Purified water and water for injection pretreatment and production systems

Purified water and water for injection pretreatment and production systems

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1   Scope

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.