A leading developer and manufacturer of injection and infusion systems for self-medication is required to comply with strict quality and regulatory requirements for process control and traceability.
"We have been working according to the principles of Industry 4.0 since 1999, only it wasn't called that then," said Uwe Herbert, manager CSV & ITP services at Burgdorf, Switzerland-based Ypsomed AG. "We operate in a highly regulated environment, which means the quality of our products must be ensured. Everything needs to be 100 percent traceable when it's a question of a person's health. People's lives depend on our products."
Fulfilling that requirement, however, meant a major investment in people "which was simply not manageable," Herbert said. The company instead invested in automation as a way to achieve better quality and a lower error rate.
"After researching the market, we first invested in an MES solution from TIG. The functionality was easy; it supported the digital handling of production orders and kept track of the 'eight holy parameters' for injection molding: If one of these changed during the process, the others were also affected. It was possible to go back to the machine and adjust it," Herbert explained.
Ultimately, however, the company took the strategic decision to move away from the branch-specific TIG system, opting instead for a system that was able to integrate all the equipment used by the company, not just the molding machinery. The new system was based on SAP software. From the start, however, the company has benefited from the availability of the data generated by the systems.
"We are able to do much less manual testing," Herbert said. "For some processes we had to take measurements every half hour, against once every eight hours today. This is made possible by the data provided by the system — all completely traceable. Errors are immediately evident from the data, which means for the future we can ensure quality without any manual measurements required."