Good Practice Guide: Membrane-Based WFI Systems

Published: May 2022
Pages: 196

• Table of Contents
• Special Pricing for Emerging Economies

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.

• ISPE Baseline Guide: Volume 4 – Water and Steam Systems (Third Edition)
• ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems
• ISPE Good Practice Guide: Critical Utilities GMP Compliance
• ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems

Guide Core Team

Brian Pochini

Principal Engineer

Sanofi

Fritz Röder

Senior QA Manager

Merck

Nissan Cohen, PhD

Owner

Biopharmaceutical Water Doc

Brian M. Cox

Assoc. Sr. Consultant - QA

Eli Lilly and Co.

Brian M. Hagopian, CPIP

Chemist and President

Clear Water Consulting, Inc.

Nikola Krpan

President

Cheme Engineering Inc.

Joseph Manfredi

President

GMP Systems Inc

Stephan Neumann

Global Governance Critical Utilities

Boehringer Ingelheim GmbH

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.

President

Soli Pharma Solutions, Inc.

Anders Widov, M Sc Chem Eng

Sales Director

BWT Pharma & Biotech AB

Marcel Zehnder

Sales Manager

BWT AQUA AG

Gary V. Zoccolante, BSME

President

Plymouth Rock Water Consultants

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