ISPE_07.制药用蒸汽.docVIP

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 h