ISPE3水选项和系统规划.doc

WATER OPTIONS
and
SYSTEM PLANNING
水选项
和
系统规划
3 WATER OPTIONS AND SYSTEM PLANNING 水选项和系统规划
INTRODUCTION 简介
This chapter outlines basic water system design criteria and, along with subsequent chapters, aims to provide a better understanding of pharmaceutical water, how it is used, and how it can be provided. The primary goal of this chapter is to provide the user with a methodology for:
此章,连同后面的章节一起概述了基础的水系统设计标准,目的在于更好的了解制药用水,它应该如何使用,如何提供。此章的首要目标是为用户提供一个方法,关于:
a) Evaluating water quality options for product manufacturing
针对产品制造来评估水质选项
b) Evaluating basic system configurations available to provide the water
评估用于供水的基础系统配置
Detailed information on unit operation design, maintenance and cost factors is addressed in later chapters.
关于单元操作的设计、维护以及费用等因素的详细信息在后面章节说明。
The chapter also outlines the system planning effort for pharmaceutical water systems. This planning starts with the selection of water quality based upon product requirements, processing operations, and end use. A decision tree concept is included to assist in selection pendial and pendial waters for production, cleaning, and support. The program then provides steps to guide the user through a use-point and system analysis, to set-up the water system distribution strategy. Finally, evaluation points are provided for the selection of the primary system configurations.
此章节也概述了制药用水系统的系统规划。此规划从根据产品需求、加工操作以及最终用途进行水质选择开始。在协助选择法定或非法定水进行生产、清洁以及支持时包括一个决策树概念。然后此规划提供方法来指导用户通过一个使用点和系统分析,建立水系统的分配策略。最后,为最初选择的系统配置提供评估点。
WATER QUALITY OPTIONS 水质选项
Quality requirements for water used in pharmaceutical manufacturing and product development are driven by the product characteristics, manufacturing processes, and the intended use of the product. To aid in the water selection process, the USP Monographs define minimum requirements for general types of pharmaceutical water used in almost every pharmaceutical application. However, there is also the opportunity for a manufacturer to determine water quality re