Pure steam generation system for sterilization purposes
Ensure sterile production with pure steam capable of eradicating contaminants from equipment, cleanroom environments, and critical pharmaceutical components, safeguarding quality in every batch.
Generates Sterile, Pyrogen-Free Steam
Fabtech’s Pure Steam Generator is designed to meet the stringent needs of pharmaceutical and biotech industries, offering reliable and sterile steam generation for critical applications. It efficiently produces pyrogen-free steam, essential for sterilizing equipment and components such as tanks, vessels, and cleanroom uniforms. The generator operates on a principle of using purified water as input, with compliance to USFDA, WHO, and cGMP guidelines. It features an energy-saving design with customizable configurations and can be integrated seamlessly into automated production lines through its automatic and semi-automatic variants, which support 21 CFR Part 11 with SCADA for control. The system’s high-quality construction includes electropolished components, ASME BPE-compliant piping, and zero dead leg valve designs to ensure optimal performance and hygiene. Maintenance is streamlined with standard skids and a complete documentation suite for ease of validation. For those seeking tailored solutions, Fabtech offers engineering support for bespoke configurations, ensuring precise alignment with production requirements.
Benefits
- Ensures sterile production environments with pyrogen-free steam generation.
- Increases efficiency with energy-saving design, minimizing operational costs.
- Facilitates regulatory compliance with adherence to USFDA and cGMP standards.
- Enhances process flexibility with customizable configurations and automation.
- Streamlines maintenance and validation with integrated CIP systems and comprehensive documentation.
- Applications
- Healthcare equipment,Sterile equipment components,Biopharmaceuticals,Cleanroom air humidification,Sterilization systems,Pharmaceuticals
- End products
- Vaccines,Injectable medications,Cleanroom uniforms,Sterile preparation vessels,Surgical instruments,Pharmaceutical vials,Infusion bags
- Steps before
- Purification
- Steps after
- Sterilization,Humidification
- Input ingredients
- purified water,PW
- Output ingredients
- pure steam,sterile steam,pyrogen-free steam
- Market info
- Capacity
- Various capacities
- Pressure
- Various pressures
- Compliance
- USFDA,WHO,MHRA
- Guidelines
- ASME BPE,ISPE,cGMP
- Automation
- Automatic/semi-automatic
- Configuration
- Customisable
- Combination option
- WFI and Pure Steam
- Compliance
- 21 CFR Part 11 with SCADA
- Welding
- High quality orbital welding with videoscopy
- Piping
- Standard skids,ASME BPE grade,electropolished
- Insulation
- Fully drainable with zero dead leg valves
- Documentation
- DQ,FAT Protocols,IQ,OQ
- Automation level
- Automatic / Semi-automatic with 21 CFR Part 11 compliance
- Integration capability
- Combined space saving option of WFI and Pure Steam
- Energy efficiency
- Energy saving design
- Customizable configuration
- Various capacities and pressures
- Sterilization capability
- Sterile and pyrogen free pure steam
- Machine footprint
- Compact/Space-saving
- Configuration
- Customisable
- Control panel type
- SCADA compliant
- Discharge method
- Fully drainable
- Electropolished generators
- Yes
- Field piping material
- ASME BPE grade
- Welding quality
- Orbital welding with boroscopy and videoscopy