SCAIR 50HP 1.2MPa Isolator Compressor for Aseptic Filling & VHP Decontamination
Product Spotlights
SCAIR 50HP 1.2MPa GMP Compressor: Sterility-Assured Air for Isolator-Based Aseptic Processing
SCAIR’s 50HP compressor delivers 7.0 m³/min at 1.2MPa with EU GMP Annex 1 compliance, preventing $3.6M batch losses where airborne contamination causes 0.3% sterility failures in isolator-based vial filling lines running 300 vials/minute.
Nanocontamination-Controlled Air Engineering for Critical Barrier Integrity
Featuring radical-assisted purification and electropolished 316L SS flow paths (Ra
Isolator Performance Specifications
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Air Delivery: 7.0 m³/min @ 1.2MPa (6.2m³/min @ 1.5MPa for RABS)
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Overpressure Stability: ±0.15% during glove port interventions
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Purity Certification: ISO Class 0 (oil), Class 1 (particulates), Class 1 (moisture)
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Microbial Control:
Sterility Assurance Technologies
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VHP Resilience: Validated for 1000ppm vaporized hydrogen peroxide cycles at 45°C
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Endotoxin Control: 0.1μm filtration maintains
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Biofilm Prevention: 222nm Far-UVC achieves 6-log spore reduction
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Data Integrity: 21 CFR Part 11 compliant controls with blockchain audit trails
Core Pharma Applications
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Isolator Overpressure: Supplies ISO Class 5 environments maintaining 25Pa differential
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Lyophilizer Charging: Powers transfer systems achieving
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Stoppering Stations: Drives pneumatic rams with 300N±5N capping force accuracy
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Sterile Connections: Feeds rapid transfer ports (RTPs) meeting ISO 10648-2 integrity standards
Global Compliance Matrix
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Certifications: EU GMP Annex 1 (2022), FDA 21 CFR Part 211, PIC/S PE 009-14
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Material Standards: USP Class VI & EP 3.1.9 compliant
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Validation: ASTM E2500-compliant IQ/OQ/PQ protocols
Validation Q&A
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Q: How to maintain ISO 5 during glove changes?
A: Active overpressure control prevents ingress with 25Pa±1Pa stability during interventions.
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Q: Solution for endotoxin in WFI supply lines?
A: -70°C PDP eliminates microbial growth in pure steam generators.
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Q: Decontamination cycle time reduction?
A: Validated 15-minute VHP cycles achieve 6-log reduction per FDA FCN 229.
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