Production processes in medical technology are constantly evolving – and with them the requirements for the cleanroom environment. At Tegra Medical c/o Stamm AG in Hallau (Switzerland), the focus was on precisely this challenge. 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 connects seamlessly to the existing cleanroom and at the same time opens up new technical possibilities. While the existing room works with a closed plenum, the extension was deliberately designed as an open system. Two FFUs with bypass grilles take over the air flow, supplied by an air-conditioning ceiling unit that feeds in cooled air directly. This streamlined, well thought-out solution illustrates the adaptability of modular cleanroom concepts.
Im Zentrum des neuen Anbaus steht eine halb integrierte Spritzgießmaschine für den Mikrospritzguss, die das Herzstück eines automatisierten Prozesses bildet. Ein Robotersystem übernimmt das präzise Einlegen und Ablegen feinster Nadeln für die Augenchirurgie – ein sensibler Ablauf, der unter konstant kontrollierten Reinraumbedingungen stattfindet.
The careful technical design shows its benefits in daily operation. A pneumatically operated sliding cover has been integrated into the ceiling for tool changes, allowing access from above. This reduces intervention in the cleanroom to a minimum and the processes remain stable and efficient. In this case, access to the cell extension is via an electrically interlocked sliding door.
The project was implemented by the cleanroom company’s service technicians during ongoing operations and was carried out efficiently. The existing cleanroom was only out of operation for a week, after which it was requalified and put back into operation. During this time, an electric door was installed in the existing wall as access to the new room and integrated into the existing control system, including commissioning. The new extension was then also qualified. In the future, both areas are to be combined in a joint qualification document – a further step towards a holistically planned cleanroom solution.
This project demonstrates the flexibility offered by modular cleanroom systems. With the solutions from Schilling Engineering, cleanrooms can be precisely adapted and even sophisticated production facilities can be easily integrated into existing structures. For companies in the medical technology sector, this means future-proofing, as production processes can be flexibly expanded without interrupting ongoing operations for long periods.
