Fabtech’s WFI generation systems produce 100% pyrogen-free water. Water for Injections is stored in a continuously circulating system and maintained at an elevated temperature (80-85 degrees C) to prevent microbial growth from taking input from purified water. Distillation is simply the phase change from liquid to vapour, thus enabling the pre-treated feed water to be stripped of any residual ionic materials, particulates, colloids and non-volatile organic compounds as well as bacterial endotoxins. Our systems meet USFDA, WHO, MHRA regulations as well as ASME BPE, ISPE, cGMP guidelines.
MCD (Multicolumn Distillation Unit) + Distribution Systems Energy saving design Working principle based on falling film technology Inbuilt sanitization mode for maintaining the loop under sterile conditions Customisable configuration Combi-unit option for Pure Steam generation from the 1st Still outlet of the WFI generator Automatic/semi-automatic variants with 21 CFR Part 11 compliance with SCADA Standard/reduced skids for optimum performance/minimum footprint High quality orbital welding with boroscopy and videoscopy ASME BPE grade field piping with insulation – fully drainable and integrated with zero dead leg valves, instruments, pendants Elaborate document dossiers including DQ, FAT Protocols, IQ, OQ to support validation
