ISO 22519:2019
Purified water and water for injection pretreatment and production systems
This document specifies design, materials selection, construction and operation of Purified Water (PW) and Water for Injection (WFI) pretreatment and membrane-based production systems.
As many different types of feed water are possible, different components and configurations are presented. A decision matrix is provided to give guidance for the different types of feed water.
This document excludes
— selection of the appropriate compendial water definition per system: e.g. PW, WFI or other;
— thermal process for generation of PW/WFI;
— loops, storage and distribution;
— pure steam generation and distribution;
— laboratory water systems and
— validation.
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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 Design and practices
4.1 Setting system boundaries
4.2 General system requirements
4.3 User Requirements Specifications (URS) scope
4.4 Detailed system capacity calculation
5 Selecting materials, methods and system components
5.1 Recommended system components/treatment stages
5.2 Advantages and disadvantages of system components/treatment stages
5.3 Materials of construction — General
5.4 Stainless steel (SS) piping — General
5.5 Non-final product water piping/tubing in the PW/WFI pretreatment and production
5.6 Piping/tubing in contact with PW/WFI product
6 Sampling
6.1 Sampling principles
6.2 Minimum sampling point and locations
6.3 Sampling conductivity
7 Instruments
7.1 Minimum instrumentation for installation
7.2 Parameters for measuring, alarming, storing and graphing from online instruments
8 System design
8.1 Specification of feed water
8.2 System selection table based on feed water quality
9 Operation
9.1 Production
9.2 Recirculation when storage tank full
9.3 Sanitization
9.4 Chlorine and chlorination
10 Maintenance
10.1 Standard Operating Procedure (SOP´s)
10.2 Filter replacement
10.3 Chlorine instrumentation
10.4 Carbon dioxide
10.5 Membrane Integrity for polishing UF
11 Specific Good Manufacturing Practice (GMP) requirements
11.1 General
11.2 Safety considerations
11.3 Commissioning and qualification requirements
12 Control philosophy
12.1 Minimum control loops needed for installation
12.2 Automation
13 Alarms
13.1 Required alarms
13.2 Recommended alarms
14 Recommended engineering documentation
14.1 General user guide
14.2 Instrumentation documentation
14.3 General piping/tubing
14.4 PW/WFI product piping/tubing
14.5 Tanks
14.6 Pumps
14.7 Insulation
14.8 Signs
14.9 Software
14.10 Electrical documentation
14.11 Factory acceptance test (FAT) protocol
14.12 IQ/OQ protocol
14.13 Spare parts list
Annex A (informative) Examples of PW production systems
Annex B (informative) Examples of feed water categories
Annex C (informative) System selection table
Annex D (informative) Configuration of typical integrity test for polishing UF
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 Design and practices
4.1 Setting system boundaries
4.2 General system requirements
4.3 User Requirements Specifications (URS) scope
4.4 Detailed system capacity calculation
5 Selecting materials, methods and system components
5.1 Recommended system components/treatment stages
5.2 Advantages and disadvantages of system components/treatment stages
5.3 Materials of construction — General
5.4 Stainless steel (SS) piping — General
5.5 Non-final product water piping/tubing in the PW/WFI pretreatment and production
5.6 Piping/tubing in contact with PW/WFI product
6 Sampling
6.1 Sampling principles
6.2 Minimum sampling point and locations
6.3 Sampling conductivity
7 Instruments
7.1 Minimum instrumentation for installation
7.2 Parameters for measuring, alarming, storing and graphing from online instruments
8 System design
8.1 Specification of feed water
8.2 System selection table based on feed water quality
9 Operation
9.1 Production
9.2 Recirculation when storage tank full
9.3 Sanitization
9.4 Chlorine and chlorination
10 Maintenance
10.1 Standard Operating Procedure (SOP´s)
10.2 Filter replacement
10.3 Chlorine instrumentation
10.4 Carbon dioxide
10.5 Membrane Integrity for polishing UF
11 Specific Good Manufacturing Practice (GMP) requirements
11.1 General
11.2 Safety considerations
11.3 Commissioning and qualification requirements
12 Control philosophy
12.1 Minimum control loops needed for installation
12.2 Automation
13 Alarms
13.1 Required alarms
13.2 Recommended alarms
14 Recommended engineering documentation
14.1 General user guide
14.2 Instrumentation documentation
14.3 General piping/tubing
14.4 PW/WFI product piping/tubing
14.5 Tanks
14.6 Pumps
14.7 Insulation
14.8 Signs
14.9 Software
14.10 Electrical documentation
14.11 Factory acceptance test (FAT) protocol
14.12 IQ/OQ protocol
14.13 Spare parts list
Annex A (informative) Examples of PW production systems
Annex B (informative) Examples of feed water categories
Annex C (informative) System selection table
Annex D (informative) Configuration of typical integrity test for polishing UF
Bibliography