ISPE 6.终处理选择：注射用水.doc

ISPE Pharmaceutical Engineering Guides For New And Renovated Facilities 1 FINAL TREATMENT OPTIONS: WATER FOR INJECTION (WFI) 终处理选择:注射用水 ISPE Pharmaceutical Engineering Guides For New And Renovated Facilities 2 6. FINAL TREATMENT OPTIONS: WATER FOR INJECTION (WFI) 终处理选择:注射用水 INTRODUCTION 介绍 Th is chapter addresses the USP approved final treatment methods for the production pendial WFI. W FI is the purest grade of bulk water monographed by the USP and would be expected to be used for the m anufacture of parenteral, some ophthalmic and inhalation products, and for finishing steps of parenteral gr ade active pharmaceutical ingredients (API's). 本章着重介绍了 USP 批准的注射用水的终处理方法,注射用水是 USP 中水的最高纯度等级,用于制备注射类药品、一些眼科及吸入类药品,并用于注射级原料药(API's) 的最后步骤。 mended systems include either distillation or RO as the final processing step, but may also include trafiltration (UF), deionization (Dl) and/or ion exchange (IX), pliment the RO or distillation unit opera ti on. 推荐使用蒸馏系统或反渗透系统作为水处理的最后步骤, 同时还包括使用超滤、消电离和/ 或离子交换来增强蒸馏系统或反渗透系统的效果。 the technology, operation, maintenance, and relative cost issues for the approved process methods are di chapter includes USP monograph information, regulatory issues, and subsections that cover the unit operations: 本章还讨论了这些经批准的处理方法的技术、操作、保养以及相关的费用,本章包括了 USP 中相关的信息、法规条文、以及涉及设备操作的部分: ? Single effect (SE) distillation 单效蒸馏? Multi-effect (ME) distillation 多效蒸馏? pression (VC) distillation 压汽蒸馏? Reverse osmosis (RO) 反渗透 F eed water pretreatment is covered along with economic factors such as construction materials, surface fi nishes, and instrumentation and controls. parison table on USP-WFI final treatment options and rel ative attributes is provided. 本章还涵盖了水的预处理以及一些经济因素:比如建筑材料、表面抛光处理、仪器和控制器。本书还提供了一个比较表格,对美国药典注射用水终处理方法以及其相关的特性进行了比较。 US PHARMACOPOEIA ISSUES 美国药典要求 T he United States Pharmacopoeia (USP) allows WFI to be "purified by distillation or by RO". This statement do es not imply that the regulated process step is the only process step, but the USP