WHO水系统 GWCZ-2016-008_中英文(4)

feed-water to downstream treatment stages, should be reviewed and the result of the review documented.

应进行趋势分析以发现趋势。如果饮用水质量有显著变化，但仍在质量标准范围内，应审核作为WPU直接使用，或作为下游处理用源水的情况，审核结果应有书面记录。

5.2.6 Where drinking-water is derived from an ―in-house‖ system for the treatment of raw water, the water-treatment steps used and the system configuration should be documented. Changes to the system or to its operation should not be made until a review has been completed and the change approved by the QA department in accordance with change control procedures.

如果饮用水由公司内部对原水进行处理产生，则所使用的水处理步骤和系统配置应有记录。对该系统或其操作的变更只有在审核完成后，才能进行，变更应由QA部门根据变更控制程序批准。

5.2.7 Where drinking-water is stored and distributed by the user, the storage systems must not allow degradation of the water quality before use. After any such storage, testing should be carried out routinely in accordance with a defined method. Where water is stored, the system design and operation should ensure a turnover or recirculation of the stored water sufficient to prevent stagnation.

如果饮用水由使用者存贮并分发，则存贮系统必须保证水质量在使用前不会降低。在存贮之后，应根据定义的检测方法进行常规检测。如果水是被存贮的，系统设计和操作应保证所存贮的水的周转或循环足以防止死水。

5.2.8 The drinking-water system is usually considered to be an ―indirect impact system‖ and does not need to be qualified.

饮用水系统一般被认为是一个“间接产生影响系统”，不需要进行确认。

5.2.9 Drinking-water purchased in bulk and transported to the user by tanker has additional problems and risks not associated with drinking-water delivered by pipeline. Vendor assessment and authorized certification activities, including confirmation of the acceptability of the delivery vehicle, should be undertaken in a similar way to that used for any other starting material. 如果饮用水是散装采购，采用槽罐运至使用者处会有另外的问题和风险，这些问题是管道输送的饮用水所没有的。供应商评估和有资质的活性，包括对运输卡车的可接受性确认，均应采用与其它起始物料相似的方法进行。

5.2.10 Equipment and systems used to produce drinking-water should be able to be drained and sanitized. Storage tanks should be closed with appropriately protected vents, and should allow for visual inspection and for being drained and sanitized. Distribution pipework should be able to be drained or flushed and sanitized.

用于产生饮用水的设备和系统应可以排空和消毒。贮罐应采用适当的保护阀关闭，应可以进行目视检查，可以排空和消毒。分配管道应可以排空或吹扫和消毒。

5.2.11 Special care should be taken to control microbiological contamination of sand filters, carbon beds and water softeners. Once microorganisms have infected a system, the contamination can rapidly form biofilms and spread throughout the system. Techniques for controlling contamination such as back-flushing, chemical and/or thermal sanitization and frequent regeneration should be considered as appropriate.

需要特别注意控制砂滤、活性碳床和水软化剂产生的微生物污染。一旦微生物感染了一个系统，污染可以迅速形成生物膜，在整个系统中蔓延。控制污染的技术，如反冲、化学和/热力学消毒和频繁再生可以作为是适当的方式。 5.3 Production of purified water 纯化水生产

5.3.1 Any appropriate qualified purification technique or sequence of techniques may be used to prepare purified water (PW). PW is commonly produced by ion exchange, RO, ultrafiltration and/or electro-deionization processes and distillation.

所有适当确认过的纯化技术，或一系列纯化技术均可以用于制备纯化水（PW）。PW一般采用离子交换、反渗透膜、超滤和/或电子去离子工艺和蒸馏。

5.3.2 The following should be considered when configuring a water purification system or defining user requirement specifications (URS):

在配置水纯化系统或起草用户需求手册（URS）时需要考虑的内容 — the feed-water quality and its variation over seasons; — 源水质量和其随季节变动情况 — the quantity of water required by the user; — 使用者要求的水量

— the required water-quality specification; — 要求的水质量标准

— the sequence of purification stages required; — 要求的纯化步骤顺序 — the energy consumption; — 能耗

— the extent of pretreatment required to protect the final purification steps; — 能保持最终纯化步骤所要求的预处理程度

— performance optimization, including yield and efficiency of unit treatment-process steps; — 性能优化，包括单元处理步骤的产水率和效率

— appropriately located sampling points designed in such a way as to avoid potential

contamination;

— 适当选择的取样点，其选择应可以避免潜在污染

— unit process steps should be provided with appropriate instrumentation to measure parameters

such as flow, pressure, temperature, conductivity, pH and total organic carbon.

— 单元处理步骤应提供适当的仪表，以测量参数，如流量、压力、温度、电导率、pH值和

总有机碳

5.4 Production of highly purified water 高纯水的生产

5.4.1 Highly purified water (HPW) can be produced by double-pass reverse osmosis coupled with ultrafiltration or by any other appropriate qualified purification technique or sequence of

techniques. ）可以采用两级反渗透膜配以超滤装置生产，也可以采用其它适当确认的纯化高纯水（HPW

技术或一系列纯化技术。

5.4.2 The guidance provided in section 5.3 for PW is equally applicable to HPW. 在5.3部分的PW指南也同样适用于HPW。 5.5 Production of water for injection(s) 注射用水的生产

5.5.1 Some pharmacopoeias prescribe or limit the permitted final water purification stage in the production of BWFI. Distillation is the preferred technique; it is considered a more robust technique based on phase change, and in some cases, high-temperature operation of the process equipment.

有些药典描述或限制了BWFI制备的最终纯化步骤。蒸馏是首选技术，基于其阶段性的变化，被认为是较为耐用的技术。因为在有些情况下，工艺设备会采用高温操作。

5.5.2 The following should be considered when designing a water purification system and defining URS:在设计水纯化系统和起草URS时应考虑以下内容 — the feed-water quality; — 源水质量

— the required water quality specification; — 要求的水质量标准 — the quantity of water; — 水量

— the optimum generator size or generators with variable control to avoid over-frequent start/stop

cycling;

— 理想的产水量，变动控制以避免频繁开关机 — blow-down and dump functions; — 吹扫和排空功能

— cool-down venting to avoid contamination ingress. — 呼吸阀以避免污染进入

5.5.3 The system configuration guidance provided in section 5.3 for PW is equally applicable to water for injection.

在第5.3部分的PW系统参数指南同样适用于注射用水。 6. Water storage and distribution systems 水存贮和分配系统

6.1 This section applies to WPU systems for PW, BHPW and BWFI. The water storage and distribution should work in conjunction with the purification plant to ensure delivery of water of consistent quality to the user points, and to ensure optimum operation of the water purification equipment.

本部分适用于PW, BHPW和BWFI的WPU系统。水存贮和分配系统应与精制车间联合工作，以保证向使用点输送的水质量保持一致，并保证水纯化设备的最优操作。

6.1 General 概述

6.1.1 The storage and distribution system should be considered as a key part of the whole system and should be designed to be fully integrated with the water purification components of the system. 存贮和分配系统应作为整个系统的关键部件来考虑，其设计应与水纯化部件完全结合。 6.1.2 Once water has been purified using an appropriate method it can either be used directly or, more frequently, it will be fed into a storage vessel for subsequent distribution to points of use. The following text describes the requirements for storage and distribution systems and point of use (POU).

一旦水被采用适当的方式纯化，则其可以直接用于，或，更常见的，注入贮罐中，分配至各个使用点。下文描述了存贮和分配系统和使用点（POU）的要求。

6.1.3 The storage and distribution system should be configured to prevent microbial proliferation and recontamination of the water (PW, BHPW, BWFI) after treatment. It should be subjected to a combination of online and offline monitoring to ensure that the appropriate water specification is maintained.

存贮和分配系统的配置应能防止微生物滋生，和在处理之后的水（PW, BHPW, BWFI）被再次污染。应采用在线和离线结合的监控方式来保证维持适当的水质。 6.2 Materials that come into contact with systems for water for pharmaceutical use 与药用水系统接受的材质

6.2.1 This section applies to generation equipment for PW, BHPW and BWFI and the associated storage and distribution systems.

本部分适用于PW，BHPW和BWFI制水系统，及其配套的存贮和分配系统。

6.2.2 The materials that come into contact with WPU, including pipework, valves and fittings, seals, diaphragms and instruments, should be selected to satisfy the following objectives.

与WPU接触的材质，包括管道、阀门和配件、封口、隔膜和仪表，其选择均应满足以下要求

? Compatibility. The compatibility and suitability of the materials should encompass the full

range of its working temperature and potential chemicals that will come into contact with the system at rest, in operation and during sanitization.

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