Cleanroom Technology
The cleanroom has a protective function. The concentration of airborne particulates must be kept very low there in order to protect the product from environmental or human influences on the one hand, or to protect the environment and people from the product on the other.
ISO- / GMP Classes
Cleanrooms are classified either according to ISO standard 14644-1 or according to the Good Manufacturing Practice (GMP) Guide, annex 1.
According to EN ISO 14644-1 Classification of air cleanliness, cleanrooms are divided into nine classes, ascending from class nine to the cleanest class 1.
In the GMP guidelines, cleanrooms are divided into classes A, B, C and D, with class A being subject to the strictest standards.
The classification is based on the maximum permissible particle count of the sizes 0.5 and 5.0 µm / m³ in the resting state (without personnel) as well as in the operating state (with personnel) for the production of sterile drugs.
Clean Air at the Workplace
The degree of air purity to be achieved at the “clean workplace” depends on the type of work:
- on the quality of the filters, their receiving device and their arrangement
- of the air volume flow and the air speed
- of air stream in the room and its guidance
- the occurrence of contamination at the “clean workplace”, taking into account the interaction with neighbouring workplaces
Cleanroom Models
- Fully air-conditioned clean rooms
- Clean room systems
- Room-in-room solutions
- Air locks
- Technical components for processes in clean rooms
Cleanliness Classes
| ISO classification |
3 |
4 |
5 |
6 |
7 |
8 |
| (U.S. FS 209)* |
1 |
10 |
100 |
1.000 |
10.000 |
100.000 |
|
Micro-electronics
Semi-conductor production |
|
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Chemistry |
|
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Data media
CD / Video / Hard discs |
|
|
Electronics / Optronics
Components / Connections / Lighting circuits |
|
Micro-mechanics
On-board instruments / gyroscopes |
|
Pharmacy
Medicaments / OP's / Implants / Scales |
|
Food industry
Drinks / Creameries / Dairies |
|
|
|
|
Aerospace / Aircraft industries
Satellites / Carrier rockets / Mirrors |
|
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|
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Car industry
Painting booths / Electronic equipment |
*Was cancelled on 29th November 2001.
Filters for Cleanroom Technolgy
| Filters |
Application |
| Compact filters |
as fine dust filters in technical facilities |
| HEPA filters |
HEPA filters as high efficiency particulate absorbers in cleanroom systems |
| Pocket filters |
as pre- and primary filters in technical devices and plants |
Particulate Air Filters according to EN 1822-1:2009
| Filter Class |
Retention (average) |
Transmission Rate |
Fields of Application |
| E10 |
85 |
15 |
Final filters for rooms with high and highest rquirements (e.g. in medicine, in laboratories; production rooms in food- pharmaceutical- and electrical industries) |
|
| E11 |
95 |
0,5 |
|
| E12 |
99,5 |
0,05 |
Exhaust air filters in nuclear facilities and for cleanrooms of classes ISO 7 and 5 |
| H13 |
99,95 |
0,05 |
|
| H14 |
99,995 |
0,005 |
|
Final filters for cleanrooms of classes ISO 4 and 3 |
| U15 |
99,9995 |
0,0005 |
|
|
| U16 |
99,99995 |
0,00005 |
|
|
| U17 |
99,999995 |
0,000005 |
|
|
Smart Finish
The cleanest room in the world …
The cleanest cleanroom is 10 times cleaner than the ISO 1 air cleanliness class, which is officially considered the cleanest cleanroom class. This means that there may only be a single 0.1 micrometer particle in one cubic meter of air. This cleanroom is operated by the Fraunhofer Institute for Manufacturing Engineering and Automation in Stuttgart. The cleanroom is equipped with a laminar air flow of 0.45 m/s, coming from the ceiling.
