CSB Investigation — Explosion & Fire
Sterigenics Ethylene Oxide Explosion
Sterigenics International
📍 Ontario, CA
Incident Date: August 19, 2004  |  CSB Report Released: 2006
0
Fatalities
Several
Workers Injured
4
CSB Recommendations
Ethylene Oxide
Chemical / Hazard
📋 Incident Summary

On August 19, 2004, an explosion and fire occurred at the Sterigenics International medical sterilization facility in Ontario, California. The incident involved the release of ethylene oxide (EO) — an extremely flammable and toxic gas used to sterilize medical equipment — which ignited and caused structural damage to the facility, injuring several workers.

During a sterilization cycle, a flammable EO mixture was discharged from the sterilization chamber to an abator — a thermal oxidizer designed to destroy residual EO. The abator contained an open flame ignition source as part of its design. The EO-air mixture entering the abator was within the explosive concentration range when it contacted the open flame, causing an explosion that damaged the treatment equipment and surrounding facility.

The CSB found that Sterigenics lacked engineering controls to prevent a flammable EO mixture from reaching the abator's ignition source, and that the process hazards of the EO sterilization cycle were insufficiently evaluated. The absence of interlocks to verify safe EO concentrations before ignition sources were engaged was a critical safeguard gap. EO's exceptionally wide explosive range (3%–100%) makes concentration control a fundamental design requirement.

🔎 Key Findings
Finding 1
Flammable EO Mixture Reached Open Flame
The EO-air mixture discharged to the abator was within the explosive concentration range when it contacted the abator's open flame. No engineering interlock prevented this flammable condition from reaching the ignition source.
Finding 2
Abator Design With Open Flame Ignition
The abator used an open flame as its thermal oxidation mechanism — an inherently incompatible design when EO inlet concentrations are not positively controlled below the lower explosive limit (LEL).
Finding 3
Inadequate Process Hazard Analysis
The EO sterilization process was not adequately evaluated for the specific hazard of explosive concentrations reaching the abator. A PHA following the process stream end-to-end would have identified this scenario.
Finding 4
No Concentration Interlock on Abator Inlet
No instrumentation or interlock verified that EO concentrations at the abator inlet were below the LEL before the abator's ignition source was active.
Finding 5
Exceptionally Wide Explosive Range of EO
Ethylene oxide has an explosive range of 3% to 100% — the widest of any common industrial gas. Any concentration of EO-air mixture (except near-pure EO) is potentially explosive.
Finding 6
PSM Coverage Gap for EO Sterilization Facilities
EO sterilization facilities below PSM threshold quantities operated without mandatory process hazard analysis requirements, leaving engineering safeguard gaps unaddressed by regulation.
🔍 Root Causes
1
Engineering Controls Not Designed for Explosive Mixture Protection
The abator lacked the engineering controls necessary to prevent a flammable EO mixture from reaching its open flame — no concentration monitoring, no interlock, no automatic shutdown.
2
Incomplete Process Hazard Analysis
A PHA that analyzed the EO discharge-to-abator pathway end-to-end would have identified the risk of explosive concentrations contacting the ignition source.
3
Abator Technology Selection Without Adequate Hazard Analysis
Open-flame thermal oxidizers are incompatible with variable EO concentration inlet streams unless robust concentration interlocks are installed and verified.
4
Deficient PSM Application
EO sterilization facilities below OSHA PSM thresholds often operated without formal PHAs or engineering safeguard reviews, leaving hazard gaps unmanaged.
☑ CSB Recommendations
→ Sterigenics / EO Sterilization Industry
Conduct comprehensive process hazard analyses for all EO sterilization operations, specifically addressing the scenario of flammable EO mixtures reaching abator ignition sources.
→ Sterigenics
Install engineering interlocks that prevent abator ignition sources from operating when EO inlet concentrations are within or above the explosive range.
→ OSHA
Review regulatory coverage of EO sterilization facilities and evaluate whether PSM threshold exemptions leave significant process safety gaps in this industry sector.
→ Industry Associations
Develop and distribute engineering design guidance for EO sterilization facility abators, specifically addressing inlet concentration control and ignition source management.
💡 Lessons Learned
⚠ Ethylene oxide is simultaneously one of the most useful and most hazardous industrial chemicals. Its explosive range spans from 3% to 100% — nearly any EO-air mixture is potentially explosive.
⚠ An abator with an open flame is an ignition source. Routing a potentially explosive process stream to an ignition source without verified concentration control is a fundamental safeguard design failure.
⚠ Engineering interlocks must prevent flammable mixtures from reaching ignition sources. A written procedure to “check LEL before starting the abator” is not equivalent to an interlock that enforces the check.
⚠ Process hazard analysis must follow the process stream end-to-end, including all waste treatment and abatement equipment. Hazards that arise in the abatement phase are still the facility's process hazards.
⚠ EO facilities below PSM threshold quantities still require systematic hazard identification. The regulatory threshold does not define the hazard level — the chemistry does.
PSM Elements: PSI · PHA · MI · SOP
🔨 Safety Meeting Toolbox Talk
Topic: Ethylene Oxide Process Hazards & Engineering Safeguards
💬Does our process involve ethylene oxide or other chemicals with exceptionally wide explosive ranges? Have we mapped all pathways by which flammable concentrations could reach ignition sources?
💬Do we have engineering interlocks — not just procedures — that prevent flammable concentrations from reaching ignition sources in abatement, oxidation, or treatment systems?
💬Has our PHA specifically analyzed the abatement and waste treatment portions of our process, not just the primary production or sterilization operations?
💬Do we monitor EO or other flammable gas concentrations continuously at the inlet to any thermal treatment device that contains an ignition source?
💬Are all combustible gas detectors and EO monitors in our facility on a calibrated maintenance schedule with current calibration records?
💬Have we evaluated whether our abatement system technology is compatible with the range of EO concentrations it may receive under all credible operating scenarios?
✎ Team Action Items
✓Identify all abatement, treatment, or destruction systems that use open flames, high-temperature oxidation, or other ignition sources for flammable chemical streams
✓Verify that flammable gas detection and interlock systems are installed at the inlet of any thermal treatment device receiving potentially flammable streams and are on a calibration schedule
✓Pull the PHA for EO or other highly flammable chemical processes and confirm abatement equipment was specifically included in the hazard analysis
✓Check calibration records for all LEL/combustible gas monitors in your area and confirm they are within their current calibration interval
🔗 PSM Failures Behind This Incident

This incident traced to breakdowns across 4 PSM elements (PSI · PHA · MI · SOP). Each represents a documented gap that process safety documentation and consulting can close before a similar event occurs at your facility.

Process Safety Information (PSI)
Accurate, complete Process Safety Information is the foundation every other PSM element depends on. When PSI is missing or wrong — chemistry data, equipment specs, P&IDs — the entire hazard analysis is built on a flawed base.
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Process Hazard Analysis (PHA)
A structured PHA or HAZOP study exists to identify exactly these scenarios before they occur. When PHA is absent, superficial, or overdue for revalidation, hazards operate unseen until they kill someone.
Supporting documents in our library →
Mechanical Integrity (MI)
Equipment must be designed, inspected, and maintained to operate safely in its intended service. Mechanical integrity failures — degraded equipment, missed inspections, deferred repairs — contributed to loss of containment here.
Supporting documents in our library →
Operating Procedures (SOPs)
Operators cannot reliably hold safe operating limits without clear, current, enforced procedures. Deviation from acceptable operating conditions — a root cause here — is a direct consequence of SOP failure.
Supporting documents in our library →
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