bar coding will be the redundant feature for RFID for a long time to come. We are involved in several RFID pilots looking at 1-D and 2-D codes as the back up for the EPC. The bar code will scan back to a data base for tracking packaging’s migration paths,” says Metcalf.
Kevin Erdman, CEO of Verify Brand Inc. (Minneapolis), offers a Web-based ASP model that supports product serialization, authentication and track and trace, and reporting and event management. Early adopters are using Data Matrix codes for carrying unique product identifiers. “We are working with pharmaceutical and medical device companies in the early stages of large-scale deployment,” he says.

FLEXO VERSUS VARIABLE

Digital printing is most suitable for companies with significant variable-data needs. Flexo has proven capable of printing the small, high-quality marking the marketplace requires. It is often more cost-effective for printing repeatable data. “From a risk-based standpoint, there is less risk if you are using flexo printing, providing you have done up-front quality control. Dynamic printing technology introduces more chances for error. But we are seeing a great increase in variable printing, as people want to avoid the time and expense of plate changes,” says Tim Lydell, director of sales and marketing, Label Vision Systems Inc. (Peachtree City, GA).

Davis says that Quint’s polymer flexo plates “go through hundreds of checks before a plate is shipped out. All that expertise is eliminated when you do printing in-house. We emphasize educating customers on quality control and equipment verification.”

For rotary flexo printing, Griffin-Rutgers is manufacturing TruFlex UV. TruFlex is based on and improves upon the the flexo printing methods that the company has provided for in-line printing of blister packages. For form-fill-seal (FFS) machines operating in either intermittent or constant motion, TruFlex UV is available in a variety of printing sizes to accommodate FFS machine widths from less than 100 mm to 320 mm or larger, says Umbdenstock.

“TruFlex is the result of listening to our customers’ requests for a simple machine, both in operation and maintenance, that provides high-print quality at a reasonable price,” he says.

TruFlex prints text, all bar codes, graphics, and logos in registered or random format. UV curable inks eliminate the need for production-run cleaning and support simple start up and shut down.

Umbdenstock says that because the printing of the lidding stock takes place upstream from the material being matched to the product carrier and is on the outside of the package, product is never exposed to UV inks. “The curing process takes place immediately after the printed material exits the print cylinder. The material then travels a good distance before it is married to the PVC, and the printed side of the material doesn’t come in contact with the product,” he says.

In eliminating the costs associated with preprinted solutions, in-line UV flexo blister printing provides high-quality print on a variety of substrates, including foil, and lower cost on a per-print basis than with digital and thermal- transfer systems, because inks, toners, solvents, and ribbons are eliminated, Umbdenstock points out.
Vendors including Greydon, Romaco HAPA, and Zed have come out with in-house plate-making systems. However, “these systems are relatively expensive. The cost effectiveness relates to the volume of plate changes. In addition, a pharmaceutical company takes on all of the responsibility for print set up, print/tool size fitting, and validation of the entire process. Big pharma, for the most part, is running large batch sizes, in one language, where plate changes are less frequent,” Umbdenstock says.

Yet Greg Rochon, president of Greydon Inc. (York, PA), says that in-house plate-making has become a more attractive option, and users can achieve quick payback on their investment in the technology. Equipment has become more compact and easier to use, and water-soluble print plate material has replaced plates requiring solvent wash. Rochon say that as companies expand globally, plate-making self-sufficiency can be more convenient than using the services of plate-making companies.

Greydon has partnered with Anderson & Vreeland Inc. (Bryan, OH) to offer a plate-making system to work with Greydon flexo printers. The water-wash, water-soluble photopolymer plates use UV light for curing. Cornerstone Inc., a packager of vitamin packs, is one user. “They are printing product identification as well as lot and expiration date. By making their own plates at relatively low cost, they can discard the old plate when the lot number changes and quickly make a new plate on short notice,” Rochon says. Using the plate-making, companies avoid the cost of a digital printer. “Cornerstone would have needed a $35,000 programmable ink-jet printer with traversing heads for printing on multiple packages,” he says.

The Greydon/Anderson & Vreeland plate system has also been adopted by Hospira (Lake Forest, IL) for printing multiple colors, text, and codes on FFS packaging for catheters. Replacing preprinted labels, Hospira uses Greydon’s MicroMax Rotary Platen Printer. It is paired with a thermal-transfer printer as a back-up alternative for printing variable data, including bar codes that require changing for small packages, says Rochon.

“This gives them total flexibility for any application that might come up,” he says.

Hospira required the printing of three colors on the outside of the web and one on the inside to print insert text, replacing an insert. Instead of wrapping the film around an impression roller and printing while the web is moving, MicroMax stamps the web against a flat plate when the web is stopped.

“We get the best print quality out of rotary, but avoid stressing the web when doing a succession of wraps to print multiple colors,” he says. Code128 is printed at a flexo station or by the thermal-transfer printer.

Companies buying the $25,000 plate maker can produce printing plates at a cost of $15, a fraction of the cost of using a plate-making company, Rochon says.

SMALL PRINT FOR MEDICAL DEVICES

Morin Automation (Bristol, CT) and PRP Flexo (Indianapolis) address package design issues in medical packaging with the FlexoOne printer and PRP ExSpect plate system, which can print bar codes and text in as tiny as a two-point font.

With such printing, companies can put more information into the same space and fit printing onto small device packages. FlexoOne is a synchronous printer for use with FSS machines, where a motor drives the print drum to move at precisely the same rate as the top web.

“There is no demand for a two-point font. But our emphasis has been that if you build the quality into the machine, we can achieve higher quality for print and code downsizing,” says Phil Morin, president, Morin Automation.

A 2-D bar code along with human-readable data is printed on the bottom of a molded bottle using a Videojet Technologies continuous ink-jet printer.

European market requirements for 11 major languages on labels and the momentum toward bar coding of medical devices are fostering interest in in-line printing alternatives. The Medex division of Smiths Medical (Southington, CT) has purchased the FlexoOne to print seven languages. They are also reducing the cost of having 72 different package types preprinted to support the multiple colors used in catheter packaging.

Alkar-RapidPak (Lodi, WI) has adopted the FlexoOne for integration in horizontal FFS machines geared for the medical device sector. “The FlexoOne has the highest-resolution printing capability in the market. Printing two-point type on Tyvek 1059B was unheard of [before now]. The high-resolution capabilities demonstrated with the FlexoOne have significantly advanced the state-of-the-art for in-line rotary flexographic printing. Type size, as well as detail of graphics and diagrams often printed on medical packaging, now is truly limited by the visual needs and preferences of the consumer as opposed to the limitations of the printer itself,” says John Merritt, director, medical business development, Alkar-RapidPak.

“Scanability of the bar code is dependent on the resolution of the print. With this technology, we can print smaller, denser bar codes that will still comply with HIBCC standards, as well as print tiny text,” he adds.

Merritt says that “the enthusiasm to bar code by medical device companies has to a large degree been limited by the state-of-the-art of printing. Using Alkar-RapidPak’s HFFS machine with the FlexoOne printer, companies could incorporate the bar code, for printing on increasingly smaller packaging for needles, sutures, syringe barrels, and other products.”

Thermal transfer is an alternative to flexo for the digital printing on flat surfaces such as webs, when high image definition and durability is required.
Firms with a high percentage of repeatable data often chose a two-printer set up, using an ink-jet or thermal transfer, for example, for the variable requirement. “You are not going to beat the quality of flexo for high-resolution printing,” says Glenn Breslauer, director, IT marketing, Bell-Mark (PineBrook, NJ), “so many companies choose a second printer for variable data. This set up is necessary to produce many of today’s sophisticated packages.”

Programmable printing may be used for printing an entire top web, however, such as when marking versatility is paramount. Merit Medical (South Jordan, UT) replaced preprinted labels with blank stock and a Bell-Mark EasyPrint programmable traversing thermal-transfer printer, integrated with a Multivac unit, for its medical device packaging.

Merit was overlabeling packages to meet EU requirements and required on-the-fly changeovers to support its contract packaging business.

“By stacking two EasyPrints, they were able to effectively print complex packages, which include variables, in multiple places at the same time,” says Breslauer.

Bell-Mark has introduced the EasyPrint off-line printing system, which pairs a thermal-transfer printer with a high-speed conveyor for marking individual pouches, blister cards, and Tyvek sheets. Freestanding from a forming station, the intermittent-motion unit allows device makers to eliminate preprinted labels. It supports printing all 1-D and 2-D codes, at 200 cycles per minute.

The EasyPrint off-line system features the 32-bit RISC microcontrollers that Bell Mark has adopted in the past year for its EasyPrint line. “There is nothing like this on the marketplace. The off-line unit handles individual pouches and sheets, with the same functionality of our other EasyPrint systems. In moving from 16-bit technology, we are able to process variable data faster. Printers can print faster and handle more data effectively,” Breslauer says.

Pharmaceutical and medical device manufacturers are using the ThermalPak Model-4000 from Norwood Marking Systems (Downers Grove, IL). The unit is a multihead thermal transfer printer for printing fixed and variable data simultaneously in multilane configurations. More than 30 of the printers have been installed to date. In many cases, companies are replacing ink-jet to improve plant sanitation, says Bill Delmolino, director of sales and marketing.

“The Model TP-4000 is the industry’s only multihead thermal transfer printer designed to match the high throughput of a variety of multilane packaging machines. We have machines supporting up to 14 heads,” he says.

The standard TP-4000 includes three to six print heads. Integrated with vertical and horizontal FFS machines, blister packaging machines, and flexible pack units, the model is fully programmable with bar codes and variable data, as products are packaged in-line. Each printhead prints up to 5.5 in. (250 mm) per second.

“This provides a much more cost-efficient solution for multilane marking compared with using multiple individual printheads, and it improves throughput. Printhead changes and positioning are accomplished in minutes, when lane configurations change,” says Delmolino.

Using a handheld display, print images can be recalled from memory. “You can store the information on a handheld device, quickly edit it, and send it to the printer, without the need for a dedicated computer,” he says.

Ribbon feeds are sequenced in short or longer cycles to maximize the use of a 4000-ft ribbon roll. “Depending on how the heads are spaced, we can optimize the ribbon movement, virtually eliminating ribbon waste,” Delmolino adds.

CODE QUALITY

As companies adopt equipment for verifying bar codes to standards, both in-line and off-line, they should be aware that bar code quality is not the only issue. Bar code structures and symbology must conform to GS1 and HIBCC standards on data structure and symbology to meet FDA’s rule. And verifiers must meet hardware specifications and perform to accuracy standards.

When codes meet all standards, they can be read by any scanner in proper working order. “There is a mixture of readers out there. If you verify to the ISO standards, then you know that any reader that can’t read it is probably out of calibration,” says Label Vision Systems’ Lydell.

“The majority of people are getting good guidance from the print device makers and the prepress people. Where they run into problems is in understanding what the specifications mean, and why it is important to print to standards and check the results. In many cases, companies are not conforming to the UCC/EAN data structure standards,” he says.

“If you get the encoding wrong, the quality of the printing is academic,” concurs PIPS’s Wright.

FDA specifies that structure and symbology must follow standards outlined by HIBCC and GS1 and achieve a minimum ANSI/ISO grade quality of “C,” as specified by the applicable guidelines published by those standards development organizations (SDOs). Under FDA’s rule, codes that don’t meet standards are “tantamount to a mislabeled drug” and risk enforced recalls, Wright says.

“FDA’s bar code rule has forced companies to reexamine their bar code production and printing processes and has revealed flaws across the market, from initial symbol creation to final printing quality. Quality is critical, because it is now covered by current good manufacturing practices (cGMP). We have seen symbol quality improve dramatically under this mandate,” says Wright.

Firms must establish that bar code verifiers follow ANSI/ISO standards and ensure they are grading to a defined level of accuracy. Standard test cards from the GS1 are employed for this purpose, says Wright.

J&J and Pfizer perform off-line verification using Label Vision’s Integra 9500. Drug firms and printer companies are adopting the LVS 7000 for in-line code verifying. The LVS l validates code and text readability and content and verifies any combination of linear, matrix, and stacked codes, in any orientations, to ISO quality standards in-line at line speeds. Its camera imaging technology supports 2-D codes employed on smaller packages.

“Our hottest application is in blister packaging. We support machines doing 150 to 250 ft a minute, with as many as 80 individual blisters across the web, which is the most we have seen,” Lydell says.

Lydell notes that some companies are verifying codes before sealing, because of line space, time, and motion issues. However, “we recommend postseal inspection, as sealing can distort the bar codes. ISO rules say verification should be done closest to the end-use environment of the product.”

TruCheck verifiers from Webscan Inc. (Brentwood, NY) provide in-line and off-line grading of RSS codes, the composite element, and serialized codes, and Data Matrix. After experiencing demand from large drug companies in recent years, “now some smaller pharma companies that had not even started are buying our equipment,” says Glenn Spitz, president of Webscan.

“Off-line checking is very reliable for ensuring that all codes are being printed to standards, because the statistical process variation is small. By using our new in-line verification model, called TruInline, companies achieve efficiency by avoiding direct human effort and receiving immediate notification of process problems,” Spitz says.

Spitz notes that UCC/EAN standards are application specific, using the ISO standards as a foundation. “In the context of bar coding at the unit-dose level, this translates to the specific wavelength and aperture that is to be used, as well as the data content of the bar code. Our verifiers control wavelength and aperture to implement the specification faithfully,” he says.

PRINTING ON 3-D CONTAINERS

Videojet Technologies Inc. (Wood Dale, IL) has developed a range of inks for use with its continuous ink-jet (CIJ) printers for marking small characters on foil, metals, plastics, and glass. Inks for CIJ units that air dry in two seconds or less provide an option for firms concerned about exposing product to UV curing.
As opposed to CIJ, “the inks for thermal ink-jet are almost all water based. It becomes very difficult to impossible to print on nonporous surfaces,” says Scott Prochaska, product manager for supplies, Videojet.

Videojet Technologies’ CIJ printers produce small-character UV codes.

Ink-jet is useful for applications where ink has to be controlled and directed over a throw distance, such as in noncontact printing directly onto bottles, caps, and necks. A company printing Data Matrix code directly onto HDPE bottles used a Videojet 47s CIJ printer with a methylethylkeytone solvent-based ink. “You need an ink with good adhesion, good performance, and crisp codes. They were printing onto the bottom of molded containers,” he says.

For printing Code 128 on corrugated boxes and cases, Videojet has launched the Marsh 3100 and Marsh 100 large-character ink-jet printers. Featuring piezo-style, drop-on-demand printheads, the units print characters up to 2 in. tall at 300 dpi.

“Code 128 has taken off in Europe for secondary packaging. The six-inch wide, four-bar code accommodates much more information than code I-205,” says Scott Prochaska, product manager for supplies.

The models print higher quality than valve-jet printing, support more-efficient ink use, and more-consistent uptime in warehouses where dust and fibers from corrugated packaging becomes an issue. The units feature patented automatic self-cleaning and self-maintenance.

Later this year, CSAT America will (Louisville, CO) introduce into the United States its latest digital printer that features 1200 × 1200 dpi print, or twice the dpi of its other models. CSAT printers handle bar codes, variable data, text, and graphics, creating and storing print layouts for quick access and modification. The systems use electrophotographic printing, where images are created with dry toner on an photoconductive drum, then transferred via electrical charge to the substrate.

Besides allowing higher image resolution, the new model works with wider webs. “The model is currently being tested in Europe. We expect this to give us a wider range of potential customers,” says Karl Gragger, managing partner.

THE END-USER

FDA has sought unit-dose-level bar coding so that drugs can be adequately identified at hospital bedsides. Hospitals are increasingly implementing bar code scanning, and the majority of drug firms are coding pharmaceuticals consistent with FDA guidelines to meet the deadline, says Joseph Pleasant, CIO of Premier Inc., a purchasing group for nonprofit hospitals (San Diego, CA).

Though some firms are including lot and expiry data in bar codes at higher packaging levels, concerns about meeting the deadline as well as slowing lines have caused some to hold off coding this information at the item level, Pleasant notes.

“The item level is where the bar code comes into play for safety purposes. We would like to see lot and expiry date on the labeling at the unit-of-issue level. But we all agree, let’s walk before we run and get the NDC in there as a basic identifier,” says Pleasant.

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