Medical technology manufacturer eucatech AG commissions new site in Weil am Rhein

The stents produced by eucatech are coated with a special layer that prevents the body's immune reactions. They are ultra-thin and feather-light, yet must be highly flexible and withstand enormous pressure at the same time. The high-tech products, which are produced exclusively in cleanrooms, are minimally invasively inserted into the affected arteries via a catheter.

The 180 sqm large room of the cleanroom facility CleanMediCell® provides space for the assembly line of catheter and stent system manufacturing.

Another cleanroom of ISO Class 8 with laser cutting systems for precise processing of stainless steel tubes for the production of stents.

The South Baden eucatech AG develops and manufactures minimally invasive medical devices for the treatment of vascular diseases. The highly sensitive products, such as heart catheters and stents, are used in cardiac and vascular surgery and are produced under the highest hygienic standards in cleanroom conditions. The high-tech company has established a unique position internationally through the development of various product variants and coatings in the field of implantation technology and has experienced steady growth in recent years.

The expanding company had to relocate at the end of 2015 because the expansion possibilities at the previous headquarters in Rheinfelden were exhausted. In Weil am Rhein, also located in the tri-border area of Germany, Switzerland, and France, eucatech AG was able to acquire a hall that meets the increased space requirements of the current approximately 70 employees and also provides room for planned future expansions.  

With the move to the new premises, a significant new investment was also made. The cleanroom production was greatly expanded, and the necessary technology was rebuilt. The management saw the move as an opportunity to reorganize the production concepts that had developed over the years and to implement them optimally in a new cleanroom technical facility. Since cleanroom production constitutes the core of the high-tech company, the investment was also directed towards the latest and most reliable technology.  

"Our products must demonstrate consistent quality and be manufactured under strict hygienic conditions. Production under cleanroom conditions is the prerequisite for our innovative and flexible solutions, which often operate within millimeter and nanometer ranges. With the relocation of our company, we also set the highest standards for the investment in the new cleanroom technology," explains the technical Managing Director Dr.-Ing. Michael Giese.

The development and installation of the system was commissioned to SCHILLING ENGINEERING GmbH. The engineers of the cleanroom specialist, also based in South Baden, were involved in the initial planning phases. In close collaboration, an extremely functional concept was developed that enables an optimal process flow. With the relocation of the staff, the cleanrooms were already installed and qualified, avoiding longer production downtimes. 

The new cleanroom system CleanMediCell® achieves ISO Class 8 cleanroom standards and was designed on a total area 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 options 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 system is the new assembly line for catheter and stent system manufacturing, which provides over 180 square meters of space for high-tech production machines.

In a final section of the cleanroom, the medical devices undergo a concluding quality control and are packed in sterilization pouches before being safely transferred via a material lock to sterilization.

The installed cleanroom system CleanMediCell® is modularly constructed. Wall and ceiling panels are connected via an innovative GMP sealing clip system that ensures high airtightness without the use of silicone. This allows the cleanrooms to be flexibly reconfigured in case of expansion. The wall modules with large surface windows are designed as recirculating air chambers. The innovative recirculation operation, where the already filtered and conditioned clean air is reintroduced into the cleanroom, requires significantly less energy at the same air exchange rate compared to comparable cleanroom systems. Laminar flow units with ULPA high-performance filters, integrated into the ceiling, ensure consistently clean areas.

The entire cleanroom facility is equipped with the latest energy-optimized climate technology and maintains temperature and humidity at a set level with tight tolerances. All room parameters can be centrally adjusted and controlled via the integrated control device CRControl®. The clear control device allows all individual cleanrooms to be selected via a touchscreen and also displays possible disruptions, such as a door left open too long or upcoming filter maintenance, with clear warning indications. 

Production Manager Sascha Senger, responsible for setting up the new cleanroom production 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. A trouble-free and secure system is absolutely necessary for us. The system from SCHILLING ENGINEERING has the latest technology and is modularly designed. This allowed us to plan a clear and functional layout of our production flexibly. The setup of the system worked flawlessly; even during the move of our equipment, the cleanrooms were qualified and operational. We could start immediately."

The investment in high-quality, safe, and energy-efficient cleanroom technology secures eucatech AG's position in the highly competitive global market. Further growth of the innovative company can be expected.