Medical technology manufacturer eucatech AG putting new plant in Weil am Rhein in production

The stents produced by eucatech are provided with a special coating that suppresses the defence reactions of the body. They are extremely thin and light as a feather, and simultaneously have to be very flexible and withstand enormous pressure. These high-tech products, produced exclusively in clean rooms, are introduced into sick arteries in a minimally invasive manner using a catheter.

The largest room in the CleanMediCell® clean room facility, at 180 square metres, provides plenty of space for the assembly line for manufacturing catheters and stents.

Another ISO class 8 clean room with laser cutting systems for the precision machining of stainless steel pipes for manufacturing stents.

South Baden company eucatech AG develops and produces minimally invasive medical products for the treatment of vascular disease. Their highly sensitive products, such as heart catheters and stents, are used in cardiac and vascular surgery and are manufactured under the strictest of hygienic standards in clean room conditions. This high-tech company has developed a variety of product variants and coatings in the area of implant technology, placing it in a unique position worldwide, and they have experienced continuous growth over the past few years.

The expanding company had to move at the end of 2015 because the expansion possibilities of its previous headquarters in Rheinfelden were exhausted. In Weil am Rhein, also located in the Germany/Switzerland/France triangle, eucatech AG could purchase a building that can provide for both the expanded space requirements of their current staff of 70, while still offering space for planned expansion in future.  

The move to the new facilities represented a significant new investment as well. The clean room production area was greatly expanded and the systems required were rebuilt. As a result, company management saw the move as an opportunity to rearrange the production concepts that had grown up over the years, and implement them optimally in a new clean room facility. Since clean room production is the heart of this high-tech company, they also intended to invest in the latest and most reliable technology.  

"Our products demand constant quality and are manufactured under the strictest hygienic conditions. Production under clean room conditions is absolutely essential for our innovative, flexible solutions, which are often in the millimetre and nanometre range. While we were moving, we therefore implemented the highest standards when investing in the new clean room technology. "To set up the new production line, we had already worked with clean room specialists with the latest technology on the market to select the location," explains technical managing director Dr.-Ing. Michael Giese.

SCHILLING ENGINEERING GMBH was entrusted with the development and installation of the system. The engineers of the clean room specialist, also based in South Baden, were involved right from the initial planning phases. This close collaboration permitted the development of an extremely functional concept that supported an optimum process flow. By the time the staff moved, the clean rooms were already installed and qualified, avoiding longer production downtime. 

The new CleanMediCell® clean room facility meets the requirements of ISO clean room class 8 and was designed to cover a total of 630 square metres. The layout of the clean rooms is based on the requirements of the different production areas. In addition to personnel locks with separate dressing rooms for men and women, separate production rooms were also built for different manufacturing processes such as laser cutting, stent heat treatment, extrusion and balloon formation. The heart of the facility is the new assembly line for catheter and stent system manufacture, which provides 180 square metres of space for the high-tech production machines.

The final area of the clean room is used to subject medical products to a final inspection and package them in sterile bags before safely locking them out through a material lock for sterilisation.

The CleanMediCell® clean room system used is based on a modular design. Wall and ceiling panels are connected using an innovative GMP-tight clip system that provides a high level of tightness without the use of silicone. That means that the clean rooms can be reconfigured flexibly in case of future expansion. The wall modules, with large windows, are designed as circulation walls. The innovative air circulation mechanism, which introduces existing filtered, air-conditioned clean air back into the clean room, can provide the same air exchange rate as comparable clean room system with significantly lower energy requirements. Laminar flow units flush with the ceiling and equipped with ULPA high-performance filters ensure reliable clean areas. 

The entire clean room system was equipped with the latest in energy-optimized air conditioning systems, and its temperature and humidity are kept at predefined levels with close tolerances. All the room values can be set and controlled centrally from the integrated CRControl® control unit. This easy-to-operate controller permits the selection of all individual clean rooms from a touch screen, also showing possible faults such as a door that has been open too long or upcoming filter service dates with clear warning messages. 

Production manager Sascha Senger, who was responsible for setting up the new clean room production in the Weiler building, is visibly satisfied with the new manufacturing process:

"Only under clean room conditions can be guarantee the quality and hygiene of our products without exception. An error-free, reliable system is absolutely crucial for us. The system from SCHILLING ENGINEERING has the latest in technology and a modular design. That gave us flexible options in planning the clear, functional arrangement of our production area. Building the system worked perfectly, and when we moved our equipment, the clean rooms were already qualified and ready to operate. We could get started right away."

The investment in high-quality, safe, energy-saving clean room technology secures the position of eucatech AG on the intensively competitive world market. This innovative company can count on further growth.