Two key elements of a capital-intensive manufacturing process: 1. High-tech products 2. A controlled environment 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. Zhejiang Sujing Purification Equipment Co., Ltd., located in Daoshui Town, Shangyu District, Shaoxing City, Zhejiang Province, is an excellent manufacturer in the purification equipment industry in East China. Can provide professional air purification systems for industries such as microelectronics, biomedicine, hospital operating rooms, fiber optic cables, food and beverages, precision instruments, semiconductors, and new material applications in accordance with ISO14644-1, GB50073-2001 national standards, and national GMP regulations. Engineering design, construction, testing and technical services. Roller Label,Pvc Label Sticker,Waterproof Label,Crystal Label Guangzhou Mingyin Packaging Trading Co.,Ltd. , https://www.mingyinpackage.com
Therefore, cleanliness is a crucial issue, and the process must be clean. Otherwise, the cost will be severely lost.
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Clean room level overview