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Help CenterSCAIR 60HP GMP Compressor 0.8MPa for Pharma Isolators & Bioreactor Systems
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SCAIR 60HP GMP Oil-Free Compressor: Critical Air for Aseptic Manufacturing
SCAIR's 60HP compressor delivers 7.0 m³/min at 0.8MPa with EU GMP Annex 1 compliance, preventing $2.8M/year batch losses where hydrocarbon contamination causes 0.3% vial particulate failures in lyophilized drug production.
Contamination-Free Air Engineering for Life Sciences
Featuring electropolished 316L stainless steel flow paths (Ra
Pharma-Grade Performance Specifications
Air Delivery: 7.0 m³/min @ 0.8MPa (6.2m³/min @ 1.0MPa for isolator overpressure)
Purity Certification: ISO 8573-1 Class 0 (oil), Class 1 (particulates), Class 1 (moisture)
Microbial Control:
Material Finish: Electropolished 316L SS (Ra
Sterility Assurance Technologies
VHP Compatibility: Steam-sterilizable components withstand 100 cycles at 121°C SIP
Biofilm Prevention: 254nm UV-C lamps in air stream eliminating 99.99% microorganisms
Data Integrity: 21 CFR Part 11 compliant controls with blockchain audit trails
Leak-Free Design: Double mechanical seals with nitrogen purge barrier
Bioprocessing Applications
Sterile Filling Lines: Supplies ISO Class 5 isolators for vial filling with
Bioreactor Systems: Powers pneumatic valves in single-use bioreactors maintaining 0.005 DO accuracy
Lyophilization: Maintains -70°C PDP for freeze-dryers producing lyophilized vaccines
Cleanroom HVAC: Feeds HEPA-filtered air handling units meeting ISO 14644 Class 5
Global GMP Compliance
Certifications: EU GMP Annex 1, FDA 21 CFR Part 211, PIC/S PE 009-14
Validation Package: Full IQ/OQ/PQ documentation with ASTM E2500 methodology
Material Traceability: USP Class VI & EP 3.1.9 compliant materials
Validation Process Q&A
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Q: How to prevent endotoxin contamination?
A: 254nm UV-C + 0.1μm filtration achieves
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Q: Solution for cleanroom pressure cascade failures?
A: Dual-redundant VFD control maintains ±5Pa pressure gradients between zones.
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Q: Steam sterilization cycle compatibility?
A: All wetted parts withstand 200+ SIP cycles at 134°C/3bar.
Technical Differentiation:
Pioneering pharma/biotech focus with EU GMP Annex 1 compliance
Industry-first -70°C PDP and endotoxin control systems
Applications in single-use bioreactors and lyophilization
Compliance with PIC/S PE 009-14 and USP Class VI standards
Solved particulate contamination and pressure cascade pain points
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