2　术语和符号

• 2.1　术语

• 2.2　符号

4　工艺系统设计

• 4.1　一般规定

• 4.2　工艺用水制备

• 4.3　设备

• 4.4　工艺用水的分配输送

• 4.5　纯化水、注射用水系统的清洗、消毒和灭菌

• 4.6　纯化水、注射用水的检测和控制

• 4.7　纯蒸汽制备及输送

5　管道

• 5.1　一般规定

• 5.2　管道的材质、阀门和附件

• 5.3　管径确定和压力损失计算

• 5.4　管道安装

• 5.5　保温

6　站房

• 6.1　一般规定

• 6.2　站房布置

• 6.3　设备布置

7　建筑与结构

• 7.1　建筑

• 7.2　结构

8　公用工程

• 8.1　电气

• 8.2　给水排水

• 8.3　暖通空调

附录A　工艺用水系统的管理和检查、维护

• A.1　工艺用水系统的管理

• A.2　工艺用水系统的检查、维护

附录B　纯化水、注射用水系统确认要求

• B.1　纯化水、注射用水系统确认的内容

• B.2　纯化水、注射用水确认文件目录

2 Terms and symbols

• 2.1 Terms

• 2.2 Symbols

4 Process systems design

• 4.1 General requirement

• 4.2 Preparation of process water

• 4.3 Equipment

• 4.4 Distribution and transportation of process water

• 4.5 Cleaning,disinfection and sterilization of purified water and water for injection system

• 4.6 Detection and control of purified water and water for injection system

• 4.7 Preparation and transportation of pure steam

5 Piping

• 5.1 General requirement

• 5.2 Materials,valves and accessories of piping

• 5.3 Determination of pipe diameter and calculation of the pressure loss

• 5.4 Installation of piping

• 5.5 Thermal insulation

6 Station building

• 6.1 General requirement

• 6.2 layout of station building

• 6.3 layout of equipment

7 Architecture and structure

• 7.1 Architecture

• 7.2 Structure

8 Utilities

• 8.1 Electric

• 8.2 Water supply and drainage

• 8.3 HVAC

Appendix A Management and inspection, maintenance of pharmaceutical process water system

Appendix B Qualification requirements of purified water and water for injection system