ASME-BPE-中英对照.pdf

生物加工设备 GR GR GGRR部分 一般要求 GR-1 简介 INTRODUCTION GR-1 简介 INTRODUCTION GGRR--11 简简介介 IINNTTRROODDUUCCTTIIOONN 此标准所规定的要求，在生物处理﹑制药和个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﹑材料接合和密封等。主要应用于： 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: （a） 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; （b） 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 product, raw materials, or product intermediates during manufacturing, development, or scale-up; (b)systems that are a critical part of product manufacture [e.g., water-for-injection (WFI), clean steam, filtration, and intermediate product storage]. 此标准不能应用于以下部分：不与成品或制造阶段介质部分直接接触的系统（如 计算机系统，电气 导管以及外部系统支撑结构）。 This Standard does not apply to those components of the system that are not in contact with the finished product or are a part of the intermediate manufacturing stages (e.g., computer systems, electrical conduits, and external system support structures). 蒸汽消毒系统通常要满足压力容器设计编码。其他的设备或系统在经过厂家和用户同意下，不需要 遵循这些编码。 Steam sterilized systems normally meet pressure vesseldesign codes. Other equipment or systems as agreed to by the manufacturer and owner/user may not require adherence to these codes. 在压力条件下操作时，系统的设计结构应分别符合ASME锅炉和压力容器编码，第VIII章节，第1部分和 ASME B31.3管道处理编码，用户能对说明和要求另行规定。当法律或强制机构（如市级，省级，州级 或联邦）对此应用程序有明文规定时，最终的设计要求应符合这些法律规定。然而，一些标准虽然不符 合现在BPE标准，以前所提到的构造编码也是满足的（如焊接接受标准，检察要求，压力测试等）。 When operating under pressure conditions, the systems shall be constructed in accordance with the ASME Boiler and Pressure Vessel Code (BPVC),