In a risk-based approach, BWT engineers have taken all applicable regulations into account when designing membrane-based WFI systems. In addition to the European Pharmacopoeia (Ph. Eur.), these include the United States Pharmacopoeia (USP), the provisional Q&A document from the European Medicines Agency (EMA), the latest draft of the revised Annex 1 as well as the ISPE manual "Herstellung von WFI ohne Destillationsverfahren" (Generating WFI without distillation) from the ISPE DACH Group "Pharma Wasser und Dampf" (Pharma water and steam).
The result are two standardized systems: OSMOTRON WFI and LOOPO WFI. When a tank and loops are added, they have everything needed for producing safe, cost-effective WFI between a potable water inlet and the point of use of systems technology.
BWT places emphasis on monitoring and maintenance for constantly safe system operation and maintaining long-term value. The European and the US Pharmacopoeia does - too. That's why we take a holistic, risk-based approach across the whole of the life cycle. That is Quality by Design.
Antiscalant or softener - which pretreatment is best for membrane-based WFI production? The answer must be within the framework of an individual risk assessment.
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