Counterfeit products are booming in the pharmaceutical sector. Complete traceability along the entire supply chain helps patients and manufacturers to protect themselves against plagiarism. With the "PALC unit", the North German company ISW offers a track & trace system that uses image processing and networked databases to check the products. The complete design and conveyor technology comes from MiniTec.

The immense importance of the pharmaceutical industry for society and the community is particularly evident at the moment. In less than a year after the outbreak of the pandemic, several companies have succeeded in bringing highly effective corona vaccines to the approval stage. In the drug sector, too, new, effective preparations are being developed year after year. It is obvious that a lot of money is earned with this and is an important driver for the manufacturers. At the same time, this circumstance repeatedly brings product pirates onto the scene, who want a piece of the pie with deceptively genuine plagiarisms.

EU regulation binding since 2008
This not only results in considerable economic damage, but also entails high risks, especially for patients. In order to put a stop to counterfeiters, countries as well as affected companies are making great efforts. These include the EU's so-called Counterfeiting Directive (2011/62/EU), which has made product labeling and traceability of pharmaceuticals mandatory since 2008. The aim is to label products unambiguously, i.e. down to the smallest packaging unit, so that origin, production date and other information can be traced back seamlessly at any time, right back to the production batch.

Plant for serialization of folding boxes
Against this background, ISW GmbH from Kölln-Reisiek near Hamburg developed the image-processing-supported Track & Trace System PALC unit together with MiniTec several years ago. PALC stands for Package Aggregation Line Controller. This is a flexibly configurable solution that can be integrated into any production line for the serialization of pharmaceutical products that have already been packaged. The PALC unit is ideal for pharmacists, packagers or contract manufacturers. The PALC requires little space, is flexible and solidly constructed from MiniTec profiles.

Pressure and control in one system
Within a production line, the PALC is supplied with packaged pharmaceutical products by the infeed system. At the infeed, the folding cartons are separated and then printed to make them uniquely identifiable and traceable by means of various codes with plain writing. This is followed by quality control and evaluation. The marked 1D and 2D codes, pictorial representations such as logos, and plain text are checked for correctness and quality using high-performance cameras. This is where the advantages of image-processing-based systems over code-scanning solutions become apparent: In addition to codes, they can also check plain text and the overall quality of the printed image. Faulty products are rejected directly by ejecting them through a nozzle by means of compressed air over an inclined plate into the NIO container. This is verified by sensor technology.

Transport speed and packaging size flexibly adjustable

The cartons are transported through by a total of three synchronously running toothed belt conveyors, two at the bottom and one at the top. The belt speed can be up to 500 mm/s and can be adjusted via the touch surface. This makes it possible to serialize up to 400 products per minute, depending on the packaging size and the respective marking specifications. The conveyor belts can be adjusted separately in height and distance using a hand crank. The size of the folding boxes in the throughput direction can thus vary: Up to 30 cm wide and between 1.5 and 13 cm high, the packages can be conveyed through the system.

A convenient HMI networks the machine, printing and control equipment, and possible extensions into an easy-to-operate overall concept. A software kernel controls the production process via the software modules, sensors and actuators and communicates with the connected ERP/MES system. Safety is also taken care of, as interlocked safety devices prevent the manual submixing of products.

Individually configurable thanks to MiniTec
Because production processes often differ, each PALC plant must be adapted to the individual conditions. The required flexibility is ensured by the MiniTec profile system and the company's know-how in the field of conveyor technology. MiniTec customer consultant André Hintz comments: "ISW's expertise in image processing and automation, our experience in mechanical engineering, and our profile construction kit complement each other ideally in the PALC systems." ISW Managing Director Tobias Wichmann can only confirm this: "The demand for our PALC units is constantly increasing. We are familiar with the diverse international requirements for putting a stop to drug counterfeiting and, thanks to our cooperation with MiniTec, we can adapt the PALC individually and flexibly as an automated, modular track & trace system. This is also reflected in the range of applications, which extends from medium-sized pharmaceutical companies to international corporations."