? 兼容性。材质的兼容性和适用性应围绕在运行和消毒过程中，整个工作温度范围，和可
能与系统接触的化学物质。
? Prevention of leaching. All materials that come into contact with WPU should be non-leaching
at the range of working and sanitization temperatures of the system.
? 防止溶出。所有与WPU接触的材质均应在系统的工作范围和消毒温度没有溶出。 ? Corrosion resistance. PW, BHPW and BWFI are highly corrosive. ? 防腐蚀。PW, BHPW和BWFI具有强腐蚀性。
To prevent failure of the system and contamination of the water, the materials selected must be appropriate, the method of jointing must be carefully controlled and all fittings and components must be compatible with the pipework used. Appropriate sanitary specification plastics and stainless-steel materials are acceptable for WPU systems.
为防止系统失效和污染，所选择的材质必须适当，接头方法必须严格控制，所有配件和元件必须与所用的管道相容。对于WPU系统，可以采用适当的卫生级质量塑料和不锈钢材质。 When stainless steel is used it should be at least grade 316. In general 316L or a higher grade of stainless steel is used.
如果采用了不锈钢，则至少应为316级，一般采用316L或更高级别的不锈钢。 The system should be passivated after initial installation or after significant modification. When accelerated passivation is undertaken the system should be thoroughly cleaned first and the passivation process should be undertaken in accordance with a clearly defined documented procedure.
在初次安装或重大改造后，系统应进行钝化。如果要采用加速钝化，则在之前应对系统进行彻底清洁，然后再根据明确定义的书面程序进行加速钝化。
? Smooth internal finish. Once water has been purified it is susceptible to microbiological
contamination and the system is subject to the formation of biofilms when cold storage and distribution are employed. Smooth internal surfaces help to avoid roughness and crevices the WPU system. Crevices can be the source of contamination because of possible of microorganisms and formation of biofilms. Crevices are also frequently sites where can commence. The internal material finish should have an arithmetical average surface roughness of not greater than 0.8 micrometre (Ra). When stainless steel is used, mechanical and
electro-polishing techniques may be employed. Electro-polishing improves the resistance of the stainless-steel material to surface corrosion.
? 内表面光洁。一旦水经过纯化，则极易被微生物污染，在采用冷存贮和分配系统时，系
统极易形成生物膜。内表面光洁度有助于避免WPU系统内的粗糙和裂缝。裂缝可能是污染的来源，因为微生物可能会在这里积聚，形成生物膜。裂缝还通常是最易被腐蚀的地方。内表面抛光后表面粗糙度算术平均应不超过0.8微米（Ra）。如果采用的是不锈钢，可以采用机械和电子抛光技术。电子抛光有助于提高不锈钢材质表面耐腐蚀性。 ? Jointing. The selected system materials should be easily joined by welding in a controlled
manner. The control of the process should include, as a minimum, qualification of the operator, documentation of the welder set-up, work session test pieces (coupons), logs of all welds and visual inspection of a defined proportion of welds, e.g. 100% hand welds, 10% automatic welds. ? 接头。选择的系统材质应易于通过受控焊接方式连接。焊接控制应包括，至少，焊接工
的资质、焊接设备的记录、测试件工作任务、所有焊接点的登记和对要求焊接部分的目视检测，例如，100%手动焊接，10%自动焊接。
? Design of flanges, unions and valves. Where flanges, unions or valves are used they should be
of a hygienic or sanitary design. Appropriate checks should be carried out to ensure that the correct seals and diaphragms are used and that they are fitted and tightened correctly. Threaded connections should be avoided.
? 法兰、连接和阀门设计。如果采用了法兰、连接或阀门，则其应该是卫生或隔膜设计。
应对其进行适当检查，以保证采用的密封和隔膜正确，尺寸适当，正确坚固。应避免死角连接。
? Documentation. All system components should be fully documented and be supported by
original or certified copies of material certificates.
? 文件记录。所有系统部件均应进行完整记录，由原始材质证明或其授权复印件支持。 ? Materials. Suitable materials that may be considered for sanitary elements of the system
include 316L (low carbon) stainless steel, polypropylene, polyvinylidene-difluoride and perfluoroalkoxy. The choice of material should take into account the intended sanitization method. Other materials such as unplasticized polyvinyl-chloride (uPVC) may be used for treatment equipment designed for less pure water such as ion exchangers and softeners.
? 材质。系统的卫生部件选择应考虑选用选用的材质，包括316L（低碳）不锈钢、聚丙烯、
聚偏氟乙烯和全氟烷氧基。材质选择应考虑要使用的消毒方法。其它材质，如，不加增塑剂的聚氯乙烯（uPVC），也可以用于非纯水处理设备，例如离子交换器和软水器。 None of the materials that come into contact with WPU should contain chemicals that will be extracted by the water. Plastics should be non-toxic and should be compatible with all chemicals used. They should be manufactured from materials that should at least meet minimum food grade standards. Their chemical and biological characteristics should meet any relevant pharmacopoeia specifications or recommendations.
所有会与WPU系统的材质均不应含有会被水萃出的化学成分。塑料应无毒，并与所有使用的化学物质相容。这些材质应最少符合食品级标准。其化学和生物特性应符合相关的药典要求或推荐。
Precautions should be taken to define operational limits for areas where water circulation is reduced and turbulent flow cannot be achieved. Minimum flow rate and change volumes should be defined. 应拟定操作限度，以防止水循环降低而达不到湍流速度。要制订最低的流速和变化体积。 6.3 System sanitization and bioburden control 系统消毒和微生物控制
6.3.1 Water treatment equipment, storage and distribution systems used for BPW, BHPW and BWFI should be provided with features to control the proliferation of microbiological organisms during normal use, as well as techniques for sanitizing the system after intervention for maintenance or modification. The techniques employed should be considered during the design of the system and should take into account the interdependency between the materials and the sanitization techniques. 用于BPW, BHPW和BWFI的水处理设备、存贮和分配系统，均应能在正常使用过程中控制微生物的滋生，在维护或改造之后，同样还需进行消毒。在系统设计时应考虑所用的技术，应考虑材质和消毒技术相互依赖性。
6.3.2 Systems that operate and are maintained at elevated temperatures (e.g. > 65) are generally less susceptible to microbiological contamination than systems that are maintained at lower
temperatures. When lower temperatures are required due to the water treatment processes employed or the temperature requirements for the water in use, special precautions should be taken to prevent the ingress and proliferation of microbiological contaminants (see section 6.4.3 for guidance).
在较高温度（例如> 65）下运行和维护的系统，相比在较低温度维护的系统而言，一般更不易受到微生物污染的影响。如果由于所采用的水的处理工艺，或者用水温度有要求，而需要采用低温，则应采取特殊预防措施防止微生物污染物的侵入和滋生（通风指南6.4.3部分）。 6.4 Storage vessel requirements 贮罐要求 6.4.1 General 概述
6.4.1.1 The water storage vessel used in a system serves a number of important functions. The design and size of the vessel should take into consideration the following.
系统中使用的水的贮罐具有很多重要的功能。贮罐的设计和尺寸应考虑以下因素 6.4.2 Capacity 容积
6.4.2.1 The capacity of the storage vessel should be determined on the basis of the following requirements:
贮罐的容积应根据以下要求决定
? It is necessary to provide a buffer capacity between the steady-state generation rate of the
water-treatment equipment and the potentially variable simultaneous demand from user points. ? 需要提供一定的缓冲容积，用平衡制水系统恒定的产水量与使用点可能会变动的需求 ? The water-treatment equipment should be able to operate continuously for significant periods
to avoid the inefficiencies and equipment stress that occur when the equipment cycles on and off too frequently.
? 水处理设备应可以持续相当长的时间，以避免设备过于频繁的开关引起的设备低效率和
设备紧张
? The capacity should be sufficient to provide short-term reserve capacity in the event of failure
of the water-treatment equipment or inability to produce water due to a sanitization or regeneration cycle. When determining the size of such reserve capacity, consideration should be given to providing sufficient water to complete a process batch, work session, tank turnover by recirculation to minimize stagnation, or other logical period of demand.
? 容积应足以提供短时间内的用水量，如制水系统失效，或因为消毒或再生循环时无法产
水的情况。在决定贮存能力时，应考虑能供应一批生产全部用水量，贮罐的周转率以减少水的积存，或其它需求的逻辑时间。
6.4.3 Contamination control considerations 污染控制考虑内容
6.4.3.1 The following should be taken into account for the efficient control of contamination: 应考虑以下内容来有效控制污染
? The headspace in the storage vessel is an area of risk where water droplets and air can come
into contact at temperatures that encourage the proliferation of microbiological organisms. The use of spray-ball or distributor devices should be considered in these systems to wet the surfaces during normal operation, chemical and/or thermal sanitization.
? 贮罐的顶部空间是一个有风险的区域，这里水会滴下来，空气可能进入，温度会使得微
生物滋生。在这种系统里可以考虑使用喷淋球或分配设施，以在常规操作、化学和/或热力学消毒过程中润湿贮罐内表面，
? Nozzles within the storage vessels should be configured to avoid dead zones where
microbiological contamination might be harboured.
? 贮罐内的喷嘴可以适当设计以避免死角，这些死角处可能会产生微生物污染 ? Vent filters are fitted to storage vessels to allow the internal level of liquid to fluctuate. The
filters should be bacteria-retentive, hydrophobic and should ideally be configured to allow in situ testing of integrity. Offline testing is also acceptable. The use of heated vent filters should be considered for continuous hot storage or systems using periodic heat sanitization to prevent condensation within the filter matrix that might lead to filter blockage and to microbial growth that could contaminate the storage vessels.
? 呼吸器安装在贮罐上，以使得内部的液位可以有波动。呼吸器应可以防止细菌存留、不
易被水沾湿，易于在原位进行完整性测试。离线检测也可以接受。在使用连续热存贮时，或采用周期加热消毒系统时，应考虑使用加热过的呼吸器，以防止过滤器内部冷凝可能会导致的过滤器阻塞，以及微生物生长，这种情况下可能会对贮罐造成污染。
? Where pressure-relief valves and bursting discs are provided on storage vessels to protect them
from under- and over-pressurization, these devices should be of a sanitary design. Bursting discs should be provided with external rupture indicators to ensure that loss of system integrity is detected.
? 如果在贮罐上安装了泄压阀和爆破片保护其超低压或超高压，这些装置应为隔膜设计。
爆破片应具有外部破裂指示器，以保证能随时检测到系统的完整性。 6.5 Requirements for water distribution pipework 水分配系统管道要求 6.5.1 General 概述
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