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(Bar Code Supplement) Raising the Bar: The Future of Bar Codes (archive Mar 2001)

BAR CODE SUPPLEMENT

Raising the Bar: The Future of Bar Codes

As companies require more information to control their supply chain, the use of product bar codes and the information that codes contain will expand and become increasingly sophisticated.


Ralph Dillon, director, quality engineering, Pharmacia; Edward Arling, senior director, quality assurance, Pharmacia; and Lucas Lindsey, student, Marquette University.

Currently, as for the past 6000 years, the cheapest way to encode information onto an item is either to add a small bit of inexpensive material, such as ink, or to remove small bits of the substrate material. Although ink-jet printers have replaced quill pens and stone chisels have been upgraded to computer-controlled lasers, the basic marking principle has not changed.

The aspect that has changed significantly, however, is the code itself and how it is used. After periods of seeming stability, code technologies have rapidly advanced, driven by the need for more-efficient transmission of increasing amounts of information.

Code represents the understood system used for writing information. Over the course of written history, pictures became hieroglyphics; hieroglyphics became symbols; single-idea symbols were replaced by alphabets and words. During the Twentieth Century in packaging, words were replaced by alphanumeric codes, which in turn were replaced by more-efficient linear bar codes.

Concurrently, the responsibility of product manufacturers has progressed from the provision of goods to the inclusion of value-added features such as codes that facilitate product authentication as well as tracking through the sales transaction. More sophisticated manufacturers can now use these codes to improve the quality of their products, to verify customer feedback, to control and validate authenticity, to respond to regulatory inquiries, and to significantly reduce investigation and follow-up costs.

The Linx small-character continuous ink-jet system from Diagraph Corp. can print bar codes and characters in sizes from 0.04 to 0.44 in. at speeds up to 1200 feet per minute.

GREAT EXPECTATIONS

Consumers often base the value of a product on its brand reputation, manufacturer, and package integrity. Current transactional bar codes help ensure that a product is correctly identified, charged, and reimbursed by the supply chain. In the future, however, manufacturers will come to rely on bar codes to assure purchasers that individual products are of appropriate quality.

Bell-Mark Sales Co.
331 Changebridge Rd.
Pine Brook, NJ 07058

Tel: 973/882-0202
Fax: 973/808-4616
E-mail:info@bell-mark.com
Web site: http://www.bell-mark.com
Products: Designs and manufactures code-dating, marking, and flexographic printers for packaging and converting. The product line includes a flex printer for printing Tyvek in-line on form-fill-seal machines, and reciprocal coders for lot and expiration coding on flexible films, labels, Tyvek, and foil. A complete line of electronic thermal-transfer printers for in-line printing and coding on horizontal and vertical form-fill-seal machines is available.

DVT Corp.
1670 Oakbrook Dr., Ste. 330
Norcross, GA 30093-1849

Tel: 770/449-4960
Fax: 770/449-3073
E-mail: info@dvZzensors.com
Web site: http://www.dvtsensors.com
Products: Offers SmartImage sensors that provide high-speed on-line vision and intelligence for inspection, motion control guidance, and SPC data output for pharmaceutical and medical applications. The CCD-based systems use a patented image acquisition technology to deliver repeatability, image stability, and price performance.


For instance, packaged computer software, high-value cosmetics, and currency typically contain a unique, hard-to-replicate mark, such as a watermark, seal, or hologram. These marks allow manufacturers and consumers to determine that a product is authentic. Currently, these must be manually read and registered. If additional information were to be embedded into a bar code, though, existing equipment could be set up to read and verify authenticity automatically.

A good example in the healthcare industry of how sophisticated codes can help manufacturers control their products is the coding of high-cost oncology and biotechnology products that treat cancer patients. Controlling the distribution of these items is critical, since some of these medicines cost in excess of thousands of dollars per gram to manufacture. In many cases, only one company will have the patent for a particular treatment, so loss of product or product quality could affect the entire patient population. Manufacturers must carefully track these types of products and their conditions during production, storage, and shipment to ensure authenticity and product quality at the time of use. With enhanced tracking and controls, costs and waste can be minimized, benefiting everyone from the manufacturer to the suppliers to the patients who depend on these products.

Adolph Gottscho Inc.
835 Lehigh Ave., P.O. Box 3130
Union, NJ 07083-1930

Tel: 908/688-2400
Fax: 908/687-9250
E -mail: gottscho@gottscho.com
Web site: http://www.gottscho.com
Products: Offers a broad line of automated, in-line printing equipment ranges from compact imprinters to sophisticated platen printers. With extensive experience in the development of variable, consecutive-print machines, the company offers models that imprint product identification, code dating, lot numbers, bar codes, and similar information on webs of most films, foils, and papers.

Griffin-Rutgers Company, Inc.
25 Trade Zone Ct.
Ronkonkoma, NY 11779

Tel: 631/981-4141
Fax: 631/981-4171
E-mail: custserv@griffin-rutgers.com
Web site: http://www.griffin-rutgers.com
Products: Offers a comprehensive selection of printing and labeling technologies, replacement parts, consumable supplies, systems engineering, and technical services for all in-line and off-line printers, coders, and imprinters.

Although there are a variety of technologies that can be used to connect information to products, the addition of bar codes is the cheapest. For instance, adding a code to a package by ink-jet printer or laser costs fractions of a cent per package, according to Jon Jensen, sales executive at Domino Amjet (Gurnee, IL). Other techniques, such as radio-frequency tags, show technical promise, but they will have difficulty competing with the low cost of ink-application techniques.

To include more-detailed authenticity and tracking data onto the limited package real estate common in the healthcare industry, engineers will need to use space-efficient coding technology. Shrinking the size of the print to fit all necessary information is no longer an option, given FDA's recent over-the-counter drug labeling regulation. (See "Regulations Spark Package Redesign" in the February 2001 issue of PMP News.)

Marconi Data Systems Inc.
1500 Mittel Blvd.
Wood Dale, IL 60191

Tel: 630/860-7300
Fax: 630/616-3657
E-mail: infocenter@marconidata.com
Web site: http://www.marconidata.com
Products: Specializes in data application, capture, transmission, and management. The firm manufactures and distributes Videojet, Cheshire, and Marsh products, which are premium-quality, digital imaging, marking and coding systems and information business process solutions.

Quint Co.
3725 Castor Ave.
Philadelphia, PA 19124

Tel: 215/533-1988
Fax: 215/533-7784
E -mail: quintco@erols.com
Web site: http://www.erols.com/quintco
Products: Manufactures printing plates for unit-dose, pharmaceutical, and medical packaging. The company produces photopolymer and rubber printing plates tailored to the specific printing equipment and substrate used. It maintains a GMP-compliant environment in addition to SOPs in keeping with industry standards.


Several new bar code technologies offer a means of verifying product authenticity, as well as automatically tracking product through the supply chain from the moment it is manufactured and through its useful life. In particular, three emerging code technologies will enable manufacturers to include more information on packages. They are two-dimensional codes, nonvisible light spectra, and individual product serial numbers. In addition, linking a bar code to a product manufacturer's Web site allows users to obtain even more information.

TWO-DIMENSIONAL CODES

How 2-D codes printed in UV-light-visible ink appear under UV and minimal natural light (top), UV light only (center), and UV and full light (bottom).

The universal product code (UPC) and other linear codes easily support simple tracking through the distribution chain. But as more information is required, these linear codes will need to be replaced or supplemented by two-dimensional bar codes in many products. Although there are many codes and many opinions as to which particular code is best, the following are some examples of how 2-D code formats are being used successfully.

Internal Tracking. One of the oldest codes used for internal product tracking is DataMatrix. This code is in widespread use in the automotive and electronics industries. For instance, it has been adopted by Daimler-Chrysler, Ford, General Motors, Motorola, and others. DataMatrix seems to be the leading code for internal tracking. The Barcode Software Center (Evanston, IL) explains that DataMatrix "is a 2-D bar code that can store from 1 to about 2000 characters. The symbol is square and can range from 0.001 in. per side to 14 in. per side. As an example of density, 500 numeric-only characters can be encoded in a 1-in. square using a 24-pin dot matrix printer."

Package Shipment Tracking. MaxiCode is used by UPS and seems to be the leading code for distribution package tracking. According to The Barcode Software Center, MaxiCode is a "fixed-size code that holds up to 93 data characters. The symbol is composed of a central bulls-eye locator and offset rows of hexagonal elements; the overall dimensions of the symbol are approximately 1.11 ¥ 1.054 in. Each element measures 0.035 ¥ 0.041 in."

Retail Transaction Tracking. Although its use is in its infancy, composite component codes from the Uniform Code Council (UCC) appear to be the leading codes for retail transaction tracking. Composite codes can be read with all existing linear bar code readers, but with appropriate 2-D readers, they can supply even more information.

:CueCat Clues Users into Product INFORMATION

:CueCat is a new bar code reader and computer software program that links end-users to various product Web sites via the Internet. Using an LED optical reader to scan universal product codes or other bar codes, the system's software links the end-user's Internet browser to the product's corresponding Web page, locating further product information. The supporting software system is also capable of linking with enhanced television programming, enabling the software to launch the browser to that Internet site.

Under a special arrangement, this technology is available through Radio Shack stores, manufacturer Digital Convergence's Web site (http://www.crq.com), and even as an integral feature of a new pen offered by Cross.

Consumer-Use Tracking. Some Internet products track consumer use, but this is not done for most packaged products. There are, however, pilot programs at hospitals throughout the world. No clear standard has been widely implemented for hospital dispensing and patient-compliance tracking. Various agencies have set this as a goal, so when a clear accepted standard is evident, rapid adoption is expected.

Pharmaceutical and Medical Package Tracking. UCC and European Article Number (EAN) groups are developing code standards for medical device and drug packaging and have involved team members from various pharmaceutical companies. Currently, the code of choice is Reduced Space Symbology (RSS)-14, a composite code. More information can be found at the Web sites http://www.uc-council.org and http:www.ean-ucc.org or in the March 2000 PMP News feature, "Using Bar Codes to Reduce Medical Errors." See the sidebar on pages 66–67 for information on current industry efforts.

Most products do not currently carry 2-D bar codes, but in the future, products will most likely carry multiple 2-D codes that support the various requirements of efficient supply chain and product use.

Packing Data into a Dense Code
The Snowflake code can be scanned from any angle.

Two-dimensional codes offer significant advantages over standard bar codes: They can hold a lot of data, they are compact, and they often feature error correction technology.

For instance, one particular code, the Snowflake code from Marconi Data Systems (Wood Dale, IL) can contain up to 73 numeric data digits in a 7 x 5-mm code, explains Marconi's Joel Fenton. The Snowflake code is a 2-D code produced by an array of dots set in rows and columns.

Ink-jet printers and laser marking systems that employ dot-matrix technology are well-suited for printing 2-D codes such as the Snowflake code because these codes do not need solid lines or circles to determine read orientation, unlike most other 2-D codes. Snowflake codes provide 360º read flexibility with a range of on- or off-line readers that meet or exceed today's production speeds.

Laser-coding systems can also be used to print 2-D codes, which permanently apply the code to substrates and help to reduce the use of MEK or other solvents. However, using ink-jet technology to print these codes allows for more varied applications, since ink-jet fluids can be applied to a wider range of materials.

Ink-jet printing also allows for the use of inks visible only under ultraviolet light, which can be applied without altering the appearance of the package. This gives producers the ability to apply security codes to their products to reveal imposter or pirated products.

The Marconi Snowflake code can be applied to metal, glass, rubber, plastic, leather, electronics, and packaging, to ensure internal and external traceability.

NONVISIBLE LIGHT SPECTRA

Despite little recognition, the use of near visible or invisible light spectra is already taking place in every retail operation in the United States. Hidden in each new United States Treasury note with the larger presidential portrait is a stripe that indicates the validity and denomination of the bill. This bar is barely visible under normal light, but under ultraviolet (UV) light it becomes the most discernable feature of the bill.

Reduced Space Symbology Squeezes into Packaging
Reduced Space Symbology can easily fit into labels with limited room.

The North American RSS/Composite Implementation Group, working with The NOSCO Printing Group (Carrollton, TX) and companies throughout the healthcare supply chain, has proved the commercial feasibility of bar coding medications in units as small as 2 ml. Bar coding down to the dispensed unit has the potential to reduce medication errors significantly.

Approximately 90% of all healthcare items can be coded using existing linear symbologies. The other 10%, which typically include unit-of-use and unit-dose items dispensed to the patient at the hospital bedside, are too small for linear symbology.

The Uniform Code Council Inc. (UCC), a not-for-profit voluntary standards organization, developed Reduced Space Symbology (RSS) for packages too small for traditional linear technology. Complemented with correct software, RSS can provide all the information available through UPC codes.

The group's efforts have shown that bar codes can be placed on virtually any healthcare product. The implementation group selected RSS Limited for items such as syringes and RSS-14 Stacked for items requiring a narrow symbol such as vials. RSS encodes the full 14-digit global trade item number (GTIN), meeting the basic identification needs of worldwide healthcare manufacturers, distributors, and suppliers. With appropriate software, RSS can be used to confirm that appropriate dosages are being administered and to track inventory and other information. (For a discussion on the different RSS versions, see the October 1999 PMP News editorial, "Cracking the Bar Code Quandary.")

RSS Limited is 70% more space efficient than an EAN/UPC character. Also, while a UPC-A symbol requires a nine-module quiet zone on each side, no quiet zones are required around RSS codes. They can also be printed as a composite symbol with the accompanying EAN/UCC 2-D Composite Component printed directly above the RSS linear component. (RSS encodes a linkage flag to indicate the existence of a 2-D composite component.)

Two package sizes, 3 ml and 5 ml, were selected for the first RSS test, one using RSS Stacked and the other, RSS Limited. After determining that the 0.5-mil bar-width reduction (BWR) was the most readable, The NOSCO Printing Group produced labels. Each label contained two symbols, one for ladder and one for picket fence.

In accordance with a test plan developed by Frank Sharkey of UCC, each BWR figure was verified successfully, determining the optimum BWR. The Diversco Inc. facility then produced both paper and film labels using both the rotary letterpress and flexographic printing technologies.

The labels were then shipped to a pharmaceutical manufacturer, who applied the labels successfully, and they were scanned 100% after application. The samples were then packed and identified and shipped to the UCC and to a healthcare facility for on-site testing.

Final testing was done at the St. Alexius Medical Center, a 300-bed facility in Bismarck, ND, known for its promotion and implementation of bar code identification technologies for healthcare products down to the unit of dose.

After determining the appropriate angle for the scan, St. Alexius personnel performed 30 successful first-time scans. Current linear technology often requires two scans, St. Alexius noted.

Because human-readable characters were often larger than the RSS itself, there was frequently not enough space to also print this information. But omission of human-readable characters was deemed practical because the new drug code number is printed on the pharmaceutical products in compliance with FDA regulation.

The nonvisible light spectra of UV light and infrared (IR) light offer manufacturers an additional dimension to add even more information to already-crowded packages. Most current package presentations have two dimensions of visible information wrapped around the package itself. Adding information in ink visible only under UV light means that the entire package facing is open for as much information as is currently on the visible package. And if ink that only shows up under IR light is also added, three times as much space is available for information.

Sato America Inc.
545 Weddell Dr.
Sunnyvale, CA 94089

Tel: 408/745-1300

Fax: 408/745-1309
E-mail: satosales@satoamerica.com
Web site: http://www.satoamerica.com
Products: Offers direct-thermal and thermal-transfer printers, OEM print engines, printer accessories, label design software, labels, and thermal-transfer ribbons. Its new e Series of CL printers offer high-speed data transmission, high processing speeds, and large amounts of onboard memory to quickly and easily manage any label printing requirement.

Tharo Systems Inc.
2866 Nationwide Pwy.
P.O. Box 798
Brunswick, OH 44212-0798

Tel: 800/878-6833

Fax: 330/225-0099
E-mail: tharo@tharo.com
Web site: http://www.tharo.com
Products: Designs high-performance labeling products, including Easylabel. The company's Apollo 1 printer applicator is designed for small, high-precision print applications for its Gemini and MS Access printers. The company distributes Sony thermal-transfer ribbons and Datamax printers.

A small selection of inks and coding media is already commercially available for UV and IR light detection. Since these spectra have not been claimed by marketing or regulatory authorities, they are open for discreet use in internal supply chains. Many pharmaceutical companies have already put pilot programs in place for internal product tracking and verification.

SERIALIZATION

Serialization has been used on currency since well before the founding of the United States. It allows for traceability and enables law enforcement agencies to ensure authenticity. It has also been used as a tool to trace illicit monetary transactions such as theft, ransom, and bribery.

Since serial-number use has proved effective, it has become popular with durable-goods manufacturers, being placed on cars early in the last century and on computer software almost as soon as it was offered for sale.

INSOECO (Mundelein, IL) helped the authors install equipment from Domino Amjet and SYSTECH (Cranbury, NJ) for applying near-visible 2-D codes to vials.

Manufacturers can benefit from using serial numbers to track individual product quality for handling warranty claims and complaints. If certain products need to be redirected from the supply chain, they can be culled on an individual rather than a full-batch basis. For example, if a filler performs improperly for a period of time, those affected serialized products could be more specifically tracked for rework, culling, or removal. Likewise, should there be a product complaint, it would be much easier to prove postmanufacturing tampering if product quality parameters were tracked individually.

Until recently, serialization was not practical for lower-value products because the cost of data management was prohibitive. Now, with inexpensive computer access, processing, and storage, the serial numbers of items worth less than one dollar can be individually tracked.

CODES AND THE INTERNET

With present UPCs, there simply is not enough room to fit in all the characters associated with a Web address. But with the increased information that new technology allows to be placed in codes, it is now possible to embed a Web address into a package. Theoretically, a scanner could capture a product code, serial number, and Web address. Appropriate software could be used to access a company database through the Internet, locating all the information on that particular product.

From left, examples of a DataMatrix code in its traditional and dot-matrix versions.

Bell-Mark's Easy-Print thermal-transfer printer can reproduce the PDF-417 code, a common medical 2-D code.

That database might include everything from the manufacturer's batch record, time of dosing, and individual weight to individual product inspection results. With inclusion of subsequent tracking data, a product could be monitored through each distribution point and use until it is finally destroyed. One of these technologies is called :CueCAT, which scans UPCs and associates the code to a software directory of advertisers' Web addresses.

A single U.S. dollar bill can be tracked through serialization using the Internet. In January, we received a Series 1995 bill with the serial number A48957298K. We logged onto the Web site http://www.wheresgeorge.com and entered the bill's serial number and began tracking its movements. Since that time, we have followed this bill's movement from city to city as it circulates.

If durable medical goods could be tracked in a similar way, manufacturers, users, and even regulatory agencies could locate manufacturing and operational history quickly and easily.

CONCLUSION

Through the use of bar codes, products can be tracked through all steps of production, distribution, and use. Manufacturers who don't want to risk losing control of their products' destinies should increasingly apply more-sophisticated bar codes to their products.

Perhaps we will need to change the definition of bar code from referring to the stripes of certain types of code to an acronym for "Business at Risk" code. Bar codes have the potential to be the most effective packaging defense against inappropriate or improper product use through the supply chain, while providing the required information for enhancing quality and validating customer feedback on product-related issues.

Three years ago, Arling and Dillon began the 2-D, UV-light-ink coding program at Pharmacia/Monsanto, and Lindsey worked part time with the integrator INSOECO on pioneering coding equipment. The authors can be contacted at these e-mail addresses: ralph.l.dillon@pharmacia.com, edward.r.arling@pharmacia.com, and lucas.lindsey@marquette.edu


Ethyl Acetate Inks: Low Hazard, High Performance

Recent developments in ink formulations are making printing safety attainable.


Alberta Millar, product manager, Willett America Inc. (Grapevine, TX)

Over the past decade, there has been constant pressure to reduce hazards in the workplace and eliminate potential hazards. For instance, if you use industrial continuous ink-jet printing, the ink you choose should balance performance and safety, without incurring a hidden liability. Some ink-jet printing inks are safer to use, presenting fewer health or regulatory problems than other inks.

Many companies have turned to industrial ink-jet printing as a convenient way of coding their products. As a general rule, the inks that perform the best are characterized by a quick drying time, an excellent adhesion to nonporous substrates, and a durable film. Unfortunately, many inks that display these qualities are based on hazardous solvents.

For example, two common solvents that ink-jet inks are based on, MEK and methanol, have high field performance but are not acceptable in most food and medical industries because they are harmful to humans. (See Table I.) If you choose to use either of these, you may stain your company's reputation.

Ink Ethyl Acetate MEK Methanol
Source Naturally occurring in fruit and in the fermentation of yeast Not known to occur in nature Occurs in volcanic gases
Permissible Exposure Limit 400 ppm 200 ppm 200 ppm
Odor Not unpleasant Pungent None
Toxicity Not alien to the human body Alien to the human body Toxic to the human body
Use in Food and Medical Industry Acceptable in most applications Unacceptable in most applications Unacceptable in most applications
Table I. Properties of industrial ink-jet inks.

According to Eric Wilhelmsen, a research consultant and applied technology specialist at the Alliance of Technical Professionals and a lecturer at San Jose University, there are ink-jet printing inks that can balance performance with safety. In his paper, "Will Your Industrial Jet Printing Ink Stain Your Reputation?", Wilhelmsen outlines a variety of societal conditions and technological innovations that make ethyl acetate inks a good option for manufacturers.

Wilhelmsen urges manufacturers to operate in a regulated safety environment, adhering to the following federal regulations:

The Environmental Protection Agency's (EPA) Clean Air Act sets the regulatory standard for air pollution. To meet localized state implementation plans, manufacturers, particularly those in nonattainment areas, should strive to reduce hazardous air pollutants (HAPs) to meet EPA standards.

Occupational Safety and Health Administration regulations mandate that companies enforce a permissible exposure limit, which determines how much solvent an employee can be exposed to in an eight-hour period.

Ink-jet printing technology and innovation have advanced very rapidly, according to Wilhelmsen. Now users can print on almost any surface without releasing hazardous chemicals such as MEK and methanol. New ethyl acetate inks feature attributes that maintain optimum performance, such as excellent adhesion, fast drying time, and good resolution, without compromising the environmental safety. They help manufacturers meet regulatory requirements.

In addition, "hazardous waste disposal costs can be associated with the use of ink-jet printing. Some ink tanks are designed such that the process does not consume all of the ink. The end-user now has a partial tank of hazardous waste that requires proper disposal, which is increasingly costly. Also, MEK and methanol are on EPA's original HAP list. Switching to an ink based on ethyl acetate solvents eliminates the need to achieve the HAP standard, which could save companies money," says Wilhelmsen.

Manufacturers can now rely on ink-jet equipment and ink suppliers to assist them in reducing hazardous pollution levels. Wilhelmsen concludes, "More environmentally friendly products, combined with a knowledgeable supplier, can provide manufacturers with both safety and performance." Compliance with federal regulations used to mean added clean-up expenses or a sacrifice in quality. With improvements in ethyl acetate–based inks, packaging engineers in the medical industry can now attain high field performance without forgoing safety.

Copyright ©2001 by Pharmaceutical & Medical Packaging News