Water for Injection (WFI)

Guidance Docs
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.
Technical
This article presents the results of applying artificial intelligence (AI), such as machine learning algorithms, to identifying and predicting anomalies for corrective maintenance in a water for injection (WFI) processing plant. The aim is to avoid the yearly stoppage of the water for injection...
iSpeak Blog
The design, construction, commissioning, qualification, and continued performance of water and steam systems for the pharmaceutical industry present significant challenges. These systems need to meet Good Manufacturing Practice (GMP) regulations...
Video
Listen to Fritz Röder and a team of panelist as they discuss ten of the most asked or most interesting questions from the Water for Injection Using Non-Distillative Methods Webinar. Panelists: Fritz Roeder of Merck is...
Video
Since April 2017, the European Pharmacopeia allows to produce Water for Injection using other methods than distillation. Meanwhile, the additional water quality "Highly Purified Water" could be found in the Ph. Eur. but...
Training
This course will cover the principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory....
iSpeak Blog
Design Considerations for Water for Injection (WFI) Distillation Systems for Improving Quality, Project Performance, and Equipment Life Cycle Cost Reduction was featured in the September/October 2015 issue of Pharmaceutical Engineering® magazine. This...
iSpeak Blog
Design Considerations for Water for Injection (WFI) Distillation Systems for Improving Quality, Project Performance, and Equipment Life Cycle Cost Reduction was featured in the September/October 2015 issue of Pharmaceutical Engineering® magazine. This...