Water for Injection (WFI)

Guidance Docs

Good Practice Guide: Membrane-Based WFI Systems

Good Practice Guides
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.
Figure 3: AUC used as the metric evaluator for models 1 to 5 (2020 data) and model 1 (2018 data, bottom right).
Technical
Case Study: Water for Injection Plant AI-based Maintenance

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 plant for preventive maintenance activities, common in the industry, and use a more scientific...

Video

Podcast: Water for Injection Using Non-Distillative Methods Webinar Q&A

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

Water for Injection Using Non-Distillative Methods – ISPE D/A/CH Approach Webinar

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
Training

Pharma Water Generation USP WFI & Purified Water Training Course

This course will cover the principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP and non-compendial waters. These concepts include specification....