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.
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.
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