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GMP Standard Medical Device Clean Room

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

GMP Standard  Medical Device Clean Room
GMP Standard  Medical Device Clean Room

Large Image :  GMP Standard Medical Device Clean Room

Product Details:
Place of Origin: China
Brand Name: GCC
Certification: ISO
Payment & Shipping Terms:
Minimum Order Quantity: 1 Set
Price: Negotiation
Packaging Details: Plywood Box
Delivery Time: 14-30 Workdays
Payment Terms: T/T, L/C
Supply Ability: 1000 Sets/Month

GMP Standard Medical Device Clean Room

Description
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
Highlight:

GMP Standard Medical Device Clean Room

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GMP clean room class for medical devices

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ISO8 Medical Device Clean Room

 

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.

Contact Details
Guangzhou Cleanroom Construction Co., Ltd.

Contact Person: Ms. Sophie

Tel: +8613316272505

Fax: 86-20-84557249

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