What does 10,000-level clean workshop mean, and what is the standard of 10,000-level clean workshop

What does 10,000-level clean pharmaceutical cleanroom mean? It refers to the air cleanliness level divided according to the number of particles suspended in the air within its clean range; The number of particles is less than 350,000, but the number of particles with a diameter greater than or equal to 5 μm should be less than 2,000; the requirements for 'thousand-level' and 'hundred-level' are higher, that is, after purification, the number of remaining particles is allowed to be less. What are the testing standards for a class 10,000 clean room? What are the standards for a class 10,000 clean room? Countries all over the world have their own specifications, but generally according to the standards promulgated by the federal government of the United States, clean rooms can be divided into six classes. Level 1, Level 10, Level 100, Level 1000,
Class 10000, Class 100000, if the class of the clean room is only described by the number of dust particles, the size of the dust particles can be assumed to be 0.5 μm, for example, Class 1, Class 10, Class 100
The maximum number of dust particles in a class clean room is less than or equal to 1, 10, and 100 particles, respectively. If the size of the dust particles is not 0.5 μm, the clean room class should be expressed as a series of a specific particle size. Example: 10
Class 0.2 μm (dust particle size of 0.2 μm or greater, density not greater than 75 particles/cubic foot), Class 1 at 0.1 μm (dust particle size of 0.1 μm
or greater, with a density of no more than 35 grains/cubic foot). 1. The standard of the 10,000-level clean room (defined by the number of dust particles and the number of microorganisms): 1. The allowable number of dust particles (per cubic meter): the number of particles greater than or equal to 0.5 microns shall not exceed 350,000; greater than or equal to 5 The number of micron particles should not exceed 2000. 2. The allowable number of microorganisms: the number of planktonic bacteria shall not exceed 100 per cubic meter; the number of settled bacteria shall not exceed 3 per petri dish. 2. The main testing standards for class 10,000 clean rooms include: 1. Air velocity and its uniformity testing. This test is the premise of other tests of the clean room effect. The purpose of this test is to determine the average airflow and uniformity of the one-way flow clean room work area. 2. Air volume detection of the system or room. 3. Inspection of indoor cleanliness. The detection of cleanliness is to determine the level of air cleanliness that can be achieved in a clean environment, and a particle counter can be used to detect it. 4. Detection of self-cleaning time. By determining the self-cleaning time, the ability to restore the original cleanliness of the pharma clean room when contamination occurs inside the pharma clean room is identified. 5. Air flow pattern detection. 6. Noise detection. 7. Illumination detection. The purpose of illumination detection is to determine the illumination level and illumination uniformity of the clean room. 8. Vibration detection. The purpose of vibration detection is to determine the vibration amplitude of each indication of the clean room. 9. Detection of temperature and humidity. The purpose of temperature and humidity detection is the ability to adjust temperature and humidity within a certain limit. Its contents include detecting the supply air temperature of the clean room, detecting the air temperature of a representative measuring point, detecting the air temperature at the center point of the clean room, detecting the air degree at the sensitive element, detecting the relative temperature of the indoor air, and detecting the return air temperature. . 10. Detection of total air volume and fresh air volume. 3. The channel high-precision handheld laser dust particle counter is designed according to the international standard ISO14644-1 and GMP, and there are Chinese and English versions to choose from. It can be widely used in clean room environment testing, indoor environment testing, filter efficiency analysis and testing, pollution source inspection, particle size distribution analysis, etc. in the electronics and pharmaceutical industries. Consultation number Add WeChat Same as above mobile phone or scan the QR code below
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