Bar Coding Rules
As industry awaits FDAï¿½s final bar coding rule, PMP News takes a look at what pharmaceutical companies have doneï¿½and what they still need to doï¿½to bar code their products down to the unit-dose level.
Industry is poised to make some drastic changes to bar coding its pharmaceutical and biological products once FDAï¿½s proposed bar coding rule is issued. Some pharmaceutical companies have already instituted changes. PMP News reported in its bar coding supplement a year ago that Pfizer had selected RSS/Composite symbology (Reduced Space Symbology with a 2-D component) to bar code all of its hospital unit-dose blister products. The bar code would contain national drug code, expiration date, and lot number. Pfizer planned to have the project completed by December 2003.
ï¿½At that time we committed to ensuring all of our lines were producing with those codes,ï¿½ says Rich Hollander, senior director of pack-aging services for Pfizer. ï¿½This included three of our own sites and one contract packager.ï¿½ By December 2003, the project was complete.
ï¿½We still need to convert the new sites we acquired from the Pharmacia acquisition in April 2003, but we have initiatives underway to do just that as quickly as possible.ï¿½ Pfizer is also actively engaged with similar activities in support of Europe and Asia, says Hollander.
Abbott Hospital Products Division has also announced that it has completed its initiative to affix unit-of-use bar codes to 100% of its hospital injectable drugs and IV solutions. The achievement encompasses more than 1000 products, a quarter of which require RSS technology. Initially, Abbott adopted UCC/EAN-128 to bar code items such as its corrugated packaging. However, a portion of its products was too small to accommodate UCC/EAN-128, so RSS was even used for bar codes on the smallest unit-of-use containers. Due to the large number of products and the wide variety of shapes and sizes, the project was extremely challenging, requiring labeling changes on every product package, from corrugated boxes to individual unit-of-use containers. Labels had to be updated to include a bar code, and that required some equipment changes. But ultimately the undertaking was successful.
Bristol-Myers Squibb has also pushed ahead in its printing of RSS/Composite bar codes on hospital unit-dose (HUD) blisters. George Wright IV, vice president of Product Identification & Processing Systems Inc. (PIPS; New York City) notes that ï¿½other pharmaceutical manufacturers, both large and small, have been actively developing plans and running print tests to gauge their ability to comply with the anticipated FDA mandate using their current equipment.ï¿½
But even though change is imminent, some pharmaceutical firms have not yet committed to bar coding at the unit-dose level. ï¿½Some companies are taking a wait-and-see attitude,ï¿½ says Jim Umbdenstock of Griffin-Rutgers (Ronkonkoma, NY). ï¿½The market isnï¿½t pushing them yet.ï¿½ Susan Snyder, global training manager for Microscan Systems Inc. (Renton, WA), agrees. ï¿½There has been a lot of talk and some experimentation, but not a lot of actual implementation,ï¿½ she says. And while these companies would rather wait until FDA mandates what codes to use before implementing solutions, suppliers have noticed that end-users are more educated about available technologies and better prepared to adopt them when the time comes.
A Symbol of Quality
FDAï¿½s proposal requires the use of any linear bar code in the EAN.UCC system. Many pharmaceutical companies, such as those mentioned above, are adopting RSS and RSS/Composite codes for unit-dose packages. Others favor the use of 2-D codes, such as Data Matrix, which has been adopted by the UCC, and hope that FDA will include this symbology in its final rule. ï¿½Our customers have been asking for the ability to print 2-D Data Matrix as opposed to RSS because of its error-correcting nature,ï¿½ says Mike Shaw, vice president of sales for Nutec Systems Inc. (Princeton, NJ). ï¿½You can be missing almost a third of the code, and you can still read it.ï¿½ The compact size of the Data Matrix symbols and their ability to contain more information than RSS also makes them desirable for certain applications. But, warns Umbdenstock, UCCï¿½s acceptance of Data Matrix could also further complicate the issue for companies that are already unsure of which symbology to use. FDAï¿½s proposal also expresses concern that hospitals may not have the financial resources to invest in new equipment needed to read Data Matrix codes.
On the other hand, Wright points out that Data Matrix is already ap-proved for use on small packages in the forthcoming revision to the Health Industry Business Communication Councilï¿½s Supplier Labeling Standard, an established bar coding standard widely followed by the medical device industry. ï¿½The point to be made,ï¿½ says Wright, ï¿½is that if a 2-D matrix symbologyï¿½something that requires a camera/area-imager-type scanner in order to be readï¿½is allowed by an ac-cepted industry standard and is used anywhere at the point of care, then traditional linear laser and CCD scanners will no longer be the right tools for that application. Even if imagers cost somewhat more than some bar code scanners, the good news is that the additional cost is not prohibitive.ï¿½ Moreover, says Wright, ï¿½the vast majority of healthcare providers have yet to adopt bar code scanning technology at the point of care. This makes the decision to invest in modern imagers much easier because these tools not only scan bar codes but also capture signatures and other images. And they can be upgraded easily through software to read new bar code symbologies if necessary.ï¿½
Whether a company chooses Data Matrix or RSS, the quality of the printed symbol is extremely important. ï¿½Not all companies seem to take bar code print quality seriously,ï¿½ notes Wright. ï¿½The number of bar codes currently being printed that fail to meet minimum industry-standard ANSI/ISO/IEC criteria for quality (a grade of C or better)ï¿½both for supply chain scanning as well as for internal component trackingï¿½is very discouraging. A global recognition of the critical nature of bar codes and a corresponding commitment to print them to the highest achievable standards is absolutely necessary to enable widespread healthcare supply chain efficiencies, not to mention the patient safety goals that underlie FDAï¿½s bar code mandate.ï¿½
|The Integra 9500 from Label Vision Systems inspects all nine of the ANSI/ISO parameters.|
Current prepress, printing, and verification technologies will help achieve the goal of producing a high-quality bar code symbol, says Wright. ï¿½While in-line flexographic printing on HUD blisters has been the primary focus for many companies because of the relatively abundant label space available for bar codes, other packaging configurations and printing technologies are also being actively examined in anticipation of the new ruling,ï¿½ he says.
Thermal-transfer printing is a good solution for unit-dose bar codes, says Mindy Nyberg, marketing manager of Dynic USA Corp. (Hillsboro, OR). ï¿½It has the ability to print variable information on demand with excellent quality at high speeds,ï¿½ she says. ï¿½Printing resolutions are from 300 to 600 dpi. In addition, thermal-transfer printing is the easiest way to be ahead of the curve on RFID implementation,ï¿½ she says. ï¿½Most thermal-transfer printer manufacturers have printers capable of printing and encoding smart labels. These are labels that are both thermal-transfer printed and have an embedded RFID chip that is encoded at the same time.ï¿½
Thermal ink-jet technology is also being used successfully for unit-dose applications. Dan Briley, engineering program manager for the Specialty Printing Systems division of Hewlett-Packard (HP; San Diego), says that HPï¿½s technology offers high-resolution printing necessary for small, detailed bar codes. The company has several customers that have designed printing systems using HPï¿½s thermal ink-jet technology. These printing systems can be easily integrated into an existing blister packaging or carton line. Bell-Markï¿½s Intellijet R, for instance, is an ink-jet printer that uses HP ink-jet technology. The system is very economical, says Glenn Breslauer, director of IT marketing for Bell-Mark Corp. (Pine Brook, NJ), and it supports RSS and Data Matrix.
Videojet Systems (Wood Dale, IL) also offers continuous ink-jet printers, which are suitable for applications in which high-speed printing on pack-aging is necessary. However, Scott Liniger, product manager, notes that for higher-resolution codes, thermal transfer or laser technologies may be more suitable.
|HPï¿½s thermal ink-jet technology prints small, high-resolution bar codes needed for unit-dose packaging.|
Charles Geraldi, director of sales and marketing for Adolph Gottscho Inc. (Union, NJ), says that platen printers are still a viable solution for printing bar codes on unit-dose packages, but customers are also looking at digital technologies because these allow them to make quicker changes. ï¿½Some companies are considering printing static information on the unit dose using platen printers and then tying that together with digital printing to print the bar code (high-resolution RSS, Data Matrix, and other 2-D symbologies), lot, batch, and expiration date on the rest of the package at the end of the process, rather than the beginning,ï¿½ he says. Using the platen printer on the front end is cost-effective, Geraldi explains, while digital printing at the end of the process saves on materials. At the same time as the variable data are applied with the Gottjet, using HP technology, a UV-readable stamp can be applied to ensure product authenticity. ï¿½These stamps can be applied over what youï¿½ve already printed with the platen printer,ï¿½ says Geraldi.
Quint Co. (Philadelphia) has been working with Pfizer, BMS, and many other pharmaceutical manufacturers to help them implement in-line bar coding with the flexographic printing process. ï¿½We have spent $200,000 in purchasing new bar-code software, verifiers, and a flexographic proofing press to improve our plate-making process,ï¿½ says Rich Davis, president. Davis says that the in-line printing processï¿½either flexographic or digitalï¿½will need to be improved and controlled to achieve the goal of printing quality bar codes in-line.
ï¿½Over the years that I have spent in packaging rooms, I have learned that the in-line printers have been purchased as an add-on to the packaging line and are never fully integrated into the GMP system,ï¿½ he says. ï¿½The in-line printers must be integrated into the system.
SOPs need to be written and implemented for areas such as printer setup, cleaning, preventive maintenance, and change control.ï¿½
Implementing SOPs will provide the control needed to print quality bar codes, says Davis.
CSAT America (Louisville, CO) offers a complete digital in-line printing system aimed at simplifying in-line printing requirements and eliminating the cost and time associated with printing plate design and development. The system prints variable data, sequential numbers, and scannable bar codes on a variety of commonly used packaging materials.
|The Xaminer Elite verifier series from Stratix provides bar code verification in a single unit for linear and 2-D bar codes.|
One of the challenges of printing unit-dose bar codes is making sure your printing technology is compatible with your substrate. ï¿½In all printing systems you need to have a compatible ink and substrate interaction,ï¿½ says HPï¿½s Briley. ï¿½Blister packs, for example, can have a foil or paper backing, so weï¿½re working with foil manufacturers and other blister pack material providers to make sure we have the right ink or we can find a substrate thatï¿½s compatible with available printing systems.ï¿½ For in-stance, if the material is porous, says Bell-Markï¿½s Breslauer, it will absorb the ink well, in which case an ink-jet printer, such as the Intellijet R would be suitable. However, if foil is used, he suggests a thermal printer, such as the companyï¿½s Easyprint MLP.
For thermal-transfer ribbon manufacturer Dynic, one of the biggest challenges in unit-dose bar coding has been helping customers and their end-users identify the right thermal- transfer ribbon formulation to match some of the substrates used in healthcare. ï¿½When thermal-transfer printing, the label substrate and the ribbon must be a match so that the ink stays adhered to the label and provides the resistance that the application re-quires,ï¿½ says Nyberg. ï¿½Dynic has its own testing lab where we can work with customers to determine which ribbon would work best on their label, their type of printer, and in their specific application.ï¿½
|CSATï¿½s digital in-line printing systems feature an electronic position unit for use with bottom thermoform foil that automatically compensates for foil shrinkage.|
As companies begin to bar code their unit-dose packaging, they will also need to consider investing in the equipment necessary to scan and verify these codes. ï¿½Bar code print quality is not a subjective measure,ï¿½ says Wright, ï¿½nor is it one that the eye can sufficiently judge. On the contrary, there are internationally recognized technical standards by which bar code quality is measured and quality assessment tools called print quality verifiers that are used to judge the parameters that must be measured. The most important standards in this regard are ISO/IEC 15416 and ISO/IEC 15426-1. It is paramount not only that the print quality verification procedures conform to ISO/IEC 15416 but that the verification instrument itself be shown to conform to ISO/IEC 15426-1.ï¿½ The earlier ANSI X3.182-1990 print quality verification standard has been superseded by ISO/IEC 15416, Wright explains, but the two standards are essentially identical.
Elizabeth Urvan, senior account manager for Stratix Corp. (Atlanta), believes that it is more important now than ever before for pharmaceutical manufacturers to invest in verification equipment because of the small size and complexity of RSS bar codes, one of the EAN.UCC system linear symbologies that FDA seems to be leaning toward accepting. ï¿½Itï¿½s critical to evaluate print quality to ensure those codes can be scanned,ï¿½ says Urvan. The companyï¿½s Xaminer MD and Xaminer Elite series are ANSI/ISO-compliant laser-based verifiers that are capable of reading standard linear bar codes, RSS, and Pharma codes. The units are fully portable, giving users the flexibility to verify the print quality of bar codes anywhere in their facility.
David DeJean, regional sales manager for Systech International (Cranbury, NJ), has noticed that some companies are pushing to perform ANSI/ISO grading of bar codes in- line. ï¿½Most people are doing QA sampling for grading, but that doesnï¿½t guarantee that every code is readable,ï¿½ he says. ï¿½So thereï¿½s a big push to move grading technology on-line where it can verify 100% of the products.ï¿½ Systech currently offers a technology that integrates printing and verification technology while complying to 21 CFR Part 11 regulations. The company is working on full in-line ANSI/ISO grading, and DeJean notes that the technology has to meet specific challenges. ï¿½If you take a blister manufacturing machine, for instance, and you have a 12-in. blister pack, there could be 20 tablets across that 12-in. pack, and each one has to have a bar code on it. So itï¿½s an overwhelming amount of information that needs to be processed to create grades for all those bar codes.ï¿½
ï¿½Most pharmaceutical companies are satisfied with in-line monitoring of the bar codes to an established standard and ensuring they are readable,ï¿½ says Microscanï¿½s Snyder, ï¿½but most do not want to spend the additional amount of money required to do complete in-line ANSI grading of every bar code.ï¿½ Also, ï¿½performing complete in-line ANSI grading of every unit-dose bar code without slowing down production line speeds could be one of the biggest challenges manufacturers face,ï¿½ she continues. ï¿½Several factors can have a positive or negative effect on line speed, such as symbology selected, how the bar code is presented to the reader, and bar code quality. Manufacturers must also decide where to inspect bar codes. For example, should a manufacturer inspect the bar codes on blister packs before they are sealed or after they are sealed? Preseal inspection is easiest to verify because it has the best quality bar code. Postseal inspection produces the highest deformation degree but provides the highest as-surance of end-user readability.ï¿½ Microscanï¿½s Quadrus EZ smart cameras are used for in-line verification of unit-dose bar codes. Patented rapid-capture software enables Quadrus EZ to read unit-dose RSS/Composite codes on the web, verify several quality parameters, and output the data in real time at speeds of 60 symbols a second. The company also offers bar code scanners capable of decoding RSS symbols at speeds of 2000 symbols a second.
Tim Lydell, director of sales and marketing for Label Visions Systems (Peachtree City, GA), feels that verifying bar codes to ANSI/ISO standards in-line is an integral part of producing a quality bar code. The companyï¿½s Integra 9000 is a high-speed ANSI/ISO in-line bar code verification system that provides 100% inspection of all bar codes, RSS, RSS/Composite, and matrix codes like Data Matrix. The system looks at every 0.006 in. of bar code height, ladder or picket fence orientation, at the rate of 60 bar codes per second, up to eight lanes across the web. It reports the grade of the bar codes in real time as well as archives the data for audit trail purposes. The LVS 6000 system also adds the ability to inspect on demand printed data such as date and lot codes on small items like blister packs without any loss in line speed.
Cognex Corp.ï¿½s (Natick, MA) In-Sight vision sensors are also being used in-line to read and verify bar codes. Carl Gerst, industrial ID marketing manager for ID Products, explains that the sensors read both RSS and RSS/Composite codes and support ISO/IEC 15416. ï¿½Our systems are able to keep up with line speeds,ï¿½ says Gerst, ï¿½and weï¿½re seeing a lot of interest from pharmaceutical companies.ï¿½
Companies may not be ready to move to in-line bar code verification, but many are already investing in equipment to scan bar codes in-line. DVT Sensors Intelligent Scanners previously read only linear RSS, but the companyï¿½s FrameWork software now supports RSS and 2-D Composite codes as well. ï¿½RSS is the code of choice today,ï¿½ says Phil Heil, chief technology officer, ï¿½but as reporting and tracking requirements grow, the symbology may need to be updated to contain the additional information.ï¿½ DVT provides free software updates for all of its current hardware products. For example, says Heil, customers who purchased Series-600 systems in 1998 can download the latest firmware from the Web and add the RSS reading functionality to their existing systems at no charge.
For companies that are facing the task of bar coding their pharmaceuticals, Pfizer and Abbott are good role models. ï¿½Implementing a bar code system is a comprehensive effort that involves partnership, teamwork, and support,ï¿½ says Laurie Hernandez, general manager, strategic marketing for Abbott. ï¿½Above all, it is most important to remember the patient and the impact that bar codes can have on preventing medication errors and improving patient safety.ï¿½
Clearly the technologies and equipment are available to make unit-dose bar coding a reality. ï¿½Printing and marking technology is constantly improving,ï¿½ says Snyder. ï¿½However, some of the responsibility for creating a quality bar code rests on the user. If users educate themselves on the fundamentals of how a bar code functions, a lot of unnecessary application challenges can be avoided.ï¿½
Quintï¿½s Davis agrees: ï¿½Any new bar coding project must begin with the foundation of education,ï¿½ he says. ï¿½The many complexities of bar coding need to be learned and understood from the very beginning. Everyone involved in a bar coding project needs to learn about the bar codes, what bar code print quality is, and how to verify bar code print quality.ï¿½