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Clean Room rules and regulations: everything you need to know

Clean Room regulations

Air quality and cleanliness represent two essential elements for Clean Rooms, and are measured through the monitoring of the number of particles inside the environment. During the design phase of a clean room, air cleanliness classes are defined based on the needs of the production process, which can make reference to different classification standards.
Various classification models have been developed starting from 1963:

  • Federal Standard 209D, 209E
  • British Standard 5295
  • EU GMP
  • VDI 2083.

However, among all standards for clean rooms, what is now taken as reference on a global level is UNI EN ISO 14644-1.