Achieving Necessary Control
The need for packaging line control as well as further collaboration among supply chain partners was emphasized during AIM Expo’s panel discussion, “Serialization in the Pharmaceutical Supply Chain: Lessons Learned and Remaining Challenges,” moderated by Bob Celeste, Director, Healthcare, GS1 US.
Distribution giant Cardinal Health, whose Dirk Rodgers participated during the panel discussion, has participated in a number of pilots with the pharmaceutical industry. These include Accenture’s Jump Start pilot in 2004–2005, an in-house end-to-end pilot in 2006–2007, and California’s RFID pilot in 2007–2008.
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“We found that GS1’s EPCIS and DPMS standards are both capable of handling serial numbers and aggregation,” Rodgers said during the panel. “The challenge now is to increase efficiencies, but that is more of a software issue.”
And greater collaboration is needed among partners. “Many companies have a ways to go in complying with GS1 standards,” observed Rodgers on the panel. “Many smaller suppliers have no idea what they’re doing with GS1’s bar code standards on their existing case labels. We receive a lot of cases that have errors in the way the data is encoded in their bar codes. The industry has a long way to go for a smooth transition to reliance on serial numbers on everything.”
Critical is “the performance of track and trace systems,” said Rodgers during the panel discussion. “I am not yet confident that the industry can scale up to handle unit-level serialization through the entire supply chain.”
At the neighboring trade show, Pack Expo Las Vegas, several machinery providers were exhibiting their latest systems for implementing track and trace on the pharmaceutical packaging line.
Mettler-Toledo (www.mt.com), which just acquired Pharmacontrol Electronic (PCE) and previously Garvens, showcased camera systems and software for capturing and verifying Data Matrix printing and aggregating items into cases.
Mettler-Toledo’s Mark and Verify systems can be employed on packaging lines as “aggregation stations” that inspect the quality of printed codes and capture serial numbers. Linking all line software together, these stations can then connect to upper-level systems to communicate serialized data. Even the company’s new ProdX system, developed to inspect package
quality attributes, will be able to integrate such data management.
MGS Machine (www.mgsmachine.com) has been working with all major vision and printer suppliers to support secondary packaging serialization. MGS Machine offers the Carton Inspection Module (CIM) for printing, inspecting, and rejecting. Once cartons pass through the module, they are securely conveyed to MGS’s case packer.
“We achieve a full view of the carton array to capture serialized carton codes in order to start aggregation of cartons to the case, one layer at a time,” explains president and CEO Richard Bahr.
“It might be difficult to justify a new case packer for a serialization effort alone,” Bahr continues. “However, a new case packer provides a higher OEE, which helps make the argument. [And] we are seeing generic drug companies interested in
In addition, the case-packing sytem was developed to be ergonomically friendly and to control the security of the cartons and cases.
Microscan is (www.microscan.com) offering its new AutoVISION line of machine vision products, comprising the Vision MINI and the Vision HAWK, explained Cathy McBeth, product marketer, at the show. Intended to simplify machine vision for packagers, the line can be used to support what Microscan calls track, trace, and control initiatives.
McBeth explains that these smart cameras operate on either the firm’s Visionscape platform or its simplified AutoVISION interface to capture information such as serial number and bar code data, print legibility, and product measurements for quality inspection and product identification.
Thanks to its acquisition of Seidenader in January 2011, Körber Medipak (www.koerber-medipak.com) is offering serialization and track and trace for its family of pharmaceutical packaging lines. The Seidenader T&TSolution is available as a T&TSingleUnit
station, a T&TSingleUnit mounted adjacent to a top labeler, a T&TSingleUnit integrated with a checkweigher,
and a T&TSingleUnit with up to three label applicators.
Körber Medipak’s systems can support item, bundle, case, and pallet serialization; the addition of coders and vision systems can support aggregation and transmit data to ERP/MES systems.
Glenn Siegele, president of Omega Design Corp. (www.omegadesign.com), part of the 4Serialization team, advocates the approach “track now, code early.” Demonstrating bottle coding, inline inspection, and bundling at Pack Expo Las Vegas, he explained that using serialized codes on the bottom of bottles can facilitate aggregation.
“When the supply chain relies on inference, accuracy is critical,” he explained. “Every company needs to ensure that case contents are accurate. We believe that if you start by creating the bundle first, then query the data next, you ensure integrity. Read the bottom codes on the bottles secured in the bundle, make sure they belong, then establish the relationship and let the bundle go. It is a fail-safe approach.”
Pharmaworks (www.pharmaworks.com/) exhibited with vision system provider Scanware Electronic GmbH (www.
scanware.de), where Harald Mätzig explained that pharmaceutical companies have already learned a lot from projects developed to comply with European deadlines such as France’s CIP rule.
“Many companies wanted to learn from others’ experiences. People thought that building a database would be the problem, but for vision system experts, data management is not the problem. If the vision system is designed and implemented correctly, companies shouldn’t have to worry about it or the database,” said Mätzig.
Scanware works with Pharmaworks to integrate its Lynx-Signum HR on cartoners or integrated into existing or new
checkweighers. Lynx-Signum HR can also be integrated on labeling machines with a variety of printers, including continuous ink-jet, laser, or digital printers. It can also serve as a stand-alone printing and inspection station with a conveyor belt and eject station.
The biggest challenge, says Mätzig, “is handling the unexpected—guiding cartons to present them to the printer and managing rejects. Printer and camera position is critical for handling rejects and unbooking serial numbers.
“Support is key; otherwise, you lose a lot of product,” he added. “Capacity is also affected, and lines are not as
efficient. Simple things are more of an issue in the serialized environment.”