Guangzhou Cleanroom Construction Co., Ltd.
GCC : You All-in-one Cleanroom Construction and Solutions Partner
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There are three categories of medical devices. Masks belong to the second class of medical devices. Whether they are medical cup-type protective masks or disposable medical masks, their production environment must be at a cleanliness level of 100,000 (GMP specification: Class D clean workshop) The above dust-free workshops carry out production. This is a national compulsory requirement. The production environment must be dust-free and sterile. Masks with special requirements must be produced under the specified constant temperature and humidity range.
Medical masks from the raw materials workshop to the final molding inner packaging workshop, all functions of the production line are required to be dust-free and sterile. The layout of the medical masks cleanroom should be reasonable, and the process flow should be smooth, the front and back processes should be connected smoothly, and the transportation distance should be short and straight to avoid the risk of contamination caused by detours and round-trip transportation.
Level Of Airborne Particulate Cleanliness In Prefab Cleanroom
| FED STD 209E | ||||||
| Level | >=0.1um | >=0.2um | >=0.3um | >=0.5um | >=5um | Equivalent |
| 1 | 35 | 7 | 3 | 1 | ISO3 | |
| 10 | 350 | 75 | 30 | 10 | ISO4 | |
| 100 | 100 | ISO5 | ||||
| 1000 | 1000 | 7 | ISO6 | |||
| 10000 | 10000 | 70 | ISO7 | |||
| 100000 | 100000 | 700 | ISO8 | |||
| ISO 14644-1 Cleanroom Standards | |||||||
| Level | >=0.1um | >=0.2um | >=0.3um | >=0.5um | >=1um | >=5um | Equivalent |
| ISO1 | 10 | 2 | |||||
| ISO2 | 100 | 24 | 10 | 4 | |||
| ISO3 | 1000 | 237 | 102 | 35 | 8 | 1 | |
| ISO4 | 10000 | 2370 | 1020 | 352 | 83 | 10 | |
| ISO5 | 100000 | 23700 | 10200 | 3520 | 832 | 29 | 100 |
| ISO6 | 1000000 | 237000 | 102000 | 35200 | 8320 | 293 | 1000 |
| ISO7 | 352000 | 83200 | 2930 | 10000 | |||
| ISO8 | 3520000 | 832000 | 29300 | 100000 | |||
| ISO9 | 35200000 | 8320000 | 293000 | Room Air | |||
Why Choose US
We are cleanroom designer and manufacturer, and we have a R&D department,and have our own factory. Also we have some long-time cooperated suppliers. For the whole dust free project, from design until the dust free plant installation,we will do one-stop service for you,and we will keep one year after sales service for your cleanroom project. Otherwise, all equipment for cleanroom we are provide for you,cleanroom booth, cleanroom air shower, cleanroom pass box, fan filter unit(FFU), clean bench, weighing booth ect.
How To Get A Prompt Reply
Please provide these information with your quotation:
1. Whether have layout plan, if yes, please send it to us.
2. How many people work in this medical masks cleanroom ?
3. What kind of voltage and socket in you need ?