The following summary, from the editors of ControlGlobal.com, was derived from a presentation at Rockwell’s Automation Fair 2009 in Anaheim, California.
Drug counterfeiting has become a major issue for pharmaceutical companies and governments around the world. The threat to patient safety and the economic impact of drug counterfeiting has made this a top priority.
"Just looking at a product doesn't tell you if it's an original or it's a counterfeit," said Sandro Gisler, manager, marketing and product development at Bosch Packaging Services, who related his company's story of creating a track-and-trace solution with mass serialization capabilities in a regulated production environment. "Track-and-trace is the tracking and tracing of products through the supply chain from manufacturing to the end customer. It's used for high-quality requirements, when there's an impact on consumer health and safety, when there's a threat of counterfeits and in case of the need for a full product history."
During manufacturing, each package receives a unique serial number so it can be tracked through the entire process. "It originally starts as a reaction to something negative, but benefits can be realized from it," said Gisler. "It provides proof of origin, identifies and eliminates the introduction of counterfeit products, locates each manufactured product in case of quality problems or recalls, provides supply chain savings through better visibility of inventory and gives detailed market intelligence."
According to Gisler, three levels of functionality must be implemented for track-and-trace. Systematic Printing and verifying numbers on each package. Unique serial numbers are required for mass serialization. And the information has to be entered and maintained in a database.
Bosch has 17 manufacturing and packaging plants around the world with in-depth knowledge of pharmaceutical processing and packaging, as well as longstanding experience in the automotive industry, which has used track-and-trace for years. Bosch's scalable carton-printing system can be used for print-and-verify mass serialization and product traceability. The Bosch modular concept of printing and control systems can be integrated into new or existing packaging lines or complete production plants of all manufacturers.
The machine that was developed, the CPS High End, is a stand-alone unit to make it easier to validate the component. "The throughput is 400 cartons per minute, and it has a relatively small footprint," said Gisler. "The CPS High End receives cartons from the outfeed belts of the upstream machine. Cartons are then transported through the printing module via a belt system. Once in the infeed zone, the carton is guided between the upper and lower belts. In this area, the carton is printed and print quality is verified."
The serialized solution includes a central FactoryTalk Pharma Suite server and site database, which interfaces to third-party enterprise systems, along with FactoryTalk Pharma Suite clients for rework scanning and high-speed device management on an Ethernet network. The operator must see what happens on the machine, so the HMI was developed with all components, from the camera to the printer, in mind.
