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In Europe it has become possible to produce water for injection (WFI) using non-distillation methods since March 2017. The change in the European Pharmacopoeia allows WFI production by means of suitable methods such as reverse osmosis. However, the EU Commission has also pointed out that in order to ensure the quality of a “cold-produced” WFI, other measures have to be taken than those required previously for the mandatory distillation. The robustness of this new process has to be demonstrated. The Q&A document prepared for this purpose by the EMA provides further assistance in some areas, but also leaves many questions unanswered. In addition, the monograph on Highly Purified Water (HPW) will be suppressed as of April 2019. Now, the most obvious question is: how will HPW - after its suppression from the European Pharmacopoeia - become Water for Injection (WFI)?
The Webinar on 25 June will address and answer the following questions:
What is the current regulatory status? What do Pharmaceutical Associations say?
Which technologies are appropriate for the cold production of WFI?
Where do the new risks lie?
What are the measures to counter those risks?
What does happen to existing HPW systems?
How to set up a suitable control strategy?
What is the feedback from pharmaceutical “cold WFI” projects?
The target group of this Webinar are specialists from pharmaceutical companies (production, qualification, quality assurance) as well as from planning and plant engineering who are entrusted with the construction, operation or maintenance of WFI producing equipment.
Fritz Röder (Merck KGaA) is Senior QA Manager Qualification, Validation & Engineering at Merck in Darmstadt. He is a member of the expert group “Water” of the EDQM and the working group “Pharma Water” of the ISPE DACH. He has many years of experience in water treatment through his activities in plant engineering and pharmaceutical companies, including Bayer, Allergan and Merck.
Jochen Schmidt-Nawrot (CRB Group GmbH) has been working in the field of pharmaceutical water for more than 20 years, among others at BWT (Christ), Hager + Elsässer and Chemgineering and is an expert for membrane processes. He is currently Lead Engineer Process Utilities for Pharma and Biotech at the pharmaceutical engineering service provider CRB in Basel. Through numerous publications on WFI without distillation, he has supported the approval of membrane technologies for the production of WFI in Europe.