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.
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GMP Standard Medical Device Clean Room Images
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