Contract EO Sterilization Designed for Medium Batches, Complex Devices, and Custom Cycles
Low-volume, high-attention ethylene oxide sterilization and validation for medical device teams who need precision, flexibility, and regulatory confidence.
Custom cycles for for medium- to low-volume devices with rapid turnarounds.
Most contract sterilizers optimize for throughput. That works for standardized, high-volume manufacturing. It doesn’t work as well for first-generation devices, evolving designs, complex products, or programs requiring technical flexibility.
We built Andersen Scientific for exactly those projects. Our flexible-chamber EO systems, engineering-led approach, and custom validated cycles are available so that complex, small-batch work gets the same rigor and attention that high-volume programs take for granted.
FDA Innovation Challenge II Winner
for low-volume EO emissions
Multi-core capabilities. One team
From early feasibility through validated production, we handle sterilization so you can focus on your device.
EO Sterilization
Flexible-chamber EO sterilization optimized for small-to-medium loads, clinical studies, and specialty production.
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Sterilization Validation
Scientifically justified validation programs developed in accordance with ISO 14937 and applicable FDA-recognized consensus standards.
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Feasibility Studies
Development testing designed to evaluate sterilization feasibility and support downstream product functionality, and biocompatibility.
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Requalification & Adoption
Requalify existing sterilization processes, adoption of new products and product changes, or production changes.
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Documentation & Regulatory
Comprehensive documentation and regulatory support for your sterilization program lifecycle.
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Single Lot Release
Controlled sterilization and release of individual production or clinical lots, with the documentation and testing required to support release.
Learn more chevron_rightWe offer an award-winning, high-efficiency EO process—perfect for delicate and complex devices.
Traditional EO sterilization systems often rely on large metal chambers and centralized gas delivery systems. Our process uses sealed flexible bags paired with unit-dose 100% EO cartridges, allowing the sterilization volume to more closely conform to the product load. This approach helps maximize EO concentration around the product while using a lower controlled EO dose.
The result is an efficient, targeted EO process well suited for delicate geometries, including long, narrow lumens and other technically challenging devices, while also reducing overall EO consumption and environmental emissions.
Technical Resources arrow_forwardDevices that require a customized sterilization approach
PMA devices and new or existing 510(k)s
Devices already in commercial production
Implantable and invasive medical devices
Complex devices with challenging geometries
R&D and preclinical devices
Devices for clinical studies and IDE submissions
Devices transitioning toward commercialization
Custom or low-volume products
Technical depth, not just processing capacity
We support organizations ranging from early-stage startups to global manufacturers requiring hands-on engineering involvement.
Medical Device Startups
Navigating clinical lot releases, validations, regulatory submissions, and initial production runs.
Small to Mid-Sized OEMs
Flexible EO sterilization that scales with your evolving production needs.
Pharma & Drug Development
Specialized sterilization support for pharmaceutical and combination products.
Universities & Research Labs
Sterilization support for university research, novel products, and early-stage development programs.
Hospitals & Clinical Programs
Controlled EO processing for clinical research groups and healthcare systems.
Tissue Culture & Research Laboratories
Validation-focused EO processing for tissue culture and research applications.
Built Clean From the Ground Up
The most efficient EO facility on the market. Process uses 90% less gas than comperable chambers
Responsible sterilization is not a marketing claim for us. It is an engineering outcome.
FDA Registered
FDA-registered facility with an FDA-recognized ultra-low-emissions EO sterilization process.
FDA Master File Support
We can provide technical data from our FDA Master File in support of your 510(k) submission.
ISO 14937 Validation
Validations developed in accordance with ISO 14937, with third-party testing performed to applicable FDA-recognized consensus standards.
Decades of EO Experience
Experience spanning EO cycle development, validation, process adoption, requalification, and ongoing process support.
Audit & Regulatory Support
Experience supporting customer audits, notified body reviews, and FDA inspections.
Not a high-volume sterilizer. And that's the point.
Large contract sterilizers optimize for throughput. Andersen Scientific customizes our process for your device and your specific needs. If your project requires careful engineering judgment, direct communication, and defensible documentation, you're in the right place.
Fast turnaround
Most small loads are processed the day they arrive.
No Minimum Lot Size
Flexible lot sizing from pilot studies through ongoing production.
Direct Engineer Access
You talk to the people who run your process, not a ticketing system.
Full Transparency
Clear pricing, defensible documentation, and no surprises.
A practical, risk-based approach to every project
We apply the same disciplined framework whether you need a single feasability study, single batch release or a full validation program
Understand the Product
Evaluate the device, materials, configuration, and intended sterilization process.
Define the Risk
Identify the conditions and variables that challenge the process and determine what must be demonstrated.
Build the Strategy
Develop a proportionate testing and validation approach supported by scientific rationale and applicable standards.
Document the Rationale
Carry the technical justification through testing, qualification, and reporting so the decisions are clear and defensible.
Registered and audited for medical device work
ISO 13485 certified and FDA registered. Every lot is tracked and documented from receipt through release.
ISO 13485 Certified & FDA Registered
Est. No. 1064858
FDA Innovation Challenge 2 Winner
Recognized for responsible innovation
Environmental Stewardship Award
Small Business recipient
NC Permit Exemption
Exceptionally low emissions
Meet Our Leadership Team
Daryl Woodman has spent more than two decades at Andersen Scientific developing breakthrough sterilization techniques and building the systems our clients depend on.
Learn why we chose sealed flexible-chamber EO systems, how our validation approach supports complex medical devices, and what differentiates Andersen Scientific from traditional sterilization providers.
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Trusted by device teams nationwide
“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 affordability that are not available elsewhere.”
“We 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 Andersen Scientific was clearly the best choice.”
“I 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 sterilization solutions.”
Ready to discuss your project?
Tell us about your device and timeline. We’ll help determine the right sterilization and validation approach for your project.