New guidance for membrane-based water for injection systems

The International Society for Pharmaceutical Engineering (ISPE) has released a new Good Practice Guide on Membrane-Based Water for Injection Systems.

While production of water for injection (WFI) has traditionally been a distillation-based process for nearly a century, rising costs and environmental pressures have prompted pharmacopoeias around the world to focus on the quality attributes of WFI to allow for the consideration of other production technologies.

In 2017, the European Pharmacopoeia joined the US, Japan and other regulatory bodies in accepting membrane-based 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.

Commenting on the release, Guide Co-lead Fritz Roeder, Global Engineering Manager at Merck Healthcare KGaA, stated: “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.”

“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,” added Guide Co-lead Brian Pochini, CPIP, Principal Engineer at Sanofi.

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.