ISO-22519：2019《纯化水与注射用水预处理与生产系》(中英文对照).docx

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 ? 1 Scope 范围 2?Normativereferences 引用标准 3 Terms, definitions andabbreviated terms 术语、定义和缩写术语 4 Design and practices 设计和规范 4.1 Setting system boundaries 确定系统边界 ? 4.1.1?A PW/ WFI Pretreatment and Production system starts at thevalve (inclusive) before the first supplied water filter component/ MMF. PW/WFI?预处理和生产系统的系统边界开始于第一个供水过滤器组件/多介质过滤器之前的阀门(包括阀门)。 4.1.2?APW/?WFIPretreatment and?Production?system end boundary is?atthe?inlet?valve?(inclusive)?ofthe PWjWFI?storagetank or at the?POU if?a tank?is not?installed. PW/WFI?预处理和生产系统的系统边界末端位于PW/WFI?储罐的进水阀(包括)处，如未安装储罐，则位于使用端。 4.1.3?ThePW/WFI?storagetank?should?not?be?includedin the?PW/WFIPretreannent?and?Production. PW/WFI?储罐不应包含在?PW/WFI?预处理和生产系统中。 4.1.4?Industrial treatment?systemsupstreamto the?PW/WFI Pretreatment?and Production.?Including?supplyto?other plant?utilities e.g. steam?boilers,?potable?water?usage,?feed?to cooling?towers?etc.?should?not be?includedin?the PW/?WFI Pretreatment?and Production. PW/WFI预处理和生产上游的工业处理系统。包括向工厂其他公用设施的供应，如蒸汽锅炉、饮用水使用、冷却塔进水等，不应包括在?PW/WFI?预处理和生产系统中。 ? 4.2 General system requirements 系统一般要求 4.2.1?A?build cleanconcept shall?be employed?duringthe?installation of?PW/WFI?Pretreatment?andProductionsystems:?supply?of?piping/?tubingand?equipment?in clean?condition?and?installation methodsthat?prevent?ingress?of?contaminants. 在安装PW/WFI?预处理和生产系统时，应采用洁净施工概念：提供洁净条件下的管道和设备，以及防止污染物进入的安装方法。 4.2.2?Incoming?feed water?shall meet local?standards?or WHO?standards?for?potable?water.?Ifthis?is?notthe?case, additional systems?shall?be?installed to?improve?the?water?feed?parameters before?the?PW/W?FIPretreatment?and?Production. 原水应符合当地标准或世卫组织饮用水标准。否则，则应安装额外的系统，以改善PW/WFI预处理和生产系统前端的进水参数。 4.2.3?The?PW/WFI Pretreatment and?Production?water quality?shall?show?improvement?in?all qualityparameters?as?the?water?advances?through?the system. 越往PW/WFI?预处理和生产系统的后续阶段，水的所有质量参数应越好。 4.2.4?The?following?para