On the Edge of a Breakthrough
Near-edge thermal-transfer printing and servomotor control help a biotech leader reduce labeling defects and costs.
By Daphne Allen
Avery Dennison Printer Systems' 64-series printers are configured with integrated bar code verifiers.
As a biotechnology product innovator, Genzyme (Cambridge, MA) has a diverse product portfolio. The company’s products and services are focused on rare inherited disorders, kidney disease, orthopedics, cancer, transplant and immune diseases, and diagnostic testing. “Several of our products require us to produce onesies and twosies of patient-specific cells,” explains Richard Azaroff, one of Genzyme’s staff packaging engineers. “We have products focusing on targeted therapies and personalized medicines, such as live tissues and combination products. For some of these, like cartilage, patients can only accept their own tissues.” Some product lots are as small as two or three individual product cultures.
To meet patient needs, Genzyme cannot afford any production or packaging delays—or mistakes. “We have to be extremely responsive,” says Azaroff. “And we must verify labeling and lot identity of all patient-specific products before use.”
Labeling plays a key role in product delivery. “Often we are producing labeling for a very limited number of patients in another country, as we do with our products for Fabry’s Disease,” says Azaroff. Because Genzyme markets products around the world, producing 12-language labeling as well as market-specific labeling is routine. In the area of bar coding, “we primarily print Code 128, but we also print Data Matrix and Reduced Space Symbology (RSS) codes. “We are also experimenting with the composite portion of RSS for patient-specific information,” he says.
To handle such varied labeling operations in-house, Genzyme decided to set up its own print shop to produce and encode labels. The operation would primarily handle medical device and combination-product labeling, but also support shipping labels as well as labeling for small-volume parenterals and pharmaceuticals. Bar code labels for internal inventory control were also in order.
The labeling operation was set up to be an independent one that, while owned and operated by Genzyme, would operate just as an external vendor would. Printed and encoded labels would be received in lots and go through the same quality control and inspection processes that any purchased material to be used in a GMP environment would.
After operating the labeling shop for a few months using laser and thermal-transfer printers, Azaroff says he and his team began accumulating data on defect levels, waste, costs, and efficiency. “We were experiencing some bad ribbons, as well as drop-outs in print,” he says. And, because of creases in the ribbons, “We would end up wasting entire rolls,” he says. In addition, printing large labels (4 × 6 in. and 6 × 8 in.) for its pouches and cartons made them “go through ungodly amounts of ribbon,” he says.
When the operation turned a year old, the team decided that higher-throughput production lines with fewer print-quality defects and less stock waste were needed. They also sought automated bar code inspection and a reduction in thermal print ribbon waste. “Our answer turned out to be Avery Dennison Printer Systems’ 64-series printers, configured with integrated bar code verifiers,” says Azaroff.
The 64-series printers were installed in April 2005, and automated bar code verification systems were brought on-line in June 2005. Since then, the “label shop must have printed more than 500,000 labels,” says Azaroff. In the last quarter alone, about 180,000 glossy finished-product labels were printed, each containing multiple bar codes; a somewhat smaller number of carton, shipper, and pallet labels, as well as specialty overlabels containing bar codes, were produced for use in Genzyme’s supply chain.
Azaroff has found Avery Dennison’s 64-series near-edge printing technology key to image quality. According to Mike Shabet from Avery Dennison, near-edge technology refers to the amount of pressure that is required to transfer ink from the thermal-transfer ribbon to the labeling substrate. A thin-film ribbon is used that is highly reactive to image elements, explains Shabet. “With the 64-series, you don’t need as much pressure as you do with some traditional systems,” he continues. “Low pressure translates into low heat and low friction, and therefore a longer printhead life.”
Azaroff adds that he has also been able to speed up the printing line. Shabet says that near-edge printing on paper-based labeling can operate as fast as 16 in./sec, but for this film-based label and durable resin ribbon, 8 in./sec is the most reliable for the application of fine copy and high-density bar codes. And printing on polypropylene and polyethylene stock could reach 12 in./sec. “Three-point fonts and 2-D bar codes are clear,” says Shabet.
Three independent servomotors are used to enhance printer control. Shabet explains that one motor controls the up-and-down motion of the printhead; a second controls the movement of label ribbon; and a third controls the advancement of label stock. “All three are synchronized by the 64-bit processor, so users can optimize label ribbon use and ensure accurate placement,” says Shabet. “The printer will calibrate itself as you change label sizes and shapes, and the printhead will only contact the label when the printer is printing.”
After months of operation, “defective labels downstream of the label shop operations had dropped to nearly nothing,” says Azaroff. The operation is verifying bar codes on every label (100% inspection) in real time as the production line runs. “The verification systems allow us to stop the line and address any problems that result in substandard bar code printing or readability immediately, without awaiting discovery in subsequent inspections.”
Azaroff and his team determined that, given the shop’s reliability, equipment, and procedures, Genzyme could reduce manual inspection requirements for printed materials provided by the shop. “While inspection is still an on-going requirement, a significant number of man-hours of quality control involving sampling inspection have also been saved in this process,” he explains.
Azaroff says that printer use has enabled Genzyme’s labeling shop to “greatly increase efficiency through fewer adjustments and calibration steps, significantly reduce operator intervention, reduce defects and waste, and reduce ribbon changes and down time. “The Averys have also saved us big money,” he says. Savings include a “better than 75% reduction in ribbon waste when printing larger labels, reduced manual inspection requirements, and an enhanced ability to catch any print-quality-related problems during print jobs, allowing us to reprint any bad labels before they can ever be released from the shop to QA.”