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SIT System Integration Technology AGLetzaustrasse 19462 Montlingen/Schweiz

Project Report CMP Cleanroom

GMP Cleanroomrealized with the module system

Fig 1 exterior view of finished clean room

● Expansion of production capacity ● rapid availability ● additional usable area with connectable units possible ● transportable for potentially relocation

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Project Report CMP Cleanroom

1 Project DescriptionAn innovative medical technology company with high-end products needed a clean room according to GMP standard for the expansion of the production capacity in the mother house. The facility should be available quickly and offer 150m2 of usable space, including access sluices. With the modular system, SIT offered the customer the ideal solution. The advantages of our concept came fully into the realization.

• The on-site intallation was reduced to a minimum• The System can be extended with additional modules should a need arise in the future• If the production has to be moved to another location the system can be dismantled and transported without any problems due to the modular system

2 Layout with over pressure controlled access lock

Depending on the specifications different module sizes up to 12 m x 3 m are used. It is possible to adjust the size of the rooms and the sections of the system individually. We advise our customers competently in the realization of their ideas, in order to find the optimal solution. In the ex-ample described, the SIT clean room was connected to an existing facility (Fig 2). With a special access lock the overpressure in the individual rooms is monitored and guarantees constant conditions in the clean room.

Modul 1

Modul 2

Modul 3

Modul 4

Modul 5

Fig 2 Layout access locks to existing system

3 Installation of a V3 modular clean room systemThe whole clean room is assembled and completely tested at our facilities prior to shipment. The re-assembly at the end user is done by our technicians. This procedure minimize the installation time on site and ensures the highest quality to the customer.

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Project Report CMP Cleanroom

3.1 Floor and support structure

The floor covering is carried out according to the requirements for the clean room. It is mostly consists of ESD dissipative plates, which are laid on the underfloor and are tightly welded (Fig 3). In order to meet the GMP standards, the floor with the side walls is laid in cavities. The supporting structure consists of a steel frame (Fig 4), which also serves as a support for the walls and makes the transport and the integration of the modules easy.

Fig 3 ESD protected floor Fig 4 Steel frame support

3.2 Interior and utilities

The wall system is executed analogously to the floor according to GMP standard. For this purpose, the aluminum cartridge plate is used (Fig 5). All joints and connections on hollow cores are sealed with a silicone seal and tightly sealed (Fig 6)

Fig 5 Wall system, GMP standard Fig 6 Joints according to GMP

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Project Report CMP Cleanroom

3.3 Infrastructure and Monitoring

The air preparation was supplied as a compact unit (Fig 7). All elements are integrated in this climate control cabinet. These include refrige-ration compressors, dehumidifiers and post-heat registers as well as steam humidifiers. Powered by EC fans, the temperature, humidity and overpressure of the fresh and circulating air are controlled. The supply and exhaust air ducts were installed in the deck construction (Fig 8). The whole area is accessible for service work. In order to meet all production requirements according to GMP, a monitoring system was integrated, which records all relevant room conditions and data.

3.4 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 inf-rastructure. Only a short installation time is required until the system can be started up.

Fig 10 complete integrationFig 9 Transport of individual modules

Fig 7 Air conditioning Fig 8 walkable roof

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Project Report CMP Cleanroom

3.5 Finish

Based on the modular design, the system can be extended as desired. Additional installations are also possible at the request of the custo-mer, such as an additional dehumidification stage, if the climatic conditions (atmospheric humidity) at the site fluctuate too much (for example, seasonally). SIT offers all units for a stable and precise air-conditioning of the clean rooms. With the SIT airhandling units an optimal working environment is implemented according to the GMP standard (Fig 11). On request, SIT also provides the service and the recommended annual qualification according to EN14644 including particle measurement.

Fig 11 Interior view of complete system

If you are interested in our solutions or you have questions to our systems, please contact us.