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Bridge between cleanroom classifications acc. to FDA CDER and EU GMP Annex 1

Air
Classification

FDA CDER Aseptic Guideline 2004

EUROPIAN Annex 1

 

In Operation

In Operation

At Rest

 

Particle lecel per
cubic meter 0.5
micron and larger

Action level
CFU/cu.m.
(plate)

Description

 

 

Grade 5

3.520
(ISO 5)

1
(1)

CRITICAL AREA

A

3.520
(ISO 5)

3.520
(ISO 5)

Grade 6

35.200
(ISO 6)

7
(3)

Supporting clean

 

Grade 7

352.000
(ISO 7)

10
(5)

CONTROLLED
AREA

B

3.520
(ISO 5)

3.520
(ISO 5)

Grade 8

3.520.000
(ISO 8)

100
(50)

 

C

3.520
(ISO 5)

352.000
(ISO 7)

CNC (with local monitoring)

NA

NA

 Support

D

None

3.520.000
(ISO 8)

CNC

NA

NA

 

 

 

 

Unclassified