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ISPE Guidance on Membrane Based Water for Injection Systems

Membrane-based water for injection is a state-of-the-art method that should be used whenever possible. This Guide will be useful to pharmaceutical engineers, production, quality assurance, and quality control professionals and regulators who have some water expertise.

For nearly a century, production of WFI was universally accepted to be distillation-based. As emphasis on costs and environmental concerns has grown, pharmacopeias around the world have focused on the quality attributes of WFI to allow for consideration of other production technologies.

In 2017, the European Pharmacopoeia joined the US, Japan, and many other regulatory bodies (except for China) in accepting #membranebased technologies for WFI production.

The new Guide provides expert advice on the design, operation, maintenance and quality aspects of membrane-based WFI systems, including generation, storage and distribution.

It combines information on proven technological solutions, microbial control methods, process analytical technology, and operations and maintenance practices.

This new Guide is complementary to several other ISPE Guidance Documents, including ISPE Baseline Guide:

  • Volume 4 – Water and Steam Systems (Third Edition) and ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems.
  • It is recommended that the readers have a baseline knowledge of pharmaceutical water systems and their unit operations prior to reading the Membrane-Based Water for Injection Systems Guide.

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