📋 Case Study

Ethylene Oxide Sterilization Facility QRA and Bow-Tie Implementation

Regulatory pushback on offsite risk due to proximity to residential area (≤500 m)

🏗️ Project Overview

New 12-ton EO storage and sterilization unit in North Carolina pharmaceutical campus

🎯 Challenge

Regulatory pushback on offsite risk due to proximity to residential area (≤500 m)

🔧 Design Approach

Full QRA using ALOHA/PHAST; implemented double-containment EO tanks, nitrogen inerting, explosion-proof ventilation, and community alert system linked to fixed gas detectors

📐 Design Diagram

EO TankDouble ContainmentExplosion-Proof VentCommunity Alert SystemResidential Zone (≤500 m)IR = 1.8×10⁻⁵ /yrIgnition Prob. = 0.032EO Sterilization FacilityN₂ Inerting

AI-generated project design illustration

📐 Key Calculations

Frequency × Fatality Probability × Population Density
Result: 1.8×10⁻⁵ /yr
Below EPA’s 1×10⁻⁶ benchmark after mitigation

Vapor Cloud Ignition Probability

Leak rate × ignition source density × dispersion persistence
Result: 0.032
Drove inerting design requirement

📊 Results

IR reduced from 4.1×10⁻⁴ to 1.8×10⁻⁵ /yr; permit approval secured in 8 weeks instead of projected 6 months

💡 Lessons Learned

  • QRA must include worst-case credible scenarios—not just design basis
  • Community engagement early in QRA builds regulatory trust
  • Inerting effectiveness depends on leak detection speed

Key Takeaways

  • 1QRA must include worst-case credible scenarios—not just design basis
  • 2Community engagement early in QRA builds regulatory trust
  • 3Inerting effectiveness depends on leak detection speed