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FAQ

Cleanroom Classifications acc. to EU GMP Annex 1.

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

-