⚗️ Quick Spec: EtO Gas Sterilization
{
"job_id": "ETO_batch_001",
"target_temperature_c": 55,
"hold_time_seconds": 7200,
"sensor_uncertainty_c": 2.0,
"hold_logic": "continuous",
"min_relative_humidity_pct": 45,
"min_eto_concentration_mg_l": 600,
"max_time_to_threshold_seconds": 3600,
"sensor_mode": "min_of_set"
}
55°C for 2 hours
EtO + humidity validation
🧮 How we decide PASS/FAIL
Math: Temperature ≥ target; RH ≥ 45%; EtO concentration ≥ 600 mg/L; continuous exposure ≥ N hours.
📋 Detailed validation criteria
- Temperature control: Chamber temperature must reach and maintain 50-60°C throughout exposure phase. Higher temperatures improve gas penetration and reduce cycle time.
- Humidity validation: Relative humidity 45-85% required for proper microbial kill. Too low reduces efficacy; too high causes condensation problems.
- Gas concentration: EtO levels monitored continuously. Minimum 600 mg/L typical for medical devices, with leakage compensation calculated automatically.
- Exposure time calculation: Begins when all parameters (temperature, humidity, gas concentration) simultaneously reach target values and continues until aeration phase.
- Pressure monitoring: Sub-atmospheric pressure maintenance validated to prevent gas leaks and ensure uniform distribution throughout load.
- Aeration validation: Post-exposure air changes and residual EtO levels tracked to ensure safe handling of sterilized items.
📊 Example EtO sterilization cycles
❓ EtO sterilization FAQ
🎯 Why is EtO sterilization used instead of steam autoclaving?
EtO sterilization operates at low temperatures (50-60°C) making it ideal for heat-sensitive materials like plastics, electronics, and complex medical devices. It penetrates packaging and reaches all surfaces, including lumens and crevices that steam cannot access effectively.
🏭 How does ProofKit handle the preconditioning and aeration phases?
ProofKit automatically detects and validates preconditioning (temperature and humidity equilibration), gas injection, exposure, and aeration phases. Each phase is time-stamped and parameters verified against your specifications. Residual EtO levels are tracked during aeration to ensure safe handling.
📈 What safety and environmental monitoring does ProofKit include?
ProofKit validates chamber leak rates, gas concentration stability, and emission control systems. Environmental monitoring includes workplace EtO levels during aeration and chamber venting. All data is timestamped and archived for occupational safety compliance and EPA reporting requirements.