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 USA Federal Standard209E1992

Cleanliness level um
 
0.1 0.2 0.3 0.5 5.0
1 35.0 7.50 3.00 1.00 NA
10 350 75.0 30.0 10.0 NA
100 NA 750 300 100 NA
1000 NA NA NA 1000 7.0
10000 NA NA NA 10000 70.3
100000 NA NA NA 100000 700

unit:Dust quantity/ft3

 In pharmaceutical production of clean room (area) of the air cleanliness standards

Cleanliness level Dust is the most allowable number / square meter Maximum allowable microbial number
 
≥0.5um ≥5um Planktonic bacteria / cubic meter Sedimentation bacteria / dish.30min
100 3500 0 5 1
10000 350,000 2,000 100 3
100000 3,500,000 20,000 500 10
300000 10,500,000 61,800 NA 15

Implementation of the national drug supervision and Administration Bureau in August 1, 1999


 More than 0.5um diameter around the cleanliness level meter based on approximate control

A/M3≥0.5um ISO
14644-1(1999)
US
209E(1992)
US
209D(1988)
EEC
GGMP(1989)
FRANCE
AFNOR(1981)
GERMANY
VDI 2083(1990)
JAPAN
JAOA(1989)
1 - - - - - - -
3.5 2 - - - - 0 2
10.0 - M1 - - - - -
35.3 3 M1.5 1 - - 1 3
100 - M2 - - - - -
353 4 M2.5 10 - - 2 4
1,000 - M3 - - - - -
3,530 5 M3.5 100 A+B 4,000 3 5
10,000 - M4 - - - - -
35,300 6 M4.5 1,000 1,000 - 4 6
100,000 - M5 - - - - -
353,000 7 M5.5 10,000 C 400,000 5 7
1,000,000 - M6 - - - - -
3,530,000 8 M6.5 100,000 D 4,000,000 6 8
10,000,000 - M7 - - - - -

 Cleanliness level of suspended particles in the air of clean room and clean area

Air cleanliness class (N) The maximum concentration limit of particle size greater than or equal to the table. (pc/m3)
 
0.1um 0.2um 0.3um 0.5um 1um 5um
1 10 2        
2 100 24 10 4    
3 1000 237 102 35 8  
4 10000 2370 1020 352 83  
5 100000 23700 10200 3520 832 29
6 1000000 237000 102000 35200 8320 293
7       352000 83200 2930
8       3520000 832000 29300
9       35200000 8320000 293000

GB50073-2001

 
     
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