In this section of GMP-inspection.com, our translators provide definitions and explanations of various specialized terms from the pharmaceutical industry and GMP (Good Manufacturing Practice).
Cleanrooms are specifically monitored rooms that are designed and equipped to minimize the concentration of aerosol particles and germs in the room. They are widely used in various industries, e.g. in the pharmaceutical industry, biotechnology, microelectronics, medical technology, microchip manufacturing, etc., where small particles or microorganisms can have a negative impact on product quality or research results.
The main purpose of cleanrooms (translation into German: Reinräume) is to control the number and size of particles present in the air and to ensure sterility and cleanliness in manufacturing or research processes. This is achieved through the use of special air filtration systems, the control of environmental parameters (including temperature, humidity and air pressure) and strict cleaning and hygiene protocols for personnel working in cleanrooms.
Cleanrooms are classified according to the number of particles of a certain size contained in the air in accordance with ISO 14644-1. The classification (German translation: Klassifizierung) is based on a scale from ISO 1 (cleanest rooms, lowest number of particles) to ISO 9 (highest number of particles). The lower the number, the stricter the requirements for the cleanliness of the room and the processes carried out in it.
The use of cleanrooms in various industries has the following benefits:
It should be noted that cleanrooms must be regularly maintained and monitored to ensure their function and compliance. This includes regular cleaning and disinfection, device calibration, filter changes, staff training and much more.
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