GMP Classification

EU-
GMP-
Class

At Rest

In Operation

Max. permitted Nuber of Particles /m³ (equal or above)

0,5 µm

5,0 µm

A

3.520

20

3.520

20

B

3.520

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

Comparison of the Cleanroom Classification according to DIN EN ISO 14644-1
and US FED 209D

ISO Class

Corresponds roughly to US FED 209E

Corresponds roughly to US FED 209E

ISO 1

 

 

ISO 2

 

 

ISO 3

M1,5

Class 1

ISO 4

M2,5

Class 10

ISO 5

M3,5

Class 100

ISO 6

M4,5

Class 1.000

ISO 7

M5,5

Class 10.000

ISO 8

M6,5

Class 100.000

ISO 9

M7,5

 

Comparison of the Cleanroom Classification according to DIN EN ISO 14644-1 and
the EU GMP Guideline

ISO 14644-1

EG-GMP non operational

EG-GMP operational

1

 

 

2

 

 

3

 

 

4

 

 

5

A / B

A

6

 

 

7

C

B

8

D

C

9

 

 

Cleanroom Classification according to DIN EN ISO 14644-1

 

Limits (Particles per m³) for Partikel equal or above:

ISO Class

0,1 µm

0,2 µm

0,3 µm

0,5 µm

1,0 µm

5,0 µm

ISO 1

10

2

 

 

 

 

ISO 2

100

24

10

4

 

 

ISO 3

1000

237

102

35

8

 

ISO 4

10.000

2.370

1.020

352

83

 

ISO 5

100.000

23.700

10.200

3.520

832

29

ISO 6

1.000.000

237.000

102.000

35.200

8.320

293

ISO 7

 

 

 

352.000

83.200

2.930

ISO 8

 

 

 

3.520.000

832.000

29.300

ISO 9

 

 

 

35.200.000

8.320.000

293.000

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Fax +49-451-38171
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