Ready to cross the pond
Process automation increases flexibility and production reliability

Fresenius Kabi has modernized a production line at its Graz plant in record time using the Siemens Simatic PCS7 process control system. The infusion solutions manufactured there satisfy all the stringent FDA documentation requirements.

Herbert Neuhold has experienced some turbulent times. The Manager of Automation Technology at Fresenius Kabi Graz has just completed the conversion of one of the five production lines and he is already planning two more. He is used to having external contractors in his company bringing his Graz plant to a standstill. The Graz plan normally operates on a three-shift basis six days per week and manufactures high quality infusion solutions. Two to three weeks are usually put aside at Christmas and during the summer for regular servicing work but the last phase of the modernization process needed the plant to be shut down for longer than this. One of the five production lines was converted and modernized. In the course of this modernization the control system was also brought up to date – the Graz-based Grazer Siemens solution provider PLS Automation installed the Simatic PCS7, a system that can handle the highly flexible batch process fully automatically. “The challenge of this project was the extremely short completion schedule that kept us on our toes around the clock,” says Johannes Brandl, responsible for the Fresenius project at PLS Automation.

“One of the benefits of the PCS7 is its simple and consistent engineering with a high level of integration of both the hardware and software. This was the only thing that made such short project schedules possible in the first place.” Peter Kajtna, Production Manager Emulsions, explains this latest investment. “We produce infusion solutions for parenteral nutrition here made of fats, amino acids and sugar.” Parenteral nutrition is required if the stomach or intestines are unable to function properly, for example as a result of illness or an operation.
Fit for the US market
When artificial nutrition is provided through a vein, all the main nutritional components are placed straight into the blood in the form of their molecular blocks. Kajtna explains, “Our new process control system means that we satisfy the strict FDA regulations for batch documentation. That will enable us to supply our products to the US market in the future. The registration phase for this is currently taking place.” At the moment Fresenius infusion solutions are supplied either straight from Graz to customers throughout the world or are delivered to customers via the Fresenius logistics center in Germany.
High quality infusions from Fresenius Kabi Austria are decanted into both glass and plastic containers, ranging from small ampoules to one-liter bags. “Before the stopper can be inserted into the glass bottle, it must be ensured that the product is free of oxygen, which is achieved by extracting the air in several operations,” says Herbert Neuhold, Manager of Automation Technology.
Complex processes
As far as Neuhold was concerned, the need for the Siemens solution was highlighted by the ever more complex production process, in addition to the stringent documentation requirements of the FDA, “The tolerances in terms of temperature, pressure and density during the preparation of infusion products are becoming smaller and smaller. Moreover there is the fact that the products themselves are becoming more complicated.” According to Neuhold, the main positives from process automation using the Siemens system are in the secure operation management within the integrated Simatic Batch flexible software system, “All product compositions, in other words the batch processes, are fully reflected in it and therefore prevent the possibility of errors. All the variables within the product composition are protected from manipulation, and only the batch size can be changed manually. The batch can therefore be traced accurately with precise timings and to specific personnel.” The new PCS7 system also enables Fresenius Kabi Austria to use the production line with a good deal more flexibility. “This means that we can compensate for capacity problems within the group,” says Neuhold, “and there is considerably competition for these orders between the various subsidiaries within the Fresenius Group”.
Flexibility is trumps
Fresenius in Austria made the decision to use Siemens products as their standard automation systems over 20 years ago,
not least because of the high level of continuity provided by the products and
their quality. The interlinking between the automation systems and high level systems was previously achieved at Fresenius using an AS/400. As from 2006, how-
ever, the Group as a whole has decided to use an SAP system for these functionalities. “The article master data are sent from SAP via a file server straight to the production system.” After the successful completion of the project, the company is already planning more modernization work using the Simatic PCS7 process control system.