Introduction to the level of clean room cleanliness - air filter

Clean room cleanliness level standard 1. ISO-14644 is an international standard. Now the United States, Europe, Japan, Russia and my country all adopt this standard. The United States originally used the United States federal standards 209A, B, C, D, and E. Not anymore. The 100, 1000, 10000 and 100000 grades that we are familiar with are all derived from the US Federal Standard FS 209B, and now they are replaced by the international standard ISO-14644 standard 5, 6, 7 and 8. . The cleanliness class standards of ISO-14644 are listed below. Cleanliness class of suspended particles in clean room and clean air ISO-14644 Air cleanliness class (N) ≥ the maximum concentration limit of particle size in the table (pieces/m3) 0.1μm0.2μm0.3μm0.5μm1μm5μm1102////210024104 //31000237102358/4100002370102035283/51000002370010200352083229610000002370001020003520083202937///3520008320029308///3520000832000293009///352000008320000293000 注：① 每点应至少采样3次。 ② This standard is not applicable to characterize the physical, chemical, radiological and biological properties of suspended particles. ③ According to the process requirements, 1~2 particle sizes can be determined. ④ The maximum allowable concentration of particles according to the required particle size D is determined by the following formula (particle size 0.1μm~5μm)   (pieces/m3)   In the formula, N is the cleanliness level. It can be inserted in the smallest unit increment of 0.1 in the middle of grades 1 to 9. 2. my country's cleanliness grades are divided according to GB 50073-2013 'Code for Design of Clean Workshops', which is basically the same as the ISO-14644 standard, but the grade names of various industries are slightly different. The industries with special requirements are as follows: 1. The pharmaceutical industry has stricter requirements on cleanliness due to its particularity. The requirements of the new version of GMP are as follows: Maximum allowable number of suspended particles in cleanliness level/cubic meter static and dynamic (3)≥0.5μm≥5.0μm (2 )≥0.5μm≥5.0μmA (1) 352020352020 Class B 3520293520002900 Class C 3520002900352000029000 Class D 352000029000 Not specified Not specified (1) To confirm the level of the A-level clean area, the sampling volume of each sampling point shall not be less than 1 cubic meter. The level of airborne particles in Class A clean areas is ISO 4.8, with suspended particles ≥5.0μm as the limit standard. The level of airborne particles in the Class B clean area (static) is ISO 5, and includes the suspended particles of the two particle sizes in the table. For Class C clean areas (static and dynamic), the levels of airborne particles are ISO 7 and ISO 8, respectively. For Class D clean area (static) airborne particles the level is ISO 8. The test method can refer to ISO14644-1. (2) When confirming the level, a portable dust particle counter with a short sampling tube should be used to avoid the sedimentation of suspended particles ≥ 5.0 μm in the long sampling tube of the remote sampling system. In a unidirectional flow system, an isokinetic sampling head should be used. (3) The dynamic test can be carried out during the routine operation and the simulated filling process of the culture medium to prove that the dynamic cleanliness level is achieved, but the simulated filling test of the culture medium requires dynamic testing under the 'worst case' condition. 2. The cleanliness level of the hospital is in accordance with the requirements of GB 50333-2013 'Technical Specifications for the Construction of Hospital Clean Operating Departments', the cleanliness level is consistent with the ISO-14644 standard, and there are also requirements for the level of clean rooms: 3. The food industry is in accordance with GB 50687 - Requirements of 2011 'Technical Specification for Food Industry Clean Room Construction'.

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