Multi-Effect Distillation / Vapor Compression Systems for Pharmacopoeial-Grade WFI
A Water for Injection (WFI) system generates and distributes water meeting the stringent chemical purity and microbiological/endotoxin limits defined by USP, EP, and IP pharmacopoeias for use in parenteral formulation, final rinsing, and other applications where water becomes part of the drug product or contacts product-contact surfaces. Generation is most commonly achieved by multi-effect distillation (MED) — using purified water (PW) as feed and plant steam as the heating medium — or by vapor compression (VC) technology. The distribution system then delivers WFI continuously to points of use via a validated, continuously circulating loop, either maintained hot (65–80°C) or at ambient temperature with periodic ozone/UV sanitisation, to prevent microbial and biofilm growth.
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Key Features — Generation
• Multi-effect distillation column (typically 2–8 effects) or mechanical/thermal vapor compression still
• Purified water (PW) feed with automatic feed-water pretreatment and preheating using recovered heat
• Pyrogen and endotoxin removal through validated distillation/vapor-liquid separation mechanism
• All contact parts electropolished SS316L, orbital-welded piping with no dead legs
• PLC/SCADA-based automatic operation, self-sanitising and self-draining design
• Online monitoring of conductivity, TOC (Total Organic Carbon), temperature, and flow -
Key Features — Distribution
• Continuously circulating loop design (turbulent flow, Reynolds number > 5000) with no dead legs
• Storage tank with hydrophobic 0.22 µm sterilising-grade vent filter and spray-ball CIP/SIP
• Orbital-welded SS316L piping, sanitary diaphragm valves, and validated slope for self-draining
• Loop maintained hot (65–80°C) or ambient with scheduled ozonisation/UV disinfection
• Multiple validated use-point outlets with sample valves for routine quality monitoring -
Typical Applications
• Preparation of parenteral (injectable) formulations and large/small volume parenterals
• Final equipment/vial/ampoule rinsing prior to sterile filling
• Feed water for pure steam generators and other high-purity utility systems
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Technical Specifications
