近日，ISO发布了全球首个制药用水系统国际化标准，ISO 22519：2019《纯化水和注射用水预处理和生产系统》，前面发布了第一部分——1-8章的内容，本文为余下章节翻译，如下：
ISO 22519：2019 Purifiedwater and water for injection pretreatment and production systems
ISO 22519：2019 纯化水和注射用水预处理和生产系统
点开超链接查看章节1-8翻译
9 Operation
运行
9.1Production
生产
9.1.1 The PW/WFIPretreatment and Production system shall operate/circulateconstantly 24/7,nostoppage of the pump or flow.
PW/WFI预处理和生产系统应每周七天24小时全天候持续运行/循环，泵或流量不得停止。
9.1.2 The constantoperation/circulation shall keep the water moving without stagnation.
持续运行/循环应使水保持无停滞状态。
9.1.3 There is noobjective criterion ofminimum flow or minimum speed.Minimum flow or turbulentflow may be defined per system.
最小流量或最小流速没有客观的标准。可根据系统定义最小流量或湍流。
9.1.4Savings may be realized bythrottling of the concentrate and lowering speed of pumps when storage tank full.
在储罐满时可以节流浓水并降低泵的速度以实现节约。
9.1.5Asystemwithelectricscale control(ESC) andUVdechlorination shall continuously reduce bacteria whileoperating.
具有电子除垢(ESC)和紫外线脱氯功能的系统在运行时可持续减少细菌。
9.1.6Areasof thesystemthat do not have constant flow, as in ClP return lines and bypasses, shall be gravitydrained between uses. Every time the system has not been in operation for a certain period of time a subsequent start up should be carried out according to aStandard Operating Procedure (SOP).
系统中没有稳定流量的区域(如ClP回流管和旁路)应在使用前后进行重力排空。系统长时间内未运行后重新启动，应按照标准操作规程 (SOP) 进行。
9.2 Recirculation when storage tank full
储罐满时再循环
9.2.1WhenthePW/WFI storage tank is full, the PW/WFI Pretreatment and Production shall shunt the product water back to the raw/supplied water inletof the PW/WFI Pretreatment and Production.
当 PW/WFI 储罐满时，PW/WFI 预处理和生产系统应将产品水分流回 PW/WFI 预处理和生产的原始/供水入口。
9.2.2Theproduction system shall not operate Start/Stop when the storage tank is full. The production system should continue to operate continuously.
储罐满时，生产系统不得操作启/停。生产系统应继续持续运行。
9.3Sanitization
消毒
9.3.1 Hot water sanitization shall be the method for keeping the systems clean of microbial contamination.
热水消毒是保持系统清除微生物污染的方法。
9.3.2Toprevent build-up of scale on the heating surfaces, water used shall be soft (less than 20 ppmasCaCO3).
为了防止加热表面的水垢沉积，所使用的水应为软水(CaCO3小于20ppm)。
9.3.3Appropriatetemperature, time and cycle shall be determined, for example: A periodic heat sanitization shall be performed so that the lowest temperature in the system is 80°C for at least 30 min
应确定适当的温度、时间和周期，例如：应定期进行热消毒，使系统中的最低温度为 80℃,至少30 分钟。
9.3.4 All equipment units in the PW/WFI Pretreatment and Productionshall becompatiblewith hot water sanitization (HWS). This includes the electric scale control (ESC), UV, filters, RO, CDI/EDI/CEDI and UF units - For example, all shall be able to withstand the minimum sanitization temperature at 80 ℃for one hour. If Activated Carbon Filter (ACF)is used itshall besanitizedatleast twicea weekwith steam.Ifhot water is used, the minimum sanitization temperature shall be 85 °C for one hour at least.
PW/WFI预处理和生产系统中的所有设备单元应可以耐受热水消毒 (HWS) 。这包括电子除垢 (ESC)、紫外灯、过滤器、RO、CDI/EDI/CEDI和 UF 单元 - 例如，所有装置都应能够耐受最低温度为 80℃消毒一小时。如果使用活性炭过滤器(ACF)，应每周至少用蒸汽消毒两次。如果使用热水，最低消毒温度应为85℃，至少一小时。
9.3.5 Activated Carbon Filter (ACF) sanitization shall include all downstream filter elements.
活性炭过滤器(ACF)消毒应包括所有下游的过滤元件。
9.3.6 Activated Carbon Filter (ACF) steam sanitization shall be performed with Pure steam (PS) only; industrial steam for direct Activated Carbon Filter (ACF) contact sanitization shall not be used.
活性炭过滤器 (ACF) 蒸汽消毒只能使用纯蒸汽 (PS) 进行；不得使用工业蒸汽直接与活性炭过滤器(ACF)接触进行消毒。
9.4Chlorine and chlorination
余氯和氯化
9.4.1 Thefeed water may be chlorinated inaccordance with the feed water quality and per system configuration.
可根据原水水质和系统构造对原水进行氯化处理。
9.4.2 A pretreatment including an electric scale control (ESC) and UV dechlorination combination will not need any chlorination, as continuous operation will continuously reduce the bacterial load.
预处理，包括电子除垢(ESC)和紫外脱氯组合将不需要任何氯化，因为连续运行可不断减少细菌负荷。
9.4.3Residualchlorine shall be left in the system for maximum process steps.
余氯应保持在系统中尽可能多的步骤中。
9.4.4Chlorine shall be removed at the last possible point before the RO while leaving upstream equipment chlorinated.
余氯应在RO前最后一个可能的点进行清除，以使上游设备氯化。
10Maintenance
维护
10.1 Standard Operating Procedure(SOP's)
标准操作规程（SOP）
10.1.1 MaintenanceStandard Operational Procedures(SOP's) shall be composed duringthe systemcommissioning for implementation duringthe first stage of PerformanceQualification (PQ).
应在系统调试期间建立维护的标准操作规程 (SOP)，以便在性能确认 (PQ) 的第一阶段实施。
10.1.2 Standard Operational Procedures(SOP's) shall include:
标准操作规程 (SOP) 应包括:
- procedures for operatingthe system;
- 系统操作的程序;
- list of scheduled preventive maintenanceper: day, week, month, quarter, yearetc.;
- 计划的预防维护清单:每日、每周、每月、每季度、每年等；
- monitoring tablefor recording critical qualityparameters and operatingconditions;
- 用于记录关键质量参数和操作条件的监测列表；
- calibration schedule of instruments;
- 仪器校准计划
- schedule for periodic sanitization;
- 定期消毒计划
- control of changesto the mechanical system and to operatingsystem;
- 机械系统和操作系统的变更控制
- sanitization procedure;
- 消毒程序
- filter replacement procedureand:
- 过滤器更换程序
- filter replacement schedule.
- 过滤器更换计划
10.1.3 The Standard Operating Procedures (SOP's) shall be regularly reviewed periodically, when equipmentis replaced, or whenthe system is otherwise updated.
应在设备更换，或系统其它变更时，对标准操作规程进行定期审核
10.1.4 Any maintenance StandardOperating Procedure (SOP) shallinclude a daily check list of thesystemthat will includeat a minimum:
维护的标准操作规程应包括系统的日常检查，至少包含以下内容：
- screen alarm log check;
- 屏幕报警日志检查
- visual inspection of system for faults: e.g.Leaks, vibrations;
- 系统错误的目视检查，如泄漏，震动
- check of free chlorine orchlorine dioxide (CD) levels at critical samplepoints and:
- 关键取样点余氯和二氧化碳水平的检
- other critical parameterslike pressure, flow that arenot saved to a historyfile on the screenalarm log check.
- 其他不在屏幕报警日志检查历史文件中保存的关键参数，如压力、流量
10.2 Filter replacement
过滤器更换
10.2.1 Filter replacementshall always be accompaniedby an inspection of the cartridge surfacetodetect changes in system operation.For pretreatment filtersthat shall be based on differential pressure,time orother relevant parameter, Standard OperatingProcedures (SOP) shall be provided.
过滤器更换应同时检查卡盘表面，以检测系统运行的变化。对于应基于差压、时间或其他相关参数的预处理过滤器，应提供标准操作程序(SOP)。
10.2.2 Any out of theordinary discoloration, buckling, surface crushing orsagging shall be reported andinvestigated.
任何异常变色、弯曲、表面破碎或下垂，应当予以报告和调查。
10.3 Chlorine instrumentation
氯检测仪器
10.3.1 A chlorine metermeasuring zero chlorineusually needs maintenance every2-3 months. TheexactStandard Operating Procedure (SOP) shallbe written up on the basis of manufacturer's instructions.
测量余氯的仪表通常需要每 2-3 个月维护一次。具体的标准操作程序 (SOP) 应根据制造商的说明进行编写。
10.3.2 If Oxidation-Reduction Potential(ORP) instrumentation is installed,usually in conjunction withSBSdosage, the instrument shall becleaned and checked every month.
如果安装了氧化还原电位(ORP) 仪器(通常与 SBS 联用)，则应每月清洁和检查仪器。
10.4Carbon dioxide
二氧化碳
10.4.1 A degasification step shallbe installed when incomingCO2 can pass 10 ppm level.
当引入CO2 的浓度达到10 ppm 时，应安装脱气步骤。
10.4.2 Either NaOHdosing or contact membranes maybe used.
NaOH或接触膜均可使用。
10.4.3 If contact membranesare considered, clean, dry, oil free airshall be used as the sweep gas. Oil orothercontaminants in thesweep air can clog the membrane and render it useless.
如果考虑接触膜，应使用洁净、干燥、无油的空气作为吹扫气体。吹扫气体中的油或其他污染物会堵塞膜并使膜失效。
10.4.4 If incoming CO2 levelscan pass 40 ppm then two membranes in seriesshall be installed.
如果引入的 CO2 水平超过 40 ppm，则应安装两个膜串联。
10.4.5 NaOH dosing shall be realizedafter the first stageRO; the dosing shallbe controlled with onlinepH monitoring.
应在RO第一阶段之后实现NaOH 给药；给药应使用在线pH监测控制。
10.5MembraneIntegrity for polishing UF
超滤膜完整性
10.5.1 Membrane integritytests for polishing UF shall be performedto identify membrane moduleswith breaches.
应执行精制超滤膜的完整性测试，以确定是否破损。
10.5.2 The selectionof integrity monitoring method is dependent uponmembrane supplier or watersystems supplier's recommendation.
完整性监测方法的选择取决于膜或水系统供应商的建议。
10.5.3 Polishing UF shall pass the integritytests on a regular basis, per recommendation ofsuppliers/manufacturesbut not less than twicea year.
精制超滤膜应定期根据供应商/制造商的建议进行完整性测试，且每年不少于两次。
10.5.4 Membrane replacementshall be performed on the basisof the integrity tests results.
应根据完整性测试结果更换膜。
See Annex D for configuration oftypical integrity test
有关典型完整性测试的配置，请参阅附录D
11 Specific Good Manufacturing Practice (GMP) requirements
特定GMP要求
11.1 General
一般要求
11.1.1 This clause describes specificGood Manufacturing Practicerequi rements such as for monitoringandtesting that shall be metto demonstrate that the system is operatingwithin the predeterminedacceptance criteria and the systemis maintained in a stateof control.
本条款描述了特定的GMP要求，例如监测和测试，以证明系统运行符合既定的接受标准，且保持在受控状态.
11.1.2 Physical breaks shall beprovided at all drain lines.
所有排水管路均应物理隔断。
11.1.3 Physical breaks shall be atleast 50 mm.
物理隔断至少为50mm。
11.1.4 There shall be no pipingbypass on filters.
过滤器上不得有管道旁路。
11.1.5 There shall be separation betweensystems to protectagainst cross contamination, e.g. industrialsteamand PW/WFI. Air breaks, non-return valves and cut-offvalves may be used.
不同系统应进行隔离以防止交叉污染，例如工业蒸汽和 PW/WFI。可使用气闸、止回阀和截止阀。
11.1.6 System monitoringand recording shall be established as following.
系统监测和记录应按如下规定进行。
- Alert limits shall be establishedfor all system operatingparameters that will beused on a regularbasis to ensurethat the system is operatingproperly;
- 应对所有日常使用的系统运行参数建立警戒限，以确保系统正常运行;
Action limits shall beestablished based on maximum operating parametersto ensure system andassociatedequipment or products are not compromised;
- 应根据最大运行参数制定行动限，以确保系统和相关设备或产品不受影响；
- Testingat sample points to the established standards shall be completed as part of theongoing monitoring of the water system and;
- 取样点进行既定标准的测试应作为持续监测水系统的一部分完成;并应完成对水系统的监测。
- Thetesting shall confirm that the water specifications are met and the integrityof the distribution system is maintained.
- 测试应确认符合水质标准，并维持分配系统的完整性。
11.2 Safety considerations
安全考虑
11.2.1Aschlorine dioxide (CD) is a dangerous substance in high concentration, wherebyfumes are liable to explode and are toxic._Only custom made equipment fromrespectable suppliers shall he used to generate small amounts ofen forimmediate dosage and use in system.
由于二氧化氯(CD)是一种高浓度的危险物质,因此烟雾容易爆炸,并且有毒。只有定制设备从可敬的供应商,他应用来产生少量的立即剂量和系统使用。
11,2.2Hot water sanitization (HWS): suitable harriers and/or signage shall he usedfor personnel protection from hot surfaces during sanitization.
热水消毒 (HWS): 在消毒过程中,应使用合适的护炉和/或标牌进行人员保护,防止热表面。
11.2.3Suitable signage of chemicals and hot surfaces shall be used.
应使用适当的化学品和热表面标志。
11.3Commissioning and qualification requirements
调试和确认要求
11.3.1Pressure testing.
压力测试
11.3.2 Piping/tubing and equipment flushing.
管道和设备冲洗
11.3.3 Design Qualification (DQ), Installation Qualification (IQ), OperationalQualification (OQ) and Performance Qualification (PQ) protocols.
设计确认 (DQ)、安装确认 (IQ)、运行确认 (OQ) 和性能确认 (PQ) 方案。
12 Control philosophy
控制原理
12.1Minimum control loops needed for installation
安装所需的最小控制环路
- watertank level control;
- 水罐液位控制
- watertank temperature control;
- 水罐温度控制
- Electricscale control (ESC) operation;
- 电子除垢操作
- Hydrooptical dechlorination (HOD) operation;
- 水力光学脱氯(HOD)操作;
- RO-CEDI skid operation;
- RO-CEDI撬装操作
- pressurecontrol of RO feed water;
- RO进水压力控制
- pressurecontrol of HP RO pump and;
- 高压RO泵压力控制
- Temperatureand during the sanitization from the supplied water inlet to the CDI/ED I/CEDIoutlet.
- 温度和供水进口到CDI/EDI/CEDI 出口的消毒。
12.2Automation
自动化
Anautomated process monitoring and process control system shall be implemented inthe water system Computer (PC) or control panel.
水系统计算机（PC）或控制面板中应实施自动化过程监测和过程控制系统。
13 Alarms
报警
13.1Required alarms
要求的报警
Table3 - Required alarms
表3 要求的报警
Parameter
参数
Alarm
报警
Action
行动
Alarm display
报警显示
Chlorine level after chlorine destruction stage
氯清除后的余氯水平
＞alarm set point
＞报警设置点
The supply valve to the RO unit shall close and open drain valve
关闭RO供水阀并打开排放阀
Y
Conductivity level at CEDI
CEDI电导率
＞alarm set point
＞报警设置点
Recirculate to Supplied Water Tank
再循环到供水罐
Y
13.2Recommended alarms
建议的报警
Table4 - Recommended alarms
表4-建议的报警
Parameter
参数
Alarm
报警
Action
行动
Alarm display
报警显示
Tank low levels
罐低水位
> alarm set-point
＞报警设置点
Alarm and/or pump stop
报警和/或泵停止
Y
Temperature levels high
高温
＞alarm set-point
＞报警设置点
Alarm and/or cooling
报警和/或冷却
Y
Temperature levelslow
低温
＜alarm set-point
＜报警设置点
Alarm and/or heating
报警和/或加热
Y
Conductivity levels high
电导率水平高
＞alarm set-point
＞报警设置点
Alarm and/or fill stop
报警和/或停止入罐
Y
Flow rates high
流量高
＞alarm set-point
＞报警设置点
Alarm
报警
Y
Flow rates low
流量低
＜alarm set-point
＜报警设置点
Alarm and/or system stop
报警和/或系统停止
Y
Pressure levels high
压力高
> alarm set-point
＞报警设置点
Alarm and/or pump stop
报警和/或泵停止
Y
Pressure levels low
压力低
＜alarm set-point
＜报警设置点
Alarm and/or pump stop
报警和/或系统停止
Y
14 Recommended engineeringdocumentation
建议的工程文件
14.1General user guide
通用用户指南
Theminimum documents to be included in the user guide shall be as follows:
用户指南至少应包含如下:
- Pipingand Instrumentation Diagram (P&ID);
- 管道和仪表图(P&ID);
- updatedconsumer table including all design parameters;
- 更新使用指南，包括所有设计参数;
- startup and tuning (water flow quantities, correct instrument readings etc.);
- 启动和调试(水流量、正确的仪器读数等);
- operationinstructions (including system operation parameters);
- 操作说明(包括系统操作参数);
- maintenanceinstructions;
- 维护指南
- componentslist - equipment and devices;
- 组件清单——设备和部件;
- "Toscale" Piping layout drawings and;
- "缩放"的管道布局图和;
- equipmentlayout.
- 设备布局
14.2Instrumentation documentation
检测文件
Theminimum instrumentation documents to be included in the user guide shall be asfollows:
用户指南中应包含的最小检测文档如下:
- instrumentlist;
- 仪器清单
- datasheets;
- 数据表
- operating and calibrating instructions;
- 操作和校准说明;
- "asmade" instrumentation wiring diagrams;
- "竣工"仪表接线图;
- calibration certificates with traceability of the calibrating instrument to international standards and;
- 计量仪器符合国际标准的校准证书;
- original manufacturer catalogue.
- 原始制造商名单
14.3 General piping/ tubing
一般管道
Theminimum general piping/tubing documents to be included in the user guide shall be as follows:
用户指南中至少应包含的一般管道/管道文件如下:
- piping/tubing isometrics;
- 管道单线图
- technicalspecifications (piping/tubing material,wall thickness; pressure rating etc.);
- 技术规格(管道材质、壁厚、压力额定值等);
- materialcertificate;
- 材质证明
- pressure test reports;
- 压力测试报告
- welderqualification certificates;
- 焊工资质证明
- weldinglog and;
- 焊接日志
- cleaningreport (water flush; to clean from construction debris).
- 清洁报告（水冲洗；清理施工垃圾）
14.4 PW/ WFI product piping/ tubing
PW/WFI生产管道
Theminimum PW/WFI piping/tubing documents to be included in the user guide shall be as follows:
用户指南中应至少包含的PW/WFI管道文件如下:
- surfacefinishcertificate;
- 表面光洁度证明
- weldinspection certification;
- 焊接检查证明
- piping/tubing passivation protocol/report and;
- 管道钝化方案/报告;
- video of borescope inspection.
- 内窥镜检查视频。
14.5Tanks
罐
Theminimumtankdocuments to be included in the user guide shall be as follows:
用户指南中至少应包含的罐体文档如下:
- technicalspecifications (tank material, wall thickness,pressure rating etc.);
- 技术规格(罐体材质、壁厚、压力额定值等);
- materialcertificatesand;
- 材质证明
- manufacturer'sdrawing.
- 生产商的图纸
14.6 Pumps
泵
Theminimum pump documents to be included in the user guide shall be as follows:
用户指南中至少应包含的泵的文档如下:
- technicalspecifications (material, graphs, rating etc.);
- 技术规格(材质、图纸、额定值等);
- original manufacturer catalogue;
- 原始制造商列表
- materialcertification and;
- 材质证明
- manufacturer's drawing.
- 制造商的图纸
14.7Insulation
隔热层
The minimuminsulation documents to be induded in the user guide shall be as follows:
用户指南中至少应包含的隔热层文件如下:
- spec forinsulation, without asbestos and without chloride.
- 隔热层规格，不含石棉，不含氯化物。
14.8Signs
标识
The minimumsigns to be posted on and around the system shall be as follows:
至少应在系统及其周边张贴如下标识:
- Allequipment shall be marked. This includes instruments, manual valves, pneumatic valvesandany other equipment supplied.
- 所有设备均应标识。包括仪器、手动阀门、气动阀门，以及其他任何设备。
- Allelectrical and instrument wires shall be marked according to client standard.
- 所有电气和仪表导线均应按照客户标准进行标记。
- Pipingshall be marked with the relevant fluid and the flow direction.
- 管道应标明相关内容物和流动方向。
14.9Software
软件
Theminimum software documents to be included in the user guide shall be as follows:
用户指南中至少应包含的软件文档如下:
- detailedscheduleof system operation- Functional Design Specification (FDS);
- 系统操作的详细计划-功能设计规范CFDS;
- softwarecomponent data sheet;
- 软件组件数据表;
- listofmessages and warnings;
- 消息和警告列表;
- softwarecode;
- 软件代码graph list and printout;
- 图表列表和打印件;
- synopticscreen list and printout;
- 概要列表和打印件;
- functionalscreenlistand printout and;
- 功能检查列表和打印件;
- softwaredocumentation - software documentation and human services data specification (HSDS).
- 软件文档 - 软件文档和人工服务数据规范 (HSDS)。
14.10Electrical documentation
电气文档
Theminimumelectricaldocumentsto be included in the user guide shall be as follows:
用户指南中至少应包含的电气文档如下:
- listofallrelevant electric components;
- 所有相关电气部件的列表
- "asmade"electrical wiring diagrams;
- 电气接线竣工图
- grounding reports;
- 接地报告
- electricalcupboard layout and;
- 电柜布局
- electricalcupboard specification.
- 电柜规格
14.11Factory acceptance test (FAT) protocol
工厂验收测试（FAT）方案
TheminimumFATdocumentstobe includedinthe user guide shall be as follows:
用户指南中至少应包含 FAT 文档如下:
- pretreatmentskid(protocolandreport);
- 预处理skid（方案和报告）
- RO-CEDI skid (protocol and report) and;
- RO-CEDIskid (方案和报告)
- tank(protocolandreport).
- 罐（方案和报告）
14.12 IQ/ OQ protocol
IQ/OQ方案
This protocolis a minimum requirement for validationof the systems.
此方案是系统验证的最低要求。
14.13 Spare parts list
备件清单
The minimum spare partslists to be includedin the user guideshall be as follows:
用户指南中至少应包含的备件清单如下:
- criticalspare parts list and;
- 关键备件清单
- general spareparts list.
- 通用备件清单
AnnexA
附录A
(informative)
（资料性附录）
Examples of PW production systems
纯化水生产系统案例
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Annex B
附录B
(informative)
（资料性）
Examples of feed water categories
原水分类案例
Table B,l - Specification orfeed water
原水的标准
Water parameter
水参数
Typical
典型
High bioburden and high organics
高生物负荷和高有机物
High hardness
高硬度
High silica/high iron/ high manganese
高硅/高铁/高锰
TOC
≤30 ppm
＞30 ppm
≤30 ppm
≤30 ppm
pH
≤8.0
≤8.0
≤8.0
≤8.0
Conductivity
电导率
(at 25℃)
≤600uS/cm
≤600uS/cm
＞600uS/cm
≤600uS/cm
Hardness
硬度
≤300 ppm CaCO3
≤300 ppm CaCO3
＞300 ppm CaCO3
≤300 ppm CaCO3
Microbial Total Count
微生物总数
＜500cfu/ml
≥500cfu/ml
＜500cfu/ml
＜500cfu/ml
Total Coliforms, Pseudomonas, E. coli, Fungus
总大肠菌，假单胞菌，大肠杆菌，真菌
＜1cfu/100ml
＞1cfu/100ml
＜1cfu/100ml
＜1cfu/100ml
CO2 level
CO2含量
≤30ppm
≤30ppm
＞30ppm
≤30ppm
Total Silica
总硅
＜12ppm
＜12ppm
＜12ppm
≥12ppm
Iron
铁
＜0.2ppm
＜0.2ppm
＜0.2ppm
≥0.2ppm
Manganese
锰
＜0.01ppm
＜0.01ppm
＜0.01ppm
≥0.01ppm
Water may be characterized on the basis of one criterion or more. The high range of measured parameters shall always be used.
水可以根据一项或一项以上标准来表示。应始终使用测量参数的范围上限。
AnnexC
附录C
(informative)
（资料性）
System selection table
（系统选择表）
Table C.1 – system selection table(see Annex A)
系统选择表（见附录A）
Process
工艺
Sanitant
消毒
Initial filtration
初过滤
Anti-scaling
抗垢
Sanitant removal
消毒剂清除
Production
生产
CO2 reduction
除CO2
Polishing
精制
Feed
原水
Final product
最终产品
CL2
CD
DF/MF
UF/MF
MMF
Softener
AS
ESC
ACF
SBS
UV
SPRO
DPRO
NaOH
Degassing
CEDI
UF
Typical
(A.1.)
典型（A.1）
PW
纯化水
P
P
P
P
R
P
P
R
NR
P
R
R
P
P
R
R
P
WFI
注射用水
P
P
P
P
R
P
P
R
NR
P
R
NR
R
P
R
R
R
High Bioburden and high organics(A.2.)
高生物负荷和高有机物（A.2）
PW
纯化水
P
P
P
R
P
P
P
R
NR
P
R
P
R
P
R
R
R
WFI
注射用水
P
P
P
R
P
P
P
R
NR
P
R
NR
R
P
R
R
R
High Hardness (A.3.)
高硬度（A.3）
PW
纯化水
P
P
P
P
R
P
P
R
NR
P
R
P
R
NR
R
R
P
WFI
注射用水
P
P
P
P
R
P
P
R
NR
P
R
NR
R
NR
R
R
R
High Silica/High Iron/ High Manganese(A.3.)
高硅/高铁/高锰（A.3）
PW
纯化水
P
P
P
P
R
NR
P
R
NR
P
R
P
R
P
R
R
P
WFI
注射用水
P
P
P
P
R
NR
P
R
NR
P
R
NR
R
P
R
R
R
Guideline forthe system selection table(Table C.l)
系统选择表指南(表C.l)
a) Only one optionshall be selectedfor every processstage apart from thepolishingstage;
除精制阶段外，每个工艺阶段只需选择一个选项;
b) A 1-micronfilter shallbe installedpostCDI/EDI/CEDIforas aparticle trap;
在 CDI/EDI/CEDI 后，应安装一个 1 微米过滤器以过滤颗粒;
c) A polishingUltra Filtration (UF)unit shall beinstalled as an addition to CDI/EDI/CEDIand not inplace of the CDI/EDI/CEDI;
精制超滤(UF) 装置应安装作为CDI/EDI/CEDI 的补充，而不是代替CDI/EDI/CEDI;
d) The table details onlymain process equipment,break tanks,heatexchangers, micron filterswere not detailedeven though theyshall be part ofthe system and;
表中仅详细说明了主要工艺设备，缓冲罐、热交换器、微过滤器则未详细说明，尽管它们是系统的一部分;
e) Pre RO filtrationshall bestaged, first stage5-10 micron,second stage 3-5 micron.
RO前过滤应分阶段进行，第一阶段5-10微米，第二阶段3-5微米。
Annex D
附录D
(informative)
（资料性）
Configuration of typical integrity test for polishing UF
精制超滤典型完整性测试的结构
When a membrane is used for a long period of time, the membranemodule can be damaged due to physical defect s or chemical deterioration.
当膜长时间使用时，膜模块可能会由于物理缺陷或化学变质而损坏。
This can cause deterioration in membrane separation performancebut may not be apparent in monitored water quality. Therefore, it is necessaryto monitor the membrane integrity during the system operation.
这可能导致膜过滤性能的恶化，但在监测的水质中可能并不明显。因此，在系统运行过程中，有必要监测膜的完整性。
These techniques include direct integrity monitoring and indirectintegrity monitoring. Direct integrity monitoring can ensure free of anyintegrity breaches. Indirect integrity monitoring involves surrogatemeasurement of membrane integrity. The selection of integrity monitoring methodis dependent upon membrane supplier's recommendation,
这些技术包括直接完整性监测和间接完整性监测。直接完整性监测可确保没有任何完整性破坏。间接完整性监测涉及膜完整性的替代检测。完整性监测方法的选择取决于膜供应商的建议。
See Figure D,1 below
见图D.1
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