Ethylene Oxide (EtO) Sterilization
In-house ethylene oxide sterilization with 6 dedicated 3M STERI-VAC chambers across two facilities. Quick-turn, small-batch EtO processing with full ISO 11135 validation. Emissions-compliant for the long term.
Quick-Turn EtO Sterilization — In-House, Not Outsourced
Most contract manufacturers outsource EtO sterilization to large-chamber facilities with multi-week lead times and minimum lot requirements. LSO runs EtO in-house — six dedicated 3M STERI-VAC GS8XL chambers across two facilities (four in California, two in New Hampshire). That means small-batch, quick-turn processing without waiting for an external sterilizer's schedule.
For medical device manufacturers dealing with capacity constraints, long lead times, or minimum batch requirements at their current EtO provider, LSO's in-house capability eliminates the bottleneck. Your devices are sterilized on our schedule, not someone else's.
LSO's EtO Capabilities
6 In-House 3M STERI-VAC Chambers
Four chambers at LSO West (Brea, CA) and two at LSO East (Somersworth, NH). All use 3M STERI-VAC GS8XL all-in-one cycles — preconditioning, sterilization, and aeration happen in-chamber, reducing total processing time and eliminating inter-step transfer risk.
Customizable Cycle Parameters
Cycle times range from 1 to 8 hours (4-hour standard). Temperature range of 37–55°C accommodates different material sensitivities — from rigid plastics to flexible packaging to temperature-sensitive combination devices. All cycles conform to ISO 11135 and meet EPA, OSHA, and SCAQMD regulatory requirements.
Full EtO Validation (IQ/OQ/PQ)
Complete validation packages from protocol design through performance qualification. Includes half-cycle/overkill qualification, fractional cycle development, and routine processing setup. Regulatory documentation formatted for FDA 510(k), EU MDR, and other submissions. Validation and routine processing happen in the same chambers — no transfer between validation and production environments.
In-House Biological Indicator Testing
Biological indicator (BI) testing performed on-site by LSO's microbiology team. No waiting for external lab results. For EtO cycles processed at LSO, BI results are typically available within 48 hours of cycle completion — meaning your sterilized product releases faster than it would with a contracted sterilizer sending BIs to a third-party lab.
Emissions-Compliant for the Long Term
EtO emissions regulations are tightening — EPA and state agencies (particularly California's SCAQMD) are imposing stricter limits that will force some large-chamber EtO facilities to retrofit or shut down. LSO's small-batch chamber design is specifically positioned to remain compliant under these evolving standards. Your EtO sterilization supply won't be disrupted by regulatory changes that affect high-volume emitters.
When EtO Is the Right Choice
EtO sterilization is the right method when your device contains temperature-sensitive materials that can't withstand gamma radiation or steam autoclaving. This includes most plastics, electronic components, optical devices, adhesives, and many combination products. EtO is used for over 50% of all disposable medical devices worldwide.
EtO may not be the best choice if your device can tolerate gamma or e-beam (faster cycle times, no residual concerns) or steam (lower cost for heat-stable metal instruments). If you're unsure which method fits your device, our method selection consultation evaluates your materials, geometry, and timeline before committing to a sterilization approach.
EtO Residual Testing & Safety
Ethylene oxide is a toxic gas — post-sterilization residual management is a critical part of the process. ISO 10993-7 sets allowable limits for EtO and ethylene chlorohydrin (ECH) residuals on medical devices. LSO's all-in-one chamber cycles include an integrated aeration phase that begins immediately after sterilization, reducing total aeration time compared to systems that require transfer to a separate aeration cabinet.
Residual testing is performed to confirm EtO and ECH levels are within acceptable limits before product release. Combined with in-house BI testing, this means complete lot release — both sterility confirmation and residual clearance — happens under one roof with one team managing the process.
Key Capabilities
6 Chambers
3M STERI-VAC GS8XL across California and New Hampshire — no external facility scheduling
Quick-Turn
Small-batch processing with customizable 1-8 hour cycles. Single-lot release capability.
ISO 11135
Full IQ/OQ/PQ validation with regulatory documentation for FDA and EU MDR submissions
In-House BI Testing
On-site biological indicator testing for faster lot release — results within 48 hours
Emissions-Ready
Small-batch chamber design positioned ahead of tightening EPA and SCAQMD regulations
Related Services
FDA-Registered
Manufacturing Facility
ISO 13485
Certified Quality System
12 Cleanrooms
Class 5–8
125,000+ Sq Ft
Regulated Manufacturing
3 Facilities
CA | NH | Costa Rica
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Talk to a specialist about ethylene oxide (eto) sterilization.