Clean rooms are specially constructed rooms that offer a controlled environment in which the concentration of particles and microbiological impurities is minimised. These rooms are decisive for quality and safety in various industries such as the semi-conductor industry, pharmaceuticals, biotechnology and food production. Clean rooms were originally developed in medicine to create sterile environments for operations. Over time, they have established themselves in various industries, in particular in semi-conductor manufacture, where the tiniest of particles could disrupt production..
Clean rooms are constructed in such a way that the quantity of airborne particles is kept below a certain value required for the application. These is achieved by using special filters (EPA, HEPA and ULPA) that filter the air. In addition, parameters such as temperature, humidity and pressure are kept constant. Clean rooms are subdivided into different classes based on the quantity of particles per cubic metre of air. These classes reach from ISO 1 (highest class, lowest number of particles permissible) to ISO 9 (lowest class, highest number of particles permissible). This classification helps to define the appropriate conditions for various different applications.
Aside from the semi-conductor industry and pharmaceuticals, clean rooms are also used in biotechnology, food production, aeronautical and space technology and in optical and laser technology. In pharmaceuticals, compliance with Good Manufacturing practices (GMP) is especially important. GMP includes guidelines on quality assurance for production processes and environments in the manufacturing of medicines and active ingredients. These guidelines ensure that medicines are produced under defined quality conditions in order to guarantee the safety and effectiveness of theproducts.
There are two main flow principles in clean rooms: the turbulent dilution flow and the low-turbulence displacement flow. The former dilutes the air in the room, whereas the latter generates an even, piston-like displacement flow, which is particularly suitable for sensitive working spaces.