Letzaustrasse 1 CH-9462 Montlingen Switzerland. V3 Modular Clean Room System GMP certified for medical products

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1 sit system integration technology ag Letzaustrasse 1 CH-9462 Montlingen Switzerland info@sit.ch V3 Modular Clean Room System GMP certified for medical products (Abb. 1) exterior view of finished clean room Content 1. Project description Layout with over pressure controlled access lock Installation of a V3 modular clean room system Floor and support structure Interior and utilities Installation Finish...5

2 1. Project description An innovative medical company with high end products needed an extension of their production capacity. This had to take place at the same site and the clean room was specified as GMP environment. Of course a short delivery time was essential to increase the production volume quickly. The desired footprint is 150 m 2 including sluices. With the modular system of SIT (SIT System Integration Technology AG) those specifications were met and realised accordingly. Again the advantages of our concept were proven in this project! A minimal installation time at the customer site. The System can be extended with additional modules should the need arise in the future. If the production will move to another site it is very easy to move the System and reduce the investments. 2. Layout with over pressure controlled access lock Depending on the specifications different module sizes up to 12 m x 3 m are used. Like this it is possible to adjust the size of the rooms and the sections of the system individually. We provide the expertise and consulting to find an optimal solution with our customers. It is our goal to define the facilities to fit their needs. In this case it was requested to connect the clean room to an existing system. To ensure the production within the GMP environment SIT installed a special access lock. The air pressure in the individual rooms is monitored and thus the access to the different compartments enabled. Modul 1 Modul 2 Modul 3 Modul 4 Modul 5 (Abb. 2) Layout with access locks to existing system V3 RMS indoor_0216 page 2 of 5

3 3. Installation of a V3 modular clean room system The whole clean room is assembled and completely tested at our facilities prior to shipment. It is then divided into the individual finished modules and delivered to the customer. Like this we secure highest quality and minimize the installation time at the customer site. 3.1 Floor and support structure The floor inside the clean room is ESD protected. Those panels are placed on subsoil and welded tight. To fullfil the GMP specifications all corners are sealed off with silicone glue. As a support structure for the system SIT uses a welded steel frame. This will serve as an interface to mount all appliances like walls, filter units and media distribution. It also provides a rigid frame that allows us to ship the modules separately. (Abb. 3) ESD protected floor (Abb. 4) steel frame support 3.2 Interior and utilities The walls are just like the floor built to meet the GMP standards. The panels have creased edges and thus the joints can be sealed with the same silicone glue with anti-fungus properties. (Abb. 5) wall system, GMP standard (Abb. 6) joints according to GMP V3 RMS indoor_0216 page 3 of 5

4 The air conditioning is one compact unit. All components are integrated into this cabinet. There is a cooling compressor, a dehumidifier as well as a heat exchanger and a steam humidifier. Driven by EC Ventilators we control the temperature and humidity of the air. To ensure the clean room is working in the proper range we also control the pressure of fresh and circulated air to maintain the right amount of pressurization within the system. SIT is able to keep the environmental conditions inside the modules within very tight specs to ensure a stable quality of all processes running inside our clean rooms. For ventilation and waste air all connection are integrated in the roof. This area is also accessible and walkable for service and maintenance. (Abb. 7) air conditioning (Abb. 8) walkable roof 3.3 Installation The modules of your system are delivered individually. After that they are set and integrated to form the complete modular clean room system at the site specified by the customer. Like this the SIT technicians are able to efficiently install the containers with all components and the infrastructure. Only a short installation time is required until the system can be started up. (Abb. 9) transport of individual modules (Abb. 10) complete integration V3 RMS indoor_0216 page 4 of 5

5 3.4 Finish The modules of your system are delivered individually. After that they are set and integrated to form the complete modular clean room system at the site specified by the customer. Like this the SIT technicians are able to efficiently install the containers with all components and the infrastructure. Only a short installation time is required until the system can be started up. (Abb. 11) interior view of complete system If you are searching for an innovative solution for your clean room situation we would be happy to help you! Please contact us for further information! SIT System Integration Technology AG Letzaustrasse 1 CH-9462 Montlingen Tel Fax info@sit.ch V3 RMS indoor_0216 page 5 of 5