In May 2017 Bosch presented its new MWFI series for the production of water for injection (WFI). The generation unit employs the “cold” membrane processing methods reverse osmosis and electrodeionization, together with an additional ultrafiltration step. Until now, in the European Union this method was only approved for the production of highly purified water (HPW), while in the USA and Japan it has already been approved for obtaining WFI. In the future, the process will also be permitted by European authorities – albeit with additional, specific requirements.
Essentially, the unit must produce water under conditions that prevent the growth of microorganisms and other impurities. For reverse osmosis systems, the EMA stipulates regular sanitization of the unit using hot water – primarily to prevent the formation of biofilms. For additional protection, chemical sanitization must also be an option. The unit offers both options. To prevent contamination as a result of insufficient barrier properties, the membranes’ integrity is checked on a regular basis.
Bosch has now reworked the WFI unit, including a more hygienic design and built-in measuring technology to monitor the system.
Monitoring all the processes in the production chain is essential to guaranteeing the microbial quality of the water which is why Bosch fitted the unit with various sensors and measuring devices to monitor the water quality throughout the process and to check Total organic carbon (TOC), conductivity and other important parameters. An online microbe counter is available as an option.
The new MWFI series offers a production range from 1,000 to 12,000 liters of WFI per hour.
Dr. John Medina
+49 351 28278 689