5 Selecting materials, methods and system components
选择材料、方法和系统组件
5.1 Recommended system components/treatment stages
推荐的系统组件/处理阶段
略（没有特殊要求）
5.2 Advantages and disadvantages ofsystem components/treatment stages
略（没有特殊要求）
5.3 Materials of construction – General
构造材料——一般要求
5.3.1 All componentsin the PW/WFIPretreatment and Productionsystem shall be manufactured from StainlessSteel (55) 316/316L. All PW/WFI contactparts to befabricated from SS 316L. including:piping/tubing, tanks,pumps, heat exchangers,valves, instruments and otheraccessories.
PW/WFI 预处理和生产系统中的所有部件均应由不锈钢(SS) 316/316L 制造。所有 PW/WFI 接触部件均由 SS 316L 制造，包括:管道/管道、储罐、泵、热交换器、阀门、仪器和其他附件。（预处理也要求316感觉有点过了）
5,3.2 Additionalmaterials thatshall be used are as following:
应使用的其他材料如下:
· EPDM:
· 三元乙丙橡胶PTFE-Polytetrafluoroethylene(PTFE);
· 聚四氟乙烯fluoroelastomers (FKM PEEK);
· 含氟弹性体(FKMPEEK)
PFA;
· PFA塑料highgrade(low impurity) fusedquartz and;
· 高级(低杂质)熔融石英othernon-corroding. hot water sanitization(HW5) resistant. non-particlesheddingand nonleaching materials.
· 其他非腐蚀、耐热水消毒 (HW5)、非颗粒脱落和非脱脂材料。
5.3.3 For materials of construction,exposure to hotwater sanitizationat 80℃- 90℃shallbe taken intoaccount.
对于构筑材料，应考虑能在80°C- 90°C下暴露于热水消毒。
5.3.4 Elastomersand plasticsshall be compatible with national regulations.
弹性体和塑料应符合国家规定。
5.4 Stainless steel (55) piping– General
不锈钢管道——一般要求
5.4.1 SS piping/tubing in contact with free chlorine and/or low conductivity water shall be SS 316/316L
与无余氯和/或低电导率的水接触的 SS 管道应为 SS 316/316 L（吸验管道为含有大量氯离子，一般不采用不锈钢）
5.4.2 SS tubing shallhave dimensions as pernational standards.
SS 管的尺寸应达到国家标准。
5.4.3 Tubingmay be seamlessor welded withseam.
管道可以是一体的，也可以用接缝焊接。
5.4.4 Materialused for piping and fittings shall meetthe pressure requirements for the systemand specifically forthe high pressureRO feed andconcentrate.
用于管道和配件的材料应满足系统的压力要求，特别是高压RO 进水和浓水。
5.4.5 Welding shallbe performedwith TIG/GTAW99,97 %or better,argonshieldgasshall be used.
焊接应使用TIG/GTAW99.97 %或更高的氩气保护。
5.4.6 Thedimensions of the physicalair break shallbe at least 50 mmfrom the bottom of piping/tubing to the highestpoint on the drain.Piping/tubingshall have identification labelswithin line of sight ofaccess areas. Thecontent of the pipingand direction of nowshall be clearly indicated.
· combinations of inert, Hot Water Sanitization (HWS)resistant, non-particle shedding and nonleaching elastomers.
· 惰性、耐热水消毒 (HWS)、非颗粒脱落和非脱脂的弹性体组合。
5.4.8 Dead legs:
死角
Dead Legs shall bemeasured by theterm L/D, where L is the legextension from theinside diameterwall normal to the flowpatternor directionand D is theinside diameter of the extensionor leg of a tubing fittingor the nominaldimension of a valve or instrumentand;
Dead legs should beavoided whereeve r possible. otherwise L/Dratio should be3:1 or less
应尽可能避免死角。如不可避免，L/D应为
dateof weld;
· 焊接日期
· weldername;
· 焊接人名字
· supervisor/inspector;
· 主管/检查员
· weldidentification number and description;
· 焊缝识别号和描述
· descriptionof items being welded;
· 焊接物品描述
· itemsdiameter and;
· 物品直径
· heatnumbers of the items being welded.
· 焊接物品的炉号
5.6.7 Passivation shall be performed during commissioning/startup.
应在调试/启动期间进行钝化。
5.6.8 Only certified welders shall he used.
只能使用经过认证的焊工。
5,6.9 Piping/tubing connections shall he Tri Clamp (TC) or othersanitary style connection.
管道连接应使用卡箍(TC) 或其他卫生方式连接。
5.6.10 Threaded or flangedconnections shall not be used.
不得使用螺纹或法兰连接。
5.6.11 Drainage slopes shall apply to the following:
以下方面应使用排水斜坡：
· a 1 % minimum drainage slopes shall be designed where everpossible and;
· 在可能的情况下，须设计1%最小排水斜坡;
· the slope direction shall be towards the piping low point, whichshall be drainable.
· 斜坡方向应朝向管道排水的低点。
5.6.12 Installed valves shall be one of the following types:diaphragm or other aseptic design with barrier between valve mechanism side andPW/WFI side.
安装的阀门应为以下类型之一：隔膜阀或其他无菌设计,阀门机构侧和 PW/WFI 侧之间有屏障。
6Sampling
取样
6.1 Sampling principles
取样规则
6.1.1 There shall be provision for sampling the water upstreamand downstream of all components that could affect the microbial or chemicalquality of the water.
应规定对上游和下游可能影响水微生物或化学质量的所有组件进行取样。
6.1.2 Zero dead leg sample valves shall be used throughout thesystem, both on non PW/WFI piping/tubing and on product water piping/tubing.
6.1.3 The sample valves shall be installed on short outlet teesso as not to contaminate samples by bioburden growing in the fitting.
取样阀应安装在短出口三通上，以免因生物负荷生长而污染样品。
6.1.4 Every process relevant component in the water system shallhave a sample valve before and after the component, e.g. heat exchanger,filter, pump etc.
水系统中每个工艺相关部件的前后应有一个取样阀，如换热器、过滤器、泵等。
6.1.5 The sample valves shall be above a tundish drain that willallow full drainage of the sample valve flow before taking thesample.
取样阀应位于漏斗排水管之上，在取样之前，允许将取样阀中的水完全排出。
6.1.6 There shall be sufficient clearance between the samplevalve and the tundish to allow insertion of all the standard sample bottles.
取样阀和漏斗之间应有足够的间隙，以便放入所有标准取样瓶。
6.2 Minimum sampling point and locations
最小采样点和位置
· beforeand after MMF;
· 多介质过滤器前后
· atsupplied water tank inlet;
· 供水管入口
· aftercirculation pump;
· 循环泵之后
· afterhardness reduction stage;
· 硬度降低阶段后;
· at thecartridge filters inlet and outlet;
· 滤芯过滤器进出口;
· afterheat exchangers;
· 换热器之后
· afterdechlorination stage;
· 脱氯后;
· aftereach RO housing and at their joint stream and;
· 在各RO后，并在其并流处;
· at ROreject lines and;
· RO排出口
· CDI/EDI/CEDIfeed, product and reject.
· CDI/EDI/CEDI进水、出水和排水。
6.3 Sampling conductivity
电导率取样
If an online conductivity instrument is installed and the online conductivity has already met national regulations, there is no need for samples to be taken for off line conductivity testing.