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asme bpe 中英文对照
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更新于2023-03-16
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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:
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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,
Division 1, 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 BPVC Ⅷ,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, Division 1, 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.
GR-5.1 压力容器 Pressure Vessels
用户检查员职责按照 ASME BPVC, VIII 章节,第 1 部分,UG-91 规定。
The responsibilities of the owner’s Inspector shall be the same as the inspector in
ASME BPVC, Section VIII, Division 1, UG-91.
GR-5.2 管道,管子件和非标准容器 Piping, Tubing, and Noncode Vessels
用户检查员职责按照 ASME B31.3 340.2 部分的规定。
The responsibilities of the owner/user’s inspector shall be in accordance with ASME
B31.3, para. 340.2.
GR-6 检验用人孔 ACCESS FOR INSPECTORS
生物处理设备和部件厂商应允许在设备和部件运作时,用户和授权人员自由进入,紧急检查通知
应经过厂家和检查人员的互相同意。厂家设备的组装﹑制造﹑焊接和特殊设备和部件的操作地点不允
许进入。检查员有权对任何检查审核,能使用规定在设计说明(包括订购单)中的任何检查方法检查
部件,能核实为满足 GR-5 要求的所有必要档案和证书。厂家应把工作程序更新材料提供给检察员。
Manufacturers of bioprocessing equipment and components shall allow free access of
owner/user and authorized inspection personnel at all times while work on the
equipment or components is being performed. The notification of an impending
inspection should be mutually agreed to by the manufacturer and the inspector. Access
may be limited to the area of the manufacturer’s facility where assembly, fabrication,
welding, and testing of the specific equipment or components is being performed.
Inspectors shall have the right to audit any examination, to inspect components using
any examination method specified in the Design Specification (including Purchase
Order), and review all certifications and records necessary to satisfy the requirements of
GR-5. The manufacturer shall provide the inspector with work progress updates.
GR-7 厂家的质量保证程序 MANUFACTURER’S QUALITY ASSURANCE PROGRAM
厂家将执行质量保证程序,对用于控制原料﹑制图﹑说明﹑制造﹑装配技术以及生物处理设备检
查的系统﹑方法和程序进行描述。
The manufacturer shall implement a quality assurance program describing the
systems, methods, and procedures used to control materials, drawings, specifications,
fabrication, assembly techniques, and examination/ inspection used in the
manufacturing of bioprocessing equipment.
GR-8 公制单位 METRIC
此标准的公制单位是从 U.S.惯用单位变换而来,如无特殊要求,仅供参考。
Metric units in this Standard are conversions from U.S. Customary units, and are for
reference purposes only unless specified otherwise.
GR-10 术语及解释 TERMS AND DEFINITIONS
退火: 是钢处理过程中为降低硬度,提高机械加工性,促进冷加工或生产出理想的机械﹑物理以及其
他性能的处理过程。
annealing: a treatment process for steel for the purpose of reducing hardness,
improving machinability, facilitating cold working, or producing a desired mechanical,
physical, or other property
不规则性:比起周围地方,局部表面积不符合 说明,此时被定义为反常的,即不规则性 。
anomaly: a localized surface area that is out of specifications to the surrounding area,
and is classified as abnormal.
起弧:由任何的局部再融化金属,受热金属的间断组成及由弧产生的焊接或贱金属部分的表面轮廓的
变化,在焊接或贱金属表面间经过的地方发生。例如焊接电极, 磁性粒子或电解抛光电极。
arc strike: a discontinuity consisting of any localized remelted metal, heat-affected
metal, or change in the surface profile of any part of a weld or base metal resulting from
an arc, generated by the passage of electrical current between the surface of the weld
or base material and a current source, such as a welding electrode,magnetic particle
prod, or electropolishing electrode.
无菌:无病原(能导致疾病的)微生物。
aseptic: free of pathogenic (causing or capable of causing disease) microorganisms.
无菌处理:能防止污染物过程中的操作形式。
aseptic processing: operating in a manner that prevents contamination of the process.
自生焊接:在不增加填充物的情况下,通过对底部材料熔化进行的焊接(参考气体钨-电弧焊)。
autogenous weld: aweld made by fusion of the base material without the addition of
filler. (See also gas tungstenarc welding.)
自动焊接:在无需焊接员控制调节下进行的焊接操作,设备不用进行装卸工作(参考机械焊接)。
automatic welding: welding with equipment that performs the welding operation
without adjustment of the controls by a welding operator. The equipment may or may
not perform the loading and unloading of the work. (See also machine welding.)
生物制剂:对自然资源净化而产生的诊断及治疗产品。
biologics: therapeutic or diagnostic products generated and purified from natural
sources.
生物制药:经过生物处理后形成的药物。
biopharmaceuticals: ethical pharmaceutical drugs derived through bioprocessing
生物处理:利用活生物体生产产品。
bioprocessing: the creation of a product utilizing a living organism.
生物处理设备:利用活生物体生产产品所使用的设备﹑系统或器具。
bioprocessing equipment: equipment, systems, or facilities used in the creation of
products utilizing living organisms.
盲目焊接:所设计的焊接点不可行。
blind weld (or closure weld): a weld joint by design that cannot feasibly be visually
inspected internally.
管道镜:间接查看设备,安装在很难进入位置如设备和管。
borescope: a device for indirect visual inspection of difficult access locations such as
equipment and pipes.
断开:面对配件的中断。
break: a discontinuity in the face of a fitting.
烧焦:熔化过度或焊缝处出现小洞。
burn-through: excessive melt-through or a hole through the root bead of a weld.
毛刺:在切割或饰边操作中出现的过多边缘物质。
burr: excess material protruding from the edge typically resulting from operations such
as cutting or facing.
对焊接头:处在同一平面上两部分之间的接合处。
butt joint: a joint between two members lying approximately in the same plane.
气穴现象:在液体流动条件下,经过液体蒸发,产生蒸发泡沫,致使产品表面受损。
cavitation: a condition of liquid flow where, after vaporization of the liquid, the
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