ISO 22519:2023
Membrane-based generation of water for injection (WFI)
This document provides a benchmark for evaluation of the design, operation and performance of water for injection (WFI) generation systems based on membranes.
This document is applicable to the design of new systems.
This document covers the following topics:
— principles of membrane-based WFI generation systems;
— process design, construction, operation and maintenance of membrane-based WFI generation systems;
— controlling membrane-based WFI generation system parameters.
This document does not cover the following topics:
— validation;
— distillation.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
3.2 Abbreviated terms
4 System boundaries
5 Feed water
6 Process design for membrane-based WFI generation systems
6.1 General
6.2 Design conditions
6.3 Important design factors
6.4 Examples of possible configurations of water technology stages in WFI generation systems
6.5 Primary microbial reduction unit operations
6.6 Instrumentation
7 Sanitization
7.1 General
7.2 Sanitization types
8 Construction
9 Demonstrating performance of critical quality attributes
10 Sampling
11 System operation
12 System maintenance
13 Control
14 Other considerations
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
3.2 Abbreviated terms
4 System boundaries
5 Feed water
6 Process design for membrane-based WFI generation systems
6.1 General
6.2 Design conditions
6.3 Important design factors
6.4 Examples of possible configurations of water technology stages in WFI generation systems
6.5 Primary microbial reduction unit operations
6.6 Instrumentation
7 Sanitization
7.1 General
7.2 Sanitization types
8 Construction
9 Demonstrating performance of critical quality attributes
10 Sampling
11 System operation
12 System maintenance
13 Control
14 Other considerations
Bibliography