生物加工设备标准ASME BPE焊接要求

生物加工设备 标准 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 ASME BPE焊接要求 MJ-1范围SCOPE 此部分的要求适合于生物加工、制药和私人保健品行业中设备的连接，包括压力容器、罐(包 括换热器、人孔、泵以及任何满足ASME 锅炉和压力容器代码(BPVC)VIII部分，1区分的 容器设计)、管路(按照ASME B31.3)、配管、配件，应符合ASME BPVC,VIII 和IX部分和 ASME B31.3。这些材质、连接方法、检查等受到与加工处理产品或产品加工流的加工系统限 制。 The requirements of this Part are applicable to thejoining of equipment used in the bioprocessing, pharmaceutical,and personal care product industries, includingpressure vessels and tanks [which includes heatexchangers, atmospheric tanks, pumps, and any vesselsdesigned and built to the ASME Boiler and PressureVessel Code (BPVC), Section VIII, Division 1], piping(built to ASME B31.3), tubing, and fittings, and shall beused in conjunction with the requirements of ASMEBPVC, Sections VIII and IX, and ASME B31.3, as applicable.These materials, joining methods, examinations, etc.,are limited to process systems that contact bioprocessingproducts or product-process streams. MJ-2 材质MATERIALS MJ-2.1 不锈钢Stainless Steels 如果厂家和买方未特殊要求，加工表面的材质应为AISI 316L型由ASME或其他的公认说明出 版。所有的材质(管和配件)应符合表DT-3。然而，加工元件或配管的含硫量低于低限制或 高于表DT-3的上限制时，应使用焊接连接，满足以下的条件: Material for process surfaces shall conform to AISI316L (UNS S31603) and a published ASTM or otherrecognized specification, unless otherwise agreed to bythe purchaser and supplier. All materials (tubing andfittings) shall conform with Table DT-3. However, a processcomponent or tube with asulfur content eitherbelow the lower limit or above the upper limit of TableDT-3 can be used in a welded connection, provided thatall of the following conditions are met: 加工件或配管的使用应经过用户的同意。 加工件或配管的最大含硫量应满足0.030 wt. %。 加工件或配管应满足表DT-3中的要求。 对元件或配管的所有焊接进行内部检查，满足MJ-6.4的要求。 (a) Use of the process component or tube is agreedto by the owner/user. (b) The process component or tube meets 0.030 wt. %max. sulfur limit. (c) The process component or tube meets all otherrequirements of Table DT-3. (d) All welds on the component or tube are internallyinspected and meet the requirements of MJ-6.4. 如厂家和买方未有特殊要求，支架材质应为AISI 304 或304L(UNS S30400或S30403)。 Material for supporting structures shall conform toAISI 304 or 304L (UNS S30400 or S30403) unless otherwiseagreed to by the purchaser and supplier. MJ-2.2 镍合金 Nickel Alloys 镍合金的使用必须经过厂家和用户的同意，合金应符合ASTM或其他公认说明。为保证达到 预期的效果，建议焊接和抛光样品从实际热或批材质入手。 The use of nickel alloys shall be subject to agreementby the purchaser and supplier. The alloy shall conformto a published ASTM or other recognized specification.It is recommended thatweld and finish samples be madefrom the actual heat or lot of material in question, inorder to guarantee the desired results. MJ-2.3 机械抛光材质Mechanically Polished Material 机械抛光材质应适合焊接，如无粗砂和残渣。在抛光完成时，抛光材质应符合实际说明的尺 寸公差和此标准的表面抛光要求。 Mechanically polished material shall be ready forwelding, i.e., free of grit and residues. Polished materialshall meet the dimensional tolerances of the applicablespecifications, and the surface finish requirements of thisStandard, after polishing has been completed. MJ-2.4 电解抛光材质Electropolished Material 电解抛光材质应适合焊接，无化学残渣和水斑。表面应满足不锈钢或高合金SF部分的表面抛 光要求。 Electropolished material shall be ready for weldingand shall be free of chemical residues and water stains.Surfaces shall meet the surface finish requirements ofPart SF for stainless steel or higher alloys. MJ-2.5 其他材质Other Materials 如经过用户和承包商的同意，可使用其他的材质(如，钛、钽、热塑料和玻璃)。 Other materials (for example, titanium, tantalum,thermoplastic, and glass) may be used, based uponagreement by owner/user and contractor. MJ-2.6 焊接和抛光样品 Weld and Finish Samples 为证明达到预期的结果，如需使用焊接和抛光样品，应从相同的材质说明和等级中采样。 Weld and finish samples, when required, shall bemade from the same material specification and gradeto be used in production in order to demonstrate thedesired results. MJ-3 连接加工程序JOINING PROCESSES AND PROCEDURES MJ-3.1 焊接后抛光处理Welds Finished After Welding 对于焊接加工接触表面的压力容器、罐、管路和配管系统在焊接后应进行抛光，按照 ANSI/AWSA3.0的规定，焊接加工应限于弧焊或高能束(电子束和激光束)加工。所有焊接 程序应符合此标准的MJ-8部分。用户和承包商应同意能达到预期效果的焊接加工选择。 For pressure vessels, tanks, and piping and tubingsystems where the process-contact surface of the weldis to be finished after welding, the welding processesused shall be limited to the arc or high energy beam(electron beam and laser beam) processes as definedin ANSI/AWS A3.0. All welding procedures must bequalified per MJ-8 of this Standard. The owner/userand contractor shall agree that the welding processselected will provide the desired results. MJ-3.2 符合焊接条件的焊接 Welds Used in the As-Welded Condition 对于焊接加工接触表面的压力容器、罐、管路和配管系统在焊接后可以使用，按照 ANSI/AWSA3.0的规定，焊接加工应限于惰性气体弧焊加工(钨气体电弧焊接和等离子弧焊 接)或高能束(电子束和激光束)加工。所有焊接程序应符合此标准的MJ-8部分。每一步都 应努力使用自动焊或机械焊接加工。自动焊接，配线填装焊接或自耗嵌块如满足所有的实际 应用代码在此标准中是合格的。用户和承包商应同意能达到预期效果的焊接加工选择。 For pressure vessels, tanks, and piping and tubingsystems where the process-contact surface of the weldis to be used as is, welding processes shall be limitedto the inert-gas arc processes (such as gas tungsten-arcwelding and plasma arc welding) or the high energybeam processes (such as electron beam or laser beamwelding), as defined in ANSI/AWS A3.0. All weldingprocedures must be qualified per MJ-8 of this Standard.Every effort shall be made to use an automatic ormachine welding process. Autogenous welds, weldswith filler wire, or consumable inserts are acceptable for this Standard provided they meet the requirements forall applicable codes. The owner/user and contractorshall agree that thewelding process selected will providethe desired results. MJ-3.3 非金属物质Nonmetallics 经过材质制造商的建议，通过用户的批准，可使用非金属材质(如玻璃、橡胶、陶瓷和塑料) 连接，所选用的材质或化合物应为惰性物质。 Joining of nonmetallic materials (e.g., glass, rubber,ceramics, and plastics) shall be in accordance with proceduresand processes recommended by the material manufacturer,and approved by the owner/user, usingmaterials or compounds that are inert to the intendedservice. MJ-3.4 机械连接Mechanical Connections 机械连接应按照SD-3.7。Mechanical connections shall conform to SD-3.7. MJ-4 焊接连接设计和准备 WELD JOINT DESIGN AND PREPARATION MJ-4.1 概述 General 一或两个焊接面是产品接触表面的所有对接接头应有连续完整焊接接头熔透。此要求针对单 面焊或双面焊接头的焊缝。所有焊接接头必须把产品接触面适当的清洁和保护，以预防变色 或污染。外部附件(如吊环、蜂窝夹套、梯子夹子等)必须把产品接触表面的污点去除掉。 All butt joints in which one or both weld faces is aproduct contact surface shall have continuous completeweld joint penetration. This requirement exists forweldsmade from either one side or from both sides of theweld joint. All weld joints must have the product contactsurfaces properly purged or protected for the preventionof discoloration or contamination. External attachments(e.g., lift lugs, dimple jackets, ladder clips, etc.) musthave any discoloration of the product contact surfaceremoved. 任何连接的焊缝，如通过管子或容器壁，或管子或管件系统的分支连接，凡有一面或两面均 为产品接触面，应带有增强圆角和全熔透凹槽焊接接头[与图SD-14(a)相似]，或则如仅是双倒 角焊接，则至少要有一个警示孔[与图SD-14(b)相似]。所有的折叠部分、三通、拐角或边缘接 头有一或两面为产品接触面，同时不是全熔透焊接连接，则其上要求设置警示孔。警示孔应 在内部封闭焊接失败时，能为产品和试验介质的流动提供通道。当所有的焊缝在产品接触面 上时则不需要警示孔(如详见图SD-17(d)或相似)。警示孔不能大于NPS? in. (6.35 mm)，同时 分接用于预压缩空气和肥皂液对内部焊缝的试漏。当容器在使用时，警示孔应塞紧。使用的 塞紧材料不能承受折叠部分的连续压力 Welds attaching any connection that passes throughthe wall of a tank or vessel, or a branch connection ona pipe or tube system, in which one or both sides of theweld joint is a product contact surface, shall either bejoined with a full penetration groove weld with a reinforcingfillet weld [similar to Fig. SD-14(a)], or have atleast one telltale hole provided if double fillet weldedonly [similar to Fig. SD-14(b)]. A telltale hole is requiredon all lap, tee, corner, or edge joints that have one orboth welds as a product contact surface and are notattached by full penetrationwelds. The telltale hole shall provide a path for product or test media flow in theevent of inner weld containment failure. Telltale holesare not required when all welds are on product contactsurfaces, [e.g., Fig. SD-17(d) detail or similar]. The telltalehole shall be no larger than NPS ? in. (6.35 mm)and may be tapped for a preliminary compressed airand soapsuds test for tightness of inside welds. Thesetelltale holes may be plugged when the vessel is inservice. The plugging material used shall not be capableof sustaining pressure between the lapped surfaces. 不允许在工艺蒸汽系统或CIP或SIP要求处使用承插焊接。 Socket welding is not permitted in process streamsystems or where CIP or SIP requirements are defined. MJ-4.2 压力容器和罐Pressure Vessels and Tanks 压力容器和罐的设计连接必须符合ASME BPVC VIII部分和MJ-4.1部分。 Joint designs shall be those permitted by ASME BPVC,Section VIII, and shall comply with MJ-4.1. MJ-4.3 管路Piping 管路的设计应符合ASME B31. 3 和MJ-4.1部分。 Joint designs shall be those permitted by ASME B31.3,and shall comply with MJ-4.1. MJ-4.4 配管Tubing 卫生配管和配件的接头设计应为平头对接接头。配管和配件的末端应为符合表DT-5和表DT-6 的要求，为正方形。焊接前，在内外表面1/2in.的接头面积内，应对对接焊缝接头进行清洁。 除了尺寸和空间不允许的地方，配管的焊接均应使用自动焊接技术(如轨道管焊接或车床焊 接)。当然在经过用户和厂家的同意下，也可使用手焊。 Joint designs for hygienic tubing and fittings shall besquare butt joints. The tubing and fittings shall have endsprepared by machining or facing to provide a square endthat meets the requirements of Tables DT-5 and DT-6.The butt weld joints shall be properly cleaned within1/2 in. of the joint area on the inside and outside surfacesprior to welding.Welding on tubing shall be done usingautomatic (or machine) welding techniques (such asorbital tube welding or lathe welding), except wheresize or space will not permit. In that case, manual weldingcan be performed, but must be agreed to by the owner/user and contractor. MJ-5 填装材质FILLER MATERIAL 填装材质应符合AWS说明，或经过填装制造商、设备供应商和最终用户同意的私人说明。私 人特殊说明应注意:参见此标准MJ-8部分和ASME BPVC 的QW-250和QW-350，IX 部分。 填充金属应以焊条、自耗嵌块或其他形式。 Filler material shall conform to a publishedAWS specification,or to a proprietary specification agreed tobetween the filler manufacturer, equipment supplier,and end owner/user. Proprietary fillers require specialattention; see MJ-8 of this Standard and QW-250 andQW-350 of ASME BPVC, Section IX. Filler metals maybe in the form of welding wire, consumable inserts, orother shapes or forms. 经厂商的建议可使用适当的填充金属。对于不锈钢贱金属，仅能使用低碳等级的不锈钢填充 金属(如316L贱金属仅能使用316L或316L Si 填充金属;对于304L贱金属，可使用308L或316L 填充金属)。钼含量较高的不锈钢或镍合金需要特殊的填充物，这由贱金属厂商商讨决定。 Appropriate filler metals shall be used, as recommendedby the manufacturers. For stainless steel basemetals, only low carbon grades of stainless steel fillermetals shall be used (e.g., for 316L base metal only 316Lor 316LSi filler metal shall be used; for 304L base metal308L or 316L filler metals shall be used). Stainless steel ornickel alloy with high molybdenum content may requirespecial filler metals. The base metal manufacturershould be consulted. MJ-6 焊接合格标准WELD ACCEPTANCE CRITERIA MJ-6.1 概述General 无菌环境焊接要求焊接不能导致表面助于微生物生长和产品的污染。焊接不能有任何增加产 品污染的中断，如裂缝、空洞、有孔或接头未校准等。所有的焊接程序应符合MJ-8。 Welding for a sterile environment requires that theweld shall not result in a surface that will contribute tomicrobiological growth and contamination of the product.The weld shall not have any discontinuities suchas cracks, voids, porosity, or joint misalignment that willpromote contamination of the product. All welding proceduresshall be qualified to MJ-8. MJ-6.2 压力容器和罐Pressure Vessels and Tanks 压力容器和罐的焊接合格标准见ASME BPVC VIII 部分1 区和表MJ-1中的额外要求。表MJ-1 中未说明的部分，仅参见ASME BPVC VIII 部分1 区即可。 Weld acceptance criteria for pressure vessels andtanks shall be in accordance with ASME BPVC, SectionVIII, Division 1, with the additional requirements ofTable MJ-1. Where “None” is specified in Table MJ-1,the limits of ASME BPVC Section VIII, Division 1 willapply. GENERAL NOTE: All repairs shall comply with ASME Section VIII, Division 1. NOTES: (1) Must comply with paras. SF-5 and MJ-3.2. (2) The limits of ASME Section VIII, Division 1 will apply. (3) Acceptable if the following requirements are achieved: (a) the requirements of ASME Section VIII, Division 1 are met. (b) any feathering must not reduce wall thickness below the minimum required. (c) the requirements of para. SD-5.4 are met. (4) Also applies to heat-affected zone. (5) Does not apply to insulation sheathing and similar welds. MJ-6.3 管路 Piping 管路的焊接合格标准符合ASME B31.3 341.3.2到341.3.4段和表341.3.2，以及表MJ-2。同时在 表341.3.2给出了对于管路焊接实际流体种类的标准值 Weld acceptance criteria for piping shall be in accordancewith ASME B31.3, paras. 341.3.2 through 341.3.4and Table 341.3.2, along with the criterion value notesfor the applicable fluid service category in Table 341.3.2for pipe welds and the additional requirements of TableMJ-2. MJ-6.4 配管 Tubing 对于配管和管件的焊接合格标准应符合表MJ-3(参见图MJ-1)。如果需要对生产前的样品进 行焊接，应由厂商提供给用户，由用户制定焊接质量。样品焊接的数量和种类应经过用户、 承包商和检查承包商的同意。 Weld acceptance criteria (including borescopic acceptancecriteria) for tubing and fittings shall be in accordancewith Table MJ-3 (see Fig. MJ-1).Preproduction sample welds, when required, shall be submitted by the contractor to the owner/user to establishweld quality. Owner/user, contractor, and inspectioncontractor shall agree to the number and type ofsample welds. 在建造过程中，样品焊接应基于一个有序的原理，确使设备操作正常，清洁设备能阻止任何 污染，符合厂家和用户的要求等级。用户和厂商应同意样品焊接的频率。强烈建议在每个机 件转换前、净化液瓶更换时、自动焊接改变时(如轨道管焊接封头改变)进行样品焊接。 During construction, sample welds shall be made ona regular basis to verify that the equipment is operatingproperly and that the purging setup is adequate to preventdiscoloration beyond the level agreed upon by theowner/user and contractor. Owner/user and contractorshall agree to the frequency of sample welds. It isstrongly recommended that these samplewelds be madeat the beginning of each work shift, whenever the purgesource bottle is changed, and when the automatic ormachine welding equipment is changed (such as whenthe orbital tube weld head is changed). 以前段落所描述的样品焊接，应配有相关的焊接机打印记录(如从焊接机直接打印输出的或 下载的焊接参数)，如果要的话，应经过用户 书 关于书的成语关于读书的排比句社区图书漂流公约怎么写关于读书的小报汉书pdf 面形式票据和用户代表或用户检查员的处理。 The sample welds described in the preceding paragraphs,and any associated welding machine printedrecords (e.g., welding parameter printouts directly fromwelding machine or downloaded from a weldingmachine), if any, may be disposed of after written acceptanceof the coupons by the owner, the owner’s representative,or the inspector. 表MJ-2管的焊接合格标准 MJ-6.4.1二次焊接Rewelding. Rewelding (reflow) may beattempted one time only for the following defects: (a) incomplete penetration (lack of penetration) (b) incomplete fusion (lack of fusion) (c) unconsumed tack welds that can be inspected onthe product contact side All rewelds shall either totally consume the originalweld or overlap the orignial weld with no base metalbetween the welds. 如有下列缺陷应进行二次焊接: 不完全焊透(未焊透) 未焊透(未熔合) 在产品接触面也检查到的未耗尽间断焊 所有的二次焊接应全部消灭原始焊接或与原始焊接交迭，在焊缝间无贱金属。 MJ-6.4.2样品焊接Sample Welds. Sample welds for tubingshall meet all the acceptable criteria of Table MJ-3. Aminimum internal bead width of 1.5 times the nominalwall thickness is required. 配管的样品焊接应满足表MJ-3中的所有合格标准。最小内水珠宽度应为1.5 倍的公称壁厚。 MJ-7 检查和测试INSPECTION, EXAMINATION, AND TESTING MJ-7.1范围Scope 本章节是对生物加工设备和包括压力容器、罐、支架、泵、管道、配管、配件和卡箍等元件 的检查。检查的方法、内容和定义应按此标准的GR部分和其它的公认代码和标准，包括ASME BPVC ,VIII 部分， 1 区;ASME B 31.3 和AWS-QC1和SNT-TC-1A检查要求。 These paragraphs provide for the inspection/examinationof bioprocessing equipment and componentsincluding pressure vessels, tanks, skids, pumps, piping,tubing, fittings, and clamps. Examination methods,terms, and definitions shall be as defined in Part GR ofthis Standard and in other existing recognized codesand standards, including ASME BPVC, Section VIII,Division 1; ASME B31.3; and AWS-QC1 and SNT-TC-1Arequirements for examiner and inspector certifications. MJ-7.2 检查类型Types of Examinations 未另有说明时，用户、承包商、检查承包商或工程师应同意检查类型。 Owner/user, contractor, inspection contractor, and/or engineer shall agree to the types of examinations,unless otherwise specified in the applicable code. MJ-7.2.1压力容器和罐Pressure Vessels and Tanks. 视觉上的、流体渗透、X光射线、超声波等检查应符合ASME BPVC VIII 部分，1区。罐和压 力容器的制造应对产品接触表面上的所有焊接进行视觉检查。对符合ASME BPVC ,VIII 部分 1区和适当代码要求的压力容器和罐的设计由专门人员检查。 Examinationsincluding visual, liquid penetrant, radiographic, andultrasonic shall be performed in accordance with theprovisions of ASME BPVC, Section VIII, Division 1. Fabricatorsof tanks and pressure vessels must visuallyexamine allwelds on product contact surfaces. Personnelperforming examinations of pressure vessels and tanksdesigned to ASME BPVC, Section VIII, Division 1, shall meet requirements of the appropriate section of thatCode. MJ-7.2.2管路 Piping 包括视觉和任何特殊方法的检查应符合ASME B31.3 344部分。管路系统检查人员应满足 ASME B31.3 ,342.1段的要求。 Examinations including visual andany special method (as defined in ASME B31.3, ChapterVI, para. 344.1.2) shall be performed in accordance withthe provisions of ASME B31.3, Section 344. Personnelperforming examinations of piping systems shall meetthe requirements of ASME B31.3, para. 342.1, PersonnelQualification and Certification, and 342.2, SpecificRequirement. 用户、安装承包商、检查承包商或工程师应同意产品接触焊接视觉检查所选用的最小百分比。 为保证焊接满足此部分的合格标准，承包商应递交检查 计划 项目进度计划表范例计划下载计划下载计划下载课程教学计划下载 。经过厂家和用户的同意，此计 划应包括钻孔范围或产品接触表面直接视觉检查焊接最小百分比。在任何情况下，最低百分 比都不得低于每个安装系统的20%。应包括每个焊工或焊接操作人员的工作代表性样品。检 查应符合ASME B31.3 要求，应包括产品接触表面直接视觉检查的最小百分比。 Owner/user, installing contractor, inspection contractorand/or engineer shall agree to the minimum percentageof product contact welds to be selected for visualexamination. The contractor shall submit an inspectionplan to ensure that welds meet the acceptance criteriaof this Part. This plan shall include borescopic or directvisual inspection of the product contact surfaces on aminimum percentage of welds agreed to by the owner/user and contractor. In no case shall this minimum percentagebe less than 20% of each system installed. Arepresentative sample of each welder or welding operator’swork must be included. The inspection requiredfor compliance with ASME B31.3 may be included in theminimum percentage provided those inspections weredirect visual orborescopic and of the product contactsurface. MJ-7.2.3配管 Tubing 视觉上的、流体渗透、X光射线、超声波等检查应符合ASME B31.3，344部分。所有焊接内 表面应进行视觉检查。此标准不需要X射线除非用户或其它实用代码特殊说明。 Examinations including visual, liquidpenetrant, radiographic, ultrasonic, and any supplementary examinations (as defined in ASME B31.3,Chapter VI, para. 344.1.2) shall be performed in accordancewith the provisions of ASME B31.3, Section 344.The external surfaces of allwelds shall be visually examined.This Standard does not require radiography unlessspecified by the owner/user or other applicable code. 配管系统检查人员应符合ASME B31.3 342.1 段----人员确认和证书的要求。用户、安装承包 商、检查承包商或工程师应同意钻孔面积或其它内部视觉检查所选用的最小百分比。为保证 焊接满足此部分的合格标准，承包商应递交检查计划。经过厂家和用户的同意，此计划应包 括钻孔范围或产品接触表面直接视觉检查焊接最小百分比，在每个分离系统内，可选用所有 焊接20%的最小值。此程序还应包括无光焊接检查。任意选用的合理焊接检查应达到用户检 查人员的标准。同时还应有一个对每个操作人员生产第一次转化检查计划。 Personnel performing examinations of tubing systemsshall meet the requirements of ASME B31.3, para. 342.1,Personnel Qualification and Certification and 342.2, SpecificRequirement. Owner/user, installing contractor, inspection contractor,and/or engineer shall agree to the minimum percentage of welds to be selected for borescopic or otherinternal visual examination. The contractor shall submitan inspection plan to ensure that welds meet the acceptancecriteria of this Part. This plan shall includeborescopic or direct visual inspection of the internalsurfaces of an agreed-to minimum percentage of weldsby the owner/user and contractor, but a minimum of20% of all welds shall be randomly selected in eachseparate system. A procedure shall also be submittedfor examining blind welds. The random selection of theaccessible welds to be examined shall be up to theowner/user’s inspector’s discretion. There shall also bea plan for checking each operator’s first shift of production. 经过用户的判断，对钻孔面积检查或其它内部视觉检查人员应符合ASME B31.3 340.4，342.1 和342.2的要求。检查人员的鉴定等级II级和III级视觉检查人员应符合SNT-TC-1A的最新版本 或现在AWS-QC1 焊接人员证书。 At the owner/user’s discretion, personnel performingborescopic examinations or other internal visual examinationsshall meet the requirements of ASME B31.3,paras. 340.4, 342.1, and 342.2. Personnel performingthese inspections may also be certified as Level II or IIIvisual inspectors in accordance with the latest editionof SNT-TC-1A or possess a current AWS-QC1 CertifiedWelding Inspector certification MJ-7.3 检查程序Examination Procedures MJ-7.3.1压力容器和罐Pressure Vessels and Tanks. 压力容器和罐的检查程序应符合ASME BPVC VIII 部分，1 区。 Examinationprocedures for pressure vessels and tanks shall be inaccordance with ASME BPVC, Section VIII, Division 1. MJ-7.3.2管路 Piping 管路系统的检查程序应符合ASME B31.3 343段的要求。 Examination procedures for pipingsystems shall be in accordance with the requirements of ASME B31.3, para. 343. MJ-7.3.3配管 Tubing 配管系统的检查程序应符合ASME B31.3 343段的要求。 Examination procedures for tubingsystems shall be in accordance with the requirementsof ASME B31.3, para. 343. MJ-7.4 增补检查Supplementary Examinations 任何系统的增补检查和测试应符合ASME B31.3 341.5段的要求。 The execution of supplementary examinations andtesting (such as borescopic and surface finish) for anysystem shall be in accordance with ASME B31.3, para.341.5. MJ-7.5 测试 Testing MJ-7.5.1压力容器和罐Pressure Vessels and Tanks. 压力容器和罐的设计应符合ASME BPVC VIII 部分，UG-99或UG-100段的要求。 Testing of pressurevessels designed to code specifications shall be performedin accordance with ASME BPVC, Section VIII,para. UG-99 or UG-100. MJ-7.5.2管路 Piping 管路系统的静压或气动测试应符合ASME B31.3 VI章节，345部分的要求。 Hydrostatic or pneumatic testing ofpiping systems shall be performed in accordance with ASME B31.3, Chapter VI, Section 345. MJ-7.5.3配管 Tubing 配管系统的静压或气动测试应符合ASME B31.3 VI章节，345部分的要求。 Hydrostatic or pneumatic testing oftubing systems shall be performed in accordance with ASME B31.3, Chapter VI, Section 345. MJ-7.6 记录 Records MJ-7.6.1压力容器和罐Pressure Vessels and Tanks. 容器代码保留记录和记录应符合X射线ASME BPVC VIII 部分，UW-51段、UG-120厂商数据 记录和UW-52焊接斑点检查。 Records andretention of records for code vessels shall be in accordancewith ASME BPVC, Section VIII, paras. UW-51 forradiographs, UG-120 for manufacturer’s data reports,and UW-52 for spot examination of welds. MJ-7.6.2管路 Piping 管路所涉及的记录和保留记录应符合ASME B31.3 VI章节，346部分的要求。 Records and retention of recordsassociated with piping shall be in accordance withASME B31.3, Chapter VI, Section 346. MJ-7.6.3配管 Tubing 卫生配管所涉及的记录和保留记录应符合ASME B31.3 VI章节，346部分的要求。 Records and retention of recordsassociated with hygienic tubing shall be in accordance with ASME B31.3, Chapter VI, Section 346. MJ-8 程序确认PROCEDURE QUALIFICATION MJ-8.1 压力容器和罐Pressure Vessels and Tanks 压力容器和罐的焊接程序应符合ASME BPVC IX 部分,以及压力容器和罐设计详细代码部分 的补充说明。 Welding procedures for pressure vessels and tanksshall be qualified in accordance with ASME BPVC, SectionIX, plus any supplementary requirements in thespecific code section under which the vessels or tanksare designed. MJ-8.2 管路Piping 管路系统的焊接程序应符合ASME BPVC IX 部分，以及ASME B31.3 补充说明的要求。 Welding procedures for piping systems shall be qualified in accordance with ASME BPVC, Section IX, plus any supplementary requirements in ASME B31.3. MJ-8.3 配管 Tubing 卫生配管系统的自动或手工钨气电弧焊的焊接程序应符合ASME BPVC IX 部分，在以下条件 下: 净化气体的类型或公称成分的改变需要再次确认(见QW-250)。 填充金属从一个AWS等级转变为另一个，或是到私人填充金属，应进行二次确认(见QW-250)。 Welding procedures for machine or automatic or manual gas tungsten-arc welding of hygienic tubing systems shall be qualified in accordance with ASME BPVC, Section IX, with the following additions: (a) A change in the type or nominal composition of the backing (purge) gas shall require requalification (see QW-250). (b) A change from one AWS classification of filler metal to another, or to a proprietary filler metal, shall require requalification (see QW-250). MJ-9 性能确认 PERFORMANCE QUALIFICATION MJ-9.1 压力容器和罐Pressure Vessels and Tanks 压力容器和罐的性能确认焊工和焊接操作人员应符合ASME BPVC IX 部分。 Welder and welding operator performance qualifications for pressure vessels and tanks shall be in accordance with ASME BPVC, Section IX. MJ-9.2 管路 Piping 管路的性能确认焊工和焊接操作人员应符合ASME BPVC IX 部分。 Welder and welding operator performance qualifications for piping systems shall be in accordance with ASME BPVC, Section IX. MJ-9.3 配管 Tubing 卫生配管系统的自动或手工钨气电弧焊的性能确认焊工和焊接操作人员应符合ASME BPVC IX 部分的要求。 Welder and welding operator performance qualifications for manual or machine or automatic gas tungstenarc welding of hygienic tubing systems shall be in accordance with ASME BPVC, Section IX. MJ-10 文件确认 DOCUMENTATION REQUIREMENTS MJ-10.1 包装文件要求 Turn Over Package Documentation Required 对于cGMP验证分配系统(包括模块、大支架、支架和配管的车间或现场制造的配管系统等)， 提供给用户或指定人的最少文件如下: For cGMP-validated distribution systems (including the tubing systems on modules, super skids, and skids, and the shop or field fabrication of tubing, etc.) the following documentation shall be provided to the owner/user or their designee, as a minimum: ( a ) 材质文件 Materials Documentation 材质测试 报告 软件系统测试报告下载sgs报告如何下载关于路面塌陷情况报告535n,sgs报告怎么下载竣工报告下载 (MTRs) 材质测试确认报告(CMTRs) 证书 材质检查日志 (1) Material Test Reports (MTRs) (2) Certified Material Test Reports (CMTRs) (3) Certificates of Compliance (C of Cs) (4) Material Examination Logs 焊接、检查、检验确认报告(如用户未要求，不需使用标准配件、阀和元件) Welding, Inspection, and Examination Qualification Documentation (not required for standard fittings, valves, and components unless specifically required by the owner/user) 焊接程序说明(WPSs) 程序确认记录(PQRs) 焊工成绩确认(WPQs) 焊接操作人员成绩确认(WOPQs) 检查员确认 焊接前以上用户代表的批准文件。 (1) Welding Procedure Specifications (WPSs) (2) Procedure Qualification Records (PQRs) (3) Welder Performance Qualifications (WPQs) (4) Welding Operator Performance Qualifications (WOPQs) (5) Inspector and Examiner Qualifications (6) Documentation of approval of the above by the owner’s representative prior to welding 焊接文件(如用户未要求，不需使用标准配件、阀和元件)。 Weld Documentation (not required for standard fittings, valves, and components unless specifically required by the owner/user) 焊接图 焊接日志 焊接检查和检验日志 息票日志 (1) Weld Maps (2) Weld Logs (3) Weld Examination and Inspection Logs (4) Coupon Logs 测试和检查文件(如果需要的话) Testing and Examination Documentation (as applicable) 钝化报告 清洗球测试 压力测试 最终斜面核对文件 校准确认文件 净化气体证明 签名日志 焊接号-----手动和自动 以百分比形式表示的焊接检查号 必须确认、证明的完全适合安装系统的元件熔炼炉号 (1) Passivation Reports (2) Sprayball Testing (3) Pressure Testing (4) Final Slope Check Documentation (5) Calibration Verification Documentation (6) Purge Gas Certifications (7) Signature Logs (8) Number of Welds — both Manual and Automatic (9) Number ofWelds Inspected expressed as a percentage(%) (10) Heat Numbers of components must be identified, documented, and fully traceable to the installed system MJ-10.2 材质文件 Materials Documentation MJ-10.2.1材质检查 Materials Examination. 材质检查要求和文件列于DT-14中。 The requirements for materials examination/inspection and documentation are listed in DT-14. MJ-10.2.2材质测试报告 Material Test Reports. 此部分包含的所有文件至少应符合以下信息: The combination of documents, including Certificates of Compliance (C of Cs), Material Test Reports (MTRs), and/or Certified Material Test Reports (CMTRs) for all metallic equipment and component product contact surfaces defined in the scope of this Standard shall include the following information, as a minimum: ASME BPE标准，包括时间 材质类型 熔炼炉号 化学组成 填充金属AWS分类(如果使用) 插入的指定合金和材质说明(如果使用) 岗位焊接热护理文件(如果实用) 不需要给出材质性质，但必须提供精确的原料说明 (a) ASME BPE Standard, including year date (b) material type (c) heat number (d) chemical composition (e) AWS Classification of filler metal, if used (f) alloy designation and material specification of insert, if used (g) post weld heat treatment documentation, if applicable (h) mechanical properties are not required, but if included, must be accurate to the raw material specification MJ-10.3 焊接日志 Weld Log 焊接、检查的结果应记录在焊接日志上。为满足厂家、安装承包商、检查承包商或用户的需 要，焊接日志可以以任何形式，手写或列表，应包含所有所需的信息。表WL-1为焊接日志指 南。此 表格 关于规范使用各类表格的通知入职表格免费下载关于主播时间做一个表格详细英语字母大小写表格下载简历表格模板下载 应包含所需的数据加上一些不需要的信息，最小要求如下: The results of the welding, examination, and inspection shall be recorded on a Weld Log. The information required to be on the Weld Log may be in any format, written or tabular, to fit the needs of the manufacturer, installing contractor, inspection contractor, and owner/ user as long as all required information is included or referenced. Form WL-1 (see Nonmandatory Appendix B) has been provided as a guide for the Weld Log. This form includes the required data plus some other information that is not required. The minimum requirements are listed below. 等大图编号(包括修订编号) 焊接编号 焊接日期 焊工/焊接操作人员确认 尺寸 检查 日期 检查类型 合格/不合格 最初的 检查 日期 检查类型 合格/不合格 最初的 无光焊接确认 手工焊接确认 不合格成分 下列信息应记录在焊接日志、等大图或由用户批准的其他文件上: (aa)熔炼炉号 (ab)斜面 (a) isometric drawing number (including revision number) (b) weld number (c) date welded (d) welder/welding operator identification (e) size (f) examination (1) date (2) type of examination (3) acceptance/rejection (4) initials (g) inspection (1) date (2) type of examination (3) acceptance/rejection (4) initials (h) identification of blind welds (i) identification of manual welds (j) basis of rejection The following information shall be recorded on the Weld Log, an isometric drawing, or other owner/user approved documentation: (aa) heat numbers (ab) slope MJ-11 钝化 PASSIVATION 经过厂家和用户的同意，所有焊接系统在使用前，清洁后应进行钝化。 If agreed to by the owner/user and the manufacturer, all welded systems shall be passivated after cleaning and prior to use.