ISO/FDIS 14644-1 Cleanliness Classes for Cleanrooms and Associated Controlled Environments |
Classification |
Maximum permitted number of particles/m3 ofa size equal to and greater than, the considered size calculated to whole numbers |
0.1 μm |
0.2 μm |
0.3μm |
0.5 μm |
1.0 μm |
5.0μm |
1 |
10 |
2 |
--- |
--- |
--- |
--- |
2 |
100 |
24 |
10 |
4 |
--- |
--- |
3 |
1.000 |
237 |
102 |
35 |
8 |
--- |
4 |
10.000 |
2.370 |
1.020 |
352 |
83 |
--- |
5 |
100.000 |
23.700 |
10.200 |
3.520 |
832 |
29 |
6 |
1.000.000 |
237.000 |
102.000 |
35.200 |
8.320 |
293 |
7 |
--- |
--- |
--- |
352.000 |
83.200 |
2.930 |
8 |
--- |
--- |
--- |
3.520.000 |
832.000 |
29.300 |
9 |
--- |
--- |
--- |
35.200.000 |
8.320.000 |
293.000 |
Notes:• The above table is based on the Final Draft lnternational Standard 14644-1
• Concentration limits for intermediate classes can be calculated, approximately, using the following equation: Cn = 1 ON x (0.1/0)2.08
• Always refer to complete standard for exact details
US Federal Standard 209 E Cleanliness Classes of Cleanrooms and Associated Controlled Environments |
US Fed.Std. class name2) Si English3) |
Class Limits1) |
0.1 μm (m3) |
0.2 μm (m3) |
0.3 μm (m3) |
0.5 μm (m3) |
0.5 μm (m3) |
|
350 |
75,7 |
30,9 |
10,0 |
--- |
|
1.240 |
265 |
106 |
35,3 |
--- |
|
3.500 |
757 |
309 |
100 |
--- |
|
12.400 |
2.650 |
1.060 |
353 |
--- |
|
35.000 |
7.570 |
3.090 |
1.000 |
--- |
|
--- |
26.500 |
10.600 |
3.530 |
--- |
|
--- |
75.700 |
30.900 |
10.000 |
--- |
|
--- |
--- |
|
35.300 |
247 |
|
--- |
--- |
|
100.000 |
618 |
|
--- |
--- |
|
353.000 |
2.470 |
|
--- |
--- |
|
1.000.000 |
6.180 |
|
--- |
--- |
|
3.530.000 |
24.700 |
|
--- |
--- |
|
10.000.000 |
61 .800 |
Notes:1) The class limits shown in table 1 are defined for classification purposes only and do not necessarily represent the size distribution to be found in any particular situation.
2) Concentration limits for intermediate classes can be calculated, approximately, from the following equations: particles/m3 = 10M (0.5/d)2/2 where M is the numerical designation of the class based on Si units, and d is the partide size in micrometers, or: particles/ft3 = Ne (0.5/d)2.2.
3) For naming and describing the classes, Si names and units are preferred; however, English (U.S.) customary units may be used.
Comparison Classes Cleanroom Standards |
US Fed.Std. 209E 1992 |
ISO.EN FDIS 14644-1 |
Japan JACA 1989 |
VDI 2083 Part 3 1990 |
AFNOR NFX 44-101 |
BS 52951989 |
--- |
1 |
1 |
--- |
--- |
--- |
--- |
--- |
--- |
--- |
--- |
--- |
--- |
2 |
2 |
0 |
--- |
--- |
|
--- |
--- |
--- |
--- |
--- |
|
3 |
3 |
1 |
--- |
C |
|
--- |
--- |
--- |
--- |
--- |
|
4 |
4 |
2 |
--- |
D |
|
--- |
--- |
--- |
--- |
--- |
|
5 |
5 |
3 |
4.000 |
E(F) |
|
--- |
--- |
--- |
--- |
--- |
|
6 |
6 |
4 |
--- |
G(H) |
|
--- |
--- |
--- |
--- |
--- |
|
7 |
7 |
5 |
400.000 |
J |
|
--- |
--- |
--- |
--- |
--- |
|
8 |
8 |
6 |
4.000.000 |
K |
|
--- |
--- |
--- |
--- |
--- |
|
9 |
9 |
--- |
40.000.000 |
L |
Notes:1) Scandinavian standards conform US federal Standard 209E
2) Always refer to complete standard for exact details
Comparison Cleanroom Standards and GMP Guides |
US FS 209E 1992 Max.number of particles Per m3 Metric us ≥0.5 μm ≥0.5 μm |
FD-GMP 1997 USP Chapter 1116 Viable micro-organisms Class Max.CFU Per m3 |
Ec Guide to GMP1) 1997 Revision to Annex 1 Viable micro-organisms Class Max.CFU Per m3 |
|
|
|
|
|
|
M5.5 |
10.000 |
353.000 |
2.470 |
|
|
|
M6.5 |
100.000 |
3.530.000 |
24.700 |
|
|
|
|
area |
|
Notes:1) For more detailed information refer to "Rules Governing Medicinal Products in the European Community", Volume iV, Guide to Good Manufacturing
Practice. References to velocity and air chages have been deleted.
2) FDA prescribes for critical areas 0.45 m/s, ± 0.1 m/s.
3) For laminar airflow work stations.
EU GMP 1997 Revision -Total Particle Count |
|
Afrest |
In Operation |
Grade |
Maximum oermitted number of oarticleslm3 eaual to or above |
|
0.5 μm |
5.0 μm |
5.0 μm |
5.0 μm |
A |
3.500 |
--- |
3.500 |
--- |
B1) |
3.500 |
--- |
350.000 |
2.000 |
C1) |
350.000 |
2.000 |
3.500.000 |
20.000 |
D1) |
3.500.000 |
20.000 |
--- |
--- |
Notes:1) In order to reach the B, C and O grades, the number of air chages should generally be higher than
2) per hour in a room with a good airflow pattern and appropriate filters, HEPA for grades A, B and C.
2) Appropiate alert and action limits should be set for the particular operation.