WHO水系统 GWCZ-2016-008_中英文(3)

4.1 Product licensing authorities specify the minimum grade of WPU that must be used during the manufacture of the different dosage forms or for different stages in washing, preparation, synthesis, manufacturing or formulation.

产品许可批准中指定了在不同剂型，或清洁、制备、合成、生产或配方时所必须使用的最低级别的WPU。

4.2 The grade of water used should take into account the nature and intended use of the intermediate or finished product and the stage in the manufacturing process at which the water is used. 使用何级别的水，应考虑中间体或成品的特性及使用目的，和生产工艺中使用水的步骤。 4.3 BHPW can be used in the preparation of products when water of high quality (i.e. very low in microorganisms and endotoxins) is needed, but the process stage or product requirement does not include the constraint on the production method defined in some of the pharmacopoeial monographs for BWFI.

BHPW可以用于需要更高质量的水（即低的微生物和内毒素），但工艺步骤或产品要求对水的制备方法在某些药典中对BWFI没有严格限制的情况下药品生产。

4.4 BWFI should be used in the manufacture of injectable products for dissolving or diluting substances or preparations during the manufacturing of parenterals, and for manufacture of sterile water for preparation of injections.

BWFI应用于注射级产品生产中的物质的溶解或稀释，或在注射剂生产过程中制备，以及注射制剂用无菌水的生产。

BWFI should also be used for the final rinse after cleaning of equipment and components that come into contact with injectable products as well as for the final rinse in a washing process in which no subsequent thermal or chemical depyrogenization process is applied.

BWFI还应用于注射级产品生产设备的清洁后淋洗，以及与注射级产品接触的部件表面的清洁后淋洗，以及无热力学或化学去热源工艺中洗涤工艺的最终淋洗。

4.5 When steam comes into contact with an injectable product in its final container or with equipment for preparing injectable products, it should conform to the specification for BWFI when condensed. 如果蒸汽会与注射级产品在最终包装容器中有接触，或与制备注射级产品的设备有接触，则其冷凝水应满足BWFI的质量标准。 5. Water purification systems 水纯化系统

5.1 General considerations 一般考虑

5.1.1 The specifications for WPU found in compendia (e.g. pharmacopoeias) do not define the permissible water purification methods apart from for BWFI (refer to section 3.5). 除BWFI外（参见3.5部分），药典中的WPU质量标准并未指定允许的纯化方法。 5.1.2 The chosen water purification method or sequence of purification steps must be appropriate to the application in question. The following should be considered when selecting the water treatment method:

选择的水纯化方法，或一系列的纯化步骤，必须适用于所要求的目的。以下是在选择水处理方法时应考虑的内容：

— the final water quality specification; — 最终水质量标准

— the quantity of water required by the user; — 使用者所需的水量

— the available feed-water quality and the variation over time (seasonal changes); — 可以得到的进水质量，随时间的变动性（季节性变化）

— the availability of suitable support facilities for system connection (raw water, electricity,

heating steam, chilled water, compressed air, sewage system, exhaust air);

— 适当的支持性系统连接设施可获得性（原水、电、加热蒸汽、冷却水、压缩空气、排水

系统、排气）

— the sanitization strategy; — 消毒策略

— the availability of water-treatment equipment on the market; — 水处理设备在市面上是否可获得

— the reliability and robustness of the water-treatment equipment in operation; — 水处理设备操作中可靠性和耐用性

— the yield or efficiency of the purification system; — 纯化系统的产水率和效率

— the ability to adequately support and maintain the water purification equipment; — 支持和维护水纯化设备的能力

— the continuity of operational usage considering hours/days, days/years and planned downtime; — 操作连续性，考虑小时/天，天/年和计划停机时间

— the total life-cycle costs (capital and operational including maintenance). — 总生命周期成本（固定和操作，包括维保成本）

5.1.3 The specifications for water purification equipment, storage and distribution systems should take into account the following:

水纯化设备、存贮和分配系统的质量标准应考虑以下内容 — the location of the plant room; — 制水间位置

— extremes in temperature that the system will encounter; — 系统会遇到的极端温度

— the risk of contamination from leachates from contact materials; — 接触性材料浸出物污染风险

— the adverse impact of adsorptive contact materials; — 吸收性接触材料负面影响

— hygienic or sanitary design, where required; — 卫生或隔膜设计，需要时 — corrosion resistance; — 防腐蚀

— freedom from leakage; — 无泄漏

— a system configuration to avoid proliferation of microbiological organisms; — 避免微生物滋生的系统配置

— tolerance to cleaning and sanitizing agents (thermal and/or chemical);

— 对清洁和消毒剂的可接受性（热力和/或化学的） — the sanitization strategy; — 消毒策略

— the system capacity and output requirements; — 系统产能和输出要求

— the provision of all necessary instruments, test and sampling points to allow all the relevant

critical quality parameters of the complete system to be monitored.

— 所有必须的仪器、检测和取样点的设置，应使得所有与整个系统有关的关键质量参数可

以被监控

5.1.4 The design, configuration and layout of the water purification equipment, storage and distribution systems should also take into account the following physical considerations: 水纯化设备、存贮和分配系统的设计、配置和平面布置应考虑以下物理性因素 — ability to collect samples; — 采集样品的能力

— the space available for the installation; — 安装空间

— structural loadings on buildings; — 对建筑结构的负重

— the provision of adequate access for maintenance; — 进行维保的许可条款

— the ability to safely handle regeneration and sanitization chemicals. — 安全处理再生和消毒用化学品的能力 5.2 Production of drinking-water 饮用水的制备

5.2.1 Drinking-water is derived from a raw water source such as a well, river or reservoir. There are no prescribed methods for the treatment of raw water to produce drinking-water from a specific raw water source.

饮用水是从原水，如井水，河水或蓄水池制备而成的水。没有描述的方法用于从特定原水制备饮用水。

5.2.2 Typical processes employed at a user plant or by a water supply authority include: 使用者车间或制水供应商典型的处理包括 — desalinization; — 除盐 — filtration; — 过滤 — softening; — 软化

— disinfection or sanitization (e.g. by sodium hypochlorite (chlorine) injection); — 消毒或灭菌（例如，采用次氯酸钠（氯）注射液） — iron (ferrous) removal; — 除铁 — precipitation; — 沉淀

— reduction of concentration of specific inorganic and/or organic materials. — 减少特定的无机和/或有机物质

5.2.3 The drinking-water quality should be monitored routinely to account for environmental, seasonal or supply changes which have an impact on the source water quality.

饮用水质量应进行常规监控，应考虑环境、季节或供应变化可能对源水质量造成的影响。 5.2.4 Additional testing should be considered if there is any change in the raw water source, treatment techniques or system configuration.

如果水源、处理技术或系统参数有变化，应考虑增加检测。

5.2.5 Trend review may be used to identify changes. If the drinking-water quality changes significantly, but is still within specification, the direct use of this water as a WPU, or as the

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