The International Society for Pharmaceutical Engineering (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 a combination of proven technological solutions, microbial control methods, process analytical technology, and operations and maintenance practices.
NORTH BETHESDA, Md. , June 10, 2022 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering (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 a combination of proven technological solutions, microbial control methods, process analytical technology, and operations and maintenance practices.
"Membrane-based WFI is a state-of-the-art method that should be used whenever possible," said Guide Co-lead Fritz Roeder , Senior QA Manager, Merck Healthcare KGaA. "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, the production of WFI was universally accepted to be distillation-based. As the 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," said Guide Co-lead Brian Pochini , Principal Engineer, Sanofi. "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."
Purchase the ISPE Good Practice Guide: Membrane-Based Water for Injection Systems, the latest among ISPE's many educational resources, online at ISPE.org/Publications/Guidance-Documents.
About ISPE The International Society for Pharmaceutical Engineering (ISPE) is the world's largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancements across the entire pharmaceutical lifecycle. The 20,000+ members of ISPE provide solutions to complex pharmaceutical industry challenges through innovation, member and workforce development, technical, regulatory and compliance collaborations in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit ISPE.org for more information.
Kristin LeMunyon , ISPE, 813-960-2105, klemunyon@ispe.org
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