D/A/CH Affiliate: WFI Handbook (English Translation)


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Published: September 2021
Pages: 88

The ISPE D/A/C/H Affiliate Handbook: Production of Water for Injection without Distillation was first published by the ISPE Germany/Austria/Switzerland (D/A/CH) Affiliate in March 2019 in German and has been translated into English.

This Handbook has been prepared by authors exclusively from Europe and focuses on a European perspective on WFI production by non-distillation methods, however non-European regulations are mentioned to provide additional context. In the future, an additional global perspective is planned to be published by ISPE.

The publication of the revised European Pharmacopoeia Monograph on the Production of Water for Injections (WFI) in April 2017 was the result of decades of discussions and analysis. Prior to this revision, distillation was the final step in WFI production. The European Medicines Agency also published a Q&A document that incorporates additional requirements on the production of ambient WFI systems. This ISPE Handbook presents membrane processes as an alternative to distillation for the production of WFI, offering regulatory compliance with technical and operational feasibility practices.

The ISPE D/A/CH water experts created this Handbook to give clear advice on good control strategies for ambient WFI systems. The Handbook includes:

  • Regulatory Requirements
  • Production of Water for Injection
  • Discussion of Risks
  • Measurement Technology
  • Storage and Distribution
  • Sanitization
  • Qualification and Validation
  • Monitoring and Controls
  • Economic Aspects

Different aspects are evaluated in the risk discussion chapter of the Handbook, including traditional distillation methods and new processes. Specifically, the publication examines risk based on:

  • The intended use (Water for Injection / Highly Purified Water)
  • Process technologies and their capability to remove typical impurities
  • Process Reliability

The Handbook includes many tables, diagrams, pictures, and references. It can support pharmaceutical companies around the world in setting up a suitable control strategy for ambient WFI systems. In addition, it can help companies determine the most suitable process when building a new WFI system.