Water For Injections
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.
Specifications
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
