Specialists for cleanroom
technology and laminar cabintets
technology and laminar cabintets
FAQ
Cleanroom Classifications acc. to EU GMP Annex 1.
Cleanroom classification acc. to EU GMP Annex 1. rev. 2022
|
Grade |
Maximum permitted number of particles per m3 equal to or greater than the tabulated size |
|||
|
At rest |
In operation |
|||
|
0.5 µm |
5.0 µm |
0.5 µm |
5.0 µm |
|
|
A |
3520 |
Not specified (a) |
3 520 |
Not specified (a) |
|
B |
3520 |
Not specified (a) |
352 000 |
2 930 |
|
C |
352 000 |
2 930 |
3 520 000 |
29 300 |
|
D |
3 520 000 |
29 300 |
Not predetermined (b) |
Not predetermined (b) |
(a) Classification including 5 µm particles may be considered where indicated by the CCS (Contamination Control Strategy) or historical trends
(b) The manufactorer should establish in the opertation limits based on a risk assessment and routine data where applicable
|
Grade |
Recommended limits for microbial contamination |
||
|
air sample CFU/m3 |
settle plates (diameter 90 mm) CFU/4 hours (b) |
contact plates (diameter 55 mm) CFU/deska |
|
|
A |
No growth |
No growth |
No growth |
|
B |
10 |
5 |
5 |
|
C |
100 |
50 |
25 |
|
D |
200 |
100 |
50 |
- For monitoring the maximum permitted total particle concentration is following:
|
Grade |
Maximum permitted number of particles per m3 equal to or greater than the tabulated size |
|||
|
At rest |
In operation |
|||
|
0.5 µm |
5.0 µm |
0.5 µm |
5.0 µm |
|
|
A |
3520 |
29 |
3 520 |
29 |
|
B |
3520 |
29 |
352 000 |
2 930 |
|
C |
352 000 |
2 930 |
3 520 000 |
29 300 |
|
D |
3 520 000 |
29 300 |
Not predetermined |
Not predetermined |
Cleanroom classification acc. to EU GMP Annex 1. rev. 2007
|
Grade |
Maximum permitted number of particles per m3 equal to or greater than the tabulated size |
|||
|
At rest |
In operation |
|||
|
0.5 µm |
5.0 µm |
0.5 µm |
5.0 µm |
|
|
A |
3520 |
20 |
3 520 |
20 |
|
B |
3520 |
29 |
352 000 |
2 900 |
|
C |
352 000 |
2 900 |
3 520 000 |
29 000 |
|
D |
3 520 000 |
29 000 |
Not defined |
Not defined |
|
Grade |
Recommended limits for microbial contamination (a) |
|||
|
air sample CFU/m3 |
settle plates (diameter 90 mm) CFU/4 hours (b) |
contact plates (diameter 55 mm) CFU/deska |
glove print 5 fingers CFU/glove |
|
|
A |
<1 |
<1 |
<1 |
<1 |
|
B |
10 |
5 |
5 |
5 |
|
C |
100 |
50 |
25 |
- |
|
D |
200 |
100 |
50 |
- |