Views: 0 Author: Site Editor Publish Time: 2021-11-26 Origin: Site
In 1963, the United States had a clean room federal standard Fed STD 209. In 209 standards, the clean room is divided into several levels per cubic feet in the environment, such as level 100, 10,000, 100,000. China's past cleansing room standards are also graded in this way. In 1999, the International Standardization ISO promulgated clean room international standard ISO14644-1 \"clean room and controlled clean environment, primary part: air cleanliness classification\".
In 1999, the International Standardization ISO promulgated clean room international standard ISO14644-1 \"clean room and controlled clean environment, primary part: air cleanliness classification\". The ISO specified in the cleanliness level and the specific numerical value of traditional grading are shown in the table below.
|ISO14644||Concentration limit (number of particles / M3)||Approximate|
|ISO level 1||10||2|
|ISO level 2||100||24||10||4|
|ISO level 3||1,000||237||102||35||8||Level 1|
|ISO level 4||10,000||2,370||1,020||352||83||Level 10|
|ISO level 5||100,000||23,700||10,200||3,520||832||29||Level 100|
|ISO 6 level||1,000,000||237,000||102,000||35,200||8,320||293||Level 1,000|
|ISO 7 level||352,000||83,200||2,930||10,000|
|ISO level 9||35,200,000||8,320,000||293,000|
The above indicators are expressed by formulas:
CN = 10N3 (0.1 / d) 2.08
Where: CN = Variety per cubic meter allows for a number of particle size particles;
N = ISO cleanliness division number;
D = Particle size, unit is micron;
0.1 = constant, the unit is micron.
The ISO grading was adopted in the new revised draft of China's clean room. However, people have been used to \"百 \ \", \"10,000 level \", it is obvious, easy to book, people may take the old, until the new generation designers don't remember the old classification And British Metrology Unit.
Safe, cleanliness, should correspond to the status of clean room: empty state (new, empty room), static (equipment in place, no person), dynamic (normal work). Specific project said that \"clean degree \" refers to which state, and is determined by the user and design, supply, etc. agreement and clearly. Forgot to make regulations in the state, everyone will have a empty drill.
Attached: cleanliness of GMP
|Clean level||Dust number||Microorganism allows||Equivalent|
|≥0.5mm||≥5mm||Floating bacteria / M3||Substate / dish||ISO grading|
|Level 100||3,500||0||5||1||ISO level 5|
|10,000||350,000||2,000||100||3||ISO 7 level|
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