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医药工业生产过程中,由于产品质量的需要,对生产厂房的建筑设计有一定的特殊要求,主要是无菌要求。在生产中,采用无菌空气调节系统等一系列技术措施,使空气中的尘埃及菌落数控制在允许的范围之内,这样的生产空间,称为无菌洁净室。在菌种的接种、培养、检验方面,在抗菌素、生物制品生产以及各种原料药的分装过程中,无菌室的应用是很广泛的。无菌室应具备以下几项条件:
In the pharmaceutical industry production process, due to the need for product quality, there are certain special requirements for the architectural design of the production plant, mainly aseptic requirements. In production, a series of technical measures such as a sterile air-conditioning system are used to control the number of airborne dust and bacteria within the allowable range. Such a production space is called an aseptic clean room. In the inoculation, cultivation and inspection of strains, the application of sterile chambers is very extensive in the production of antibiotics, biological products, and the dispensing of various raw materials. The sterile room should have the following conditions: