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Specialized Ethylene Oxide Sterilization for Complex, Small-Batch Medical Devices
We provide low-volume, high-attention EO sterilization and validation services for medical-device innovators who need precision, flexibility, and regulatory confidenceânot a production line.
Chosen by device makers who demand precision
Big sterilizers are built for scale. Weâre built for your device.
At Andersen Scientific, we specialize in EO sterilization projects that donât fit the high-throughput model. We excel in processing early-stage devices, unique packaging, research programs, and validations that require engineering judgment and regulatory fluency.
Organizations that need technical partnershipânot just processing capacity.
While our core focus is supporting small and mid-sized organizations, we are also engaged by large, global manufacturers for specialized projects that require a high level of technical expertise and direct engineering involvement.
If your project needs careful thoughtânot just capacityâweâre the right partner.
Medical Device Startups
Early-stage and emerging companies navigating first validations and regulatory submissions.
Small to Mid-Sized Manufacturers
Device companies seeking flexible EO sterilization aligned with evolving production needs.
Pharma & Drug Development
Pharmaceutical and drug development organizations requiring specialized sterilization support.
Universities & Research Institutions
Academic and translational research programs working on novel devices and packaging systems.
Hospitals & Clinical Programs
Clinical research groups and healthcare systems requiring controlled EO sterilization support.
Life-Science Laboratories
Tissue culture and laboratory environments requiring validation rigor and documentation clarity.
Requalification & Equivalence Projects
Organizations requiring requalification, adoption, or equivalence strategy support.
Industries & Applications
We support devices that require thoughtful sterilization strategyâparticularly those that donât fit neatly into high-throughput models.
- PMA devices as well as new and existing 510(k)s
- Devices for clinical studies
- Implantable and invasive medical devices
- Large complex devices that are difficult to sterilize
- R&D and preclinical devices
- Custom or low-volume products
- Devices transitioning toward commercialization
If your product doesnât fit neatly into a box, thatâs usually a good sign.
Built clean from the ground up
We've engineered our facility to emit less ethylene oxide than naturally occurs in ambient air. That's not marketingâit's measured and verified by the State of North Carolina.
Three Core Capabilities
Everything your device program needs from one partner.
Ethylene Oxide Sterilization
Flexible-chamber EO sterilization optimized for small-to-medium loads, clinical studies, and specialty production.
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Sterilization Validation
Full ISO 14937-compliant validation strategies grounded in risk, science, and regulatory defensibility.
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Feasibility & Development
Early-stage testing to confirm process suitability before formal validation.
Learn moreGas cartridges in sealed bags, not rigid chambers
Traditional EO sterilizers rely on large metal chambers and external gas tanks. We use sealed bags paired with unit-dose 100% EO cartridges, a fundamentally different approach that eliminates dead space and cuts gas consumption to a fraction of what conventional systems require.
The result is a gentler cycle that protects delicate geometries like long, narrow lumens without sacrificing sterilization reliability.
Registered and audited for medical device work
ISO 13485 certified and FDA registered (Est. No. 1064858). Every lot is tracked and documented from receipt through release.
FDA registration and standing
ISO 13485 certification details
Lot traceability and documentation
Not a High-Volume Sterilizerâand Thatâs the Point
Large contract sterilizers are optimized for throughput. ANSCI is optimized for thinking. We work best when:
A Practical, Risk-Based Philosophy
Scientifically Justified
Every process is grounded in sound scientific rationale.
Proportionate to Risk
Controls and validation scaled appropriately to product risk
Transparent to Auditors
Clear documentation and defensible technical decisions.
Adaptable
Flexible processes that evolve with your product lifecycle.
Hear From Our General Manager
Watch a brief conversation about the thinking behind Andersen Scientific, why we chose sealed bags over chambers, why small batches matter, and what we're building for device teams right now.
Customer Testimonials
The resources at Andersen Scientific have been an invaluable asset to start-up clients of mine. Andersen provided superior and personable expertise and guidance. Their sterilization services offered us flexibility and afford-ability that are not available with other contract sterilization providers. Andersenâs attention to details, knowledge, costs, and quick turnaround times make them my only source to consider for sterilization needs.âJon D. Speer,
âWe have always been very pleased with the service we receive from Andersen Scientific. They have provided excellent customer service, pricing, and support for the process. We looked at several vendors for our sterilization needs and we are glad we chose Andersen.âEric R. Hall
âI would like to take the opportunity to endorse the services of Andersen Scientific. Daryl Woodman and his team have given my company the most excellent customer service with quick turnaround on product and cost-effective solutions to our sterilization needs. Mr. Woodman has the experience and the commitment to his clients that is so rare in todayâs business environment. I can highly recommend Andersen Scientific with confidence.â