ASME-BPE-中英对照

AMSE BPE Bioprocessing Equipment

生物加工设备

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),Section VIII, Division1,and the ASME B31.3,Process Piping Code,respectively.The owner/user can stipulate additional specifications and requirements.When an application is covered by laws or regulations issued by an Enforcement Authority(e.g.,municipal,provincial, state,or federal),the final construction requirements shall comply with these laws. However,all the previously mentioned construction codes shall be satisfied including

those instances where these codes are not referred to in the current BPE Standard(e.g., weld acceptance criteria,inspection requirements,pressure testing,etc.).

GR-2范围SCOPE

生物处理﹑制药﹑私人保健品行业的要求标准和其它相关的卫生高等级要求一样，覆盖物直接或间接的影响原料﹑设计﹑构造﹑压力系统（容器和管路）﹑检查﹑审核﹑测试和证明。此标准中没有明确规定的条款和要求并不意味着禁用，工程判断一定要符合此标准的基本原理准则，不能忽略强制规定规则或此标准明确的禁用条款。

This Standard deals with the requirements of the bioprocessing,pharmaceutical,and personal care product industries as well as other applications with relatively high levels of hygienic requirements,covering directly or indirectly the subjects of materials,design, fabrication,pressure systems(vessels and piping),examinations,inspections,testing, and certifications.Items or requirements that are not specifically addressed in this Standard cannot be considered prohibited.Engineering judgments must be consistent with the fundamental principles of this Standard.Such judgments shall not be used to overrride mandatory regulations or specific prohibitions of this Standard.

GR-3检查INSPECTION

此标准的每一部分都有详细的检查要求。如果需要一个检查程序，在经过用户﹑订约人﹑检查订约人和工程师同意后要保证系统和部件满足此标准。

The inspection requirements are specified in each Part of this Standard.If an inspection or examination plan is required,it shall be developed and agreed to by the owner/user,contractor,inspection contractor,and/or engineer ensuring that the systems and components meet this Standard.

GR-4检验员/检查员INSPECTOR/EXAMINER

检验人员和试验人员在此标准应满足以下条件：

Inspector and examiner in this Standard shall be defined for:

（a）压力容器，取得认证的检验人员应满足ASME BPVCⅧ，第一部分，UG-91。

（b）管道系统，管材和非标准容器，用户的检验员应遵照ASME B31.3，340.4（a）。

（c）管道系统和管材，试验员，作为生产厂家的员工进行质量控制试验要按照ASME B30.3，341.1（a）要求。

(a)Pressure Vessels.An Authorized Inspector,as defined in ASME BPVC,Section VIII,Division1,para.UG-91;

(b)Piping,Tubing,and Non-Code Vessels.An owner/user’s inspector,as defined in ASME B31.3,para.340.4(a);and

(c)Piping and Tubing.An examiner,defined as a person who performs quality control examinations for a manufacturer as an employee of the manufacturer as defined in ASME B31.3,para.341.1.

当地方法规要求压力设备的设计和建造依据其他标准而非ASME规范时，则此标准的检验人员应为相关权威认可的合格人员。

When local regulations require that pressure equipment be designed and constructed in accordance with standards other than ASME codes/standards,the inspector in this Standard is defined as one who is acceptable to the relevant regulatory authority.

GR-5责任RESPONSIBILITIES

检查人员的职责包括以下部分：

The responsibilities of inspection personnel are defined as follows.