Two key elements of a capital-intensive manufacturing process: 1. High-tech products 2. A controlled environment
Therefore, cleanliness is a crucial issue, and the process must be clean. Otherwise, the cost will be severely lost.
Cleanrooms and other controlled environments usually use the dust content in the air as a basis for ratings.
Activities in the cleanroom are controlled, such as the degree of cleanliness of the air, the entry and exit of personnel, the clothes and activities of the operators, and the pollution caused by the manufacturing process, tools and materials.
The more critical the processing process is, the more it needs a clean environment.
Comparison of cleanroom standards:
ISO International Standard: Dust Particles/Cubic Air
FS209D US Federal Standard: Dust Particles/cubic foot air
GMP Pharmaceutical manufacturing standards: refer to the above two, converted to the corresponding A/B/C/D rating
Specific details are as follows:
ISO14644---->
Level 3 is 35.2 particles per cubic meter of air with a particle size greater than 0.5 microns.
Level 4 is no more than 352,
Level 5 is no more than 3520,
So on and so forth...
FS209D ---->
Grade 1 has no more than one particle per cubic foot of air with a particle size greater than 0.5 microns.
Level 10 is no more than 10,
100 is not more than 100,
So on and so forth...
GMP ---->
Level A is equivalent to level 100 of ISO5/FS209D.
Class B is equivalent to Class 1000 of ISO6/FS209D.
Class C is equivalent to class 10000 of ISO7/FS209D.
So on and so forth...
The pollutants in the clean room are: dust particles, fibers, residues, biological contaminants;
Mainly comes from three ways: people, production process, tools and materials;
It is worth noting that in the clean room environment, people are the biggest source of pollution.
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