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我厂是一家国有中型医药企业,浙江省医药行业重点骨干企业,年产值近10亿元。主要生产头孢类抗生素等多种原料药产品,而其中β-内酰胺类头孢原料药就需要使用氮气作为气动输送源来压料。在无菌原料药生产企业中,由于生产工艺的需要,在生产中要用到压缩空气和氮气。由于某些工序氮气与药品直接接触,GMP规定:与药品直接接触的空气、压缩空气和惰性气体应经净化处理,符合生产要求。目前无菌原料药车间所用的氮气主要由三种方式提供: 1、钢瓶氮气供气 2、液氮气化供气 3、变压吸附式碳分子筛制氮机供气在这三种供气方式中,变压吸附式碳分子
Our factory is a state-owned medium-sized pharmaceutical enterprises, key pharmaceutical enterprises in Zhejiang Province, the annual output value of nearly 1 billion yuan. Main production of cephalosporin antibiotics and other raw material medicine products, and which β-lactam cephalosporin bulk drugs need to use nitrogen as a pneumatic conveying source to pressure material. In the sterile API manufacturers, due to the needs of the production process, the use of compressed air and nitrogen in the production. Due to the direct contact between certain processes and medicines, GMP stipulates that the air, compressed air and inert gas that are in direct contact with the medicine should be purified to meet the production requirements. At present, the nitrogen used in the aseptic API workshop is mainly provided by three ways: 1, cylinder nitrogen supply 2, liquid nitrogen gasification supply 3, PSA carbon nitrogen supply nitrogen machine gas supply in these three kinds of gas supply , Pressure swing adsorption carbon molecules