Turning Weeks into Days

Digital printing helps a drug manufacturer turn labeling changes around in days.

 

Digital printing through Nosco On_Demand Solutions allows TAP Pharmaceutical Products to change label content quickly.

Flexibility and efficiency are important to TAP Pharmaceutical Products Inc. (Lake Forest, IL). The manufacturer of such drugs as Lupron and Prevacid is implementing a high-efficiency supply-chain initiative that focuses on reducing inventory and increasing flexibility. “We want to use the best technology out there for competitive purposes,” says Robert Wiley, project manager, manufacturing technology, for TAP Pharmaceutical Products. “We want to get products out faster, and we want to respond to change faster.”

As part of that initiative, TAP reviewed its label printing for Lupron and Prevacid. Lupron is supplied in a kit, which consists of a prefilled syringe in a clamshell package. Both the clamshell package and the syringe are labeled. “We were frustrated with Lupron’s complex supply chain. The product comes from Japan, and the finished packaging is handled in the United States,” explains Wiley. “We don’t have a lot of lead time—only two weeks notice—before a shipment arrives from Japan.”

Keeping labels on hand was a challenge. Nosco Inc. (Gurnee, IL) was supplying TAP with flexographically printed labels, with a lead-time of approximately 4-6 weeks, says Wiley. “We have a lot of changes to labeling text, and we have several different Lupron products,” he explains. “We just couldn’t keep up and hold inventory—we had to discard labels. Plus, we were faced with the pure costs of holding inventory.”

In 2004 Nosco installed an HP Indigo press ws4000, an end-to-end digital system that prints pressure-sensitive labels, shrink sleeves, and glue-applied substrates. Nosco now offers digital printing through its Nosco On_Demand Solutions initiative. “We are reducing cycle time,” says Russ Haraf, Nosco’s president. “And if we take steps out, we take costs out.” These costs can include those for label inventory, label obsolescence, and expediting label production to solve out of stock situations. “If a company can gain an advantage from reduced inventory, it has more cash for other investments, like R&D,” says Haraf.

“The biggest driver for implementing digital printing is cycle time reduction,” adds Greg Verenski, Nosco’s account executive for TAP. “Digital gives us the ability to get those weeks into days.”

“Nosco came to us when they bought the equipment, and we had heard about digital printing,” says Wiley. “We want to partner with companies that embrace technologies that give us a competitive advantage. Nosco had done its homework. A few other label printers had gotten into digital printing before the technology was where it needed to be.”


Manufactured in Japan, Lupron needed a flexible labeling process with the capability for making instant changes.

TAP moved fairly quickly. Wiley started looking at digital printing in March, and Nosco and TAP began converting from flexo labeling to digital labeling for Lupron in July. “We expected a seamless transition. Our colleagues are excited, and my team has a lot of support to make sure we implement the labeling,” Wiley says.

Wiley explains that digital printing has been an easy process to embrace. Label materials are submitted electronically, and changes can be made instantly, rather than preparing and paying and waiting for new flexographic plates, he says. “Frequent changes to plates can be expensive.” After receiving label content, Nosco produces digital and print proofs for TAP’s review.

Electronic files are handled and stored according to Nosco’s quality system requirements. “Most pharmaceutical companies want to be certain of controls and consistency. We follow the same quality system, whether it is for digital or conventional printing,” says Haraf. “File integrity and storage is critical to Nosco’s quality system. Our Digital Asset Management system was invented when we switched to computer-to-plate printing.”

Haraf adds that Nosco “did extensive IQ, OQ, and PQ of the HP Indigo system. “We validated the ability to print on several substrates, and we know we can meet specifications with these substrates.”

Such control was a comfort to TAP. “We wanted to be sure that we were following the same quality standards,” says Wiley. “We were also concerned about incoming quality inspection, so we created specifications for color standards and referenced the four-color digital printing process.” TAP worked with its contact packager, which receives and applies the labels to the clamshells and syringes, to develop and implement such inspection specifications. After inspection, labels go straight to the packaging line.

TAP was pleased with the results. “The pictures we have printed on our labels are crisper than before, and the durability of the printing is the same as that of flexographic labels,” says Wiley. “A rub test shows no difference.” In addition, “flexo printing had color variations from lot to lot, whereas digital printing is more consistent.”

Digital printing offers a range of colors, but the greatest cost savings is with a four-color process.

“Offset printing is viewed as the highest in terms of printing quality,” says Craig Curran, business manager, Nosco On_Demand Solutions, “and digital’s quality is there. HP is marketing the technology as digital offset printing. People often think of digital as being low dpi, like 300 to 600, but it is really 800-1200 dpi. TAP’s photos are crisp in digital, a benefit for brand marketing for shelf presence and design flexibility. In flexo, they were grainy.”

Wiley notes that digital printing does not offer as many exotic colors, like the gold metallic TAP was using for its labels. “You can’t use fluorescents and metallics,” says Curran. “You can’t put them into the press. Your options are to accept a four-color-process rendition, change the color, or add a secondary process to apply the exotic color.”

After participating in structured line trials, Wiley says Nosco got TAP’s colors right. A four-color process was chosen to simulate TAP’s metallic color. “We ran into some technical challenges along the way, like color matching, but we solved them together,” says Wiley.

Digital printing can handle up to seven colors, including various PMS and indichrome colors, says Curran. “But the savings is greatest when running in a four-color environment,” he says.

TAP is looking to expand digital printing to other products, both within the Lupron family and to a new niche product awaiting FDA approval. “Wherever it makes sense, companies should implement digital printing. In general, if your volumes are below 150,000, it makes sense to go digital. It is ideal for small-volume products, smaller batches, niche products, and new product launches,” says Wiley.

Security Options

Greg Verenski, Nosco’s account executive for TAP Pharmaceutical Products, reports that in addition to flexibility, digital label production also offers unique brand protection and track and trace capabilities. Authentication features such as microprint, layered optical watermarks, and other overt, covert, and forensic options can be produced. These can be variably or statically printed.

Also, the system’s ability to print serialized numbers offers a “bridge” to and “redundancy” for RFID, says Verenski, helping manufacturers develop an electronic pedigree to support FDA guidelines and state legislations.

Adds Haraf: “Based on our research, most pharmaceutical, biotech, and medical device companies have a significant number of small- to medium-sized SKUs to manage. Digital label production gives procurement and planning professionals a way to meet changing demand virtually without minimum run sizes.”

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