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随着医药事业的发展,对药品生产质量的要求越来越高。1967年WHO制订的《药品生产质量管理规范》(GMP),对药品的生产环境和空气净化做出了明确的规定。1988年卫生部颁布了《药品生产质量管理规范》,根据我国实际情况提出了药品生产工艺和质量要求对制药环境洁净程度制订较严格规定。几年来,笔者参与了相当数量的医院制剂室、药厂的净化间检测、验收工作,发现净化室设计、安装及管理方面存在着不同程度的缺陷,亟待引起重视,加强科学管理。 1 设计不合理设备不完善 1.1 净化空气处理系统是通过各种过滤器实现对空气中尘埃粒子的处理。但在设计安装时,有的仅采用初效→高效两级过滤,有的尽管安装初→中→高效三级过滤,但初效、中效过滤器拆装非常困难,使用户不能定期拆洗,严重影响了净化效率和高效过滤器的使用寿命。洁净室不能维持正常压力。与不同洁净级别操作间不能保持压差,大大降低了净化效果。
With the development of the pharmaceutical industry, the requirements for the quality of pharmaceutical production have become higher and higher. The GMP formulated by the WHO in 1967 made clear provisions on the production environment and air purification of pharmaceutical products. In 1988, the Ministry of Public Health promulgated the “Standards for the Quality Control of Pharmaceutical Production”. According to China’s actual situation, the pharmaceutical production process and quality requirements have made stricter regulations for the cleanliness of the pharmaceutical environment. Over the past few years, the author has participated in a considerable number of hospital purification rooms, drug purification plant testing, inspection and acceptance work, found that there are different degrees of defects in the design, installation and management of clean room, urgently need attention, and strengthen scientific management. 1 Improperly designed equipment is not perfect 1.1 The purified air treatment system is to treat dust particles in the air through various filters. However, during design and installation, some use only primary efficiency → high-efficiency two-stage filtration, and some of them are initially installed → intermediate → high-efficiency three-stage filtration. However, it is very difficult to dismantle the primary and secondary efficiency filters, so that users cannot dismantle and wash them regularly. Seriously affect the purification efficiency and the life of high-efficiency filters. The clean room cannot maintain normal pressure. The pressure difference cannot be maintained with different clean level operation rooms, which greatly reduces the purifying effect.