Chemical additives: Utility steam is produced, in most cases, using conventional fire-tube steam boilers, normally of steel construction. Such boilers are almost always provided with systems that inject additives in the feed water to protect the boiler and steam distribution piping from scale and corrosion. Some of these scale and corrosion inhibitors may, and often do, include amines and other substances that may not be acceptable in steam being used in pharmaceutical processes. The user must determine what additives are used, and verify if they are acceptable in the particular application, i.e., do not add any impurities or create a reaction in the drug product.
化学添加剂：在多数实例中，使用常规钢结构火管蒸气锅炉产生公用蒸气。这种锅炉几乎总是规定在给水中注入添加剂来保护锅炉和蒸气分配管道以免产生水垢和腐蚀。一部分这些水垢和腐蚀抑制剂可能并且经常使用，包括胺和不适用于制药工艺所用蒸气的其他物质。用户必须决定使用哪种添加剂并且验证它们是否可适用于特定应用，比如，不能在药品中添加任何杂质或产生反应。
Utility steam can be filtered to remove particulate matter, but filtration does not remove dissolved substances and volatiles such as amines.
可以过滤公用蒸气除去颗粒物，但是滤器无法去除已溶解物质和挥发物比如胺。
Superheat: Superheated steam is produced in water tube boilers by reheating the steam or by generating the steam at a higher pressure in a fire tube boiler and then reducing the pressure through a regulating valve. When the pressure is reduced, the energy in the higher temperature steam is dissipated to generate steam at the lower pressure and produce superheated steam above the corresponding saturation temperature. Superheat is dissipated downstream of the regulating valve due to heat loss in the line. 过热：在水管锅炉中通过再加热蒸气产生过热蒸气或者在火管锅炉中通过在更高的压力下产生蒸气然后使用调节阀减低压力来产生过热蒸气。当压力减低时，较高温度蒸气中的能量消散会产生较低压力下的蒸气并同时产生超过相应饱和温度的过热蒸气。由于管线的热损失，过热在调节阀的下游消散。
pH control: In order to protect carbon steel from corrosion by the steam, it is necessary to use additives to raise the pH to between 9.5 -10.5.
pH控制：为保护碳钢制品不被蒸气腐蚀，有必要使用添加剂将pH值升高到9.5-10.5之间。
7.3.2 Clean Steam (CS) 7.3.2 清洁蒸气(CS)
Pharmaceutical clean steam is generated from treated water free of volatile additives, such as amines or hydrazines, and is used for thermal disinfection or sterilization processes. It is considered especially important to preclude such contamination from injectable drug products: 制药用清洁蒸气是从不含有挥发性添加剂（例如胺或联胺）的净水中产生，并用于热灭菌或灭菌过程。从注射用药品中清除这类污染是尤其重要的：
Clean steam is characterized as having: ? No additives
? No generated superheat except when the generated pressure is significantly higher than the
use pressure of the steam. (See Section 7.3.1 - Superheat.)
? Relatively low pH 清洁蒸气具有下列特征： ? 没有添加剂
? 不产生过热，除非产生的压力显著高于蒸气使用压力（参看7.3.1部分-过热） ? 相对低pH值
There are many terms used in the pharmaceutical industry to describe Clean Steam. These include Clean Steam, Pure Steam, Pyrogen Free Steam, WFI Steam, and USP Purified Water steam. There is no standard or accepted definition for any of these terms. However, the most commonly used terms are \Steam\and\Clean Steam\In this Guide, the term \Steam\
The condensate of Clean Steam has no buffer, and may have a relatively low pH compared to that of utility steam.
在制药工业中有很多术语用于描述清洁蒸气。这些包括清洁蒸气、纯蒸气、无热原蒸气、注射用水蒸气和USP纯化水蒸气。对任何这些蒸气都没有标准或公认定义。然而，大多数通常使用的术语是“纯蒸气”和“清洁蒸气”。在本指南中，使用“清洁蒸气”术语替代其他所有术语。
清洁蒸气的冷凝液没有缓冲系统，并且与公用蒸气相比它具有相对低pH值。
7.4 BACKGROUND AND INDUSTRY PRACTICES 7.4 背景和工业实践
7.4.1 Purity of sterilizing steam 7.4.1 灭菌蒸气纯度
When steam or the resulting condensed water comes in direct or indirect contact with the drug product, the purity should be equivalent to the water purity acceptable for final rinsing of the drug contact surfaces.
当蒸气或其产生的冷凝水与药品有直接或间接接触时，其纯度应该与最终冲洗药品接触面合格的水纯度相同。
Note: A continuous supply of Dry Saturated Steam at the point of use is considered necessary for efficient steam sterilization. Water carried by the steam in suspension may cause damp loads and superheated steam is considerably less effective than saturated steam when used for sterilization. Non-condensable gases if contained in the steam may prevent the attainment of sterilization conditions in parts of the sterilizer load.
注意：为了有效蒸气灭菌，有必要考虑在用点连续供应干燥饱和蒸气。蒸气带来的悬浮的水可能引起潮湿，当用于灭菌时，过热蒸气比饱和蒸气的效果低的多。如果蒸气中含有不可压缩气体，则可能会防碍灭菌器中的一些部位达到灭菌条件。
7.4.2 Steam used for humidification 7.4.2 用于增湿作用的蒸气
When steam is used for indirect humidification, such as injection into HVAC air streams prior to final air filtration, the steam does not need to be purer than the air that it is being mixed with. However, when humidifying process areas, the potential level of impurities, including amines and hydrazines should be evaluated in order to ascertain the impact on the final drug product. This is particularly important in areas where open processing takes place, such as aseptic filling suites and formulation areas. If the diluted water vapor is found to contribute significantly to the contamination of the drug, a purer grade of steam should be selected.
当蒸气用于间接增湿作用时（如：在最终过滤之前注入HVAC的空气气流），蒸气没有必要比将要混入的空气更纯净。然而，当给加工区增湿时，为了确定对药品终产品的影响，应该评价包括胺和联胺的杂质潜在水平。这对开放的加工区非常重要，例如无菌填充室和合成区域。如果发现稀释的水汽显著地增加药品污染时，应该选择更加纯净级别的蒸气。
7.4.3 Common practices 7.4.3 普通实践
It is common practice to generate pharmaceutical steam from compendial waters and test the steam condense for equivalency to the compendial standard. This practice ignores the ability of the pharmaceutical steam generator to remove impurities. This overprocessing is wasteful and unnecessary. An exception is when the steam quantity is small and the cost and maintenance of a dedicated feed water pretreatment system exceeds the cost of using compendial water. Pharmaceutical Clean Steam is commonly used in applications where utility steam would suffice; such as non-critical room humidification and high purity water heat exchangers.
常见的行为是用药典规定的水来生成制药用蒸气，并以等同的药典标准来检测蒸气的冷凝水。该行为忽略了制药用蒸气发生器去除杂质的能力。过度处理是浪费和不必要的。但当蒸气需求量很少，并且对专用的给水预处理系统的维护成本超过了使用药典规定的水的成本时，这就是个例外。制药用清洁蒸气通常用于公用蒸气可以满足的应用区域，例如非关键房间增湿作用和高纯化水热交换器。
Table lists the commonly accepted industry standards and highlights the trend in the
pharmaceutical industry to provide \列表中列出通常公认的工业标准和制药工业趋势的要点从而提供“比所需更加纯净的”蒸气和过度具体说明的给水。
7.4.4 Industry and Baseline Practices in the Production of steam 7.4.4 蒸气产生企业和基线实践
Table 7-1 Practices in the Production of Steam 表7-1 蒸气产生实践 Intended Use of Steam 蒸气预期用途 Method of generation 产生方法 Parenteral and Non-Parenteral Dosage form The use of a sanitary clean steam generator with applications where steam is in direct contact entrainment for the control of endotoxins & liquid with the drug. carry-over (SCSG) is both baseline and common 蒸气直接接触药品的无菌和非无菌制剂应用 industry practice. 灭菌清洁蒸气发生器的用途伴随带走内毒素&液体携带污染(SCSG)控制是基线和普通工业实践 Critical step in the manufacture of API where The use of an SCSG is both baseline and common steam is in direct contact with the Active industry practice. Pharmaceutical Ingredient (API). SCSG的用途是基线和普通工业实践 蒸气直接影响API的API生产的关键步骤 Non-Critical step in the manufacture of an API SCSGs are commonly used; however, utility steam where added impurities may be removed in a is the acceptable baseline application. subsequent step. 通常使用SCSG，然而公用蒸气也是合适的基线应加入的杂质可以在后续步骤中去除的API生用。 产的非关键步骤 WHILE THE USE OF A SCSG IS COMMON PRACTICE, AN ALTERNATIVE APPROACH IS TO Sterilization of USP water systems. USP水系统的灭菌 USE UTILITY STEAM PLUS HOT USP WATER, FLUSHING & WASTE TESTING. 当SCSG的用途是普通实践时，可选方法是使用公用蒸气加上热USP用水，冲洗&废物测试 Process humidification for dosage form application where steam is in direct contact with the drug, where open processing takes place and where the potential level of amines, SCSGs are commonly used and are the Baseline hydrazine's etc. in the condensate has been application. determined to have a detrimental effect on the 通常使用SCSG并且SCSG是基线和普通工业实践。 drug product. 蒸气直接接触药品，进行开放工艺和已确定冷凝液中胺、联胺等的潜在水平对药品有不利影响的制剂增湿过程应用 Humidification of non-critical HVAC systems such as rooms and areas where the drug is not SCSGs are commonly used but utility steam may be directly exposed to the room atmosphere. 非关键HVAC系统的增湿，例如药品不直接暴露在房间大气中的房间和区域 Where open processing takes place and where the potential level of amines, hydrazine's etc. in the condensate has been determined to have a detrimental effect on the drug product the baseline HUMIDIFICATION OF PROCESS & and common practice is the use of a SCSG. However, CRITICAL CLEANROOMS. if it has been determined that the impurities have an 工艺 & 关键洁净室的增湿 insignificant effect on the drug product, a utility steam source would qualify as the baseline approach. 在进行开放工艺和已确定冷凝液中胺、联胺等的潜在水平对药品有不利影响的地方，基线和普通实践是使用SCSG。然而，如果已确定杂质对药品具有totally acceptable. 通常使用SCSG，但公用蒸气也能够完全合格
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