ISPE Briefs: New GPG Explores Membrane-Based WFI Systems
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 mem-brane-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.
“Membrane-based water for injection is a state-of-the-art method that should be used whenever possible,” said Good Practice Guide (GPG) Co-lead Fritz Roeder, Global Engineering Manager, Merck Healthcare KGaA. “This GPG will be useful to engineers, production, quality assurance, and quality control professionals and regulators who have some water expertise.”
This is a first-of-its-kind guide that presents a global view of membrane-based WFI generation technologies and their impact on the storage and distribution system. It “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 industrywide collaborative effort by a diverse range of experts that includes equipment providers, engineering firms, consultants, and pharmaceutical manufacturers to present a holistic view of the pros and cons of membrane-based WFI systems.”
Meet the ISPE Staff: Tim Postlethwaite
In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Tim Postlethwaite, Director of Technical Communities.
Tell us about your role at ISPE: What do you do each day?
My primary role is to work with more than 20 ISPE Communities of Practice (CoPs) and Special Interest Groups (SIGs) that generate much of the key ISPE output: Guidance Documents, webinars, PE magazine articles, iSpeak Blog posts, training materials, and conference content. I meet through standing meetings with the CoP Steering Committees and SIG leadership teams, comprised of nearly 350 ISPE member volunteers, to support and guide their efforts, including generating and executing annual content plans. I serve as a liaison between the technical community members and other ISPE staff members who facilitate content delivery. I work with the ISPE Knowledge Network Council, ISPE senior leadership, and the ISPE Board of Directors to monitor the health of each community, to sunset communities, and to establish new communities as the needs of the pharmaceutical industry evolve.
What do you love about your job?
Having spent time working in the pharmaceutical industry prior to joining ISPE, I really enjoy maintaining contact with pharmaceutical professionals across the globe daily. I am constantly astonished by the commitment and knowledge our volunteers bring to bear to create outstanding content to forward the entire industry. ISPE provides a place where technical communities comprised of subject matter experts, many from competing companies, come together to share best practices and contribute to the betterment of the industry. My role also provides the opportunity to collaborate with most ISPE staff, which is a fantastically supportive group of colleagues.
What do you like to do when you are not at work?
Having recently relocated to Lake County in central Florida, I enjoy boating, bass fishing, dodging alligators, and DIY home projects. My wife and I enjoy spending time with family and friends, traveling, and keeping up with our daughter who is pursuing a graduate degree at Florida State University.
