So you work for a pharmaceutical manufacturer that’s looking to its carton supplier to handle serialization and anti-counterfeiting tasks to deliver patient safety and compliance with government mandates such as the Drug Quality and Security Act (DQSA).
One approach that’s helping digital print and process technology provider OTC Group is the Xerox® Automated Packaging Solution, or XAPS.
Installed at OTC Group’s London, Ontario, Canada facility about two years ago, XAPS provided OTC Group entry into the packaging world. Prior to the installation, OTC Group printed exclusively commercial jobs, including direct mail pieces.
“We manufacture folding cartons and labels and other collaterals digitally for a number of industries, but pharmaceuticals represent a key market because of serialization,” says Adam Egan, OTC Group’s Vice President of Packaging.
Sheet-fed carton digital printing is the company’s focus, working in thicknesses from “paper grade” to 20 pt. As is often the case in digital printing, OTC Group specializes in short-run jobs for manufacturers and consumer packaged goods (CPG) companies, and for other folding carton suppliers.
Egan says, “Counterfeiting is very significant, and serialization is a necessity in large part due to DQSA in the U.S., and similar government mandates in other countries. We do work for products in South Korea where their security standards for packaging are already pretty stringent.
“Anti-counterfeiting is not necessarily an issue that’s mandated but it’s a huge problem for pharmaceutical companies. There are billions of dollars worth of counterfeit pharmaceuticals being sold. The World Health Organization says approximately a million people die each year because of counterfeit pharmaceuticals. It’s especially a problem in the third world, but its becoming more of a first-world problem.”
He believes counterfeiting also applies to biopharmaceuticals, medical devices, foods, and other industries.
To help address counterfeits and meet serialization needs for customers, OTC Group turned to the XAPS system. “It marries well with what our processes were meant to do,” Egan explains. “We found it to be the best system for that sort of work within the processes that we are creating.”
OTC Group initially purchased Xerox’s iGen® 150 presses before investing in the XAPS system. “I believe ours is the only one in commercial use in North America,” says Egan. “We now have two iGens, which are built into our packaging lines.”
These packaging lines include an Epic Products carton coating unit, a Kama die cutter, gluing and stacking equipment. OTC Group developed software internally to handle the various processes involved in the packaging processes.
“Our XAPS system is the actual system that we bought from Xerox’s headquarters facility in Rochester. We’ve become the showcase site for Xerox when it comes to XAPS,” says Egan. “They bring people in to look at it who run similar types of products that we do to show them the unit and how we are manufacturing with it. Everything is inline, one packaging unit.”
Before adding the XAPS system, OTC Group had used two other Xerox digital printers. But, says Egan, “This one is completely different. We start with blank sheets that get fed into the press and we print things duplex, on the front and back because as that lends more security.”
Finished carton sheets printed with serial numbers are placed into corrugated shipping cases, each with a label. When the case label is scanned, it identifies the printed cartons within.
Egan says OTC Group is working on a project right now with a South Korean pharmaceutical company that for now prefers not to be identified.
For one current client requiring an 800,000-count printed carton production run, OTC Group estimates that XAPS eliminated millions of dollars worth of risk exposure by providing traceability for every carton, and giving that data to the client in an electronic format.
So how does Xerox prevent would-be counterfeiters from purchasing this technology? “Xerox is very particular about who they sell their equipment to,” explains Egan. “And in order to run it correctly, you need a license that Xerox has to approve.”
OTC Group, which will exhibit at PharmaEXPO, can employ XAPS to print overt serial numbers, micro-text, or 2D barcodes, for example. “It all depends on what problem our customer is trying to solve,” he says. “In each instance, we create a process to solve that problem.”
And solving customer problems is exactly how OTC Group justifies the investment in XAPS.
“The key way of looking at the return on investment in this case, is anti-counterfeiting, or the mitigation of counterfeiting risk,” says Egan. “Yes, the system helps our customers satisfy government mandates such as DQSA, but from a pure counterfeiting side, it is about mitigating risk and providing peace of mind and safety for our customers.”