About Andersen Scientific
Sterilization expertise that extends your team
We bring specialized EO knowledge and environmentally responsible processing to medical device teams who need technical depth, not just capacity.
Built by sterilization professionals, for device teams
Andersen Scientific was founded to fill a gap: most contract sterilizers are built for high-volume throughput. That leaves early-stage companies, research programs, and specialty devices without a partner who understands their work.
Our team brings decades of hands-on EO sterilization, validation, and regulatory experience. We stay personally involved in every project because that is what the work demands.
Clear, direct communication at every stage
Conservative, defensible decisions
Do it once, do it right
The details that matter when your device is on the line
Direct Engineer Access
You work with the sterilization engineers who run your process. No account managers, no ticketing systems.
Flexible Chamber Design
Sealed-bag systems configured for small to medium loads. Optimized for precision and economy.
Deep Validation Expertise
We design and execute validation strategies, not just run cycles. ISO 14937, overkill methods, lot release.
Audit-Ready Documentation
Practical, defensible documentation aligned with ISO standards and current FDA expectations.
FDA Sterilization Master File
We can provide authorization for you to reference it in your regulatory submissions.
Technical depth, not just processing capacity
Our core focus is small and mid-sized organizations, but we also support global manufacturers on specialized projects that require hands-on engineering involvement.
Medical Device Startups
Navigating first 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 for novel devices, packaging systems, and translational research.
Hospitals & Clinical Programs
Controlled EO processing for clinical research groups and healthcare systems.
Life-Science Laboratories
Validation rigor and documentation clarity for tissue culture and lab environments.
How we work with you
A deliberate, engineering-driven process from first conversation through regulatory support.
Understand Your Device
We start with how your device is used, packaged, and manufactured so the sterilization approach reflects real-world conditions.
Design the Strategy
Validation methods are selected based on risk, material compatibility, and regulatory pathway.
Execute with Control
Data integrity, traceability, and clear documentation are built into every stage of execution.
Support Beyond the Cycle
We stay available to help you explain and defend the work to auditors and regulators.
You will always know:
Why a particular method was or was not selected
What assumptions and justifications underpin the approach
How any changes affect your validation status
Registered and audited for medical device work
Andersen Scientific maintains the highest regulatory and environmental standards.
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
The people behind your process
Experienced professionals committed to your device's success. Click to read individual bios.
Ready to discuss your project?
Tell us about your device and timeline. We will let you know if we are the right fit and what the process looks like.