Ethylene Oxide (EO / EtO) Gas Sterilizer and Acidic Scrubber/Abator Systems - Low Temperature

Autoclave and Steriliser Equipment

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HEDONE USA LLC designs and manufactures industrial-grade ethylene oxide (EO / EtO) gas sterilizers for the validated sterilization of heat- and moisture-sensitive medical devices. Our EtO sterilization systems are engineered with comprehensive knowledge of the complete sterilization lifecycle, including pre-conditioning, gas injection, exposure, circulation, evacuation, aeration, and emission control. Our EO sterilizers are widely used for products such as surgical instruments, syringes, catheters, surgical sutures (absorbable and non-absorbable), IV sets, tubing, wound care products, PPE, gowns, and medical disposables, where deep gas penetration and controlled sterilization parameters are essential. HEDONE USA LLC EtO gas sterilizers are available in capacities ranging from 1 m³ to 100 m³, with custom-made chamber designs optimized for U.S. or Euro pallet configurations, product baskets, and client-specific loading requirements. Chambers are manufactured using high-grade stainless steel, featuring inflatable door gaskets for reliable sealing, efficient gas circulation systems for uniform exposure, and sliding or hinged door options based on operational preference and space constraints. Each EtO sterilizer system is supplied with full IQ, OQ, and PQ support. Our scope also includes validated control software and software validation services in accordance with 21 CFR Part 11, ensuring secure data integrity, traceability, and regulatory compliance. HEDONE USA LLC provides international installation, commissioning, operator training, and technical support, enabling customers worldwide to achieve safe, efficient, and audit-ready EtO sterilization operations. All systems are engineered in alignment with ISO 11135, ISO 13485, EN 1422, ATEX 2014/34/EU, and applicable global standards. Surgical Instruments, Syringe, Catheters, Surgical Sutures (absorbable and non-absorbable), IV Sets and Tubing, Wound Dressings and Bandages, PPE, Gowns and face masks, lumen product.

Hedone USA LLCS11.E74HEDONE USA LLC is a U.S.-based medical technology manufacturer and market-entry partner headquartered in Atlanta, Georgia, USA, specializing in low temperature ethylene oxide (EtO/EO) sterilization systems, environmental emission control, surgical suture manufacturing solutions, hospital air quality systems, and U.S. market access services.We design, manufacture, and supply performance-validated ethylene oxide gas sterilizers for medical device and pharmaceutical manufacturers. Our EtO sterilization systems are engineered for reliable, repeatable, and compliant sterilization of heat- and moisture-sensitive products and are developed in alignment with ISO 11135, ISO 13485, EN 1422, ATEX 2014/34/EU, and 21 CFR Part 11 requirements. To support environmental compliance, HEDONE USA LLC also manufactures acidic scrubbers that safely neutralize ethylene oxide emissions, ensuring sustainable and regulation-compliant sterilization operations. Beyond manufacturing, HEDONE USA LLC acts as a U.S. market-entry and distribution partner for international medical device manufacturers. We support FDA registration and listing, regulatory readiness, U.S. importer-of-record services, go-to-market strategy, and distributor development. Through our established healthcare network, we assist qualified manufacturers in navigating Group Purchasing Organization (GPO) pathways, enabling structured access to U.S. hospitals, healthcare systems, and purchasing networks. Expanding our industrial capabilities, we provide turnkey surgical suture production facility solutions, covering the entire manufacturing workflow from raw material processing to final sterile packaging. Our scope includes polymer extrusion lines (monofilament and multifilament), suture stretching, winding, stiffening, cutting and drying systems; braiding machines; needle manufacturing and precision needle attaching/crimping units; cleanroom systems; glove boxes; dry cabinets; coating and surface treatment processes; primary and secondary packaging solutions including foil and blister packing machines; labeling, sealing, and carton packaging equipment. These integrated and scalable production lines are designed to support the manufacturing of absorbable and non-absorbable surgical sutures in full compliance with international medical device standards, enabling manufacturers to achieve consistent quality, regulatory readiness, and efficient production throughput. Recognizing the critical importance of controlled air quality in healthcare environments, HEDONE USA LLC also designs and manufactures hospital-grade HVAC and air purification systems. Our PK-S Series air purifiers, featuring HEPA filtration, UV-C technology, and negative ion generation, are engineered for operating rooms, intensive care units, and isolation rooms. HEDONE USA LLC supplies a focused portfolio of neurosurgical products supporting cranial, spinal, and neurosurgery care procedures. Our offering includes navigation systems, external ventricular drainage (EVD) systems, shunts, aneurysm and brain clips, dural repair and dural substitute products, and allograft solutions for neurosurgical applications. Surgical Instruments, Syringe, Catheters, Surgical Sutures (absorbable and non-absorbable), IV Sets and Tubing, Wound Dressings and Bandages, PPE, Gowns and face masks are example products mainly sterilized with ethylene oxide eo eto Sterilizer.

Ethylene Oxide (EO / EtO) Gas Sterilizer and Acidic Scrubber/Abator Systems - Low Temperature

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