A Pure Steam Generator (PSG) designed for the production of clean, dry, pyrogen-free steam, suitable for use in pharmaceutical applications such as sterilization, SIP (Steam-in-Place), and autoclaves. System complies with USP, BP, and EN285 standards.

Technical Specifications:

• Capacity: [Customize – e.g., 50 to 2000 kg/hr]
• Feed Water: Purified Water / WFI (Conductivity < 5 µS/cm)
• Steam Quality (as per EN285):
• Non-Condensable Gases: < 3.5% v/v
• Superheat: < 25°C
• Dryness Fraction: > 0.95
• Endotoxin: < 0.25 EU/ml
• Pyrogen-Free, Bacteria-Free

System Components:

• SS316L Electro-Polished Evaporator & Separator (Ra < 0.4 µm)
• Double Tube Sheet Shell & Tube Heat Exchanger
• SS304/316L Skid with Insulated Panels

Automation & Control:

• PLC + HMI Based Control System
• Online Monitoring: Temperature, Pressure, Feed Conductivity
• Alarms, Interlocks & Auto Drain Functions
• Optional SCADA with 21 CFR Part 11 compliance

Validation & Documentation:

• DQ / IQ / OQ / PQ Protocols
• GA Drawings, P&ID
• MOC Certificates (EN 10204 3.1)

Compliance Standards:

• USP <1231>, EN285, BP, EP
• US FDA | WHO | cGMP
• ASME BPE | ISPE Guidelines