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1.建筑设施 用于分离血浆的建筑设施,应具备特定的规模和结构,其位置应设立在便于生产操作、清洁和按照卫生通则进行保养的场所。它们应符合修订的第1号生物制品规程(生产单位和检定实验室的基本要求)。另外,还应提供充足的空间、光线以及为下列工作所需的通风系统。
1. Building Facilities The building facilities used to separate plasma should be of a specific size and structure and should be located in a location convenient for production operations, cleaning and maintenance according to general hygiene practices. They should comply with the revised Biological Protocol No. 1 (Basic Requirements for Production Units and Verification Laboratories). In addition, adequate space, light and ventilation systems are required for the following tasks.