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Labox 30 let
Specialists for cleanroom
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

-