Sterilization Equipment in North Carolina

Novex Innovations is a contract development and manufacturing organization (CDMO) specializing in the design, development, and commercialization of biologics, pharmaceuticals, medical devices, and bioengineered tissue. Operating a 36,000 square-foot cGMP-compliant facility with Class 100 and Class 1,000 cleanroom spaces, the company provides comprehensive services spanning product and process development, clinical and commercial manufacturing, regulatory support, and distribution. Capabilities include biological formulations, clinical formulation, tissue processing, active pharmaceutical development, diagnostic materials manufacturing, and inventory management. ISO 13485 certified and FDA-registered, Novex supports clients from proof-of-concept through all phases of clinical trials to commercial scale-up and market distribution, serving both startups and multinational organizations across national and international markets.

Haywood Vocational Opportunities, Inc. is a non-profit medical device manufacturer and contract manufacturing organization based in Waynesville, North Carolina. With over 50 years of experience in the healthcare industry, HVO provides custom contract manufacturing, packaging, kitting, and logistics services for medical devices and surgical products. The company operates 100,000 square feet of climate-controlled 3PL warehouse space licensed for medical device storage and inventory management. HVO's core business services include contract cutting, packaging, and kitting for multiple industries; medical packaging and contract manufacturing tailored to healthcare sector requirements; design and development of medical devices and custom surgical drapes; and disposable medical products manufacturing. The company maintains a mature Quality Management System (QMS) aligned with industry standards and is ISO 13485-2016 registered, demonstrating commitment to medical device quality and regulatory compliance. HVO is also CARF accredited (Commission on Accreditation of Rehabilitation Facilities), reflecting excellence in service delivery. Beyond manufacturing, HVO operates as a social enterprise providing vocational training and community engagement programs for individuals with disabilities. Community services include day programs (The Hub, LTCS, ADVP, Innovations), employment training and supported employment services, transitional student services (TSS), pre-employment transition services (Pre-ETS), and long-term follow-along support. The organization serves as a vocational rehabilitation partner in Western North Carolina, supporting workforce development and community integration for individuals with developmental disabilities and disadvantages.

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.

Practicon, Inc. is an established dental supplier founded in 1982, specializing in practical innovations and comprehensive dental products and supplies for dental practices. The company curates over 3,000 dental products spanning sterilization and infection prevention, personal protection equipment, examination and hygiene supplies, treatment supplies, restorative materials, patient education tools, and home care preventive products. Practicon partners with leading dental manufacturers including Hu-Friedy, Dentsply Sirona, GC America, Kerr, Premier Dental Products, Woodpecker, Garrison, Pentron, and others to deliver a broad portfolio supporting clinical operations, office management, and patient care. Operating as a family-oriented distributor, Practicon serves dental practices with bulk ordering capabilities and membership programs.

Clinical Choice is a B2B medical equipment supplier specializing in endoscope management solutions, serving over 1,200 hospitals and surgery centers. For more than 20 years, the company has provided cost-effective products and services for endoscope transport, storage, reprocessing, and accessories. Key offerings include ScopeVault®, an innovative endoscope storage cabinet that provides a healthy, secure environment compliant with ANSI/AAMI ST91:2021 standards; SafeCap®, a user-friendly endoscope transport and short-term storage system with compatible liners offering superior infection control; compatible filters for leading endoscope reprocessor units (Olympus, Medivators, Steris, Custom Ultrasonics, J&J/ASP) delivering 30-50% savings versus OEM pricing; and a comprehensive line of single-use GI accessories. Clinical Choice emphasizes quality, affordability, infection prevention, and dedicated customer support throughout the product lifecycle.

Hydromer, Inc. is a global B2B provider of surface modification and coating solutions, specializing in hydrophilic polymer research, development, and manufacturing. Founded in 1980 and based in Concord, North Carolina, the company is ISO 9001:2015 certified with over 40 years of expertise in creating innovative polymer-based products for medical devices, industrial plastics, and specialized applications. Hydromer offers a comprehensive portfolio of hydrophilic coatings—including UV-curable and thermal-curable systems—tailored for cardiovascular, gastroenterology, neurovascular, ophthalmology, peripheral vascular, and urological devices. The company provides end-to-end services including custom formulation development, contract coating, R&D services, FDA regulatory support, and technology transfer. With a 98% repeat customer rate and support for over 1,000 medical device customers worldwide, Hydromer delivers lubricious, anti-thrombogenic, and performance-enhanced coatings for catheters, guidewires, balloons, stents, endoscopes, and other interventional and diagnostic devices. Global production and service hubs ensure consistent quality and responsive support across Asia and the Americas.