SCHILLING ENGINEERING recently completed a challenging project in Estonia. The specialist for the planning and construction of cleanrooms was commissioned to set up the cleanroom production of the company KARL STORZ Video Endoscopy Estonia. The Estonian production facility is part of the family-run KARL STORZ Group, one of the world’s leading manufacturers of endoscopes and medical devices.
High automation of the production lines
The completion of the entire cleanroom facility in Tallinn was planned in several phases. The first two construction phases have already been completed and a further expansion of cleanroom capacity is in preparation. This means that the Estonian site is not only gaining in importance within the KARL STORZ Group, but is also setting standards in the field of smart factories. Estonia is considered a role model in terms of digitalization and has developed into one of the most advanced companies in the world in this area. The production lines at KARL STORZ’s Estonian site are also highly automated and networked. For the new cleanroom technology, the Estonians were therefore looking for a system that would meet these requirements, as Riivo Ranniku, Director of Operations at KARL STORZ Video Endoscopy Estonia OÜ, explains: “We are completely rebuilding our cleanroom production and want to integrate it seamlessly into our corporate philosophy, which is based on a high degree of digitalization and automation. To do this, we need the know-how of an expert who can advise us, train us and provide us with the latest technology. In SCHILLING ENGINEERING, we have found a very reliable partner who was able to offer us this complete package. The CleanCell4.0 cleanroom system provides us with a wealth of data that we can integrate into our processes, such as automatic control and monitoring. The remote maintenance option is also very important to us.”
Development of a prototype for disposable endoscopes
The first Cleanroom of the new facility was brought forward in the planning of the overall facility in order to be able to develop a prototype for the planned production of disposable endoscopes. The 350 m² cleanroom facility has already gone into operation and achieves cleanroom class ISO 7 in operation.
A special feature of the cleanroom is the material lock, which enables control and feedback for logistics robots. The autonomous, mobile robots, which are the size of a small shopping cart, open the sliding gates of the material airlock automatically by radio. To prevent a drop in pressure in the system, interlocked doors ensure that at least one airlock door always remains closed.
The Estonians set themselves a tight schedule for commissioning the cleanroom in order to speed up the validation of the medical products. The first project phase was successfully completed within just six months, Riivo Ranniku is pleased to report. “We are very satisfied with the ultra-modern and adaptable cleanroom system. The project went smoothly.”
The cleanroom system was qualified in accordance with ISO 14644-1 and detailed documentation consisting of a room book, risk analysis and DQ-PQ was created.
Digitalized processes and quality control
The second section of the cleanroom facility also achieves ISO class 7 and has a flexible design that can be adapted to future requirements. The total area of the cleanrooms is more than 750 square meters plus personnel and material airlock systems.
One of the Estonians’ main concerns was seamless quality monitoring of the cleanroom technology, which could be integrated into the digitalized processes of the ultra-modern production facility. Schilling Engineering was able to fulfill this desire for a high level of data integration with its in-house CRControl® control system. The control system centrally manages the settings of the cleanroom technology and measures and monitors important parameters such as particles, humidity, pressure and temperature.
The cleanroom is controlled via touchscreens, which can also be accessed remotely. To make operation easier, the interfaces have been translated into Estonian. In the unlikely event of a fault, secure remote maintenance has been set up from Germany to enable efficient troubleshooting. In the event of a fault, those responsible are notified by e-mail.
Special programming makes it possible to put the cleanroom system into “sleep mode” when not in use. In this state, the air exchange rate and the pressure cascades are reduced to save energy.
Successful cooperation in Europe
The project presented the German cleanroom specialists with a number of challenges: The deployment times of the project managers and service technicians had to be planned precisely, as the Schilling Engineering employees from Baden-Württemberg traveled by plane and not in their usual service vehicles. Materials and tools were brought to Estonia by freight forwarder. To avoid delays, some tools and components were also delivered as spare parts.
With the active support of our Estonian colleagues, the logistical challenges were successfully overcome. After a construction period of eight weeks, the second cleanroom facility was qualified and handed over ready for operation. Riivo Ranniku is delighted with the successful collaboration between Germany and Estonia: “Our cleanroom project is a good example of successful cooperation in Europe. Both partners were able to learn from each other and exchange experiences on how to develop and manufacture innovative products of the highest quality. Now we are working together on the realization of the next cleanroom section”.
