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
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  • This field is for validation purposes and should be left unchanged.