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ANSCI Services
Ethylene Oxide Sterilization
Our feasibility studies support early-stage and evolving devices by confirming process suitability before formal validation begins. Through controlled testing and parallel data development, we help teams make informed decisions about sterilization pathways with clarity and confidence.
Sterilization Validation (ISO 14937)
We perform complete EO sterilization validations in accordance with ISO 14937, including worst-case strategy development, load configuration rationale, iPCD and ePCD resistance studies, and half-cycle or full overkill methods. Our focus is on defensible scientific logic—not boilerplate documentation—ensuring your validation program is technically sound and audit-ready.
Feasibility Studies
Before validation begins, run a preliminary study to confirm your device tolerates the EO cycle and packaging you've chosen. We design and execute feasibility protocols that give you early data on biocompatibility, shelf-life stability, and transport simulation—so you enter formal validation with confidence, not surprises.
Requalification & Adoption Strategies
We support periodic requalification and structured adoption of validated EO processes as products, packaging, and production conditions evolve. Our approach emphasizes documented risk evaluation and equivalence rationale development to maintain sterile label claims without unnecessary revalidation.
Documentation & Regulatory Support
We support periodic requalification and structured adoption of validated EO processes as products, packaging, and production conditions evolve. Our approach emphasizes documented risk evaluation and equivalence rationale development to maintain sterile label claims without unnecessary revalidation.
How We Work
A deliberate, engineering-driven process from first discussion through regulatory support.
Understand Your Device and Goals
We begin with how your device is used, packaged, and manufactured— so the sterilization approach reflects real-world use.
Design a Sensible Strategy
Validation methods are selected based on risk, material compatibility, and regulatory pathway—not habit.
Execute with Control & Documentation
Data integrity, traceability, and clear documentation are built into every stage of execution.
Support Beyond the Cycle
We remain available to help you explain and defend the work— not just complete it.
Registered and audited for medical device work
Andersen Scientific maintains the highest regulatory and environmental standards.
- ISO 13485 Certified & Registered with the FDA (Est. No. 1064858)
- FDA Innovation Challenge 2 Winner
- Small Business Environmental Stewardship Award recipient
- NC permit exemption for exceptionally low emissions
