Our Services
Sterilization and validation from one partner
From early feasibility through validated production, we handle the sterilization so you can focus on your device.
What we offer
Each service can be ordered separately or as part of a complete sterilization program.
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.
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A deliberate, engineering-driven process from first conversation through regulatory support.
Understand Your Device
We start with how your device is used 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.
Registered and audited for medical device work
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
Not sure which service you need?
Tell us about your device and where you are in the development process. We will recommend the right path forward.