ASME_BPE_中英对照

ASME_BPE_中英对照

生物加工设备 GR 部分 一般要求 GR-1 简介 INTRODUCTION INTRODUCTION INTRODUCTION INTRODUCTION 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.