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Cleanroom Class ISO and GMP

Cleanroom Class ISO and GMP

Cleanrooms shall be defined by ISO-Cleanroom Classes.

ISO 14644-1 Standard determines how many particles in which size shall be given in 1m³ (cubic meter) of air.

this maximum of acceptable particle concentration shall not be exceeded in order to fulfill parameters for the respective Cleanroom Class. ISO-Class 1 has the highest requirements regarding air purity, ISO-Class 9 is the Class with the lowest requirements regarding air purity. In a number of industries, such as food technology and pharmaceutics, air purity is also determined by the contents of micro-organisms or microbes / KBE (colony forming units - CFU).

In pharmaceutics it shall be complied with EG-GMP Annex 1. 

The following chart shall include the different ISO-Cleanroom Classes, the corresponding EG-GMP in respect to number of microbes as well as the prior applied US Federal Standard 209E/D (not valid any longer since 2001).