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  • 百級千級萬級實驗室是如何進行劃分的?

    來源:http://www.cyslhb.com/ 發布時間:2023-11-13
    潔凈室需要將一定范圍內空氣中的微粒子、有害空氣、細菌等之污染物排除,并將無塵室內溫度、潔凈度、室內壓力、氣流速度與氣流分布、噪音振動及照明、靜電控制在某一需求范圍內,通常根據實驗室空氣中的顆粒數量,對潔凈室進行分類。
    A clean room needs to remove pollutants such as particles, harmful air, and bacteria from the air within a certain range, and control the temperature, cleanliness, indoor pressure, airflow speed and distribution, noise, vibration, lighting, and static electricity in a dust-free room within a certain range of requirements. Typically, a clean room is classified based on the number of particles in the laboratory air.
    其中需要注意的,A、B、C、D級別的劃分是參照ISO標準(歐盟采納的方式),其本身包含了靜態要求和動態要求。舊版GMP采納的是美國的潔凈間劃分方式,舊版的潔凈間劃分僅有靜態的概念,不要求動態。
    It should be noted that the classification of levels A, B, C, and D is based on ISO standards (adopted by the European Union), which themselves include static and dynamic requirements. The old version of GMP adopted the clean room classification method in the United States, which only had a static concept and did not require dynamic classification.
    凈室按空氣清潔程度分類,如果無塵室的等級只用塵粒數目來敘述,則可假設塵粒的尺寸為0.5μm,例如,1級、10級、100級無塵室大塵埃粒子數目分別小于或等于1顆、10顆、100顆。如果塵粒尺寸不是0.5μm,無塵室等級應以在一特定塵粒尺寸的級數來表示,分別分為1級、10級、100級、1000級、10000級、100000級,數值越小,凈化級別就越高,潔凈度越高造價就越高。
    Clean rooms are classified according to the degree of air cleanliness. If the level of a clean room is described only by the number of dust particles, it can be assumed that the size of the dust particles is 0.5 μ m. For example, the number of large dust particles in level 1, level 10, and level 100 clean rooms is less than or equal to 1, 10, and 100, respectively. If the dust particle size is not 0.5 μ m. The level of a clean room should be represented by the number of levels in a specific dust particle size, which are divided into levels 1, 10, 100, 1000, 10000, and 100000. The smaller the value, the higher the purification level, and the higher the cleanliness, the higher the cost.
    微生物實驗室凈化裝修
    各行業對潔凈度等級的要求
    Requirements for cleanliness levels in various industries
    各行業對潔凈室的凈化要求也有所不同:
    The purification requirements for clean rooms vary among industries:
    1級:主要用于制造集成電路的微電子工業,對集成電路的精確要求為亞微米。
    Level 1: Mainly used in the microelectronics industry for manufacturing integrated circuits, with a precision requirement of submicron for integrated circuits.
    10級:主要用于帶寬小于2微米的半導體工業。
    Level 10: Mainly used in semiconductor industries with bandwidth less than 2 microns.
    100級:可用于醫藥工業的無菌制造工藝等。
    Level 100: Suitable for sterile manufacturing processes in the pharmaceutical industry.
    1000級:主要用于高質量光學產品的生產,還用于測試,裝配飛機蛇螺儀,裝配高質微型軸承等。
    Class 1000: mainly used for the production of high-quality optical products, as well as for testing, assembling aircraft snails, and assembling high-quality micro bearings.
    10000級:主要用于液壓設備或氣壓設備的裝配,某些情況下也用于食品飲料工業,此外,萬級潔凈室在醫工業中也很常用。
    Class 10000: mainly used for the assembly of hydraulic or pneumatic equipment, and in some cases also used in the food and beverage industry. In addition, Class 10000 clean rooms are also commonly used in the medical industry.
    100000級:十萬級潔凈室用于很多的工業部門,比如光學產品的制造,用于較小的元器件制造大型的電子系統,液壓或氣壓系統的制造,食品飲料的生產,醫、藥工業也常常使用。
    Class 100000: Class 100000 clean rooms are used in many industrial sectors, such as the manufacturing of optical products, the manufacturing of small components, large electronic systems, hydraulic or pneumatic systems, food and beverage production, and the medical and pharmaceutical industries.
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