Ensure GMP-Compliant Pure Steam for Critical Pharmaceutical Applications
Pure Steam Quality Testing (PSQT) is performed to verify that the pure steam used for sterilization, SIP (Steam-in-Place), autoclaves, sterilizers, and pharmaceutical manufacturing processes complies with applicable pharmacopeia and GMP requirements. Cleanstep provides comprehensive testing services to ensure that your pure steam system consistently delivers high-quality steam suitable for critical pharmaceutical applications
Standard We Follow:
EN 285 – Steam Sterilizers, HTM 2010 / HTM 01-01, ISO Guidance (where applicable), EU GMP, WHO GMP, FDA Expectations, ISPE Good Practice Guides
Our Testing Capabilities
- Non-Condensable Gas Test
- Dryness Fraction Test
- Degree of Superheat Test
Applications
We perform Pure Steam Quality Testing for:
- SIP Systems
- Autoclaves
- Pure Steam Generators
- Sterilizers
- Bioreactors
- Formulation Vessels
- Filling Machines
- Lyophilizers
- Sterilizers
- Clean Steam Distribution Systems
Key Deliverables
Upon completion of testing, we provide:
- Approved Test Protocol
- Raw Observation Sheets
- Non-Condensable Gas Calculations
- Dryness Fraction Calculations
- Degree of Superheat Calculations
- Calibration Certificates
- Deviations (if any)
- Final Validation Report
- Recommendations for Corrective Actions (if required)
Why Choose Cleanstep?
Trusted expertise | Proven methodology | Regulatory confidence | Reliable delivery.
- Experienced Validation Professionals
- Advanced & Calibrated Test Equipment
- Regulatory-Compliant Testing & Documentation
- Complete Validation Lifecycle Support
- Efficient Project Execution
Need to qualify your Pure Steam System?
Partner with Cleanstep Pharma and Engineering Solutions for reliable, compliant, and audit-ready Pure Steam Quality Testing services. Our experienced validation team ensures your pure steam systems consistently meet GMP and pharmacopeia expectations through accurate testing, thorough documentation, and timely project execution
