Specialists for cleanroom
technology and laminar cabintets
technology and laminar cabintets
FAQ
Bridge between cleanroom classifications acc. to FDA CDER (2004) and EU GMP Annex 1 (2007)
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Air |
FDA CDER Aseptic Guideline 2004 |
EUROPEAN Annex 1m rev. 2007 |
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In Operation |
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In Operation |
At Rest |
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Particle lecel per |
Action level |
Description |
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|
|
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Grade 5 |
3.520 |
1 |
CRITICAL AREA |
A |
3.520 |
3.520 |
|
Grade 6 |
35.200 |
7 |
Supporting clean |
|
|
|
|
Grade 7 |
352.000 |
10 |
CONTROLLED |
B |
3.520 |
3.520 |
|
Grade 8 |
3.520.000 |
100 |
|
C |
3.520 |
352.000 |
|
CNC (with local monitoring) |
NA |
NA |
Support |
D |
None |
3.520.000 |
|
CNC |
NA |
NA |
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Unclassified |
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