The pharmaceutical industry is undergoing a transformation. Digital penetration, increasingly individualized products and services, and the rapidly increasing significance of data — these developments, which have long been part of our private lives, are also radically changing production processes in the pharmaceutical sector. And they harbor tremendous potential: The manufacturing pharmaceutical industry is becoming the trailblazer for a personalized healthcare sector. Mass production is becoming more flexible.
“Pharma 4.0” is the buzzword that sums up the digital advancement of the pharmaceutical industry. It stands for self-learning machines, a networked and more flexible production process, smart data management, and more intuitive forms of interaction between human beings and machines. In many areas, Pharma 4.0 is already a reality. The K?rber Business Area Pharma Systems is conducting numerous projects to make digitization useful for its customers. The pharmaceutical companies are focusing on two major areas: networked production and ever smaller batch sizes as a result of personalized medicine.
lWith our ‘supply on demand’ solution we’re already reducing supply chain costs by more than 50 percent for all companies, while maintaining top quality.r
Hans-Peter Sü?lack, Business Process Manager
In particular, the megatrend toward personalized medicine is having concrete and wide-ranging effects on packaging. “We are observing a continuous increase in the demands made on modern packaging systems,” says Rüdiger Schlierenk?mper, Chief Digital Officer of the Business Area. “The broader range of product variants on offer is increasing the complexity of the production process. At the same time, the security and efficiency of processes are moving into the foreground. Digital technologies help to meet these requirements.”
Rondo, a Swiss company specializing in packaging, offers “supply on demand” technology that enables its customers to deliver their products within five days at most, even with very small batch sizes and short order lead times. One of the factors that make this flexibility possible is Rondo’s creation of direct connections. The company links its Enterprise Resource Planning (ERP) system with those of its customers. It also directly connects its digital printer for packaging labels with its customers’ facilities.
“This development is very benefitial because the market has changed greatly in recent years,” says Hans-Peter Sü?lack, Business Process Manager at Rondo AG. In the past, a medication was produced in two or three basic forms. Today the market is much more fragmented because of the trend toward individualization in the field of medicine. For example, in the past a customer would simply order 250,000 packages of a medication. Today the same customer may order the same number of packages, but these are subdivided into 20, 30 or more different individual orders with batch sizes as small as ten or 20 items.
But it’s not only varied dosages and mixtures of medicines that are changing the sector. In addition, today the legal regulations often vary greatly in the countries where K?rber customers sell their products. These different legal regulations and faster changes in marketing are creating one primary requirement: greater differentiation in the packaging to be printed. The diversity is increasing, because suppliers have to take into account a growing number of language and country versions as well as new requirements for serialization.
Rondo’s “supply on demand” solution, which integrates the ERP system and, even more importantly, automates work processes, saves costs for customers. “With this solution we’re already reducing supply chain costs by more than 50 percent for all companies, while maintaining top quality,” says Sü?lack. He expects to see further gains in efficiency in the future.
Efficiency improvements are also the focus of the second grand vision of Pharma 4.0: networked production. Werum IT Solutions is working to make this vision a reality. Its production control software PAS-X MES (Manufacturing Execution System) creates the pre-conditions for completely networked industrial production by means of an interface that quickly and easily integrates machines into the networks of pharmaceutical companies. “For a long time, this integration of machines into an existing network was an unproductive task that took a lot of time,” says Klaus Sauermann, Senior Head of Business Development at Werum. “Our plug & produce solution will greatly simplify this process in the future.”
Much like a USB interface, this solution enables a rapid exchange of data between PAS-X and the machines in the customers’ production halls — it basically functions as a translator. “We ensure that the software and the machines speak the same language,” says Sauermann. PAS-X recognizes new machines in the network as relevant entities and provides them with all the data that is important for them, such as quantities and batch numbers.
lWe ensure that the software and the machines speak the same language.r
Klaus Sauermann, Senior Head of Business Development at Werum
PAS-X offers many advantages for medication producers. It makes it easier to configure the production network and conduct qualification programs for employees. The likelihood of setup errors is reduced, and less time is required for completing projects. “All in all, it reduces the cost of integrating a new machine into a production network by up to 75 percent,” says Sauermann.
The plug & produce solution is open and completely independent of the supplier. Werum IT Solutions is working together with companies and organizations such as the International Society for Pharmaceutical Engineering (ISPE) to establish it as an industry standard in the medium term. Says Sauermann, “Plug & produce is extremely important for Industry 4.0. In this context, our interface is the perfect solution.”