The stents produced by eucatech have a special coating that prevents the body from reacting defensively. They are wafer-thin and light as a feather, but must also be very flexible and withstand enormous pressure. The high-tech products, which are produced exclusively in clean rooms, are inserted into the diseased arteries via a catheter in a minimally invasive procedure.
South Baden-based eucatech AG develops and produces minimally invasive medical devices for the treatment of vascular diseases. The highly sensitive products, such as cardiac catheters and stents, are used in cardiac and vascular surgery and are manufactured under the highest hygienic standards in clean room conditions. The high-tech company has established a unique selling point internationally with the development of a wide range of product variants and coatings in the field of implantation technology and has recorded steady growth in recent years. The expanding company had to relocate at the end of 2015, as the expansion possibilities of the previous company headquarters in Rheinfelden had been exhausted. In Weil am Rhein, which is also located in the border triangle of Germany, Switzerland and France, eucatech AG was able to move into a hall that meets the increased space requirements of the current 70 employees and also offers space for planned future expansions.
The move to the new premises also involved a significant new investment. Cleanroom production was significantly enlarged and the necessary technology was newly installed. The company management therefore also saw the move as an opportunity to rearrange the production concepts that had grown over the years and to implement them optimally in a new cleanroom facility. As cleanroom production is at the heart of the high-tech company, it was also important to invest in the latest and most reliable technology.
“Our products must be of consistent quality and manufactured under strict hygienic conditions. Manufacturing under cleanroom conditions is the prerequisite for our innovative and flexible solutions, which are often in the millimeter and nanometer range. With the relocation of our company, we have therefore also set the highest standards when investing in the new cleanroom technology. When deciding on the location for the new production line, we consulted cleanroom specialists who are on the market with the latest technology.”
explains Technical Managing Director Dr. Michael Giese.
SCHILLING ENGINEERING GmbH was commissioned with the development and installation of the system. The engineers from the cleanroom specialist, which is also based in South Baden, were already involved in the initial planning phases. In this way, an extremely functional concept was developed in close cooperation, enabling an optimum process flow. The cleanrooms were already installed and qualified when the employees relocated, and longer production downtimes were avoided.
The new CleanMediCell® cleanroom system achieves ISO cleanroom class 8 and was designed for a total of 630 square meters. The layout of the cleanrooms follows the requirements of the different production areas. In addition to personnel airlocks, which provide separate moving facilities for men and women, separate production rooms were created for different manufacturing processes, such as laser cutting, stent heat treatment, extrusion and balloon forming. The centerpiece of the facility is the new assembly line for catheter and stent system production, which provides over 180 square meters of space for the high-tech production machines.
In a final area of the cleanroom, the medical devices undergo a final quality check and are packaged in sterile pouches before being safely discharged for sterilization via a material lock.
The CleanMediCell® cleanroom system used has a modular design. Wall and ceiling panels are connected using an innovative GMP sealing clip system, which ensures a high level of tightness without the use of silicone. The cleanrooms can therefore be flexibly converted in the event of an expansion. The wall modules with large windows are designed as recirculation walls. The innovative recirculation mode, in which the already filtered and conditioned clean air is reintroduced into the Cleanroom, requires significantly less energy than comparable cleanroom systems with the same air exchange rate. Laminar flow units with ULPA high-performance filters integrated flush into the ceiling ensure consistently clean areas.
The entire cleanroom system is equipped with the latest, energy-optimized air conditioning technology and the temperature and humidity are kept at a fixed level with narrow tolerances. All room values can be set and controlled centrally via the integrated CRControl® control unit. The clearly laid out control unit enables all individual cleanrooms to be selected via a touchscreen and also indicates possible faults, such as a door that has been open too long or pending filter maintenance, with clear warnings.
Production Manager Sascha Senger, who was responsible for setting up the new clean room production facility in the Weiler hall, is visibly satisfied with the new manufacturing process:
“Only under cleanroom conditions can we guarantee the quality and hygiene of our products without exception, and a trouble-free and safe system is absolutely essential for us. The system from SCHILLING ENGINEERING has the latest technology and a modular design. This allowed us to flexibly plan a clear and functional layout for our production. The installation of the system worked flawlessly, and the cleanrooms were qualified and ready for operation as soon as we moved our equipment. We were able to get started straight away.”
The investment in high-quality, safe and energy-saving cleanroom technology secures eucatech AG’s position on the highly competitive global market. Further growth of the innovative company can be expected.
