FS 209E

Undoubtedly the best know cleanroom classification levels are the Federal Standard 209E, it was issued in the United States in 1963 for the first time and subsequently revised several times until the final version F209E in 1992. In the absence of an international standard, for many years the FS209E was used internationally.There are thirteen classifications of air cleanliness from class M1 to M7 as shown in the FS209E table below.The standard also indicates the conditions in accordance to which the controls must be carried out:

  • as built: Clean rooms or clean zones ready to start operating but without production equipment and personnel.
  • as rest: Clean rooms or clean zones fitted with the relevant processing machines but without personnel
  • operational: Clean rooms or clean zones in ordinary working activities with personnel and running processing machines.

This standard also determines the characteristics of the air flow, distinguishing between unidirectional (instead of linear) and non unidirectional flow (instead of turbulent).It establishes the conditions for the measurement of particles and the instruments to use.

ISO 14644.1

The need for a new international standard that covered more cleanroom environmental parameters and practices led to the formation of a technical committee of the International Standards Organisation. In 1996 ISO (International Standards Organisation) issued a new standard ISO 14644.1 with the goal of standardisation of equipment, facilities and operational methods for cleanrooms and controlled environments.

Comparison of International Standards

Standard and Date Published

USA
209D
(1988)
USA
209E
(1992)
EEC
CGMP
(1998)
EN
ISO14644-1
(1999)
Germany
VD 12083
(1990)
ISO 1
ISO 2
1M1.5ISO 31
10M2.5ISO 42
100M3.5A & BISO 53
1,000M4.5ISO 64
10,000M5.5CISO 75
100,000M6.5DISO 86

Federal Standard 209E

Fed.StdMax. Number of Particles/ m³ equal or above 
209E0.1µm0.2µm0.3µm0.5µm1µm5µm
M135075.730.910
M1.51,24026510635.3
M23,500757309100
M2.512,4002,6501,609353
M335,0007,5703,0901,000
M3.526,50010,9003,530
M475,70030,90010,000
M4.535,300247
M5100,000618
M5.5353,0002,470
M61,000,0006,180
M6.53,530,00024,700
M710,000,00061,800

Cleanroom Classification according to EN ISO 14644-1

ISO ClassMax. Number of Particles/ m³ equal or above  
0.1µm0.2µm0.3µm0.5µm1µm5µm
ISO 1102
ISO 210024104
ISO 31,000237102358
ISO 410,0002,3701,02035283
ISO 5100,00023,70010,2003,52083229
ISO 61,000,000237,000102,00035,2008,320295
ISO 7352,00083,2002,930
ISO 83,520,000832,00029,300
ISO 935,200,0008,320,000293,000

GMP Guidelines – In addition to the ISO standard the Good Manufacturing Practice Guidelines are also applicable for pharmaceutical, food, cosmetic and medical applications.

EUG GMP ClassMax. Number of Particles/ m³ equal or above  
GMPAt RestIn Operation
Class0.5µm5µm0.5µm5µm
A3,520203,52020
B3,52029352,0002,900
C352,0002,9003,520,00029,000
D3,520,00029,000
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