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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.

Federal Standard 209D, 209E

Federal Standard 209 was the first to be published in 1963 in the US with the name”Cleanroom Environments”. It was reviewed multiple times in the following years, until the latest version 209E came out in 1992.

Clean Room classification standards

The standard identifies 6 classes, the cleanest corresponds to Class 1, while the less clean is Class 100,000. To these, the ISO standard added two cleaner standards and a dirtier one. Although ISO is the classification per excellence, the Federal standard, being the first that led to the creation of all others, has remained deeply rooted within companies.