Structural integrity and chemical compatibility with the contact fluid and its constituents are two of the more practical issues that drive construction material selection for CS systems.
CS系统的构建材料的选择有两个实际的问题：结构的完整性以及材料与同它接触的液体及液体成分的化学配伍性。
The inherent corrosion potential forces CS manufacturers to consider relatively inert metal including stainless steel or titanium etc. Sanitary piping and valves, considered unnecessary for utility and simple CS generators, are often standard features for CS systems based on the specific manufacturer and model. The materials chosen should not contribute to contamination of the drug product. Typical materials of construction for Sanitary and Simple CS Generators are:
固有的腐蚀可能性促使CS生产商考虑使用相对不活泼的材料，包括：不锈钢或钛等。考虑到对于公共设施和普通CS生成器来说是非必须的，在特定的生产商和型号的基础上，清洁的管线和阀门通常是CS系统的标准特征。所选择的材料应不会助长对产品的污染。清洁的和普通CS生成器的构建材料通常是：
Evaporator and separator: 蒸发器和分离器：
Shell, tubesheets, and internals: 外壳，管板和内部结构： Evaporator tubes: 蒸发器管道：
Heat exchangers热交换器
(FEED HEATER, BLOW DOWN &SAMPLE COOLER):（加热器、放气和样品冷凝器）
300 series S.S 300系列不锈钢
300 series or titanium, or other suitable alloy 300系列或钛，或其他适用的合金 300 SERIES 300系列
300 series for water and Clean Steam, and carbon steel for utility steam contact
300系列用于水和清洁蒸气，碳钢用于公共蒸气 300 series and elastomers/diaphragms for water Carbon steel碳钢
Piping:管线 Valves:阀门
Skid and structural:滑轨和结构材料：
7.8.3.2 Materials of Construction for Utility Steam Generation 7.8.3.2 公共蒸气生成器的结构材料
Chemical compatibility with the Utility boiler generated steam and the carried over feed water chemicals are required for all materials used to condition the contaminated steam.
对用于condition污染的蒸气的所有材料都要求其与公共锅炉产生的蒸气以及给水中携带的化学试剂的化学配伍性。
Based on the particulate levels in the steam and the required steam purity, more than one filtration stage may be utilized.
基于特定的蒸气水平以及要求的蒸气纯度，可能需要使用多级过滤。
Distribution of Utility Steam following filtration follows similar practices as CS to control
condensate build up, non-condensable gases and saturation levels as required for the application.
Acceptable materials must be relatively inert and may include SS or tin-coated copper. 合适的材料必须是相对不活泼的并且可能包括不锈钢或镀锡铜。
7.8.4 Surface Finish 7.8.4 表面抛光
Mechanical polishing (MP), electropolishing (EP), and passivation processes are implemented in some stainless CS systems. Chlorine and/or chlorides will damage the generator regardless of the finish.
某些不锈CS系统需完成机械抛光（MP）、电抛光（EP）以及钝化过程。如果不抛光的话，氯和/或氯化物会损伤生成器。
The operating temperatures of these systems are more than sufficient for inhibiting microbiological growth. Therefore, MP is advocated for final finishing of mechanical welds, with mill finishes and final passivation to optimize the formation of the corrosion resistant chromium oxide barrier. Electropolishing will also optimize the chromium oxide barrier, and should be considered if passivation is not an option.
这些系统的操作温度足以抑制微生物的生长。因此，为了形成最佳的抗腐蚀的氧化铬阻挡层，在机械焊接的最终抛光、打磨抛光以及最终钝化是最好使用机械抛光。电抛光也能形成最佳的氧化铬阻挡层，当不能选择钝化作用时，可考虑它。
7.8.5 Pretreatment for CS (Sanitary and Simple) Generators 7.8.5 CS（清洁的和普通的）生成器的预处理
The feed water pretreatment for a CS generator is born from three separate and distinct considerations:
CS生成器的给水预处理应从三个不同的和独特的方面考虑： 1) Scale formation. 水垢形成 2) Corrosion.腐蚀
3) Volatiles which carryover with the steam and may affect steam purity. 蒸气中可能会携带挥发物，并且这些挥发物可能影响蒸气纯度
7.8.5.1 Scale 7.8.5.1 水垢
Scale formation is a function of generator feed water chemistry, concentration (depends on blow down rate), and temperature. It is independent of design and make, and is outside the control of the generator manufacturer or the operator.
生成器的给水的化学性质、浓度（取决于放水率）以及温度挥导致水垢形成。它和设计和制造无关，并且也不是受生成器的制造商或操作者控制的。
Because scale inhibitors are not used, and because of the relatively high operating temperatures of the CS generator, the total dissolved solids (TDS) of the feed water should be very low. Silica is of particular concern. Most manufacturers stipulate a level of less than 1 ppm (parts per million); some go as high as 5 ppm. In addition to having low TDS (Total Dissolved Solids), the feed water should have no measurable hardness. It is therefore common to use Dl or reverse osmosis as pretreatment to the CS generator. All CS generators will invariably experience some form of scale build-up and therefore must include routine visual inspections, plus cleaning of the generator during shutdown periods when appropriate. 由于没有使用污垢抑制剂，并且CS生成器的操作温度较高，给水的总溶解固体(TDS)会很低。 最值得关注的是硅。一些制造商规定给水的硅含量要小于1 ppm；有些是5 ppm。除了要求TDS (总溶解固体)低之外，给水中还应不含有可测到的硬度。因此通常使用离子交换装置或反渗透对CS生成器的给水进行预处理。所有的CS生成器都不可避免的会形成水垢，因此必须对其进行定期目检，此外还要在停工期间对其进行清洁处理。
Using compendial water as feed is wasteful, unless the steam quantity is small and the cost and maintenance of a dedicated feed water pretreatment system exceeds the cost of using compendial water.
用药典规定的水作为给水是浪费的，除非所需蒸气数量很小以及专用的给水预处理系统的成本和维护费用超过了使用药典规定的水的费用。
Some manufacturers offer generators to operate on softened water. Usually, the rate of blow down is increased in order to maintain low concentration.
一些制造商提供的生成器可用于软化的水。通常未来维持低浓度需要增加放水率。
Note: If the TDS of the soft water is relatively high, soft scale (such as sodium scale and sludge) can form.
注：如果软化水的TDS较高，就会形成软水垢（如钠水垢和淤泥）。
7.8.5.2 Corrosion 7.8.5.2 腐蚀
The most common cause of corrosion is free chlorine, not chlorides. 腐蚀通常都是由游离氯而不是氯化物引起的。
Chlorine and chlorides, at any detectable level, are very detrimental to stainless steel. The higher the temperature and chlorine level, the more severe is the attack. Chlorine is known to migrate and concentrate in localized cells where the level can reach tens, or hundreds of ppm, while the concentration in the main stream is a fraction of a ppm.
任何可检测浓度的氯和氯化物对不锈钢是非常有害的。温度和氯的含量越高，危害越大。众所周知，氯是可以移动的并且可以在某小空间里聚集，此时它的浓度可达到10或100 ppm，虽然在主液流中的浓度还不到1 ppm。
Chlorine can be removed from the feed water by chemical injection of a reducing agent such as sodium bisulfate, or by passing the chlorinated water through carbon filters.
可向给水中添加还原剂（如：亚硫酸钠）或者将经氯处理的水经过碳过滤器来将氯去除。
7.8.5.3 Volatiles 7.8.5.3 挥发物
Dissolved gasses and substances that are volatile at the operating temperature of the CS generator will carryover with the steam. If such substances are objectionable or may potentially compromise product quality, they must be removed at the pretreatment stage. Ammonia and CO2 (carbon dioxide) are examples of volatile gases that will have an effect on the conductivity, such that a condensate sample may not meet USP requirements for Purified or WFI Water.
在CS生成器的操作温度下可挥发的不溶气体和物质会带走蒸气。如果这些物质是不利的或可能对产品质量有潜在危害的，那么在预处理阶段必须将它们去除。氨水和CO2 (二氧化碳)就是挥发气体的例子，它们会对电导率有影响，这样冷凝水样就可能满足不了USP对纯化水或注射用水的要求。
For more details on pretreatment and the advantages and disadvantages of the different processes, refer to Chapters 4 and 5 of this Guide.
预处理和不同的处理的优缺点的详细内容，参见该手册的第4章和第5章。
7.8.6 Treatment of Utility steam 7.8.6 公共蒸气的处理
When utility steam is considered, it may be necessary to filter/condition the steam. In certain applications, may also be necessary to change the steam boiler treatment and substitute additives that do not contain amines or hydrazine.
当考虑使用公共蒸气时，可能需要过滤/处理它们。当应用于特定情况时，可能还需要改变蒸气锅炉的处理以及替换不含胺或肼的添加剂。
Since the type and degree of conditioning are dependent on the application, as well as on the
quality of the utility steam and additives present, this Guide cannot address all possible scenarios. 因为提供的条件的类型和程度取决于蒸气的应用以及公共蒸气的性质和使用的添加剂，所以该手册不可能描述所有的可能情况。
Prior to the elimination of amines and hydrazines, by the substitution for standard boiler pretreatment additives the Utility Steam boiler manufacturer should be consulted regarding the impact on equipment warranty performance and expected life. Some of the substitute additives are not as effective as the standard.
在替换标准锅炉预处理添加剂以消除胺和肼前，应向公共蒸气锅炉制造商咨询关于对设备保证的性能和预期的寿命的影响。一些替代的添加剂还没有标准的有效。
7.9 COST IMPLICATIONS
7.9 相关成本
Determining the economics of pharmaceutical steam production is complex. Costs are quite
