What is this ISO 22519 - Pre-treatment and production systems for PW and WFI about?
ISO 22519 discusses purified water and water for injection pre-treatment and production systems.
Water quality for Purified Water (PW) and Water for Injection (WFI) is specified in national and international standards, but a standardized system for producing PW and WFI is not in place.
ISO 22519 specifies the design, materials selection, construction, and operation of PW and WFI pre-treatment 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.
Note: ISO 22519 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
Who is ISO 22519 - Pre-treatment and production systems for PW and WFI for?
ISO 22519 on pre-treatment and production systems for purified water is useful for:
- Pharmaceutical industry
- National governments
- State authorities
- Regulatory bodies
- Public water supply systems
Why should you use ISO 22519- Pre-treatment and production systems for PW and WFI?
ISO 22519:
- Allows users to specify water systems that fit specific needs without being experts in the water system field
- Allows users to decide whether the offered systems are safe, efficient, and sustainable
- Enables national governments, state authorities, and regulatory bodies to perform professional audits
- Provides auditors a standard checklist to harmonize equipment and systems in the water industry
- Sets a high benchmark for suppliers of water systems all over the world, to be used as a point of reference for their systems and
- Improve reliability of the water generation process methods and water product while reducing downtime needed for scheduled and non-scheduled maintenance
ISO 22519 provides a standard benchmark that can be used by the industries that use PW and/or WFI, national governments, state authorities, and regulatory bodies to evaluate PW/WFI systems. ISO 22519 defines technical terms related to PW and WFI generation and discusses examples of PW production systems, examples of feed water categories, system selection table, and configuration of typical integrity test for polishing UF.
