多效蒸馏水机与WFI.pdfVIP

多效蒸馏水机及WFI 纯蒸汽发生器及多效蒸馏水机 内 容 • GMP对设备的原则要求 • 几个基本概念 • 纯蒸汽发生器 – 带冷凝器的纯蒸汽发生器 – 取样器 • 多效蒸馏水机 – 原理 – 分离手段 – 建造性能及特点 211.63 Equipment design, size, and location • 211.63 Equipment • 211.63 设备的设计、尺 design, size, and location. 寸和布置 • Equipment used in the manufacture, processing, packing, or holding of a • 用于药品生产、加工、 drug product shall be of 包装或贮存的设备应有 appropriate design, adequate size, and 适当的设计，适当的尺 suitably located to 寸/规格，其安装位置应 facilitate operations for 便于实际操作，并便于 its intended use and for 清洁和维护。 its cleaning and maintenance. 211.65 Equipment construction • (a) Equipment shall be a) 设备的建造要求：与原辅 constructed so that surfaces 料、中间物料或药品接触 that contact components, in- process materials, or drug 的表面，应无反应活性， products shall not be 无脱落或吸附性能，以致 reactive, additive, or 不会改变药品的安全性、 absorptive so as to alter the safety, identity, strength, 鉴别特征、含量（浓度/ quality, or purity of the 剂量/效价）、质量，或 drug product beyond the 纯度而使之不超出法定或 official or other established 其它规定的技术要求。 requirements. 211.65 设备的建造 • (b) Any substances required b) 生产用物品要求：如润滑 for operation, such as 剂或冷却剂，都不得与组 lubricants or coolants, shall not come into contact with 份、药品容器、密封件、 components, drug product 中间物料、或药品接触， containers, closures, in- process materials, or drug 以不改变药品的安