为节约篇幅，之前的链接不发了，自己去那里领。
传送门：在“文章”那一列，自动倒序的（
在“文章”那一列，自动倒序的）。
在“文章”那一列，自动倒序的）。 5.1.7REVERSE OSMOSIS
Reverse osmosis (RO) units use semipermeable membranes. The “pores” of RO membranes are intersegmental spaces among the polymer molecules. They are big enough for permeation of water molecules, but they limit the passage of hydrated chemical ions, organic compounds, and microorganisms. RO membranes can achieve chemical, microbial, and endotoxin quality improvement. Many factors, including pH, temperature, source water hardness, permeate and reject flow rate, and differential pressure across the membrane, affect the selectivity and effectiveness of this permeation. The process streams consist of supply water, product water (permeate), and waste water (reject). Depending on the source water, pretreatment and system configuration variations and chemical additives may be necessary to achieve the desired performance and reliability. For most source waters, a single stage of RO filtration is usually not enough to meet Purified Water conductivity specifications. A second pass of this permeate water through another RO stage usually achieves the necessary permeate purity if other factors such as pH and temperature have been appropriately adjusted and the ammonia from source water that has been previously treated with chloramines is removed.
反渗透(RO)装置使用半透膜。反渗透膜的“孔”是聚合物分子之间的节段间隙。它们大到足以让水分子渗透，但它们限制了水合化学离子、有机化合物和微生物的通过。反渗透膜可以实现化学、微生物和内毒素的质量改进。许多因素，包括pH，温度，水源水硬度，渗透和排斥流量，跨膜压差，影响这种渗透的选择性和有效性。工艺流程由供水、产品水(渗透)和废水(废液)组成。取决于水源，可能需要预处理和系统配置变化以及化学添加剂来实现期望的性能和可靠性。对于大多数水源，单级反渗透过滤通常不足以满足纯净水的电导率规格。如果对其他因素如pH和温度进行适当调整，并去除先前用氯胺处理过的水源水中的氨，则渗透水通过另一个RO级的第二次通过通常会达到必要的渗透纯度。
Concerns associated with the design and operation of RO units include membrane materials that are sensitive to sanitizing agents and to particulate, chemical, and microbial membrane fouling; membrane and seal integrity; and the passage of dissolved gases, such as carbon dioxide and ammonia. Failure of membrane or seal integrity will result in product water contamination. Methods of control involve suitable pretreatment of the influent water stream; appropriate membrane material selection; membrane design and heat tolerance; periodic sanitization; and monitoring of differential pressures, conductivity, microbial levels, and TOC.
与反渗透装置的设计和运行相关的问题包括对消毒剂敏感的膜材料以及对颗粒、化学和微生物膜污染敏感的膜材料;膜和密封完整性;以及溶解气体的通过，如二氧化碳和氨。膜或密封完整性的失效将导致产品水污染。控制方法包括对流入的水流进行适当的预处理;膜材选择适当;膜设计及耐热性;定期的消毒处理;监测压差、电导率、微生物水平和TOC。
The development of RO units that can tolerate sanitizing water temperatures and also operate efficiently and continuously at elevated temperatures has added greatly to their microbial control ability and to the avoidance of biofouling. RO units can be used alone or in combination with DI and CEDI units, as well as ultrafiltration, for operational and quality enhancements.
反渗透装置的发展可以容忍消毒水温，也可以在高温下高效连续运行，大大提高了其微生物控制能力和避免生物污染。反渗透装置可以单独使用，也可以与DI和CEDI装置以及超滤装置结合使用，以提高操作和质量。
5.1.8ULTRAFILTRATION
Ultrafiltration is a technology that is often used near the end of a pharmaceutical water purification system for removing endotoxins from a water stream though upstream uses are possible. Ultrafiltration can use semipermeable membranes, but unlike RO, these typically use polysulfone membranes with intersegmental “pores” that have been purposefully enlarged. Membranes with differing molecular weight “cutoffs” can be created to preferentially reject molecules with molecular weights above these ratings.
超滤是一种常用于制药水净化系统末端的技术，可通过上游使用来去除水流中的内毒素。超滤可以使用半透膜，但与反渗透不同的是，超滤通常使用聚砜膜，其节段间“孔”被有意扩大。可以创建具有不同分子量“截止值”的膜，以优先排斥分子量高于这些等级的分子。
Ceramic ultrafilters are another molecular sieving technology. Ceramic ultrafilters are self-supporting and extremely durable; they can be backwashed, chemically cleaned, and steam sterilized. However, they may require higher operating pressures than do membrane-type ultrafilters.
陶瓷超滤机是另一种分子筛分技术。陶瓷超滤是自支撑的，非常耐用;它们可以反冲洗，化学清洗和蒸汽灭菌。然而，它们可能需要比膜型超滤器更高的工作压力。
All ultrafiltration devices work primarily by a molecular sieving principle. Ultrafilters with molecular weight cutoff ratings in the range of 10,000–20,000 Da are typically used in water systems for removing endotoxins. This technology may be appropriate as an intermediate or final purification step. As with RO, successful performance is dependent upon pretreatment of the water by upstream unit operations.
所有超滤装置的工作原理主要是分子筛分原理。分子量截止额定值在10,000-20,000 Da范围内的超滤器通常用于水系统中去除内毒素。这种技术可能适合作为中间或最后的净化步骤。与反渗透技术一样，成功的性能取决于上游单元作业对水的预处理。
Issues of concern for ultrafilters include compatibility of membrane material with heat and sanitizing agents, membrane integrity, fouling by particles and microorganisms, and seal integrity. Control measures involve filter membrane composition, sanitization, flow design (dead end vs. tangential), cartridge replacement, elevated feed water temperature, and monitoring TOC and differential pressure.
关于超滤的问题包括膜材料与热和消毒剂的相容性，膜的完整性，颗粒和微生物的污染，以及密封的完整性。控制措施包括滤膜组成、消毒处理、流量设计(死端与切向)、滤筒更换、升高给水温度以及监测TOC和压差。
5.1.9MICROBIAL-RETENTIVE FILTRATION
Microbial-retentive membrane filters have a larger effective “pore size” than ultrafilters and are intended to prevent the passage of microorganisms and similarly sized particles without unduly restricting flow. This type of filtration is widely employed within water systems for filtering the bacteria out of both water and compressed gases as well as for vent filters on tanks and stills and other unit operations.
微生物保留膜过滤器具有比超滤器更大的有效“孔径”，旨在防止微生物和类似大小的颗粒通过而不过度限制流量。这种类型的过滤广泛应用于水系统中，用于过滤水和压缩气体中的细菌，以及用于储罐和蒸馏器和其他单元操作的排气过滤器。
In water systems, a filter’s microbial retention characteristics exhibit different phenomena than in other aseptic filtration applications.
在水系统中，过滤器的微生物保留特性表现出不同于其他无菌过滤应用的现象。
The following factors interact to create the retention phenomena for water system microorganisms: the variability in the range and average pore sizes created by the various membrane fabrication processes; the variability of the surface chemistry and three-dimensional structure related to the different polymers used in these filter matrices; and the size and surface properties of the microorganism intended to be retained by the filters. In some situations, the appearance of water system microorganisms on the downstream sides of some 0.2- to 0.22-µm rated filters after a period of use (days to weeks) seems to support the idea that water-borne microorganisms can penetrate the 0.2- to 0.22-µm rated filters. It is not known whether this downstream appearance is caused by exceeding the retentive capabilities of the filters due to high prefiltration bioburden levels of water-borne microorganisms and extended filtration times. These conditions can lead to a “pass-through” phenomenon resulting from tiny cells or less cell “stickiness”, or perhaps by a “grow-through” phenomenon in which cells hypothetically replicate their way through the pores to the downstream side. Whatever the penetration mechanism, 0.2- to 0.22-µm rated membranes may not be the best choice for some water system uses (see Sterility Assurance1211).以下因素相互作用，为水系统微生物创造滞留现象:由各种膜制造过程产生的排列和平均孔径的变异性;与这些过滤器基质中使用的不同聚合物相关的表面化学和三维结构的可变性;以及所述过滤器拟保留的微生物的大小和表面性质。在某些情况下，在使用一段时间(数天至数周)后，一些0.2 ~ 0.22µm的µ过滤器下游出现了水系统微生物，这似乎支持以下观点:水生微生物可以穿透0.2 ~ 0.22µm的限制过滤器（rated filters）。目前尚不清楚这种下游外观是否是由于水载微生物的高预过滤生物负荷水平和过滤时间延长而超出了过滤器的保留能力。这些条件可能会导致“通过”现象，这是由于细胞的“黏性”太小或更小，或者可能是“生长通过”现象，即假设细胞通过气孔复制它们的方式到下游。无论使用何种渗透机制，0.2-至0.22-µm的限制膜（ rated membranes）可能不是某些水系统的最佳选择(参▲USP <1211>无菌保证)。
Nevertheless, microbial retention success in water systems has been reported with the use of filters rated as 0.2 or 0.1 µm. There is general agreement that, for a given manufacturer, their 0.1-µm rated filters are tighter than their 0.2- to 0.22-µm rated filters. However, comparably rated filters from different manufacturers may not have equivalent performance in water filtration applications because of the different filter materials, different fabrication processes, and nonstandardized microbial retention challenge processes currently used for defining the 0.1-µm filter rating. It should be noted that filters with a 0.1-µm rating may result in a lower flow rate compared to 0.2- to 0.22-µm filters, so whatever filters are chosen for a water system application, the user must verify that they are suitable for their intended application, use period, and use process, including flow rate.
尽管如此，有报道称使用评级为0.2µm或0.1µm的过滤器可在水系统中成功截留微生物。一般认为，对于给定的制造商，他们的0.1µm额定过滤器比他们的0.2到0.22µm额定过滤器更紧。然而，由于目前用于定义0.1µm过滤器等级的过滤材料、制造工艺和非标准化的微生物滞留挑战工艺不同，来自不同制造商的可比较评级的过滤器在水过滤应用中可能没有相同的性能。值得注意的是，与0.2- 0.22-µm的µm过滤器相比，0.1µm的过滤器可能会导致更低的流量，因此无论为水系统应用选择何种过滤器，用户必须验证它们是否适合其预期的应用、使用周期和使用过程，包括流量。
For microbial retentive gas filtrations, the same sieving and adsorptive retention phenomena are at work as in liquid filtration, but the adsorptive phenomenon is enhanced by additional electrostatic interactions between the particles and filter matrix. These electrostatic interactions are so strong, particle retention for a given filter rating is significantly more efficient in gas filtration than in water or product-solution filtrations. These additional adsorptive interactions render filters rated at 0.2–0.22 µm unquestionably suitable for microbial retentive gas filtrations. When microbial retentive filters are used in these applications, the membrane surface is typically hydrophobic (non-wettable by water). A significant area of concern for gas filtration is blockage of tank vents by condensed water vapor, which can cause mechanical damage to the tank. Control measures include electrical or steam tracing and a self-draining orientation of vent filter housings to prevent accumulation of vapor condensate. However, a continuously high filter temperature will take an oxidative toll on polypropylene components of the filter, so sterilization of the unit prior to initial use, and periodically thereafter, as well as regular visual inspections, integrity tests, and filter cartridge changes are recommended control methods.
对于微生物保持气体过滤，相同的筛分和吸附保留现象在液体过滤中发挥作用，但吸附现象是由粒子和过滤器基质之间的额外静电相互作用增强。这些静电相互作用是如此之强，对于给定的过滤等级来说，颗粒滞留在气体过滤中显著比在水或产品溶液过滤中更有效。这些额外的吸附相互作用使额定为0.2-0.22µm的过滤器无疑适用于微生物滞留气体的过滤。当在这些应用中使用微生物保持过滤器时，膜表面通常是疏水的(不能被水浸湿)。气体过滤的一个重要问题是，冷凝的水蒸气会堵塞罐体的通风口，这可能会对罐体造成机械损伤。控制措施包括电气或蒸汽跟踪和排气过滤器外壳的自排方向，以防止蒸汽冷凝物的积累。然而，持续的高过滤温度会对过滤器的聚丙烯组件造成氧化损伤，因此建议在初次使用前对单元进行灭菌，之后定期进行灭菌，以及定期进行目视检查、完整性测试和更换滤芯。
In water applications, microbial retentive filters may be used downstream of unit operations that tend to release microorganisms or upstream of unit operations that are sensitive to microorganisms. Microbial retentive filters may also be used to filter water feeding the distribution system. It should be noted that regulatory authorities allow the use of microbial retentive filters within distribution systems or even at use points if they have been properly validated and are appropriately maintained. A point-of-use filter should only be intended to “polish” the microbial quality of an otherwise well-maintained system and not to serve as the primary microbial control device. The efficacy of system microbial control measures can only be assessed by sampling the water upstream of the filters. As an added measure of protection, in-line UV lamps, appropriately sized for the flow rate (see 5.3 Sanitization), may be used just upstream of microbial retentive filters to inactivate microorganisms prior to their capture by the filter. This tandem approach tends to greatly delay potential microbial penetration phenomena and can substantially extend filter service life.
在水应用中，微生物保持过滤器可用于倾向于释放微生物的单元操作的下游或对微生物敏感的单元操作的上游。还可使用微生物保持过滤器来过滤供给分配系统的水。应当指出的是，监管当局允许在分配系统内，甚至在经过适当验证和适当维护的使用点使用微生物滞留过滤器。使用点过滤器应仅用于“打磨”维护良好的系统的微生物质量，而不是作为主要的微生物控制装置。系统微生物控制措施的效果只能通过对过滤器上游的水进行采样来评估。作为一种额外的保护措施，根据流速大小(见5.3消毒)的在线紫外灯，可以仅在微生物保留过滤器的上游使用，在微生物被过滤器捕获之前将其灭活。这种串联方式往往会大大延迟潜在的微生物渗透现象，并可以大大延长过滤器的使用寿命。
5.1.10ULTRAVIOLET LIGHT
The use of low-pressure UV lights that emit a 254-nm wavelength for microbial control is discussed in 5.3 Sanitization, but the application of UV light in chemical purification is also emerging. This 254-nm wavelength is also useful in the destruction of ozone. At wavelengths around 185 nm (as well as at 254 nm), medium-pressure UV lights have demonstrated utility in the destruction of the chlorine-containing disinfectants used in source water as well as for interim stages of water pretreatment. High intensities of 185 nm alone or 254 nm in combination with other oxidizing sanitants, such as hydrogen peroxide, have been used to lower TOC levels in recirculating distribution systems. The organics are typically converted to carbon dioxide, which equilibrates to bicarbonate, and incompletely oxidized carboxylic acids, both of which can easily be removed by polishing ion-exchange resins.
使用低压紫外光，发射254 nm波长的微生物控制是在5.3消毒中讨论的，但紫外光在化学净化中的应用也正在出现。这种254 nm的波长在破坏臭氧方面也很有用。在波长约185 nm(以及254 nm)时，中压紫外光已在破坏用于水源水的含氯消毒剂以及用于水预处理的过渡阶段方面显示出效用。高强度的185 nm单独或254 nm结合其他氧化性消毒剂，如过氧化氢，已被用于降低再循环分配系统中的TOC水平。这些有机物通常被转化为二氧化碳(平衡为碳酸氢盐)和未完全氧化的羧酸，这两种物质都可以通过抛光离子交换树脂轻松去除。【号外：抛光树脂一般用于超纯水处理（EDI）系统末端，来保证系统出水水质能够维持用水标准。一般出水水质都能达到18兆欧以上，以及对TOC、SIO2都有一定的控制能力。抛光树脂出厂的离子型态都是H、OH型，抛光树脂只能一次性使用，不可再生，一般用于半导体行业。离子交换树脂：离子交换树脂是带有官能团（有交换离子的活性基团）、具有网状结构、不溶性的高分子化合物。离子交换树脂分阳离子激活树脂和阴离子交换树脂，阳树脂又分H+型和Na+型，阴树脂又分OH-型和Cl-型。用于软化和除盐水处理。】
Areas of concern include inadequate UV intensity and residence time, gradual loss of UV emissivity with bulb age, gradual formation of a UV-absorbing film at the water contact surface, incomplete photodegradation during unforeseen source water hyperchlorination, release of ammonia from chloramine photodegradation, unapparent UV bulb failure, and conductivity degradation in distribution systems using 185-nm UV lights.
得关注的领域包括紫外线强度和停留时间不足，随着灯泡寿命的增长，紫外线发射率逐渐丧失，在水接触表面逐渐形成紫外线吸收膜，在未预见的源水高氯化过程中不完全光降解，氯胺光降解释放氨，不明显的紫外线灯泡失效，以及使用185纳米紫外线灯的分配系统中的电导率恶化。
Control measures include regular inspection or emissivity alarms to detect bulb failures or film occlusions, regular UV bulb sleeve cleaning and wiping, downstream chlorine detectors (when used for dechlorination), downstream polishing deionizers (when used for TOC reduction), and regular (approximately yearly) bulb replacement. UV lamps generate heat during operation, which can cause failure of the lamps or increase the temperature of the water. Precautions should be in place to ensure that water flow is present to control excessive temperature increase.
控制措施包括定期检查或发射率报警，以检测灯泡故障或膜堵塞，定期清洁和擦拭紫外线灯泡套管，下游氯检测器(用于脱氯时)，下游抛光去离子器(用于减少TOC时)，以及定期(大约每年)更换灯泡。紫外线灯在运行过程中产生热量，这可能导致灯的故障或增加水的温度。应采取预防措施，确保有水流存在，以控制温度过高。
5.1.11DISTILLATION
Distillation units provide chemical and microbial purification via thermal vaporization, mist elimination, and water vapor condensation. A variety of designs is available, including single effect, multiple effect, and vapor compression. The latter two configurations are normally used in larger systems because of their generating capacity and efficiency. Source water controls must provide for the removal of hardness and silica impurities that may foul or corrode the heat transfer surfaces, as well as the removal of those impurities that could volatize and condense along with the water vapor. In spite of general perceptions, even the best distillation process does not ensure absolute removal of contaminating ions, organics, and endotoxins. Most stills are recognized as being able to accomplish at least a 3–4 log reduction in these impurity concentrations. They are highly effective in sterilizing the feed water.
蒸馏单元通过热汽化，雾消除，和水蒸气冷凝提供化学和微生物净化。多种设计可供选择，包括单效应、多效应和蒸汽压缩。因为后两者的能力和效率，后两种配置通常用于较大的系统。水源水控制必须去除硬度和可能污染或腐蚀传热表面的二氧化硅杂质，以及那些可能随着水蒸气挥发和冷凝的杂质。尽管普遍认为，即使是最好的蒸馏过程也不能确保绝对清除污染离子、有机物和内毒素。大多数蒸馏器被认为能够完成这些杂质浓度的至少3-4对数降低。它们对给水的杀菌效果很好。
Areas of concern include carryover of volatile organic impurities such as trihalomethanes (see 2. Source Water Considerations) and gaseous impurities such as ammonia and carbon dioxide, faulty mist elimination, evaporator flooding, inadequate blow down, stagnant water in condensers and evaporators, pump and compressor seal design, pinhole evaporator and condenser leaks, and conductivity (quality) variations during start-up and operation.
值得关注的领域包括挥发性有机杂质的携带，如三氯甲烷(见2。来源水的考虑因素)和气体杂质，如氨和二氧化碳，雾排除故障，蒸发器进水，吹气不足，冷凝器和蒸发器积水，泵和压缩机密封设计，针孔蒸发器和冷凝器泄漏，以及启动和运行期间的电导率(质量)变化。
Methods of control may involve the following: preliminary steps to remove both dissolved carbon dioxide and other volatile or noncondensable impurities; reliable mist elimination to minimize feed water droplet entrainment; visual or automated high-water-level indication to detect boiler flooding and boil over; use of sanitary pumps and compressors to minimize microbial and lubricant contamination of feed water and condensate; proper drainage during inactive periods to minimize microbial growth and accumulation of associated endotoxin in boiler water; blow down control to limit the impurity concentration effect in the boiler to manageable levels; on-line conductivity sensing with automated diversion to waste to prevent unacceptable water upon still start-up or still malfunction from getting into the finished water distribution system; and periodic testing for pinhole leaks to routinely ensure that condensate is not compromised by nonvolatized source water contaminants.
控制方法可能包括以下步骤:去除溶解的二氧化碳和其他挥发性或不可冷凝的杂质的初步步骤;可靠的除雾，最大限度地减少给料水滴的夹带;可视或自动高水位指示，检测锅炉溢水和沸腾;使用卫生泵和压缩机，尽量减少给水和冷凝水的微生物和润滑剂污染;在非活动期间适当排水，以减少锅炉水中的微生物生长和相关内毒素的积累;排污控制，将锅炉内杂质浓度控制在可控水平;在线电导率传感与自动分流废物，以防止不合格的水在仍然启动或仍然故障进入完成的供水系统;定期测试针孔泄漏，定期确保冷凝水不受非挥发源水污染物的影响。【我坦白，这段很夹生，没空了，自己研究吧】
5.1.12STORAGE TANKS
Storage tanks are included in water distribution systems to optimize processing equipment capacity. Storage also allows for routine maintenance within the purification system while maintaining continuous supply to meet manufacturing needs. Design and operation considerations are needed to prevent or minimize the development of biofilm, to minimize corrosion, to aid in the use of chemical sanitization of the tanks, and to safeguard mechanical integrity.
储罐包括在水分配系统，以优化处理设备的能力。储存还允许在净化系统内进行例行维护，同时保持持续供应，以满足生产需求。需要在设计和操作上考虑防止或尽量减少生物膜的形成，尽量减少腐蚀，帮助使用化学消毒罐，并保障机械完整性。
Areas of concern include microbial growth or corrosion due to irregular or incomplete sanitization and microbial contamination from unalarmed rupture disk failures caused by condensate-occluded vent filters.
需要关注的领域包括微生物生长或由于不规范或不完整的消毒处理造成的腐蚀，以及由于冷凝物堵塞的排气过滤器造成的未预警的破裂盘故障造成的微生物污染。
Control considerations may include using closed tanks with smooth interiors, the ability to spray the tank headspace using spray balls on recirculating loop returns, and the use of heated, jacketed/insulated tanks. This minimizes corrosion and biofilm development and aids in thermal or chemical sanitization. Storage tanks require venting to compensate for the dynamics of changing water levels. This can be accomplished with a properly oriented and heat-traced filter housing fitted with a hydrophobic microbial retentive membrane filter affixed to an atmospheric vent. Alternatively, an automatic membrane-filtered compressed gas blanketing system may be used. In both cases, rupture disks equipped with a rupture alarm device should be used as a further safeguard for the mechanical integrity of the tank.
控制方面的考虑可能包括使用内部光滑的密闭罐，在再循环回路上使用喷雾球喷洒罐顶空间的能力，以及使用加热的夹套/绝缘罐。这最大限度地减少腐蚀和生物膜的发展，并有助于热或化学消毒。储罐需要通风来补偿水位变化的动态。这可以通过一个适当的定向和热跟踪的过滤器外壳来完成，该外壳配有一个附着在大气通风口上的疏水微生物保持膜过滤器。或者，可以使用自动膜过滤压缩气体覆盖系统。在这两种情况下，应使用配有破裂报警装置的破裂盘，作为罐的机械完整性的进一步保障。
5.1.13DISTRIBUTION SYSTEMS
Distribution system configuration should allow for the continuous flow of water in the piping by means of recirculation. Use of no recirculating, dead-end, or one-way systems or system segments should be avoided whenever possible. If not possible, these systems should be flushed periodically and monitored more closely. Experience has shown that continuously recirculated systems are easier to maintain. Pumps should be designed to deliver fully turbulent flow conditions to facilitate thorough heat distribution (for hot-water sanitized systems) as well as thorough chemical sanitant distribution. Turbulent flow also appears to either retard the development of biofilms or reduce the tendency of those biofilms to shed bacteria into the water. If redundant components, such as pumps or filters, are used, they should be configured and used to avoid microbial contamination of the system.
分配系统配置应该允许通过再循环的方式使管道中的水连续流动。尽可能避免使用无再循环、死路或单向系统或系统段。如果不可能，这些系统应定期冲洗并更密切地监测。经验表明，连续再循环系统更容易维护。泵的设计应该提供完全的湍流流条件，以促进彻底的热量分布(用于热水消毒系统)以及彻底的化学消毒剂分布。湍流似乎还可以减缓生物膜的发展，或减少生物膜将细菌排入水中的趋势。如果使用冗余部件，如泵或过滤器，应配置和使用，以避免系统的微生物污染。
Components and distribution lines should be sloped and fitted with drain points so that the system can be completely drained. In distribution systems, dead legs and low-flow conditions should be avoided, and valved tie-in points should have length-to-diameter ratios of six or less. In systems that operate at self-sanitizing temperatures, precautions should be taken to avoid cool points where biofilm development could occur. If drainage of components or distribution lines is intended as a microbial control strategy, they should also be configured to be dried completely using dry compressed gas because drained but still moist surfaces will still support microbial proliferation. Water exiting from the distribution system should not be returned to the system without first passing through all or a portion of the purification system.
组件和分配线路应该倾斜，并安装排水点，以便系统能够完全排水。在分配系统中，应避免死角和低流量条件，阀门连接点的长径比应小于等于6。在自消毒温度下运行的系统中，应采取预防措施，避免出现生物膜形成的冷却点。如果组件或分配线路的排水是微生物控制策略，它们也应该配置为使用干燥压缩气体完全干燥，因为排水但仍然潮湿的表面仍然支持微生物增殖。从分配系统流出的水不应在没有首先通过净化系统的全部或部分之前返回到系统中。
The distribution design should include the placement of sampling valves in the storage tank and at other locations, such as in the return line of the recirculating water system. Direct connections to processes or auxiliary equipment should be designed to prevent reverse flow into the controlled water system. Hoses and heat exchangers that are attached to points of use to deliver water must not chemically or microbiologically degrade the water quality. The distribution system should permit sanitization for microorganism control. The system may be continuously operated at sanitizing conditions or sanitized periodically.
分配设计应包括在储罐和其他位置(如在循环水系统的回水管)放置采样阀。直接连接到工艺或辅助设备的设计应该防止逆流进入受控水系统。连接到使用点输送水的软管和热交换器不能在化学或微生物方面降低水的质量。分配系统应进行微生物控制的消毒处理。该系统可以在消毒条件下连续运行或定期消毒。
5.1.14NOVEL/EMERGING TECHNOLOGIES
New water treatment technologies are being developed continuously. Before these technologies are utilized in pharmaceutical water systems, they should be evaluated for acceptable use in a GMP environment. Other considerations should include the treatment process, reliability and robustness, use of added substances, materials of construction, and ability to validate. Consideration should be given to recognize the areas of concern during the evaluation and to identify control measures for the technology. This should include impact on chemical and microbial attributes.
新的水处理技术正在不断开发。在这些技术用于制药水系统之前，应在GMP环境中对其进行可接受的使用评估。其他考虑应包括处理过程、可靠性和稳健性、添加物质的使用、结构材料和验证能力。应考虑在评价过程中确认令人关注的领域，并确定对该技术的控制措施。这应包括对化学和微生物属性的影响。
