EO Sterilization Process Overview
Riches EO Sterilization Process is a controlled low-temperature sterilization workflow designed for medical device manufacturers requiring validated microbial inactivation under ISO-compliant conditions.
The process is based on ethylene oxide gas diffusion, which penetrates packaging materials and complex device geometries to destroy microorganisms through alkylation reactions. The system integrates vacuum technology, humidity control, gas dosing, and aeration systems to ensure stable sterilization performance. Riches designs EO sterilization systems not as standalone equipment, but as complete process engineering solutions.
1. Preconditioning Phase
Purpose: Prepare product and chamber environment for EO penetration.
- Temperature stabilization (37°C–60°C)
- Humidity conditioning (40%–80% RH)
- Product thermal balance & Moisture activation
Riches Design: Uniform air circulation, multi-point humidity injection, and real-time sensor feedback.
2. Vacuum Phase
Purpose: Remove air from chamber to improve EO penetration efficiency.
- Multi-stage vacuum pumping
- Air removal from packaging and porous materials
Riches Advantages: High-efficiency vacuum pump, leak-rate controlled sealing, and automated pressure stabilization.
3. EO Gas Injection Phase
Purpose: Introduce EO gas under controlled concentration (450–1000 mg/L).
- Dynamic gas mixing (EO + CO₂ optional)
- Controlled pressure injection & Uniform distribution
Riches Design: Multi-point nozzles, real-time concentration monitoring, and PLC-based dosing control.
4. Exposure Phase (Sterilization Holding)
Purpose: Achieve microbial inactivation through alkylation reaction.
- Exposure time: 4–15 hours
- ISO11135 compliant validation support
Riches Design: Thermal uniformity system, gas circulation optimization, and microbial load modeling.
5. Aeration Phase (Residual Removal)
Purpose: Remove EO residual from products and packaging materials.
- Heated air circulation & Forced gas exchange
- Independent aeration chamber (optional)
Riches Design: HEPA filtered air input, catalytic treatment, and residual monitoring integration.
6. Exhaust & Safety Control System
Purpose: Ensure EO gas is safely discharged and neutralized.
- Catalytic decomposition & Scrubber unit
- Explosion-proof ventilation & Leakage detection
Riches Strength: Full plant EO safety design and industrial safety compliance.
Riches Engineering Capability
Request Complete Sterilization Solution Plan