PHARMACEUTICAL
STEAM
制药用蒸气
7. PHARMACEUTICAL STEAM 7. 制药用蒸气
7.1 INTRODUCTION 7.1 序论
This chapter aims to simplify and standardize the process of selection, programming, and design of pharmaceutical steam systems. Guidelines, information, and options are provided, along with advantages and disadvantages, based on the best and most cost effective of current and proven practices and technologies.
本章旨在简化以及标准化制药用蒸气系统的选择、规划和设计。并以现行和已被证明的最好的和成本效应最高的实践和工艺为根据，给出一些指导方针、信息资料和选项，以及优缺点。
The absence of regulations governing the use of steam in pharmaceutical processes has resulted in the proliferation of differing practices and interpretations. Most interpretations are made on the side of conservatism. Unfortunately, in addition to increasing cost without an associated increase in benefits, excessive conservatism can result in system complexity, and possibly reduced reliability. One example is the use of clean steam (non-utility boiler produced steam) where a form of utility steam (utility boiler produced steam) would be adequate to maintain product quality. The installation of a clean steam generator when a simple steam reducing station would suffice results in added equipment and the associated impact on cost, complexity, and reliability.
在制药工艺中指导蒸气使用的法规缺乏导致衍生出不同实践和理解。大多数理解是保守的。不幸的是，这除了增加成本外没有相应的增加利益，过度的保守能够导致系统复杂并且可能减少其可靠性。举个例子，在一种公用蒸气（公用锅炉产生的蒸气）就足以维持产品质量的地方使用清洁蒸气（非公用锅炉产生的蒸气），在一个普通蒸气简化装置就能满足需要时安装一个清洁蒸气发生器，这导致设备增加并在成本，复杂性以及可靠性方面造成相关影响。
In some instances, interpretations are based on inaccurate assumptions of what is important or critical. An example is the over specifying of pretreatment or using WFI as feed to solve the perceived problem.
在某些情况中，理解是建立在不准确假设“什么是重要或关键的”基础上的。举个例子，比如过度规定预处理或使用注射用水作为给水来解决那些已察觉的问题。
The chapter establishes standard definitions for terms commonly associated with pharmaceutical steam and provides information that facilitates making correct and cost effective decisions. 本章为制药用蒸气相关的术语制定了标准定义，并为促使作出正确和成本有效的决定提供了信息。
7.2 cGMP ISSUES 7.2 cGMP出版物
The user has the ultimate responsibility for system design and performance, and for ensuring that the proper type of steam is used for a given process.
用户对系统的设计和性能拥有最终职责并要确保适当类型的蒸气用于给定的工艺。
There is no FDA or USP minimum standard for clean steam. However, cGMPs for large volume parenterals (LVPs) issued in 1976 indicated that feed water for boilers supplying steam that contact components, drug products, and drug product contact surfaces shall not contain volatile additives such as amines or hydrazines.
对于清洁蒸气，FDA或USP没有最低标准。然而，1976年发行的cGMP关于大容量注射液部分表明供应蒸气的锅炉的给水、接触组件、药品和药品接触面不能包含挥发性添加剂比如胺或联胺。
Few regulations govern the design and construction of clean steam generators. There are also no regulations governing materials of construction, type or level of instrumentation, surface finishes, or operating temperatures.
很少法规管理清洁蒸气发生器的设计和构造，也没有法规管理构造材料、使用仪器的类型和等级、表面抛光或操作温度。
Among US Government publications, the FDA's Code of Federal Regulations (CFR) provides culinary steam recommendations and stipulations related to heat exchanger and tank air vents design and construction. The Culinary steam recommendations apply to food applications only.
在美国政府出版物中，FDA的联邦管理法规(CFR)提供厨房用蒸气的优点和关于热交换器及水罐排气口设计、构造的规定。建议厨房用蒸气只用于食品应用。
US Public Health Service/Dairy Industry Committee, 3A Sanitary Standards, Number 609-02, adds additional limitations to Culinary steam feed water additives for food applications. It should be noted that boiler feed water additives permitted in food for human consumption may not be acceptable in drinking water or orally ingested drug products.
美国公共卫生部门/乳制品工业委员会，3A卫生标准，编号609-02，为食品应用而对厨房用蒸气给水添加剂增加附加限制。应该注意人用食品中的锅炉给水添加剂不能用于饮用水或口服药品。
7.2.1 Steam Attributes 7.2.1 蒸气特质
7.2.1.1 Quality 7.2.1.1 质量
The term \FDA or USP regulations relating to minimum \quality\or the level of non-condensable gasses present in pharmaceutical steam. (See Section 7.4.)
当涉及蒸气时，“质量”术语表示蒸气饱和标准。没有关于最低“蒸气质量”或在制药用蒸气中不可压缩气体标准的FDA或USP法规。（参看7.4部分）
European regulators have defined specific criteria for pharmaceutical steam used for equipment
sterilization. (European Standard EN 285 - Steam Sterilizers - reference section 13.3) These cover acceptable levels of saturation or dryness, the level of superheat, and the volume of non-condensable gases present.
欧洲法规对用于设备灭菌的制药用蒸气规定了具体标准。(欧洲标准EN 285-蒸气灭菌器-参考13.3部分)。这些包含饱和或干燥标准、过热标准和不可压缩气体体积。
7.2.7.2 Purity 7.2.7.2 纯度
Purity requirements for steam used in pharmaceutical manufacturing and product development are driven by the product characteristics, manufacturing process, and the intended use of the product. The product manufacturer is responsible for ensuring that steam used to process the product is appropriate.
用于制药生产和产品研制的蒸气纯度要求由产品特性、生产工艺和产品预期用途决定。药品生产商有责任确保将合适的蒸气用于药品生产。
Though steam purity requirements are product specific, it may be impractical to reliably produce special steam for each situation. Manufacturing operations typically generate and distribute only one or two steam purity grades, commonly grouped. 虽然蒸气纯度要求是因产品特性而不同，但为每个情况可靠地生产特殊蒸气是不实用的。生产操作典型地产生和分配一般分组为一种或两种的蒸气纯度等级。
7.3 TYPES OF STEAM 7.3 蒸气类型
Pharmaceutical steam is classified into two (2) types based on their respective sources. These are: 1) Utility-Boiler produced steam, hereafter called Utility Steam. 2) Non-Utility Boiler produced steam, hereafter called Clean Steam. 根据它们各自的来源，制药用蒸气分为两种类型。它们是： 1)公用锅炉产生的蒸气，此后叫做公用蒸气。 2)非公用锅炉产生的蒸气，此后叫做清洁蒸气。
7.3.1 Utility Steam 7.3.1 公用蒸气
Utility steam is characterized with usually having: ? Chemical additives to control scale and corrosion
? Relatively high pressure with the potential of generating superheat during expansion ? Relatively high pH
公用蒸气通常具有以下特征：
? 用于控制水垢和腐蚀产物的化学添加剂 ? 伴随在膨胀时产生过热潜在性的相对高压 ? 相对的高pH值
