Pure steam is a critical utility used for SIP operations, equipment preparation, sterilization applications, and maintaining microbiological control in pharmaceutical and biotech facilities. PrimeGMP provides complete lifecycle qualification of Pure Steam Generation (PSG) and Distribution Systems to ensure steam quality, purity, and performance meet global regulatory expectations.

1. Design Qualification (DQ)

• Review of URS, P&ID, and OEM technical documents
• Assessment of PSG design, still configuration, steam-water separation efficiency
• Verification of sanitary-grade piping, slopes, drainability, and PRV/valve design
• Review of feed water quality requirements
• Verification of heating mechanism, control strategy, alarms, and interlocks
• Compliance check with EN 285, USP/Ph. Eur., ISPE Baseline Guide, WHO/USFDA expectations

2. Installation Qualification (IQ)

• Verification of Pure Steam Generator installation as per approved design
• Inspection of steam traps, sanitary valves, reducers, PRVs, and loop configurations
• Verification of pipeline slopes, drainability, and orbital weld quality
• Calibration of pressure, temperature, conductivity, and flow instrumentation
• Review of weld logs, MOC certificates, FAT/SAT reports, and OEM documentation

3. Operational Qualification (OQ)

• Generator start-up verification & operational functionality
• Control system checks (PLC logic, alarms, interlocks, setpoints)
• Steam Quality Tests:
  • Non-condensable gases (NCG)
  • Dryness fraction
  • Superheat test
• Steam trap functionality tests
• Distribution line temperature & pressure stability checks
• Condensate return performance checks

4. Performance Qualification (PQ)

Comprehensive verification under actual operating conditions:

Steam Quality & Distribution Tests

• Dryness fraction (≥ 0.95)
• Non-condensable gases
• Superheat limit verification
• Temperature uniformity & line mapping
• Point-of-use performance across entire loop
• Drainability & dead-leg elimination checks

Chemical & Physicochemical Tests

• Conductivity (WFI-equivalent)
• Total Organic Carbon (TOC)
• pH
• Silica (if applicable)

Microbiological & Endotoxin Testing

• Total microbial count (condensate)
• Endotoxin test (LAL) for SIP and critical applications

SIP Cycle Validation

• Verification of SIP cycle parameters for tanks, vessels, filters, and pipelines
• Worst-case SIP HOLD time validation
• Steam penetration and condensate drain studies

Documentation Provided

• DQ / IQ / OQ / PQ Protocols & Reports
• Complete Steam Quality Test Reports (NCG, dryness, superheat)
• Chemical, TOC, Endotoxin & Microbial test reports
• Temperature/pressure mapping reports
• Weld logs, P&ID verification sheets
• Calibration certificates
• SOPs for Sampling, Operation, Monitoring & Maintenance
• Final Qualification Summary Report

Regulatory Standards Followed

• EN 285 – Steam Quality Requirements
• USP <1231> Water for Pharmaceutical Purposes
• USP / Ph. Eur. Pure Steam Requirements
• ISPE Baseline Guide – Water & Steam
• EU GMP Annex 1 & Annex 15
• WHO TRS 961 / 1019
• USFDA 21 CFR 210/211

Why Choose PrimeGMP for Pure Steam Qualification?

• Expertise in PSA, membrane, and PSG-based steam systems
• Accurate steam quality testing using calibrated instruments
• Complete loop mapping & SIP validation
• Strong troubleshooting for dryness, NCG, superheat, and condensate failures
• Audit-ready, detailed, structured documentation
• Deep experience in sterile/aseptic facility steam systems