How much do you know about clean rooms, dust-free workshop (clean room) grade description
- 2023-10-23
- 1016
- Esky Purify
I. Preface
& & amp;nbsp; The development of clean room is closely linked with modern industry and cutting-edge technology. Currently in the biopharmaceutical, medical and health, food and chemicals, electronics and optics, energy, precision instruments and other industries has been quite common and mature.
Air cleanliness class (air cleanliness class): clean space unit volume of air, greater than or equal to the maximum concentration limit of particles to be considered particle size of the classification of the level of standards. Domestic testing and acceptance of the clean room by air state, static state, dynamic, in line with the "GB50073-2013 Clean Plant Design Specification", "GB50591-2010 Clean Room Construction and Acceptance Specification".
Cleanliness and control of the continuous stability of pollution, is the test of the quality of the clean room of the core standards, the standard according to the regional environment, the degree of cleanliness and other factors, divided into a number of levels, commonly used international standards and domestic regional industry standards.
< strong> ISO14644-1 International Standard - Classification of air cleanliness
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& amp;nbsp; GB50073-2013 National Standard-Air Cleanliness Classification
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& nbsp; A 500 strong drinking water factory in China's clean plant clean plant process layout in strict accordance with the requirements of the production process, respectively, set up personnel and materials in and out of the production area of the channel, each person entering the plant must be through the air air showers, forced to blow off the staff and their clothes on the adhering dust particles. The elevator for conveying personnel and materials is also fully separated, and the material conveying elevator is set up outside the clean area to ensure the cleanliness of the air in the clean area. The materials which are very easy to cause pollution (such as some raw and auxiliary materials, production waste materials, etc.) are set up with special entrances and exits. The arrangement is reasonable and compact, which is favorable to the production operation and can ensure the effective management of the production process and prevent the mixing and cross-pollution between human flow and logistics. Personnel purification part of the indoor establishment, including rain gear storage room, changing shoes room, storage of outerwear room, changing clean work clothes room, air shower room, etc., personnel purification room and living room is arranged on the same floor.
China GMP (2010 Revision) New GMP Appendix 1 Sterile Drugs. Chapter III. Article 9 ...... clean area standards for airborne particles at all levels are specified as follows
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First, the model of the level definition is as follows:
< p>Class X (at Y μm )Class X (at Y μm )
Where X is the class of the clean room, such as 100 or 10000, etc., and Y is the particle size such as 0.2 μm , 0.5 μm, etc., which can be re-selected. Meaning that the user specifies that the clean room particulate content, in these particle sizes must meet the limits of the grade. This reduces strife, here are a few examples:
Class1 (0.1μm, 0.2μm , 0.5μm)
Class 100 (0.2μm , 0.5μm )
Class 100 (0.2μm , 0.5μm )
Class 100 (0.1μm, 0.2μm , 0.5μm )
In Classes 100 (M3.5) and Greater (Class 100, 1000, 10000....) , it is generally sufficient to look at one particle size. In Classes Less than 100 (M3.5) (Class 10, 1.... ), it is generally sufficient to look at a few more grain sizes.
The second trick is to specify the state of the clean room, e.g.
The supplier knows very well that the clean room is to be accepted in the At-rest state of acceptance.
The third technique is to customize the upper limit of particle concentration, generally in the As-built clean room are very clean, particle control ability to test is not easy, then you can simply accept the upper limit of the pressure down, for example:
Class 10000 (0.3 μm <= 10000), As-built
Class 10000 (0.5 μm <= 1000), As-built
The purpose of doing this is to ensure that the clean room in the Operational state when the still has adequate particle control.
1, yellow light workshop more built in the hundred-level clean area, thousand-level clean area is also involved
2, semiconductor clean room (raised floor) is often used in the area of the hundred and thousand levels
3, conventional semiconductor clean room (clean area: class 10,000 to 100,000)
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