The Netherlands 
Connect 2 Cleanrooms Information
Following the installation of any cleanroom and prior to completion a validation process is carried out as outlined within the international standard ISO14644. This standard determines the level required against results achieved.
The fundamental aspect of any cleanroom is to demonstrate that the cleanroom is achieving the requirements of our customer. To do this an understanding of the cleanroom definition is required. This definition is clearly identified within the above standard but is summarised as:
"Cleanroom - Room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation and retention of particles inside the room." Ref: International standard ISO14644-1 first edition 1999-05-01
Following the validation and commissioning process additional monitoring may be necessary to demonstrate the room is achieving the desired level through its use. As a part of our service your on going support is supplied by our own validation and testing engineers. We recommend the required visits with the appropriate monitoring. The parameters that can be monitored include, Particle counts, Air changes, Filter testing, temperature, Humidity, Light LUX levels and Pressure gauge accuracy.
Why choose a Softwall or Hardwall modular cleanroom?
There are several advantages to choosing one of our softwall cleanrooms:
- Capital costs are low
- Installation time is quick
- It can be validated to ISO 14644-1 from Class 5 to Class 8
- It's a permanent room but with the flexibility to be mobile
- It can be expanded easily to meet business demands
- It can be re-located easily to another area or new building
- It can be placed over a work area or piece of equipment
- It has a high rate of air change
- Equipment can be moved in and out easily
- No building control or planning permission is needed
- There is the option of transfer and change areas
- The clear ceiling panels allow lighting from external area
- It can be installed within an existing room
| Room Classifications | Class | |||||
|---|---|---|---|---|---|---|
| Classification System | ||||||
| ISO 14644-1 | Class 3 | Class 4 | Class 5 | Class 6 | Class 7 | Class 8 |
| Federal Standard 209E | 1 | 10 | 100 | 1,000 | 10,000 | 100,000 |
| EU GGMP | - | - | A/B | - | C | D |
| Air Changes per hour | 360-540 | 300-540 | 240-480 | 150-240 | 60-90 | 5-48 |
| Recommended limits for airbourne contamination | |||||
|---|---|---|---|---|---|
| Maximum permitted number of particles /m3 | |||||
| EU GGMP Grade | ISO EN 14644-1 | At rest ≥0.5µm | At rest ≥0.5µm | In operation ≥0.5µm | In operation ≥0.5µm |
| A | 5 | 3,250 | 20 | 3,520 | 20 |
| B | 5 | 3,250 | 29 | 352,000 | 2,900 |
| C | 7 | 352,000 | 2,900 | 3,520,000 | 29,000 |
| D | 8 | 3,520,000 | 29,000 | Not defined | Not defined |