SCHILLING ENGINEERING recently completed a challenging project in Estonia. The specialist in cleanroom design and construction was commissioned to build the cleanroom production facility for KARL STORZ Video Endoscopy Estonia. The Estonian production facility has been part of the family-owned KARL STORZ Group, one of the world's leading manufacturers of endoscopes and medical devices.
High level of automation on production lines
The completion of the entire cleanroom facility near Talinn was planned in several stages. The first two construction phases have already been completed, and a further expansion of cleanroom capacity is in preparation. The Estonian site is thus 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 when it comes to digitalization and has developed into one of the most advanced societies 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 focuses on a high level of digitalization and automation. To do this, we need the know-how of an expert who can advise us, train us, and supply us with the latest technology. At SCHILLING ENGINEERING, we have found a highly dependable partner who offered us a comprehensive package. The CleanCell4.0 cleanroom system provides a wealth of data that we can integrate into our processes, such as automated control and monitoring. We also place great importance on the option of remote maintenance. “
Prototype Development of Disposable Endoscopes
The initial planning of the new facility involved prioritizing the construction of a cleanroom in order to develop a prototype for the upcoming manufacture of disposable medical products. The cleanroom facility covers an area of 350 m² and has already been commissioned, achieving ISO 7 cleanroom classification during operation.
A notable feature of the cleanroom is the material lock, which permits control and feedback for logistic robots. The autonomous mobile robots that are the size of a small trolley open the sliding doors of the material lock automatically by radio. To prevent a pressure drop in the system, mutually locked doors guarantee that at least one door of the airlock always stays closed. The Estonians have set a tight schedule for the commissioning of the cleanroom to expedite the medical devices' validation. Within only six months, the initial project phase was successfully completed to the medical technology manufacturer's full satisfaction, affirms Riivo Ranniku. "We are very satisfied with the state-of-the-art and adaptable cleanroom system. The project schedule operated seamlessly."
The cleanroom system qualified according to ISO 14644-1 and generated detailed documentation, consisting of a room book, a risk analysis, and a DQ-PQ.
Digitalized Processes and Quality Monitoring
The new cleanroom facility achieves ISO Class 7 and possesses a versatile design that can be adjusted to meet future requirements. Combined area of cleanrooms area is over 750 square meters plus personnel and materials airlock systems.
The Estonians expressed concern regarding seamless quality monitoring of cleanroom technology, which can be integrated into the digitalized processes of modern production. Schilling Engineering fulfilled this request for high data integration with their in-house CRControl® control system. The control unit centrally manages the cleanroom technology settings, which involves the measurement and monitoring of crucial parameters such as particles, humidity, pressure, and temperature.
Control of the cleanroom is facilitated through touch screens, which are also accessible remotely. The interfaces have been translated into Estonian for ease of use. To allow for efficient troubleshooting in the unlikely event of a malfunction, secure remote maintenance controlled from Germany has been established. In case of malfunctions, the responsible parties are notified via email.
Special programming enables the cleanroom system to enter a "sleep mode" when it is not operational. In this state, the air exchange rate and pressure cascades are decreased, conserving energy.
Successful collaboration in Europe
The project presented the German cleanroom specialists with several challenges: The project managers and service technicians had to be scheduled precisely, as the staff of Schilling Engineering from Baden-Württemberg travelled by plane rather than their usual service vehicles. Material and tools were brought to Estonia by a freight forwarder. To avoid delays, some tools and components were planned as spares and delivered as replacements.
With the active support of the Estonian colleagues, the logistical challenges were successfully overcome. After an eight-week construction period, the second cleanroom facility was handed over, qualified and ready for operation. Riivo Ranniku is pleased with the successful cooperation between Germany and Estonia: "Our cleanroom project is a good example of successful cooperation in Europe. Both partners have been able to learn from each other and exchange ideas on how to develop and produce innovative products of the highest quality. Now we are working together on the realization of the next cleanroom section".