Serialization Delivers Benefits Beyond Pedigree Data
Pharmaceutical packagers are refocusing attention on serialization as they strive to meet California’s 2015 ePedigree deadline, and exhibitors at PACK EXPO Las Vegas 2011 (September 26-28; Las Vegas Convention Center) (www.packexpo.com) are ready.
PACK EXPO exhibitors will display hardware, software and integration solutions necessary to support track-and-trace capabilities.
Interest in adding serialized (unique) codes to pharmaceutical packages — and collecting related data — is on the rise.
Driving forces include California’s deferred ePedigree deadline in 2015, serialization requirements elsewhere in the world and the desire for another tool to authenticate product.
“The year 2015 is not as far away as you might think,” says Mark Drochek, application engineer at Rockwell Automation (Milwaukee, WI; Booth # 5417), the supplier of FactoryTalk Pharma Suite, which includes functions packaging machinery builders use for serialization applications serving the pharmaceutical industry.
Another driver is the long lists of business benefits — beyond meeting regulatory requirements — serialization facilitates. Serialization technology can help track packaging line performance, revealing inefficiencies that might have otherwise gone unnoticed, such as variations in speed or product weight. It also can help prevent out-of-stocks, brand switching and loss of sales. Finally, serialization helps validate returns, charge-backs and reimbursement claims.
But there is one big challenge: Serialization involves many functions – software, coding, material handling, inspection, integration and data collection and management – but few standards. Existing and emerging legislative requirements differ worldwide, and harmonization of serialization requirements is still years away.
Further complicating implementation is the sheer quantity of serialization strategies available, the need to link information technology (IT) with the packaging floor, and the fact that no single vendor possesses all of the necessary hardware, software and integration skills needed to enable serialization.
In addition, packaging lines vary too much for a one-size-fits-all solution.
“A full engineering assessment must be performed for each packaging line,” says Jean-Pierre Allard, product manager/Serialization Solutions at Optel Vision (Quebec City, Quebec, Canada; Booth #C-4806), a supplier of vision systems and software that is working with GE Healthcare (Chalfont St Giles, UK) to implement serialization solutions on more than a dozen lines worldwide.
“Every line is different,” agrees Dennis McLaughlin, director of engineering at Nutec Systems Inc. (Lawrenceville, NJ; Booth # 1217), a supplier of product handling, thermal inkjet coders, vision and integration services. “Some need new printers; others can use existing equipment. There also are many options for when the serialized code is applied — after the cartoner, after the form-fill-seal machine, etc.”
The variability of packaging lines isn’t likely to change. Nor is the need to retain as much existing equipment as possible during implementation.
What is evolving, however, is a consensus that a two-dimensional DataMatrix code is currently the best option for item-level coding. It not only is relatively easy to print and read, but also is defined by global identification and data standards established by GS1, a not-for-profit member-driven organization that administers the U.P.C. and develops worldwide standards and solutions for identification numbers, data carriers, electronic commerce, and global data synchronization. (Brussels, Belgium/Lawrenceville, NJ). In addition, the GS1 Healthcare US group has been working directly with pharmaceutical manufacturers and suppliers to prepare for California’s 2015 deadline, even posting its “2015 Readiness Program: Phase 1 Report – Basic Forward Logistics” on its website in 2010.
Likewise, many firms are adopting case label guidelines/standards outlined by the Healthcare Distribution Management Association (Arlington, VA) in its 2006 publication, “Guidelines for Bar Coding in the Pharmaceutical Products Supply Chain.”
Other major trends include an emphasis on turnkey solutions and a higher level of collaboration among groups of suppliers. “One party should have overall responsibility,” explains Christoph Lehmann, director at Uhlmann VisioTec (Towaco, NJ; Booth # 4206).
Realizing collaborative solutions
Omega Design Corp.(Exton, PA; Booth # 2634), for example, provides the hardware and automation expertise for turnkey serialization solutions from a group dubbed the 4Serialization Team. Other team members supply pre-serialized labels (Nosco, Inc., Waukegan, IL), data management (Acsis, Inc., Marlton, NJ) and vision technology (Cognex Corp., Natick, MA; Booth # 4218). Targeted toward small and mid-size companies that package pharmaceuticals, a 4Serialization solution can be deployed in as little as 90 days.
Omega Design applies a unique 2D code to each bottle bottom to enable
tracking of containers throughout the packaging process.
Omega Design also offers its own serialization solution. It advocates starting the serialization process as early as possible on the packaging line. Instead of waiting until the labeling or cartoning stage, Omega Design inkjets a unique code on the bottom of each bottle as it is turned upside-down for air rinsing before it exits the unscrambler. Lee Brown, business development manager at Omega Design, says visitors to PACK EXPO Las Vegas will be able to see this strategy in action.
Brown says coding the bottom of the bottle as a first step allows data like weight and cap torque to be collected about each container as it moves down the line.
“It also offers an extremely secure and reliable aggregation of the bottles at the end of the line,” he explains. “Many other serialization solutions rely on keeping bottles in exact sequence (first-in/first-out). This can be extremely inefficient and insecure, and hurt the overall efficiency of the packaging line.” Brown notes this is particularly true if a jam or other fault occurs that damages or scrambles the containers.
On Omega Design’s demo line, an Intelli-Sort SRP unscrambler orients each container bottom-up for cleaning, putting it in a perfect position to apply an inkjet or laser code from above. A vision system confirms the code is correct. Codes are read again before the bottle passes over the load cell belt of a checkweigher, and Omega Design’s DataSync software captures weight information and stores it along with the unique bottle code in the database. Later, when a code is scanned, the Bottle Integrity Profile will show all the specs tracked for the container.
At the labeler, a serialized label is applied and a camera reads the bottle code and takes an image of the bottle. LabelSync software then links the bottle code with the label code. Bottles are bundled by the dozen and a print/apply labeler applies a serialized label. One camera records information from the bundle label while a second camera captures the codes on the bottoms of the bottles. If all 13 codes are readable and authenticated in the database, the bundle is accepted and PackSync software establishes a parent/child relationship between the bundle and the bottles inside and sends the information to a supply chain database management system.
The fully integrated bottle packaging line Uhlmann will show at PACK EXPO Las Vegas features its IBC120 plus its new L250 Labeler. The Total-Bottle-Tracking System serializes each bottle with a unique bottle and label code. In a second step, bottles will be packed into a case, and a tabletop station will aggregate the bottles and case to establish a parent/child relationship.
Another pharmaceutical packaging equipment specialist that relies on the collaborative approach to serialization, Marchesini Group (Pianoro, Italy; Booth # 4615), integrates Serialized Product Tracking software from Systech International (Cranbury, NJ), and coding and vision systems from various suppliers. On a demo line shown at last year’s PACK EXPO International, each carton was printed with a unique DataMatrix code and sealed with two tamper-evident labels, 24 cartons were aggregated to a case, and each case received a serialized case code. Case codes were recorded with a handheld scanner equipped with proprietary Systech software and aggregated as pallets were manually built. Once a pallet was complete, a pallet label was printed with a unique code. Labels are inspected at each step and the carton, case or pallet code is commissioned or rejected by a Systech Sentri system. A rework station, which could be positioned at the end of the line or in the warehouse, can generate pallet labels or replacements for damaged case labels.
At this year’s PACK EXPO Las Vegas, Marchesini will demonstrate its BL300TT (Track & Trace module for cartons) and BL400(V)TE TT tamper-evident labeler with an integrated Track & Trace function and possibility to install a vignette labeling head in the future. A carton indexing system with toothed belts positively handles cartons during printing and inspection, and fail-safe logic ejects all rejects.
Other PACK EXPO Las Vegas exhibitors with serialization solutions include Videojet Technologies, Inc. (Wood Dale, IL; Booth # 2600) and Optel. Videojet, a subsidiary of Danaher Corp. (Washington, DC), will showcase its coding technologies integrated with package coding management software from Claricom, another Danaher company, or IMprints serialization software. The latter also is the basis of IMprints for Converters, a partnership that integrates coding equipment from Videojet, and inspection systems from Label Vision Systems, Inc. (Peachtree City, GA; Booth # 5566) on narrow-web presses and rewinders from Mark Andy Inc. (Chesterfield, MO; Booth # 5563), and carton-converting equipment from Roberts PolyPro, Inc. (Charlotte, NC).
Optel will demonstrate item-level serialization of both cartons and bottles. The bottle demo will continue through the bundling and case stages and perform the aggregation needed at each step.
“Although key decisions may differ, the up-front diligence and planning are crucial elements for success when embarking on a serialization project,” says Chris Riley, Videojet business unit manager, Pharma.
In fact, one of the bigger challenges involved in serialization is not the integration of the hardware and software on the packaging line, but the process changes required.
“The processes and procedures used in a packaging operation need to be modified to reflect the fact that each unit of packaging has a unique identity. The aggregation rules, the integrity of parent-child packaging relationships, the need to be disciplined for any offline packaging processes…all of these post-implementation scenarios need to be understood by the operating personnel on the line,” Riley explains.
Without good process control, the added coding and inspection requirements can affect line efficiency and may increase reject rates even though today’s vision systems can read multiple 2D codes simultaneously. Even if rejects don’t increase, rejected products carrying serialized codes require special attention. “Any rejects have to be accounted for,” says Darren Meister, vice president of sales at IMA North America, Inc. (Leominster, MA; Booth # 1817). Generally, this means decommissioning the code and making sure it isn’t included in any aggregation.
“Serialization is data,” explains McLaughlin of Nutec. The infrastructure is different than that needed for a discrete product and requires bidirectional communication between the packaging line through one or two levels to IT at the enterprise level.
The infrastructure also must be capable of handling the massive amounts of data generated. “Chances are this volume of data has not been encountered before,” says Drochek of Rockwell.
To provide maximum flexibility, the data format selected needs to be compatible with existing upstream and downstream systems as well as any new systems that might be installed in the future. “We have implemented a flat data file format, because it gives us the ability to make changes to meet all future requirements,” says McLaughlin of Nutec.
Aggregation can be tricky too, particularly in higher count cases where some codes may not be readily visible to machine vision systems because the number is not facing outward or the container is in the interior of the collation.
How serialization interfaces with the company’s enterprise system is another essential decision. Will a manufacturing execution system residing between the packaging line and enterprise level perform the serialization functions or should a parallel serialization system be installed?
“Another important consideration is code quality. Packaging materials affect how 2D barcode characters are written, read and verified,” says Drochek.
“The color, chemical composition and physical properties can have a massive effect when verifying 2D codes against ISO 15415 [Information technology -- Automatic identification and data capture techniques -- Bar code print quality test specification -- Two-dimensional symbols],” agrees Craig Stobie, global life sciences sector manager at Domino Printing Sciences plc (Bar Hill, UK), a supplier of coding equipment with a North American office in Gurnee, IL (Booth # 2015)
For maximum contrast, the ideal is 100 percent black ink on a 100 percent white substrate, but usually this is closer to 80 percent black on 80 percent white. “All of a sudden your maximum barcode score can be 60 percent, even with the best technology,” he explains.
To minimize variability in code quality, Videojet has introduced a premium thermal inkjet ink that provides high contrast against the substrate, improves barcode grades and reduces the chance of misreads or rejects.
“Printed code quality … may seem small compared to some of the data and IT challenges that exist with serialization, but the robustness of any solution still hinges on the ability to reliably print a high-quality code,” says Riley.
How a carton is made plays a role too. If a carton isn’t very stable as it’s being coded and inspected, it’s more challenging to verify code quality and accuracy and capture data.
Look for flexibility and scalability in hardware and software partners, advises Omega Design’s Lee Brown. That way a transition from a slow line to a high-speed line or vice versa doesn’t require a change in vendors or radically different technology.
Software should be configurable, adds Lehmann, so certain functions can be turned on or off as needed.
In addition, he says, “IT, packaging experts and the supplier need to sit together very early in the process. The impact of serialization within packaging lines can be much higher than it looks to be at the beginning of a project.”