ISPE 5.终处理选项：药典规定的纯化水和非药典规定的纯化水.docVIP

FINAL TREATMENT OPTIONS: NON-COMPENDIAL and COMPENDIAL PURIFIED WATER 终处理选项： 药典规定的纯化水和非药典规定的纯化水 5 FINAL TREATMENT OPTIONS: NON-COMPENDIAL AND COMPENDIAL PURIFIED WATER终处理选项：药典规定的纯化水和非药典规定的纯化水 5.1 INTRODUCTION介绍 This chapter discusses the final treatment technologies and basic system configurations related to the manufacturing process of USP Purified Water and non-compendial water. 该章讨论的是USP纯化水和非药典规定的水的制备过程相关的基本系统结构和终处理工艺。 Various system configurations are presented, and reflect a significant shift from ion exchange based systems to membrane based systems. Equipment and system materials, surface finish and other design factors are discussed to promote the use of Good Engineering Practice for proper selection of components, piping, instrumentation, and controls. 将介绍各种系统，并反应从离子交换基础系统到膜基础系统的有效转换。将·讨论设备和系统的材料、表面磨光和其他设计因素以促进《良好工程实务规范》中的正确选择组件、管线、仪器操作和控制的应用。 USP Purified Water and non-compendial water can be produced by an almost unlimited combination of unit processes in various configurations. The most common pretreatment and final treatment technologies used in purified water production are shown in Figure 5-1, Figure 5-2, and Table 5-4 at the end of the chapter. This chapter discusses the final treatment unit processes currently utilized, including ion exchange, reverse osmosis, electrodeionization, ultrafiltration, microfiltration, and ultraviolet light. These technologies as well as distillation (see Chapter 6) are utilized in thousands of systems for the successful production of purified and non-compendial water. 在生产USP纯化水和非药典规定的水时，不同的加工单元之间的组合几乎是不受限制的。本章结尾处的图5-1、图5-2和图5-3显示了纯化水生产中最普通的预处理和终处理工艺。该章讨论了当前使用的终处理操作单元，包括：离子交换、反渗透、电法去离子、超滤、微滤和紫外光。成千上万的成功的生产纯化水和非药典规定的水的系统都使用了这些工艺以及蒸馏（见第6章）。 Ion exchange based systems were the dominant systems for decades in purified water production and are still successfully utilized in facilities today. The last decade has seen the growth of reverse osmosis membrane based systems increase to the point where over 90% of new systems employ