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 ，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 owners 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/users 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 manufacturers 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 MANUFACTURERS 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 subsequent collapse of vapor bubbles can produce surface damage.证明：由权威机构出示的对系统的确认验证校准或二次确认的证书。certification: documented testimony by qualified authorities that a system qualification, calibration, validation, or revalidation has been performed appropriately and that the results are acceptable.CGMP:美国FDA现行的GMP标准，表示此GMP会随时进行改进的。cGMPs: current Good Manufacturing Practices. Current design and operating practices developed by the pharmaceutical industry to meet FDA requirements as published in the Code of Federal Regulations, Chapter 1, Title 21, Parts 210 and 211.清洁：没有污物，残留物，洗涤剂，或任何污染物，以免于影响或掺入产品或工艺中。clean: free of dirt, residues, detergents, or any contaminants that may affect or adulterate the product or process.在位清洗：clean-in-place (CIP): internally cleaning a piece of equipment without relocation or disassembly. The equipment is cleaned but not necessarily sterilized. The cleaning isnormally done by acid, caustic, or a combination of both, with Water-for-Injection (WFI) rinse.清洁蒸汽：clean steam: steam free from boiler additives that may be purified, filtered, or separated. Usually used for incidental heating in pharmaceutical applications.暗晦：cloudiness: the appearance of a milky white hue across some portion of a surface resulting from the electropolish process.药典水：compendial water: proported to comply with USP and/ or any other acknowledged body of work related to the quality, manufacture, or distribution of high purity water.压缩形变：经过长时间的压缩，橡胶能保持持久变形，在ASTMD 395中有详细描述。compression set: permanent deformation of rubber after subscription in compression for a period of time, as typically determined by ASTM D 395.凹度：concavity: a condition in which the surface of a welded joint is depressed relative to the surface of the tube or pipe. Concavity is measured as a maximum distance from the outside or inside diameter surface of a welded joint along a line perpendicular to a line joining the weld toes.自耗嵌块：在焊接过程中，开启氧炔焊设备，把一金属环放在两焊接元件间充当的填充物。自耗焊块还能用于根部焊道和外加装配电线的多重焊道焊接。（也叫插入环）consumable insert: a ring of metal placed between the two elements to be welded that provides filler for the weld, when performed with fusion welding equipment. A consumable insert can also be used for the root pass in a multiple pass weld with the addition of filler wire (also called insert ring).凸面：convexity: a condition in which the surface of a welded joint is extended relative to the surface of the tube or pipe. Convexity is measured as a maximum distance from the outside or inside diameter surface of a welded joint along a line perpendicular to a line joining theweld toes.裂纹：cracks: fracture-type discontinuities characterized by a sharp tip and high ratio of length and width to opening displacement. A crack may not be detected with a stylus. A linear crack will produce a liquid penetrant indication during liquid penetration inspection, X-ray, or ultrasound火口：焊珠终止时的缺陷。crater: a depression at the termination of a weld bead.火口裂纹：在火口，末端和焊珠中形成的焊缝。crater cracks: cracks that form in the crater, or end, of the weld bead.蠕变：在压力低于屈服点下产生的由时间决定的持久变形。creep: a time-dependent permanent deformation that occurs under stress levels below the yield stress.死角：当管路或容器使用时能导致产品污染的区域。dead leg: an area of entrapment in a vessel or piping run that could lead to contamination of the product.缺陷：defects: discontinuities that by nature or accumulated effect (for example, total crack length) render a part or product unable to meet minimum applicable acceptablestandards or specifications. This term designates rejectability. (See also discontinuity.)去离子水：deionized water: a grade of purified water produced by the exchange of cations for hydrogen ions and anions for hydroxyl ions.分层：对成分层进行分离。delamination: separation into constituent layers.划分：局部部分与周围明确划分部分不同。demarcation: a localized area that is dissimilar to the surrounding areas with a defined boundary.凹痕：较大，底部光滑凹陷，直径或宽度比深度大，不会产生迹象。dent: a large, smooth-bottomed depression whose diameter or width is greater than its depth and which will not produce an indication.弄脏：表示污染条件的相对内容。dirty: a relative term indicating the condition of being contaminated.变色：原材料的任何表面颜色变化，通常是由于在焊接点内外直径的焊接和加热过程中，被氧化所致。颜色的变化范围从蓝灰色到深蓝，从淡黄色到黑色。discoloration: any change in surface color from that of the base metal. Usually associated with oxidation occurring on the weld and heat-affected zone on the outside diameter and inside diameter of the weld joint as a result of heating the metal during welding. Colors may range from pale bluish-gray to deep blue, and from pale straw color to a black crusty coating.中断：焊件典型的不连续结构，如焊件或原料在机械，冶金和物理特性方面无均匀性。discontinuity: interruption of the typical structure of a weldment, such as a lack of homogeneity in the mechanical, metallurgical, or physical characteristics of the materialor weldment. A discontinuity is not necessarily a defect.分配系统：distribution system: centralized system for the delivery of fluids from point of generation or supply to point of use.坡口：自动轨道焊接的部分，在焊弧熄灭前，焊接流相续逐渐减少。焊接点的下坡部分和末端焊珠一样尖端较细，下坡从始端到末端可减少渗透，因此最终焊珠渗透量很小。downslope: that part of an automatic orbital weld sequence during which the welding current is gradually reduced prior to extinguishing of the welding arc. The downslope portion of awelded joint is seen as a tapering of the end of the weld bead with a reduction of penetration from the beginning to the end of the downslope so that the final weld bead is small with minimal penetration硬度计：durometer: measurement of hardness related to the resistance to penetration of an indenter point in to a material as typically determined by ASTM D 2240.人造橡胶：elastomer: rubber or rubberlike material possessing elasticity. (see also elastomeric material.)人造橡胶原料：elastomeric material: a material that can be stretched or compressed repeatedly and, upon immediate release of stress, will return to its approximate original size.电解抛光：electropolishing: a controlled electro-chemical process utilizing acid electrolyte, DC current, anode, and cathode to smooth the surface by removal of metal.规格药物：ethical pharmaceutical: a controlled substance for the diagnosis or treatment of disease.过量焊透：焊透超过内径凸面的验收限度。excessive penetration: weld penetration that exceeds the acceptance limit for inside diameter convexity. (See also convexity.)发酵：fermentation: the biochemical synthesis of organic compounds by microorganisms or cultivated cells.发酵罐：fermentor (fermenter): a vessel for carrying out fermentation.含氟聚合物：部分或全部碳链与氟原子连接的聚合体。fluoropolymer: polymer material having a carbon chain either partially or completely bonded to fluorine atoms.焊透：当焊接深度范围从表面到焊接接头时，焊接接头完全焊透，此时的焊接接头是完全熔合的。如管和管的焊接在完全焊透的内径部分没有未熔合处。full penetration: A weld joint is said to be fully penetrated when the depth of the weld extends from its face into the weld joint so that the joint is fully fused. For a tubeto-tube weld, no unfused portions of the weld joint shall be visible on the inside diameter of a fully penetrated weld.熔合：fusion: the melting together of filler metal and base metal, or of base metal only, that results in coalescence.氧炔焊：原材料在焊接时，不与任何填充物一起熔合而进行的焊接。fusion welding: welding in which the base material is fused together without the addition of filler material to the weld. (See also gas tungsten-arc welding.)气体钨电弧焊接：gas tungsten-arc welding (GTAW): an arc welding process that produces coalescence of metals by heating them with an arc between a tungsten (nonconsumable) electrodeand the work. Shielding is obtained from a gas or gas mixture. (This process is sometimes called TIG welding, a nonpreferred term.) GTAW may be performedby adding filler material to the weld, or by a fusion process in which no filler is added垫圈：gasket: static seal made from deformable material compressed between two mating surfaces.GMP设备：GMP facility: a facility designed, constructed, and operated in accordance with cGMP guidelines established by the FDA.收割：可通过过滤，沉淀或离心过滤完成对单元的分离。harvesting: the separation of cells from growth media. This can be accomplished by filtration, precipitation, or centrifugation.熔炼炉号：heat number: an alphanumeric identification of a stated tonnage of metal obtained from a continuous melting in a furnace.热影响区：贱金属未熔化部分， 但是其微观结构或机械性能优于焊接或切割已经被改变。heat-affected zo