Comparison of Clean Rooms classes/ Standards

(internal document only!!!)

Clean Rooms classes accoriding to Standards

US Federal Standard FS 209E 100.000 10.000 1.000 100 10 1
US FS 209E (1992) compl. SI M 6,5 M 5,5 M 4,5 M 3,5 M 2,5 M 1,5
GER standard VDI 2083 6 5 4 3 2* 1*
GB standard BS 5295 (1989) K J H-G F-E D C
EC Guide (for pharmaceutics) D C B-A A A
ISO/209 ISO 8 ISO 7 ISO 6 ISO 5 ISO 4 ISO 3

<5,0µm 700 70 7 - - -
Max.number of <0,5µm 100 000 10 000 1 000 100 10 1
partcles in 1ft3 of air <0,3µm - - - 300 30 3
<0,2µm - - - 750 75 7,5
<0,1µm - - - - 350 35
<5,0µm 20 000 2 000 200 - - -
Max.number of <0,5µm 3 500 000 350 000 35 000 3 500 350 35
partcles in 1m3 of air <0,3µm - - 100 000 10 000 1 000 100
<0,2µm - - 236 000 23 600 2 360 236
<0,1µm - - 1 000 000 100 000 10 000 1 000
Air flow Type turbulent turbulent combined laminar laminar laminar
Exchanges [h-1] (CR h=3m) 20÷25 40÷60 120÷300 360÷600 500÷600 500÷600
Air volume [m3/h /m2] 60÷75 120÷180 360÷900 1000÷1600 1600÷1800 1600÷1800
Air flow Velocity [m/s] - - 0,1÷0,25 0,3÷0,45 0,45÷0,5 0,45÷0,5
Exhoust Air Velocity [m/s] 2,5 1÷2,5 1÷2,5 0,3÷0,45 0,45÷0,5 0,45÷0,5
Air inflow ceiling outlet ceiling outlet filtr.ceiling filtr.ceiling filtr.ceiling filtr.ceiling
perfor.ceiling
Air exhoust wall wall - by floor wall - by floor wall - by floor
or via floor or via floor via floor via floor
Filtration area [%] 5÷10 15÷20 30÷50 >80 >90 >90
1° of Filtration EU5 EU5 EU5 EU4 EU4 EU4
2° of Filtration - - - EU7 R R
Terminal filter R/S S S S/T T U
Prefilter exchange yearly 1/2 yearly 1/4 yearly 1/4 yearly monthly monthly
Particles counting yearly monthly 2 weekly weekly daily continuous
Overpressure [Pa] 3÷5 5÷10 10 12 15 15