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SCAIR 30HP 0.8MPa GMP Compressor: Critical Air for Sterile Manufacturing
SCAIR’s 30HP compressor delivers 3.6 m³/min at 0.8MPa with EU GMP Annex 1 compliance, preventing $2.4M batch losses where microbial contamination causes 0.3% sterility failures in vial filling lines.
Ultra-Pure Air Engineering for Pharmaceutical Grade Environments
Featuring electropolished 316L stainless steel flow paths (Ra
Aseptic Performance Specifications
Air Delivery: 3.6 m³/min @ 0.8MPa (3.2m³/min @ 1.0MPa for RABS)
Purity Certification: ISO 8573-1 Class 0 (oil), Class 1 (particulates), Class 1 (moisture)
Microbial Control:
Material Finish: Electropolished 316L SS (Ra
Contamination Control Technologies
VHP Compatibility: Validated for 100+ vaporized hydrogen peroxide cycles
Biofilm Prevention: 254nm UV-C lamps achieve 6-log spore reduction
Data Integrity: 21 CFR Part 11 compliant controls with blockchain audit trails
Sterile Interface: Steam-sterilizable components withstand 134°C SIP cycles
Sterile Processing Applications
Isolator Systems: Supplies ISO Class 5 environments for vial filling machines
Lyophilization: Maintains -70°C PDP for freeze-dryers producing injectables
Sterile Formulation: Powers mixing vessels with
Blow-Fill-Seal: Feeds extrusion heads meeting FDA 21 CFR Part 211
Pharmaceutical Compliance
Certifications: EU GMP Annex 1, FDA 21 CFR Part 211, PIC/S PE 009-14
Material Safety: USP Class VI & EP 3.1.9 compliant
Validation: Full IQ/OQ/PQ documentation per ASTM E2500
Validation Process Q&A
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Q: How to maintain sterility during isolator bag changes?
A: Continuous ISO Class 5 overpressure prevents ingress during 10-minute interventions.
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Q: Solution for endotoxin control in WFI systems?
A: -70°C PDP eliminates microbial growth in pure steam generators.
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Q: Decontamination cycle compatibility?
A: Validated for 1000ppm H₂O₂ vapor at 45°C per VHP BIER standards.
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