This comprehensive 20-page guideline has considered all industry practices and regulatory requirements for a WFI system. The guides are composed through years of experience and operations gathered from many installations.


Purpose of this guide:

  • is to identify and define design features and typical industry practices
  • to note design elements which must be incorporated within Pure Water System (PWS) and Water-for-Injection (WFI).
  • provides a logical checklist for a WFI system. Any re-work or rectification of design and construction faults in these systems is a costly and time-consuming process, which usually has a severe impact on production and supply chain.
  • it is essential to review each activity critically on an ongoing basis to insure that the best option and no errors are built into the system.
  • The guideline can also used as a gap analysis for existing WFI system

Table of contents & Sample Pages:

E10-0102_WFI_Design_Guidelines- Contents

E10-0102 WFI Design Guidelines-Table of Contents

Associated Industry/regulatory guidance and requirements:

  • ISPE Baseline Guide – Water & Steam Systems
  • FDA Inspection Guide High Purity Water (7/93)
  • PIC/S Guide to GMP for Medicinal Products Part I
  • US, BP and European Pharmcopeia


High purity purified water system Water-for-Injection WFI Design Guideline critical utilities

Who needs this document?

Vendors – equipment fabricators and manufacturers; mechanical piping contractors

Projects, Validation, Engineering department

Related Documents:

E10-01    Purified Water System – Design Input

E10-03    Purified Water System – Design Estimate (water usage pattern, sizing capacities of treatment plant, storage and piping)

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