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Guangzhou Cleanroom Construction Co., Ltd.
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GMP Standard Medical Device Clean Room

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Guangzhou Cleanroom Construction Co., Ltd.

City: guangzhou

Province/State:guangdong

Country/Region:china

Tel:86-20-84554339

Contact Person:
Ms.Sophie
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GMP Standard Medical Device Clean Room

Brand Name GCC
Certification ISO
Place of Origin China
Minimum Order Quantity 1 Set
Price Negotiation
Payment Terms T/T, L/C
Supply Ability 1000 Sets/Month
Delivery Time 14-30 Workdays
Packaging Details Plywood Box
Keyword Prefab Cleanroom
Frame Material Aluminum Profile, Stainless Steel Profile, Steel Profile
Wall Material Magnesium Sandwich Panel
Video outgoing-inspectionv Provided
Machinery Test Report Provided
After-sales Service Provided Online support
Detailed Product Description

 

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
 

LevelMaximum Particles/m3Equivalent 
 ≥0.1 μm≥0.2 μm≥0.3 μm≥0.5 μm≥1 μm≥5 μm 
ISO 110bdddde 
ISO 210024b10bdde 
ISO 3100023710235bdeClass 1
ISO 4100002370102035283beClass 10
ISO 510000023700102003520832d,e,fClass 100
ISO 61000000237000102000352008320293Class 1,000
ISO 7ccc352000832002930Class 10,000
ISO 8ccc352000083200029300Class 100,000
ISO 9ccc352000008320000293000Room Air

 

Area15㎡30㎡50㎡100㎡
MaterialAluminum frame/Baking steel plate/lnsulating glass window
FFU class 1-10012pcs24pcs48pcs96pcs
FFU class-1K3pcs6pcs9pcs18pcs
FFU class-10K2pcs4pcs6pcs12pcs
Speed (m/s)0.45m/s ±20%0.45m/s ±20%
Temperature (optional)18-28°C
Humidity (opiional)50-70%50-70%
Illumination400-800LUX
Power2.4-7kw4.8-10kw9.6-19kw19.2-30kw


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.

Product Tags: GMP Standard Medical Device Clean Room   GMP clean room class for medical devices   ISO8 Medical Device Clean Room  
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