Just in time, a heart attack patient arrives at the hospital and receives emergency care that saves his life. Following his initial recovery, however, efforts to treat his elevated cholesterol with diet and medication are unsuccessful. To minimize the risk of a subsequent heart attack, doctors would have to extract LDL, commonly known as "bad cholesterol", from his blood using a process called apheresis. Similar to the more familiar dialysis procedure, apheresis is used to remove LDL cholesterol and other harmful substances from the blood of patients suffering from severe lipid metabolism disorders. The process of cleansing the blood outside the body relies on adsorbent materials that selectively bond pathogenic substances as the patient's plasma is passed through the device.
Life-saving blood cleansing: Maximum correction of a risk factor
A specialist in this type of therapy is Fresenius Medical Care. At its location in Krems, Austria, the company develops adsorbent materials for LDL apheresis, medical devices for renal replacement therapy and treatment of autoimmune disorders, as well as performing research into innovative new therapies.
New Fresenius Medical Care partner: B&R
To continue meeting the strict requirements of medical equipment with outstanding quality and performance, Fresenius Medical Care sought an absolute state-of-the-art control solution for its filling station and inline steam sterilizer – equipment that had been custom-designed for the production of adsorbents for LDL apheresis.
After evaluating numerous systems engineering companies, Fresenius awarded the task of replacing the control and logging system to Geminos. The selection of B&R for the control technology was based on Geminos' history with B&R as well as positive reports from Fresenius' sister companies.
The requirements were clearly defined – the production process needed to be designed so that the automation system could both ensure fully automated production and make the lifecycle traceable to keep the supply chain running. Prior to implementation, the new system would also have to be validated by an external company in order to comply with the pharmaceutical industry's strict quality standards. For this, Fresenius selected the company Anapur, who possesses the necessary resources and know-how for risk analysis and other requirements.
In June of 2015, the control and logging systems were retrofitted with B&R technology. The processing technology and pipeline system were in good condition and remained largely unchanged, whereas the software, control electronics and pneumatic systems were completely rebuilt from the ground up. B&R's APROL and Automation Studio software solutions were used. The APROL trend system provides long-term data archiving, while the seamlessly integrated business intelligence suite from Jaspersoft provides batch-level reporting and analysis. To improve data security, the tamper-proof databases that hold the collected process data are stored on an external network, which in turn is linked with the APROL archiving system.
"In the instrumentation cabinet, a network of 65 temperature and pressure sensors communicate with the main controller via POWERLINK using external bus nodes from B&R. This decentralized layout minimizes wiring between sensor and I/O module. And, with APROL operated via a conventional network interface, you don't need a dedicated network for data transfer and can instead use the existing IT infrastructure," explains Geminos engineer Martin Morgenbesser.
Tight schedule for project implementation
"The project started in January of 2015, and needed to be completed only six months later. Any longer, and there would be production delays. Already operating at full capacity, we wouldn't have been able to make up for the lost output by the end of the year," explains Durhofer. "Our primary goal was to complete the project in six months, but another big topic for us was long-term support."
With B&R and Geminos, Fresenius now has two reliable partners at its side, ready to take on whatever new projects the future may hold.