Good Practice Guide: Membrane-Based WFI Systems


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Published: May 2022
Pages: 196

For nearly a century, production of Water for Injection (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 (with the exception of China) in accepting membrane-based technologies for WFI production.

The ISPE Good Practice Guide: Membrane-Based Water for Injection Systems provides expert guidance on the design, operation, maintenance, and quality aspects of membrane-based WFI systems, including generation, storage, and distribution. This Guide reflects an industry wide collaborative effort by a diverse range of industry experts that include equipment providers, engineering firms, consultants, and pharmaceutical manufacturers. The information presented in this guide is the combination of proven technological solutions, microbial control methods, process analytical technology, and operations and maintenance practices.

This Guide is a complementary guide to several other ISPE Guidance Documents as indicated below. It is recommended that the readers have a baseline knowledge of pharmaceutical water systems and their unit operations prior to reading this Guide.

Guide Core Team

Brian Pochini, CPIP
Principal Engineer
Fritz Röder
Senior QA Manager
Nissan Cohen
Biopharmaceutical Water Doc
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Brian M. Cox
Assoc. Sr. Consultant - QA
Eli Lilly and Co.
Brian M. Hagopian, CPIP
Chemist and President
Clear Water Consulting, Inc.
Nikola D. Krpan
Cheme Engineering Inc.
Joseph Manfredi
GMP Systems Inc
Stephan Neumann
Global Governance Critical Utilities
Boehringer Ingelheim GmbH
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Chris Peterson
Licor Biosciences
Stefan Raabe
Head of Strategic Account Management – Life Sciences Industries
Endress+Hauser (Schweiz) AG
Jochen Schmidt-Nawrot
Fellow Process Utilities
CRB Group GmbH
Teri Cullen Soli, Ph.D.
Soli Pharma Solutions, Inc.
Anders Widov, M Sc Chem Eng
Sales Director
BWT Pharma & Biotech AB
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Marcel Zehnder
Sales Manager
Gary V. Zoccolante, BSME
Plymouth Rock Water Consultants

For the full list of contributors to this Guide see Guidance Document Teams