ISPE announced the release of the ISPE Good Practice Guide: Membrane-Based Water for Injection Systems. This Guide provides expert guidance on the design, operation, maintenance, and quality aspects of membrane-based water for injection (WFI) systems, including generation, storage, and distribution. The information presented in this guide is the combination of proven technological solutions, microbial control methods, process analytical technology, and operations and maintenance practices.
Membrane-based water for injection is a state-of-the-art method that should be used whenever possible. This Guide will be useful to 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 membrane-based technologies for WFI production. It is recommended that the readers have a baseline knowledge of pharmaceutical water systems and their unit operations prior to reading this Guide.
This Good Practice Guide provides an objective discussion of current best practices as well as critical technical information pertaining to membrane-based WFI systems. The guide reflects an industry wide collaborative effort by a diverse range of experts that include equipment providers, engineering firms, consultants, and pharmaceutical manufacturers to present a holistic view of the pros and cons of membrane-based WFI systems.