Flexible-chamber EO sterilization, optimized for your needs
Our sealed-bag systems use unit-dose 100% EO cartridges to control exposure conditions precisely while minimizing unnecessary complexity and environmental emissions.
Small to medium loads for commercialization
Development and pilot production for clinical studies
Research, preclinical, and specialty devices
Single devices and prototype runs
Four sterilization paths for your device
Whether you are running research, validation, or clinical work, we match the right process to your timeline and regulatory requirements.
Validated Exposure
Full turnkey validation for sterile label claims, including protocol development, testing, and final process specification.
Single lot release for new devices
Streamlined validation for single lots used in animal or human clinical studies during device development.
EO Exposure Only
Single-cycle processing for research, animal studies, and biocompatibility work that does not require a sterile label.
Qualified Cycle
High-level disinfection for reusable devices that are already cleaned and packaged.
Not a high-volume sterilizer. And thats the point.
Large contract sterilizers optimize for throughput. Andersen Scientific optimizes for changes. If your project requires careful engineering judgment, direct communication, and defensible documentation, youre in the right place.
24 to 48 Hour Turnaround
Most small loads process same-day and ship the next morning.
No Minimum Lot Size
Single devices and small batches are what we do. No minimums, no waiting.
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 feasibility run or a full validation program.
Regulatory Compliance
Every process decision is supported by relavent FDA and ISO guidance.
Proportionate to Risk
Controls scaled appropriately to your product and regulatory path.
Audit-Ready
Documentation designed to withstand regulatory scrutiny.
Adaptable
Validation strategies designed to support evolving products and production needs.
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