Cleanrooms for pharmaceutical and Healthcare industry
Cleanroom is a manufacturing environment, required for pharmaceutical products,
scientific research, aerospace, semi-conductor and engineering applications with
low level of environmental pollutants such as dust, airborne particles (aerosols,
microbes and chemical vapors). Cleanroom has a controlled level of contamination,
temperature and humidity (the number of particles per cubic meter at a specified
particle size).
- Strile oncology OSD injectables
- API biotechnology R&D labs iveternary
- Health care Medical divices Food & beverages Electronics
The goal of cleanroom is to provide a space in which users can build
critical components and test products for performance, durability
without having to worry about contamination. Cleanroom allows users
to simulate environment in which an item will be used. Inside control
environment testing is much more efficient and results are more
accurate. Cleanroom are essential to applications that rely on pristine
air quality and particle elimination.
| Maximum concentration limits (particles/m3 of air) for particles equal to and larger than the considered zones as shown below | ||||||
|---|---|---|---|---|---|---|
| Classification Numbers (N) | 0.1 um | 0.2 um | 0.3 um | 0.5 um | 1.0 um | 5.0 um |
| ISO Class 1 | 10 | 2 | ||||
| ISO Class 2 | 100 | 24 | 10 | 4 | ||
| ISO Class 3 | 1000 | 237 | 102 | 35 | 8 | |
| ISO Class 4 | 10000 | 2370 | 1020 | 352 | 83 | |
| ISO Class 5 | 100000 | 23700 | 10200 | 3520 | 832 | 29 |
| ISO Class 6 | 237000 | 102000 | 35200 | 8320 | 293 | |
| ISO Class 7 | 352000 | 83200 | 2930 | |||
| ISO Class 8 | 3520000 | 832000 | 29300 | |||
| ISO Class 9 | 35200000 | 8320000 | 293000 | |||