Statim Dental Steam Sterilizer N Type Vacuum Autoclave

Class N Vacuum Autoclave Sterilization Protocol: Precision Operation Guide

The Class N vacuum autoclave remains the gold-standard steam sterilization system for medical/dental instruments, achieving 10⁻⁶ SAL (Sterility Assurance Level) through optimized air removal. This vacuum autoclave variant specifically processes heat-tolerant devices – from solid surgical tools to porous textile packs – via dynamic air-steam exchange cycles. Unlike basic gravity displacement units, modern vacuum autoclave systems employ 3-stage pulsed vacuum technology, removing 99.92% chamber air within 90 seconds (per EN 13060 compliance).

Operational Workflow

Phase 1: Pre-Sterilization Preparation

1. Chamber Validation
   • Conduct ATP swab test (<2 RLU) on chamber surfaces
   • Verify gasket integrity through vacuum hold test (0.08 MPa/5min)
2. Load Configuration
   • Position instrument trays with 2.5cm inter-item spacing
   • Orient hollow lumens vertically at 7° angle for condensate drainage

Phase 2: Cycle Execution

3. Water Management

• Fill reservoir with Type III ASTM water (conductivity <50 µS/cm)
• Activate auto-deionization system if TDS >5 ppm

4. Program Selection
   

   Load Type	Temperature	Pressure	Duration
   Unwrapped	134°C	0.23 MPa	4 min
   Porous	121°C	0.11 MPa	15 min
   Liquids	115°C	0.07 MPa	30 min

5. Steam Penetration Monitoring
   • Confirm Bowie-Dick test pattern uniformity (Class 4 chemical indicators)
   • Maintain 0.5°C/cm³ steam dryness coefficient

Phase 3: Post-Cycle Protocols

6. Enhanced Drying

• Execute 3 vacuum pulses (0.09 MPa → 0.01 MPa)
• Final moisture content: ≤0.1% (measured via capacitive sensors)

7. Aseptic Unloading
   • Allow 15min cooling at 45°C chamber temperature
   • Use Class 5 integrators for immediate efficacy verification
8. Compliance Documentation
   • Record parametric data: ΔP=0.21MPa, T=134±0.5°C, t=4’15”
   • Archive sterilization printouts with QR-coded timestamps

Critical Performance Metrics

• Air Removal Efficiency: ≥99.9% (vacuum phase ≤ 90sec)
• Steam Quality: Non-condensable gas ≤3.5%
• Drying Index: Residual humidity ≤0.2%

Maintenance Requirements

• Weekly: Chamber lubrication (FDA-grade silicone)
• Monthly: Vacuum pump oil replacement
• Annually: ASME pressure vessel recertification