链接放头前儿吧，方便你从开头看。 歪翻USP44: 1231 制药用水 （1）（
歪翻USP44: 1231 制药用水 （1））
歪翻USP44: 1231 制药用水 （1）） 3.1.2WATER FOR INJECTION
Water for Injection (see the USP monograph) is used as an excipient in the production of parenteral and other preparations where product endotoxin content must be controlled, and in other pharmaceutical applications, such as the cleaning of certain equipment and parenteral product-contact components.
注射用水(见USP专论)在必须控制产品内毒素含量的注射制剂和其他制剂的生产中用作辅料，在其他制药应用中，如某些设备和注射产品接触组分的清洗。
The minimal quality of source water for the production of Water for Injection is Drinking Water whose attributes are prescribed by the U.S. EPA, EU, Japan, or WHO. This source water may be treated to render it suitable for subsequent final purification steps, such as distillation (or whatever other validated process is used, according to the monograph). The finished water must meet all of the chemical requirements specified in the monograph, as well as an additional bacterial endotoxin specification. Because endotoxins are produced by the kinds of microorganisms that are prone to inhabit water systems, the equipment and procedures used by the system to purify, store, and distribute Water for Injection should be designed to control microbial contamination and must be designed to remove incoming endotoxins from the source water. Water for Injection systems must be validated to reliably and consistently produce and distribute this quality of water.
生产注射用水的水源的最低质量是饮用水，其属性是由美国环保署、欧盟、日本或世界卫生组织规定的。这种水源可以经过处理，使其适合于后续的最终净化步骤，如蒸馏(或根据各论使用的任何其他验证的工艺)。成品水必须满足各论中规定的所有化学要求，以及一个额外的细菌内毒素规范。由于内毒素是由易于滋生在水系统中的微生物产生的，因此系统用于净化、储存和分配注射用水的设备和程序应设计为控制微生物污染，并必须设计为从水源水中清除进入的内毒素。注入系统的水必须经过验证，以可靠、稳定地生产和分配这种质量的水。
The Water for Injection monograph also allows bulk packaging for commercial use. In contrast to Sterile Water for Injection, packaged Water for Injection is not required to be sterile. However, to preclude significant changes in its microbial and endotoxins content during storage, this form of Water for Injection should be prepared and stored in a manner that limits microbial introduction and growth and/or should be used in a timely fashion before microbial proliferation renders it unsuitable for its intended use. Also, depending on the material used for packaging, extractable compounds could be leaching into the water from the packaging. Although this article is required to meet the same chemical purity standards as the bulk water, extractables from the packaging will likely render the packaged water less chemically pure than the bulk water. The nature of these impurities may even render the water an inappropriate choice for some applications. It is the user’s responsibility to ensure fitness for use of this packaged article when it is used in manufacturing, clinical, or analytical applications where the purer bulk form of the water is indicated.
注射用水各论也允许散装包装的商业用途。与无菌注射用水相比，包装注射用水不要求无菌。然而，为了防止其微生物和内毒素含量在储存期间发生重大变化，这种形式的注射用水的制备和储存方式应限制微生物的引入和生长，并/或应在微生物增殖使其不适合其预期用途之前及时使用。此外，取决于用于包装的材料，可萃取化合物可能从包装浸出到水。虽然这种产品需要满足与散装水相同的化学纯度标准，但从包装中提取的物质可能会使包装水的化学纯度低于散装水。这些杂质的性质甚至可能使水成为某些应用的不适当选择。当使用包装水应用在应更纯净的散装形式的水的情形，如用于生产、临床或分析应用时，用户有责任确保其适用性。
3.1.3WATER FOR HEMODIALYSIS
Water for Hemodialysis (see the USP monograph) is used for hemodialysis applications, primarily the dilution of hemodialysis concentrate solutions. The minimal quality of source water for the production of Water for Hemodialysis is Drinking Water whose attributes are prescribed by the U.S. EPA, EU, Japan, or WHO. Water for Hemodialysis has been further purified to reduce chemical and microbiological components, and it is produced and used on site. This water contains no added antimicrobial agents, and it is not intended for injection. Water for Hemodialysis must meet all of the chemical requirements specified in the monograph as well as an additional bacterial endotoxin specification. The microbial limits attribute for this water is unique among the “bulk” water monographs, but is justified on the basis of this water’s specific application, which has microbial content requirements related to its safe use. The bacterial endotoxins attribute is likewise established at a level related to its safe use.
血液透析用水(见USP各论)用于血液透析应用，主要用于稀释血液透析浓缩溶液。生产血液透析用水的水源的最低质量是符合美国环保署、欧盟、日本或世界卫生组织规定属性的饮用水。血液透析用水经过进一步净化，减少了化学和微生物成分，并在现场生产和使用。这种水不含添加的抗菌剂，它不被设计为用于注射。血液透析用水必须满足各论中规定的所有化学要求，以及一个额外的细菌内毒素规范。在“散装”水各论中，这种水的微生物限度属性是独一无二的，但根据这种水的特定应用是合理的，其具有与安全使用相关的微生物含量要求。细菌内毒素属性同样建立在与其安全使用相关的水平上。
3.1.4PURE STEAM
Pure Steam (see the USP monograph) is also sometimes referred to as “clean steam”. It is used where the steam or its condensate would directly contact official articles or article-contact surfaces, such as during their preparation, sterilization, or cleaning where no subsequent processing step is used to remove any impurity residues. These Pure Steam applications include, but are not limited to, porous load sterilization processes, product or cleaning solutions heated by direct steam injection, or humidification of processes where steam injection is used to control the humidity inside processing vessels where the official articles or their in-process forms are exposed. The primary intent of using this quality of steam is to ensure that official articles or article-contact surfaces exposed to it are not contaminated by residues within the steam.
纯蒸汽(见USP各论)有时也被称为“清洁蒸汽”。它用于蒸汽或其冷凝物直接接触药典产品或产品接触表面的地方，例如在制备、灭菌或清洁工艺中，没有后续处理步骤用于去除任何杂质残留。这些纯蒸汽应用包括但不限于:多孔负荷杀菌工艺，产品或清洗溶液加热直接蒸汽喷射，或用蒸汽喷射来控制加工容器内的湿度的加湿工序，因为公务物品或其在加工过程中的成品会暴露在容器内。使用这种质量蒸汽的主要目的是确保与之接触的药典产品或产品接触面不被蒸汽内的残留物污染。
The minimal quality of source water for the production of Pure Steam is Drinking Water whose attributes are prescribed by the U.S. EPA, EU, Japan, or WHO, and which has been suitably treated. The water is then vaporized with suitable mist elimination, and distributed under pressure. The sources of undesirable contaminants within Pure Steam could arise from entrained source water droplets, anticorrosion steam additives, or residues from the steam production and distribution system itself. The chemical tests in the Pure Steam monograph should detect most of the contaminants that could arise from these sources. If an official article is exposed to Pure Steam and it is intended for parenteral use or other applications where the pyrogenic content must be controlled, the Pure Steam must additionally meet the specification for Bacterial Endotoxins Test 85.
用于生产纯蒸汽的水源水的最低质量是饮用水，其属性是由美国环保署、欧盟、日本或世界卫生组织规定的，并经过适当处理。然后水被汽化并经消雾（不凝气体？）后在适当压力系统中被分配。纯蒸汽中有害污染物的来源可能来自夹带的水源水滴、防腐蒸汽添加剂或蒸汽生产和分配系统本身的残留物。纯蒸汽各论中的化学试验应检测出这些来源可能产生的大多数污染物。如果公务物品暴露在纯蒸汽中，而它是用于肠外使用或其他必须控制热源含量的应用，则纯蒸汽必须另外满足细菌内毒素试验的规范。
These purity attributes are measured in the condensate of the article, rather than the article itself. This, of course, imparts great importance to the cleanliness of the process for Pure Steam condensate generation and collection, because it must not adversely impact the quality of the resulting condensed fluid.
这些纯度属性是在专论的凝结物中测量的，而不是其本身。当然，这对纯蒸汽凝结水产生和收集过程的清洁度非常重要，因为它不能对产生的凝结水的质量产生不利影响。
Other steam attributes not detailed in the monograph, particularly the presence of even small quantities of noncondensable gases or the existence of a superheated or dry state, may also be important for applications such as sterilization.
The large release of energy (latent heat of condensation) as water changes from the gaseous to the liquid state is the key to steam’s sterilization efficacy and its efficiency, in general, as a heat transfer agent. If this phase change (condensation) is not allowed to happen because the steam is extremely hot and is in a persistent superheated, dry state, then its usefulness could be seriously compromised. Noncondensable gases in steam tend to stratify or collect in certain areas of a steam sterilization chamber or its load. These surfaces would thereby be at least partially insulated from the steam condensation phenomenon, preventing them from experiencing the full energy of the sterilizing conditions. Therefore, control of these kinds of steam attributes, in addition to its chemical purity, may also be important for certain Pure Steam applications. However, because these additional attributes are use-specific, they are not mentioned in the Pure Steam monograph.
在专论中没有详细说明的其他蒸汽属性，特别是存在甚至少量的不凝结气体或存在过热或干燥状态，对于灭菌等应用也可能是重要的。当水从气态转变为液态时，能量(冷凝潜热)的大量释放是蒸汽杀菌效果及其作为传热剂的效率的关键。如果因为蒸汽非常热，持续处于过热、干燥状态，这种相变(冷凝)被抑制，那么它的用途效能可能会严重受损。蒸汽中的不凝结气体往往在蒸汽灭菌室或其负荷的某些区域内分层或聚集。因此，这些表面将至少部分地与蒸汽冷凝现象绝缘，从而阻滞它们经历灭菌条件的全部能量。因此，除了控制蒸汽的化学纯度外，控制蒸汽的这些属性对于纯蒸汽的某些应用也很重要。然而，因为这些额外的属性是特定使用的，它们在纯蒸汽专论没有被提到。
Note that lower-purity “plant steam” may be used in the following applications: 1) for steam sterilization of nonproduct-contact nonporous loads, 2) for general cleaning of nonproduct-contact equipment, 3) as a nonproduct-contact heat-exchange medium, and 4) in all compatible applications involved in bulk pharmaceutical chemical and API manufacture.
请注意，低纯度的“工业蒸汽”可用于以下应用:1)用于非产品接触无孔负载的蒸汽灭菌，2)用于非产品接触设备的一般清洗，3)作为非产品接触的热交换介质，4)在散装化学和原料药生产的所有适用应用环境。
Finally, because Pure Steam is lethal to microbes, monitoring of microbial control within a steam system is unnecessary, as is microbial analysis of the steam condensate.
最后，由于纯蒸汽对微生物是致命的，因此无需监测蒸汽系统内的微生物控制，也无需对蒸汽冷凝液进行微生物分析。
3.2Sterile Monographed Waters
The following monographed waters are packaged forms of either Purified Water or Water for Injection that have been sterilized to preserve their microbiological properties. These waters may have specific intended uses as indicated by their names, and may also have restrictions on the packaging configurations related to those uses. In general, these sterile waters may be used in a variety of applications in lieu of the bulk forms of water from which they were derived. However, there is a substantial difference between the acceptance criteria for the chemical purities of these bulk waters versus sterile waters. The specifications for sterile waters differ from those of bulk waters to accommodate a wide variety of packaging types, properties, volumes, and uses. As a result, the inorganic and organic impurity specifications are not equivalent for bulk and packaged waters. The packaging materials and elastomeric closures are the primary sources of these impurities, which tend to increase over the shelf life of these packaged articles. Therefore, due consideration must be given to the chemical purity suitability at the time of use of the sterile forms of water when used in manufacturing, analytical, and cleaning applications in lieu of the bulk waters from which these waters were derived. It is the user’s responsibility to ensure fitness for use of these sterile packaged waters in these applications. Nevertheless, for the applications discussed below for each sterile water, their respective purities and packaging restrictions generally render them suitable by definition.
以下是经过灭菌以保持其微生物特性的纯化水或注射用水的包装形式。这些水可能具有其名称所表明的特定预期用途，也可能对与这些用途有关的包装配置有限制。一般来说，这些无菌水可以用于各种各样的应用，以代替它们的来源的散装形式的水。然而，在这些散装水和无菌水的化学纯度的接受标准之间存在着实质性的差异。无菌水的规格不同于散装水，以适应各种各样的包装类型、特性、体积和用途。因此，无机和有机杂质的规格不等同于散装和包装水。包装材料和弹性体封口是这些杂质的主要来源，这些杂质往往会随着这些包装物品的保质期而增加。因此，当在生产、分析和清洁应用中使用无菌形式的水来代替这些水的来源的散装水时，必须充分考虑化学纯度的适宜性。用户有责任确保在这些应用中使用这些无菌包装水的适宜性。然而，对于下面讨论的每种无菌水的应用，根据定义，它们各自的纯度和包装限制通常使它们适合各自应用。
3.2.1STERILE PURIFIED WATER
Sterile Purified Water (see the USP monograph) is Purified Water, packaged and rendered sterile. It can be used in the preparation of nonparenteral compendial dosage forms or in analytical applications requiring Purified Water where 1) access to a validated Purified Water system is not practical, 2) only a relatively small quantity is needed, 3) Sterile Purified Water is required by specific monograph or pharmacy practice, or 4) bulk packaged Purified Water is not suitably controlled for the microbiological quality for its intended use.
无菌纯化水(见USP专论)是经过包装和无菌处理的纯化水。它可以用于制备非注射的药典剂型，或在需要纯化水的分析应用中，在以下情况中:1)获取经过验证的纯化水系统是不实际的，2)只需要相对较小的数量，3)无菌纯化水是特定的专论或药学实践所要求的，或4)散装包装纯化水对其预期用途的微生物质量没有适当控制。
3.2.2STERILE WATER FOR INJECTION
Sterile Water for Injection (see the USP monograph) is Water for Injection packaged and rendered sterile. It is used for extemporaneous prescription compounding and as a sterile diluent for parenteral products. It may also be used for other applications where bulk Water for Injection or Purified Water is indicated but access to a validated water system is not practical, or where only a relatively small quantity is needed. Sterile Water for Injection is packaged in single-dose containers not larger than 1 L.
灭菌注射用水(见USP专论)是包装无菌的注射用水。它被用于临时处方复配和注射剂的无菌稀释。当使用验证水系统是不现实的，或只需要相对较少的量时，它也可用于注射用散装水或纯化水的其他应用。灭菌注射用水包装在不大于1l的单剂量容器中。
3.2.3BACTERIOSTATIC WATER FOR INJECTION
Bacteriostatic Water for Injection (see the USP monograph) is Water for Injection, packaged and rendered sterile, to which has been added one or more suitable antimicrobial preservatives. It is intended to be used as a diluent in the preparation of parenteral products, most typically for multi-dose products that require repeated content withdrawals. It may be packaged in single-dose or multiple-dose containers not larger than 30 mL.
抑菌注射用水(见USP专论)是指注射用水，经过包装和无菌处理，并添加了一种或多种合适的抗菌防腐剂。它被用来作为制备注射剂产品的稀释剂，特别适用于需要重复的内容物提取的多剂量产品。它可以用不超过30毫升的单剂量或多剂量容器包装。
3.2.4STERILE WATER FOR IRRIGATION
Sterile Water for Irrigation (see the USP monograph) is Water for Injection packaged and sterilized in single-dose containers that may be larger than 1 L and allow rapid delivery of their contents. Due to its usage, Sterile Water for Irrigation is not required to meet Particulate Matter in Injections 788. It may also be used in other applications that do not have particulate matter specifications, where bulk Water for Injection or Purified Water is indicated but where access to a validated water system is not practical, or where somewhat larger quantities are needed than are provided as Sterile Water for Injection.
无菌冲洗用水(见USP各论)是在单剂量容器中包装和灭菌的注射用水，可以大于1l，并允许快速输送其内容物。由于其用途，无菌冲洗用水不需要满足USP通则 <788> 注射剂中的颗粒物质。它也可以用于没有颗粒物质规格的其他应用中，如，要求使用散装注射用水或纯化水，但获取验证水系统不实际；或者需要比无菌注射用水更多的数量。
3.2.5STERILE WATER FOR INHALATION
Sterile Water for Inhalation (see the USP monograph) is Water for Injection that is packaged and rendered sterile and is intended for use in inhalators and in the preparation of inhalation solutions. This monograph has no requirement to meet
788; it carries a less stringent specification for bacterial endotoxins than Sterile Water for Injection, and therefore is not suitable for parenteral applications.
无菌吸入水(见USP专论)是经过包装和无菌处理的注射用水，用于吸入器和吸入溶液的制备。本专著不要求满足USP通则 < 788 >;与无菌注射水相比，它对细菌内毒素的规范不那么严格，因此不适合用于注射应用。
