Andersen Scientific, Inc.

Andersen Scientific is a contract sterilization service provider specializing in Ethylene Oxide (EO) sterilization for medical device manufacturers, particularly start-up and small-to-medium-sized companies. The company operates a proprietary EO-FCT (Flexible Chamber Technology) sterilization system that uses gas-impermeable sterilization bags and unit-dose EO cartridges, minimizing EO consumption and emissions compared to traditional rigid chamber systems. The facility offers 24–48-hour turnaround times and accommodates lot sizes ranging from single devices to medium volumes. Service offerings include routine sterilization, full process validation compliant with ISO 14937, feasibility studies, biocompatibility assessments, shelf-life studies, and shipping/transport simulation studies. The company is ISO 13485 certified and FDA-registered (Establishment No. 1064858). Notably, Andersen Scientific won the FDA's Innovation Challenge 2 for EO emissions reduction and received a State of North Carolina permit exemption for near-zero emissions operations. The management team brings over 75 combined years of sterilization industry experience and participates on AAMI and ISO standards committees. Beyond sterilization services, the company provides regulatory guidance and consulting support to clients developing medical device approval strategies. Located in Research Triangle Park, North Carolina, the facility serves healthcare organizations, research institutes, government agencies, clinical trial sponsors, and pharmaceutical companies.