Cleanroom Technology
The cleanroom has a protective function. The concentration of airborne particulates must be kept very low there in order to protect the product from environmental or human influences on the one hand, or to protect the environment and people from the product on the other.
ISO- / GMP Classes
Cleanrooms are classified either according to ISO standard 14644-1 or according to the Good Manufacturing Practice (GMP) Guide, annex 1.
According to EN ISO 14644-1 Classification of air cleanliness, cleanrooms are divided into nine classes, ascending from class nine to the cleanest class 1.
In the GMP guidelines, cleanrooms are divided into classes A, B, C and D, with class A being subject to the strictest standards.
The classification is based on the maximum permissible particle count of the sizes 0.5 and 5.0 µm / m³ in the resting state (without personnel) as well as in the operating state (with personnel) for the production of sterile drugs.
Clean Air at the Workplace
The degree of air purity to be achieved at the “clean workplace” depends on the type of work:
- on the quality of the filters, their receiving device and their arrangement
- of the air volume flow and the air speed
- of air stream in the room and its guidance
- the occurrence of contamination at the “clean workplace”, taking into account the interaction with neighbouring workplaces
Cleanroom Models
- Fully air-conditioned clean rooms
- Clean room systems
- Room-in-room solutions
- Air locks
- Technical components for processes in clean rooms