The European Pharmacopoeia only prescribed distillation as a method for producing WFI for a very long time. Even back then BWT had shown in practice with many customers that the OSMOTRON can easily adhere to the microbiological and chemical thresholds set out for WFI. As it became clear that the WFI monograph of the Ph. Eur. would be changed, one thing became clear for the whole BWT team from the very beginning:
As a result, the OSMOTRON WFI was totally revamped. The requirements of the pharmacopoeia, the design of annex 1 and the Q&A of the European Medicines Agency were the foundation. The system was developed in line with quality-by-design principles using a risk-based approach. Comprehensive long-term tests were carried out in cooperation with an independent university. In this case, the system's performance is verified with valid data.
|Membrane-based WFI in Best Quality||PDF, 1502 Kb||Download|
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