Traceability is key for Ypsomed

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."

At Ypsomed, however, Industry 4.0 goes beyond the connectivity provided by its ERP/MES system. The company has launched a fully automated pilot — the factory digitalis, according to Herbert — which promises to deliver safer manufacturing processes at better conditions.

"For Ypsomed, digital manufacturing means that everything is processed in an automated way. It's not just connecting the machines, whether with one another or in an MES system, but end-to-end digitalization. The internet of things offers completely new business models; we have gone from physical products to smart devices, which connect services and digital experiences to reality, including billing."

The company is also currently investing in a 5G project, together with Swisscom, who intends to introduce 5G in Switzerland in 2020, among others.

Ypsomed has joined the project in order to explore how this will fit into the company's vision for 4.0 and the new age of mobile-networked production and integrated data processing. With 5G and the increased bandwidth it provides, edge computing solutions are also within reach, with the cloud becoming an integral component of a base station, controlling IT production processes both locally and distributed.

"In an environment where quality has less impact, this level of digital management may not be necessary in that high level. For us, the quality documentation is just as important as the product itself," Herbert said. "To ensure traceability in full at the level of functionality, you need digitalization."

Summing up Ypsomed's path toward full digitalization, Herbert described a few of the takeaways from the transition process thus far. He advocated operating an off-the-shelf MES/ERP solution that could meet minimally 80 percent of the company's needs and developing custom software to meet 100 percent of these needs.

"Also, to exploit the potential of the processing gateway, data mining needs to be possible," he said. Other pointers included installing a robust hardware and network infrastructure; structuring the generated data; integrating different machine interfaces by using a smart hub; and, last but not least: "Make sure you connect all things to your superordinate system," he said.

Asked whether the ongoing process of digitalization had affected the company's workforce, Herbert said that aside from an increased need for technical personnel who could understand the systems, "not much, really."

"The same number of people still work on the shop floor," he said. What had changed was the use of remote assistance services of suppliers to ensure 24/7 support. "Otherwise you risk production interruptions that can stretch into hours and sometimes days. We exchange noncritical data with our supplier for this," he said.

He noted that Ypsomed had completed more than 20 Industry 4.0 projects since starting out in 1990 and that 10 were currently in progress at the company. These include the design of plug-and-play interfaces based on standard connectors that require no expertise to use and the development of an automated testing system to save costs and time.

In his view, the digitalization project should not be approached as a project, but as a process that can take years.

"Do not underestimate the complexity of combining different disciplines," he warned. "Enter into technical partnerships, work with others; there is no need to do it all alone. And pay attention to security and data protection."

Ypsomed is still on the path toward fulfilling its vision of Industry 4.0.

"Some day in the future we'll be able to control production and everything else from outside," he predicted. "But for now, that's still only a vision."