A major global player in vaccine manufacturing has just ordered two additional membrane-based “cold” WFI systems for one of its European sites. This facility will soon have had six (6!) of these systems installed in the past four years. What is so remarkable about this?
Water for injection, or WFI, is an essential utility in pharmaceutical manufacturing. WFI has traditionally been generated through the energy-intensive process of distillation, but the recent revision to monograph 0169 of the European Pharmacopoeia (EP) has now also made techniques other than distillation universally accepted. The revision has finally aligned the EP with the US and Japanese Pharmacopoeias in allowing more energy efficient alternatives.
Syntegon acted on this regulatory change right as it took place and was among the first industry suppliers to introduce the new type of generation unit for WFI in Europe. Our MWFI system uses the “cold” membrane process of reverse osmosis, along with electro-deionization and ultrafiltration, in a modular, full-featured design. Storage can be either hot or cold. This approach substantially reduces the associated footprint, energy consumption, investment costs, qualification expenses, and ongoing maintenance costs when compared to traditional distillation-based systems.
Modular, full-featured “cold” WFI generation represents innovation that is intelligent, affordable, sustainable, and turn-key. We are delighted to have our returning vaccine manufacturing customer order additional units. We are once again providing the full project scope, including storage and distribution for all units. And the project is right on track, with detailed engineering currently nearing completion. We know that impeccable project execution is also why our customers keep coming back.