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Clean room / hygiene facility in the medical technology industry

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Clean room / hygiene facility in the medical technology industry

Clean room / hygiene facility

A clean room is essentially defined by particles that are suspended in the air in its room. The concentration and amount of these so-called particles in the air are regulated and monitored. But how many particles can there be in space? Does the nature of the particles play a role? How do I measure the number of particles? Cleanroom refers to the particles that float in the indoor air and do not exceed a certain number and size of particles per cubic meter. The EN ISO 14644 standard defines the corresponding maximum value by defining the clean room class. Parameters such as temperature, humidity and pressure are usually kept constant in a clean room so that comparable conditions are always maintained. In addition to certain processes, the employees in the clean room, the work equipment and tools as well as the materials provided are important sources of pollution.

For this reason, a certain displacement flow with the lowest possible turbulence is generated in the clean room, which is then cleaned by a multi-stage filter system. In order to guarantee the required air purity, a high air flow rate is very important. Employees therefore need suitable work clothing that does not emit particles into the air and does not adhere to any particles. In the entrance area of the clean room, adhesive pads are used to clean the shoe soles. After completion of the clean room and during ongoing operation, a particle measurement must be carried out. Based on the number of particles recorded in each size category, certification can be carried out according to the standardized clean room category!

The functional principle of a clean room In a clean room, constant humidity, temperature and pressure conditions must be maintained. To ensure this, certain ventilation and air conditioning technologies are used. The equipment and furniture in the clean room must meet certain requirements, and all employees who work in the clean room must meet strict regulations. Code of Conduct for Cleanrooms To avoid releasing too many particles into the air, employees should avoid fast, busy movements when working in the cleanroom. Slow and steady exercise is less risky. It is important that only as many employees as possible are deployed in the clean room and they should all be well trained experts. There are no personal items such as bags, watches or jewelry in the clean room.

Since humans are usually the largest source of particles and other contaminants, suitable work clothing, special work equipment and tools, and suitable work techniques can all help to maintain the specified cleanroom class. For example, there is special lint-free clean room paper, clean room clothing, shoe hats and shoe covers. For clean rooms in microelectronics there are several layer areas with corresponding clean room categories. The clean room used with the substrate (ISO level 4 and higher) is surrounded by a separate area with the necessary systems for coating and structuring. The pumps required for vacuum technology are usually located on the lower floor.

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