GMP medical device cleanroom is a special designed room to exclude
the particles in the air, bacteria and other harmful air
pollutants, and the indoor temperature, cleanliness, interior
pressure, air velocity and air distribution, noise, vibration, and
lighting, static control within the scope of a certain demand. That
is no matter how the outside air conditions change, its indoor all
can maintain the original set requirements of cleanliness,
temperature and humidity and pressure performance characteristic.
Consider Features
1. Temperature and Relative Humidity
Except for certain special circumstances, the temperature of
medical instrument cleanrooms should be calibrated between 18~28°C,
with a relatively humidity of 45-65%. If you find that you are out
of range for these standards, consider which instruments in the
clean room may be acting as a heat source.
2. Air Velocity, Air Change Rate (ACR), and Static Pressure
The air change rate of a cleanroom is a function of the volume of
air circulated into the cleanroom and the area of the cleanroom.
Differences in static pressure result from differences in the the
amount of air circulating through the air return vs. exhaust system
vents. All of these variables can be adjusted through manipulation
of fan speed and/or opening/closing the main vents. These can be
adjusted for the entire system or for certain areas depending on
the situation.
3. Keeping Out Dust, Bacteria, and Other Contaminants
Indications that your clean room may not be up to standard include
falling out of standard in basic areas such as temperature,
relative humidity and ACR. If these variables are out of standard,
it is likely that your cleanroom is contaminated to a degree that
is out of standard.
Proper calibration of the above conditions forms a sort of
"microclimate" that is inhospitable to contaminants such as dust
particles and bacteria. Meeting standards is a result of proper
maintenance of the cleanroom. Regular, thorough testing is the only
best practice, especially in a field where product contamination
can lead to serious consequences. Besides designing your cleanroom,
E-Clean can advise on how to implement management systems to
maintain your cleanroom and minimize the risk for contamination.
Level Of Airborne Particulate Cleanliness In Prefab Cleanroom
| Level | Maximum Particles/m3 | Equivalent |
| | ≥0.1 μm | ≥0.2 μm | ≥0.3 μm | ≥0.5 μm | ≥1 μm | ≥5 μm | |
| ISO 1 | 10b | d | d | d | d | e | |
| ISO 2 | 100 | 24b | 10b | d | d | e | |
| ISO 3 | 1000 | 237 | 102 | 35b | d | e | Class 1 |
| ISO 4 | 10000 | 2370 | 1020 | 352 | 83b | e | Class 10 |
| ISO 5 | 100000 | 23700 | 10200 | 3520 | 832 | d,e,f | Class 100 |
| ISO 6 | 1000000 | 237000 | 102000 | 35200 | 8320 | 293 | Class 1,000 |
| ISO 7 | c | c | c | 352000 | 83200 | 2930 | Class 10,000 |
| ISO 8 | c | c | c | 3520000 | 832000 | 29300 | Class 100,000 |
| ISO 9 | c | c | c | 35200000 | 8320000 | 293000 | Room Air |
| Area | 15㎡ | 30㎡ | 50㎡ | 100㎡ |
| Material | Aluminum frame/Baking steel plate/lnsulating glass window |
| FFU class 1-100 | 12pcs | 24pcs | 48pcs | 96pcs |
| FFU class-1K | 3pcs | 6pcs | 9pcs | 18pcs |
| FFU class-10K | 2pcs | 4pcs | 6pcs | 12pcs |
| Speed (m/s) | 0.45m/s ±20% | 0.45m/s ±20% |
| Temperature (optional) | 18-28°C |
| Humidity (opiional) | 50-70% | 50-70% |
| Illumination | 400-800LUX |
| Power | 2.4-7kw | 4.8-10kw | 9.6-19kw | 19.2-30kw |
Our Advantage
We focus on all kinds of solutions for prefab cleanroom. If you are
unsure of what tpye of prefab cleanroom you may need for your
particular project, please feel free to contact us. We will provide
a best solution according to your requirement.
