When cleanrooms grow with the process: Modular expansion for micro-injection molding

Production processes in medical technology are constantly evolving – and with them, the requirements for cleanroom environments. At Tegra Medical c/o Stamm AG in Hallau (Switzerland), this very challenge was the focus. An existing cleanroom solution was to be expanded to create space for high-precision micro-injection molding – quickly, efficiently, and without long interruptions to ongoing operations.

Schilling Engineering implemented a 22 m² ISO-7 cleanroom extension for this purpose. It seamlessly connects to the existing cleanroom and simultaneously opens up new technical possibilities. While the existing room operates with a closed plenum, the extension was intentionally designed as an open system. Two FFUs with bypass grilles handle the air supply, fed by an air conditioning ceiling unit that supplies cooled air directly. This slim, well-thought-out solution demonstrates the adaptability of modular cleanroom concepts.

At the center of the new extension is a semi-integrated injection molding machine for micro-injection molding, forming the heart of an automated process. A robotic system handles the precise placement and removal of the finest needles for eye surgery – a sensitive process that takes place under constantly controlled cleanroom conditions.

The careful technical execution proves its value in daily operation. For tool changes, a pneumatically operated sliding cover was integrated into the ceiling, allowing access from above. This minimizes interventions in the cleanroom and keeps processes stable and efficient. Access to the cell extension is via an electrically lockable sliding door.

The project was carried out by service technicians from the cleanroom company during ongoing operation and was implemented efficiently. The existing cleanroom was taken out of service for only one week, then re-qualified and put back into operation. During this time, an electric door was installed as an access point to the new room in the existing wall and integrated into the existing control system, including commissioning. Subsequently, the new extension was also qualified. In the future, both areas are to be combined into a single qualification document – another step toward a holistically planned cleanroom solution.

This project demonstrates the flexibility offered by modular cleanroom systems. With solutions from Schilling Engineering, cleanrooms can be precisely adapted, and even demanding production facilities can be seamlessly integrated into existing structures. For companies in medical technology, this means future security, as production processes can be flexibly expanded without long interruptions to ongoing operations.