Membrane-Base WFI System
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  • Membrane-Base WFI System

 

Membrane-Base WFI System

WELKIN has mastered globally leading core technologies, including hollow fiber nanofiltration, reverse osmosis (RO), electrodeionization (EDI) membranes, and terminal ultrafiltration, to produce Water for Injection (WFI) at normal temperature. The water quality not only meets but exceeds the requirements of Pharmacopoeia standards and client specifications (MWFIS). 
Our latest-generation filtration technology features hollow fiber nanofiltration as the pretreatment core unit. This world-leading nanofiltration membrane utilizes a hollow fiber structure and surface selective charge, ensuring high-quality, stable water for subsequent purification. More importantly, it removes endotoxins at the source, guaranteeing the final WFI quality. 
Our terminal ultrafiltration membrane employs a patented double-layer structure with precise small-molecular pore sizing, effectively removing endotoxins and particles from the final water. It supports thermal disinfection, chemical disinfection, and even in-place steam sterilization. Additionally, based on the direct integrity test principle, the terminal ultrafiltration system incorporates a bubble observation test (conducted through the water production side).


MWFIS Advantages
· Prevent from external and internal contamination with CCS control Strategy. 
· Ensure the integrity performance of filtration membrane, the system sustainability, stability and reliability with PAT online analysis technology. 
· The endotoxin removal rate is greater than log5, though end ultra-filter redundant design and integrity test on line.


MWFIS application 
· Animal Vaccine production 
· Cleaning water for dosages and biopharmaceuticals process 
· Class III medical devices manufacture 
· Dialysate and controlling endotoxin dosages 
· Heat sensitive Nucleic acid and Protein reagents preparation 
· API dissolution 

 

Hollow fiber nanofiltration as pretreatment unit, replace traditional pretreatment unit which easily happen with external contamination. In a short, compared with distillation method, MWFIS has been fully qualified in particle pollution control, operation continuity, endotoxin removal rate, investment and operation cost, and carbon footprint reduction.


Keywords:

Welkin

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