6.5.1.1 The distribution of BPW, BHPW and BWFI should be accomplished using a continuously circulating pipework loop. Proliferation of contaminants within the storage tank and distribution loop should be controlled. Good justification for using a non-recirculating one-way system should be provided.
BPW，BHPW和BWFI的分配应采用连续的循环管道回路。贮罐和分配回路中污染物的沉积需要进行控制。如果采用非循环的单路系统，则需要提供非常好的论述。
6.5.1.2 Filtration should not usually be used in distribution loops or at take off user points to control biocontamination. Such filters are likely to conceal system contamination.
过滤器一般不常用在分配循环里，或在使用点来控制生物污染。这种过滤器可能会隐藏系统污染。
6.5.2 Temperature control and heat exchangers 温度控制和换热器
6.5.2.1 Where heat exchangers are employed to heat or cool WPU within a system, precautions should be taken to prevent the heating or cooling utility from contaminating the water. The more secure types of heat exchangers of the double tube plate or double plate and frame or tube and shell configuration should be considered. Where these types are not used, an alternative approach whereby the utility is maintained and monitored at a lower pressure than the WPU may be considered. The latter approach is not usually adopted in BWFI systems.
如果采用换热器对一个系统的WPU进行加热或冷却，要预防加热或冷却设施对水的污染。应考虑较为安全的双管板或双板，板框或换热管和壳的参数需要考虑。如果没有采用这些类型，也可以采用替代的方式，但换热设施的维护和监控应在WPU可能考虑的更低的压力下进行。后者在BWFI系统中不常采用。
6.5.2.2 Where heat exchangers are used they should be arranged in continually circulating loops or subloops of the system to avoid unacceptable static water in systems.
如果采用了换热器，则换热器安装应使其处于系统连续循环管路中，或支路中，以避免对系统产生不可接受的静止水。
6.5.2.3 When the temperature is reduced for processing purposes the reduction should occur for the minimum necessary time. The cooling cycles and their duration should be proven satisfactory during the qualification of the system.
如果为了处理的目的降低温度，则降温时长应限制到所需的最短时间。冷却循环和其时长的满意度应在系统验证时进行证明。
6.5.3 Circulation pumps 循环用泵
6.5.3.1 Circulation pumps should be of a sanitary design with appropriate seals that prevent contamination of the system. Where stand-by pumps are provided, they should be configured or managed to avoid dead zones trapped within the system.
循环泵应为隔膜设计，适当密封，可以防止对系统的污染。如果采用了备用泵，则其配置或管理应能避免在系统内产生死角。
Consideration should be given to preventing contamination in systems where parallel pump systems are used, especially if there is stagnant water when one of the pumps is not being used.
如果采用平行泵系统，需要考虑防止系统中的污染，尤其是如果其中一个泵不使用时会有死水的情况。
6.5.4 Biocontamination control techniques 生物污染控制技术
6.5.4.1 Water purification systems should be sanitized using chemical or thermal sanitization procedures as appropriate (production and distribution). The procedure and conditions used (such as times and temperatures) should be suitable.
水纯化系统应采用化学或热力学消毒程序在适当时（产水和分配）进行消毒。程序和使用的条件（例如次数和温度）应适当。
6.5.4.2 The following control techniques may be used alone or more commonly in combination: 以下控制技术可以单独采用或联合采用（更常见）
? maintenance of continuous turbulent flow circulation within water distribution systems
reduces the propensity for the formation of biofilms;
? 在循环系统中维持水流的湍流环境，降低微生物膜生成的倾向 ? the system design should ensure the shortest possible length of pipework; ? 系统设计应保证管道长度尽可能最短
? for ambient temperature systems, pipework should be isolated from adjacent hot pipes; ? 室温系统的管道应与邻近的热管道隔离
? deadlegs in the pipework should be minimized through appropriate design, and as a guide
should not significantly exceed three times the branch diameter as measured from the ID pipe wall to centre line of the point-of-use valve where significant stagnation potential exists;
? 管道上的死角应通过合理的设计尽可能减少，作为指南，要求死管长度不能超过支管直
径的3倍，死管长度测量应从ID管壁量至使用点阀门的中心线，那里，可能会产生死水 ? pressure gauges should be separated from the system by membranes; ? 压力表应与系统采用膜隔离
? hygienic pattern diaphragm valves should be used; ? 采应用卫生隔膜阀
? pipework for steam-sanitized systems should be sloped and fully drainable; ? 蒸汽灭菌管道应有坡度，可以完全排空 ? the growth of microorganisms can be inhibited by: 微生物的滋生可以采用以下措施抑制
1) ultraviolet radiation sources in pipework;
管道上的紫外辐射源
2) maintaining the system heated (greater than 65 °C); 系统保持加热（大于65°C）
3) sanitizing the system periodically using hot water (guidance temperature > 70°C); 系统采用热水周期消毒（指导温度> 70°C）
4) sanitizing the system periodically using superheated hot water or clean steam; 采用超热水或洁净蒸汽周期性消毒
5) routine chemical sanitization using ozone or other suitable chemical agents. When chemical sanitization is used, it is essential to prove that the agent has been removed prior to using the water. Ozone can be effectively removed by using ultraviolet radiation.
采用臭氧或其它适当的化学试剂进行常规化学消毒。如果采用了化学消毒，则需要证明在使用水
之前，这些化学试剂已经被消除。臭氧可以采用紫外辐射有效清除。
7. Operational considerations 操作时的考虑 7.1 Start-up and commissioning of water systems 启动水系统。
7.1.1 Planned, well-defined, successful and well-documented commissioning and qualification is an essential precursor to successful validation of water systems.
计划好、很好地定义、成功地很好地记录运行情况，确认是水系统成功验证的一个基本前提。 7.1.2 The commissioning work should include setting to work, system set-up, controls, loop tuning and recording of all system performance parameters. If it is intended to use or to refer to commissioning data within the validation work then the quality of the commissioning work and associated data and documentation must be commensurate with the validation plan requirements. 调试工作应包括工作设置、系统设置、控制、回路调整，和记录所有系统性能参数。如果想要或引用调试数据用于验证工作，则调试工作的质量和产生的数据和文件必须符合验证计划的要求。
7.2 Qualification 确认
7.2.1 WPU, BPW, BHPW and BWFI systems are all considered to be direct impact, quality critical systems that should be qualified. The qualification should follow the validation convention of design review or design qualification (DQ), IQ, OQ, and PQ.
WPU, BPW, BHPW和BWFI系统均被认为是产生直接影响，对质量较为关键的系统，因此均需要进行确认。确认应根据验证习惯进行设计回顾或设计确认（DQ），IQ，OQ和PQ。 7.2.2 This guidance does not define the standard requirements for the conventional qualification stages DQ, IQ and OQ, but concentrates on the particular PQ approach that should be used for WPU systems to demonstrate their consistent and reliable performance. A three-phase approach should be used to satisfy the objective of proving the reliability and robustness of the system in service over an extended period.
本指南并未对传统的DQ, IQ和OQ确认阶段界定标准要求，但对WPU系统所应采用的特殊的PQ方法比较关注，该方法应证明其持续可靠的性能。应采用三阶段方式来满足证明其可靠耐用的特性，说明系统可以在一个很长时间内正常工作。
Tests on the source water must be included within the validation programme and continued as part of the routine monitoring. The source water should meet the requirements for drinking-water and any internal specification.
对源水的检测应包括在验证计划中，并持续作为日常监控的一部分。源水应符合饮用水要求和所有内部质量标准。
Phase 1. Sample daily or continuously monitor the incoming feed-water to verify its quality.
第一阶段：对进水每天取样或进行持续监控以确认其质量
A test period of two weeks should be spent monitoring the system intensively. During this period, the system should operate continuously without failure or performance deviation. Usually water is not used for finished pharmaceutical product (FPP) manufacturing during this period. The following activities should be included in the testing approach.
对系统进行加密监控应持续两周。在此期间，系统应持续运行，不应有失败或性能偏差。一般这时，水不可以用于制剂生产。检测应包括以下活动
? Undertake chemical and microbiological testing in accordance with a defined plan. ? 根据制订的计划，进行化学和微生物检测
? Sample or continuously monitor the incoming feed-water daily to verify its quality. ? 对供水样品每天取样或进行连续监控以确认其质量
? Sample or continuously monitor after each step in the purification process. ? 在每个纯化处理步骤后进行取样或连续监控
? Sample or continuously monitor at each point of use and at other defined sample points. ? 对每个使用点和其它取样点进行取样或进行连续监控 ? Develop appropriate operating ranges. ? 建立适当的操作范围
? Develop and finalize operating, cleaning, sanitizing and maintenance procedures. ? 建立和定稿操作、清洁、消毒和维护程序
? Demonstrate production and delivery of product water of the required quality and quantity. ? 证明可以生产和输送要求质量和数据的水
? Use and refine the standard operating procedures (SOPs) for operation, maintenance,
sanitization and troubleshooting.
? 使用和定义操作、维护、消毒和问题解决标准操作规程（SOP） ? Verify provisional alert levels. ? 确认有条件的警戒水平
? Develop and refine test-failure procedure.
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