ASME BPE 中英对照.doc

生物加工设备 GR部分 一般要求 GR-1 简介 INTRODUCTION 此标准所规定的要求，在生物处理﹑制药和人保健品行业设备的设计非常实用所涉及方面包括灭菌﹑清洁﹑材质﹑尺寸﹑公差﹑表面抛光﹑料接和密封等。应用于： This Standard provides the requirements applicable to the design of equipment used in the bioprocessing, pharmaceutical, and personal care product industries, including aspects related to sterility and cleanability, materials, dimensions and tolerances, surface finish, material joining, and seals. These apply to: 在制造﹑改进和提高过程中与产品﹑原料﹑产品介质直接接触的关键部件; 产品制造中主要部件系统（如WFI，清洁蒸汽，过滤和半成品贮存等）(a) components that are in contact with the