The production of implantable medical devices has to be carried out in conditions of strictest hygiene. When device producer eucatech recently moved to bigger premises, Schilling Engineering helped the company to develop a new and more flexible cleanroom
The largest room in the CleanMediCell cleanroom facility, at 180m2, provides plenty of space in the assembly line for manufacturing catheters and stents
Eucatech, a company based in South Baden, Germany, develops and produces minimally invasive medical products for the treatment of vascular disease. Its 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 cleanroom conditions. This high-tech company has developed a variety of products and coatings in the area of implant technology, placing it in a unique position worldwide, and has experienced continuous growth over the past few years.
At the end of 2015 the expanding company had to move premises because it had exhausted the expansion possibilities of its previous headquarters in Rheinfelden. In Weil am Rhein, also located in the Germany/Switzerland/France triangle, eucatech could purchase a building that provides for both the expanded space requirements of its current staff of 70, while still offering space for planned expansion in the future.
The company management viewed the move as an opportunity to rearrange the production concepts that had grown up over the years, and to implement them optimally in a new cleanroom facility
As well as an increase in capacity, the move to the new facilities also involved a significant new investment. The cleanroom production area was greatly expanded and the systems required were rebuilt. As a result, the company management viewed the move as an opportunity to rearrange the production concepts that had grown up over the years, and to implement them optimally in a new cleanroom facility. Since cleanroom production is at the heart of this high-tech company, the company 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 cleanroom conditions is absolutely essential for our innovative, flexible solutions, which are often in the millimetre and nanometre range,’ explained Technical Managing Director Dr.-Ing. Michael Giese.
‘While we were moving, we therefore implemented the highest standards when investing in the new cleanroom technology. To set up the new production line, we had already worked with cleanroom specialists with the latest technology on the market to select the location.’
Schilling Engineering was entrusted with the development and installation of the system. The engineers of the cleanroom 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 into the new premises, the cleanrooms were already installed and qualified, which ensured that production downtime was kept to a minimum.
The new CleanMediCell cleanroom facility meets the requirements of ISO cleanroom Class 8 and was designed to cover a total area of 630m2. The layout of the cleanrooms 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 stents produced by eucatech are provided with a special coating that suppresses the defence reactions of the body. They are extremely thin and light, yet simultaneously have to be very flexible and withstand enormous pressure. These high-tech products, produced exclusively in cleanrooms, are introduced into patients’ arteries in a minimally invasive manner using a catheter
The heart of the facility is the new assembly line for the manufacture of catheter and stent systems, which provides 180m2 of space for the high-tech production machines. The final area of the cleanroom 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 cleanroom system used is based on a modular design. Wall and ceiling panels are connected using an innovative good manufacturing practice (GMP) compliant tight clip system that provides a high level of tightness without the use of silicone. This means that the cleanrooms can be reconfigured flexibly in case of future expansion.
The innovative air circulation mechanism can provide the same air exchange rate as comparable cleanroom systems with significantly lower energy requirements
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 cleanroom, can provide the same air exchange rate as comparable cleanroom systems with significantly lower energy requirements. Laminar flow units flush with the ceiling and equipped with high-performance ultra-low penetration air (ULPA) filters ensure reliable clean areas.
The entire cleanroom system was equipped with the latest in energy-optimised 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 CR-Control control unit. This easy-to-operate controller permits the selection of all individual cleanrooms 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.
Another ISO Class 8 cleanroom with laser cutting systems for the precision machining of stainless steel pipes for manufacturing stents
Production Manager Sascha Senger, who was responsible for setting up the new cleanroom production in the Weiler building, is highly satisfied with the new manufacturing process: ‘Only under cleanroom conditions can we 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 cleanrooms were already qualified and ready to operate. We could get started right away.’
The investment in high-quality, safe, energy-saving cleanroom technology secures the position of eucatech in the intensively competitive world market. This innovative company can count on further growth.