Omron’s expertise in machine automation and vision systems means it is ideally placed to advise and assist in implementing serialisation systems to reduce counterfeiting and improve consumer information in the pharmaceutical industry.
“Counterfeiting not only impacts on the revenue flow of licenced manufacturers, but falsified medicines may contain active ingredients that are of bad quality or in the wrong dosage. Without proper evaluation of the quality, safety and efficacy, such counterfeit drugs could represent a genuine health hazard” Victor Marques, Country General Manager, comments.
This means a requirement for manufacturers to ensure the ability to trace individual products and batches – not only through their own manufacturing processes, but right through the whole supply chain to the consumer.
The stringent requirements for serialisation present two key challenges for manufacturers. The first is to look at how they manage data internally, with supply chain partners and with consumer-oriented servers. The second is to look at how they will need to change production hardware and processes.
Two main approaches to meeting these new demands in terms of data management and production processes have emerged: the single-system point-to-point solution, and the flexible layer solution.
The single-system point-to-point solution (closed single supplier solution) is a ready-to-use system that fulfils all requirements from printing and inspection to data handling and exchange with the supply chain and government servers.
The flexible layer approach (open solution) separates the data/content-handling aspects from the hardware considerations in the production line. Furthermore, it works towards an open structure with defined interfaces between the different solution levels. The goal is to provide the freedom to select the printers, serialisation software, ERP/master data environment and to integrate these into existing IT and machine environments.
Data-handling solutions can be tailored to the needs of individual stakeholders, including producers, repackers, CMOs and supply-chain partners. The system is highly flexible, meaning that users can readily adapt to changes and new demands on the production line.
This solution also means simpler user training and compliance management, using the same core inspection technology on existing machines when upgrades or retrofits are required, and simplifying the integration of new inspection and serialisation stations when specifying new machines in the future.
Importantly, existing inspection systems and tasks can be easily merged with the new serialisation solution, avoiding double handling issues with changeovers and changes in multiple inspection systems in the line.
Omron’s FH vision technology can provide leading-edge quality inspection and code verification. FH vision implementation not only supports serialised code integration, but also other various inspection tasks, all set up in a single system that is accessible via one interface. Adding or modifying inspection tasks, as well as ensuring compliance management, user training and maintenance, are all significantly simplified.
Omron’s Sysmac automation platform allows data-management integration into various SCADA, MES and ERP solutions, as well as global compliance management concepts to support serialisation implementation throughout the supply chain.