A compact, fully automated system for the generation of Cold WFI (Water for Injection) using membrane-based technology (RO + EDI + UF) compliant with US FDA, EU GMP, and Pharmacopeia (USP/BP/EP) standards.

Technical Specifications:

• Design Capacity: [Customize – e.g., 500 to 5000 LPH]
• Technology: Reverse Osmosis + Electro-Deionization + Ultrafiltration (Cold Membrane WFI)
• Output Water Quality (USP/BP/EP):
  • Conductivity: ≤ 1.3 µS/cm @ 25°C
  • TOC: ≤ 500 ppb
  • Endotoxins: ≤ 0.25 EU/ml
  • Microbial Load: < 10 CFU/100 ml
  • Temperature: 20–25°C (Ambient Cold WFI)

Major Components:

• Pre-Treatment: Softener / Filtration Units
• Double Pass RO with EDI Module
• Ultrafiltration (UF) for Endotoxin Removal
• Final 0.2 µm Filter for Distribution

Automation & Controls:

• Fully Automated PLC + HMI System
• Online Monitoring: Conductivity, TOC, Temperature, Pressure
• Alarm Management and Data Logging (21 CFR Part 11 – optional)

Validation & Documentation:

• Complete DQ / IQ / OQ / PQ Protocols
• P&ID, GA Drawings, Electrical & Instrumentation Diagrams
• MOC & Calibration Certificates

Compliance Standards:

• USP <1231>, USP <645>, EP, BP
• ISPE Baseline Guide Vol 4 (Water Systems)
• cGMP, FDA, WHO
• ASME BPE, 3A, ASTM A270