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Help CenterSCAIR 75HP 0.8MPa Medical-Grade Compressor for Cleanroom Device Assembly & Sterile Packaging
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SCAIR 75HP 0.8MPa Medical Compressor: Zero-Contamination Air for Class 10000 Cleanrooms
SCAIR’s 75HP compressor delivers 8.2 m³/min at 0.8MPa with ISO 13485 certification, preventing 30% batch rejections where particulate contamination causes FDA 483 observations in implant packaging.
Critical Environment Air Engineering for Medical Device Production
Featuring pharmaceutical-grade stainless steel (Ra
Cleanroom Performance Specifications
Air Delivery: 8.2 m³/min @ 0.8MPa (7.4m³/min @ 1.0MPa for molding machines)
Pressure Stability: ±0.15% during tool changeovers
Moisture Control: Triple-stage adsorption dryer achieves -70°C PDP
Particle Control: ISO Class 1 air per ISO 8573-1:2010
Contamination Control Technologies
Nanoparticle Filtration: H13 HEPA + ULPA filters capture 99.9995% at 0.01μm
Hydrocarbon Scavenging: Platinum-group catalysts reduce VOCs to
Sterile Air Lock: Positive pressure containment prevents cross-contamination
VHP Compatibility: Validated for vaporized hydrogen peroxide sterilization cycles
Medical Manufacturing Applications
Implant Assembly: Powers ISO Class 5 gloveboxes maintaining
Sterile Blow-Fill-Seal: Supplies molding machines with 0.1 CFU/m³ air for parenteral products
Catheter Extrusion: Drives pneumatic controls with 0.01mm dimensional tolerance
Medical Packaging: Feeds thermoformers preventing 0.3% seal integrity failures
Regulatory Compliance
Certifications: ISO 13485, FDA 21 CFR Part 11, EU GMP Annex 1
Material Traceability: USP Class VI compliant elastomers
Validation: IEST-RP-CC034.5 cleanroom protocols
Sterility Assurance Q&A
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Q: How to maintain ISO Class 5 during maintenance?
A: Double-seal maintenance ports prevent cleanroom breach during filter changes.
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Q: Solution for endotoxin control in blow molding?
A: -70°C PDP + 250°C aftercoolers achieve
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Q: Air purity documentation for FDA audits?
A: Integrated particle counters generate electronic records per 21 CFR Part 11.
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