Sterilization Equipment in Texas

Rexmed Health is a medical device original equipment manufacturer (OEM) and contract manufacturer based in El Paso, Texas, with a manufacturing plant in Ciudad Juarez, Mexico. The company specializes in designing, engineering, and manufacturing medical devices for parenteral delivery, infusion therapy, and specialty applications. With over 20 years of experience, Rexmed manufactures products serving ophthalmic surgery, urology, parenteral nutrition, IV therapy, cardiology, airway management, and pain management sectors. Core manufacturing capabilities include fluid delivery sets, infusion pump systems, parenteral bags and configurations, and surgical dispensing coils, produced in certified clean rooms (Class 8 environment). The company holds FDA approval, COFEPRIS (Mexican regulatory) certification, CT-PAT customs certification, and operates under cGMP compliance. Rexmed provides integrated services including process validation (IQ/OQ/PQ), sterilization management, logistics and warehousing, testing services, and master validation planning. The company works with major national and multinational pharmaceutical organizations and emphasizes customized solutions, hand assembly capabilities, special testing, and small-lot production flexibility. Rexmed maintains lean enterprise methodology with six sigma practices and is recognized as a socially responsible company (ESR) by the Mexican Center for Philanthropy. Distribution and logistics partnerships include Silan Medexo (import/export), Doniphan Logistics (distribution center), and PJ Technologies (infusion pump system distribution).

Ross Orthodontic is a family-owned manufacturer and design firm specializing exclusively in orthodontic office environments since 1982. As the only manufacturer dedicated solely to orthodontic equipment and design, Ross has equipped over 1,000 orthodontic practices. The company provides comprehensive office design planning, consulting, and manufacturing of specialized treatment and operational equipment. Products include patient, doctor, and assistant seating; delivery units and cabinets; custom cabinetry; operatory and task lighting (including the ELEF lighting system and Polaris LED task lights); sterilization centers; and mechanical room equipment. All equipment is manufactured with industrial-grade, heavy-duty mechanical components designed for durability and long-term reliability. Ross serves as a single-source supplier for orthodontic office buildouts and renovations, handling design consultation, equipment manufacturing, and direct delivery.

Steritec Services LLC is a contract sterilization and biological testing provider specializing in medical device processing. The company operates a 54,000 square foot facility in Athens, Texas, equipped with ethylene oxide (EO) and steam sterilization chambers, along with comprehensive chemical and biological testing laboratories. Core services include 100% ethylene oxide sterilization, steam sterilization, sterility testing, LAL endotoxin analysis, EO residuals testing, and bioburden assessment. The company serves medical device manufacturers requiring validated sterilization processes and regulatory-compliant testing support, including ISO 11135 process validation, biological indicator testing, and process validation documentation. Steritec also provides professional consulting guidance for regulatory compliance and sterilization program development.

SigmaPro Engineering and Manufacturing is a Texas-based precision injection molding specialist serving medical device OEMs and Tier 1 suppliers. The company manufactures complex plastic components for minimally invasive surgical devices, drug delivery systems, diagnostic and analytical consumables, and optical/wearable medical assemblies. SigmaPro operates a 12,000 sq. ft. ISO 13485 and ISO 9001-certified facility in Fort Worth with Class 8 cleanroom capabilities for molding, assembly, and packaging. The facility integrates in-house tooling maintenance, coordinate measuring machines (CMM), optical inspection systems, and real-time process data monitoring to achieve micron-level dimensional tolerances (±4 microns) and validated production. The company is FDA-registered and maintains MDR compliance alignment. Services include design for manufacturability (DFM) consultation, tooling engineering, process validation, and scalable high-volume production. SigmaPro serves North American and European medical technology markets with emphasis on biocompatibility verification and regulatory documentation support for complex, high-precision plastic components.

SteriCUBE Surgical Systems manufactures the SteriCUBE® Multiple Tray Sterilization System, a patented rigid sterilization container technology that eliminates traditional blue wrap and streamlines surgical instrument sterilization and OR workflows. The system features a patented funnel floor design with cross-ventilation filters optimized for steam sterilization, validated for 0.7mm penetration and smaller than competing technologies. SteriCUBE containers enable rapid autoclave processing with 5-minute dry times, direct placement in operating rooms without additional unwrapping steps, and integration into sterile processing departments (SPD) to reduce labor, materials costs, and processing time by approximately 27 minutes per surgery. The company operates a consignment-based business model, positioning SteriCUBE as a service rather than capital equipment purchase. The system addresses key operational pain points: elimination of blue wrap holes and compromised sterility, faster OR set-up and case start times, reduced SPD wrapping and prep labor, and improved inventory management by eliminating loaner tray wrapping. FDA cleared (510(k) K222328) and designed for healthcare facilities seeking workflow efficiency, cost reduction, and patient safety improvements in the OR and SPD environments. SteriCUBE is backed by peer-reviewed research and customer testimonials from major healthcare systems.

Surgical Solutions is a procedural support and sterile processing services provider serving U.S. hospitals and surgical facilities. The company operates as a deeply embedded partner delivering comprehensive on-site support across operating rooms, endoscopy departments, and sterile processing departments (SPD). Service offerings include pre-operative instrument preparation, intraoperative surgical assistance, post-operative care, scope reprocessing, instrument repair, sterile processing leadership and consulting, vendor relationship management, capital equipment planning, and 24/7/365 on-site technician support. The company emphasizes process optimization, compliance adherence to industry standards (including Joint Commission), staff training and development, and efficiency improvements documented by case studies showing $1M in direct endoscopy savings, 70% increases in minimally invasive procedure volumes, and 95% reduction in unused surgical tray rates. Surgical Solutions employs a customized, collaborative approach to each facility's procedural and sterilization workflow challenges, with dedicated focus on patient safety, surgical team support, and operational reliability.

M&S Biotics is an IoT-based healthcare technology company specializing in operating room automation and surgical data analytics. The company develops real-time detection, tracking, counting, and localization systems for surgical instruments and items, designed to minimize surgical count time and improve OR efficiency. M&S Biotics offers three primary solutions: (1) OR Solution—an IoT system that automates surgical counts and provides instrument utilization data to optimize surgical sets; (2) SPD Solution—an IoT-enabled sterilization and processing department system that ensures surgical set accuracy, tracks instrument recovery, reduces shrinkage, and monitors sterilization cycles; and (3) Intraoperative Intervention®—a clinical decision support platform that captures and displays real-time intraoperative analytics through a user-friendly interface. The technology is designed to enhance surgical procedure efficiency, efficacy, and safety by providing autonomous, real-time operational intelligence previously unavailable in the OR. M&S Biotics partners with major healthcare organizations and device manufacturers, including Johnson & Johnson. The company is headquartered in Houston, Texas, at the Center for Device Innovation within the Texas Medical Center.

Steri-Tek is a contract sterilization service provider specializing in E-beam and X-ray irradiation sterilization for medical devices, pharmaceuticals, biologics, and tissue products. Founded in 2016, the company operates as a high-volume sterilization and R&D innovation center serving startups and global enterprises. The company offers proprietary expertise in optimizing E-beam/X-ray sterilization for complex and sensitive materials, including combination devices, drugs, biologics, allograft and xenograft tissue products. SteriTek provides standard turnaround times of 2–6 business days, with expedited 24-hour and same-day rush service options available. The company maintains high equipment uptime and is directly involved in ISO 11137 and AAMI standards development. SteriTek operates a Dallas-area facility in Lewisville, Texas (opened April 2023) equipped with two 80kW E-beam/X-ray DualBeam™ lines, with additional facilities in development stages to meet growing demand. The company serves the medical device, biotech, pharmaceutical, tissue product, and research sectors.

PureWay Compliance, Inc. is a healthcare waste management and compliance services provider operating since 2013, serving over 500,000 sites nationwide. The company specializes in medical waste disposal, sharps container management, pharmaceutical waste handling, hazardous waste disposal, and dental clinical waste services. PureWay serves enterprise healthcare systems, medical practices, clinics, hospitals, pharmacies, pharmaceutical manufacturers, veterinary clinics, long-term care facilities, home healthcare providers, and individuals requiring sharps disposal. The company offers flexible, contract-free disposal solutions with no hidden fees and delivers up to 30% cost savings through bundled services. PureWay operates a national infrastructure including multiple distribution centers, multi-site treatment facilities, and dedicated national truck routes with compliance and support teams. The company provides OSHA and HIPAA compliance training, pharmaceutical reverse distribution with credit options, battery recycling, and PPE/infection control products through an online store. Service models include scheduled pickups for regular waste streams and mail-back sharps disposal systems for smaller volumes. PureWay emphasizes sustainability in medical waste management and offers free site compliance assessments and regulatory guidance resources.

Quality BioResources is a contract lyophilization and custom formulation manufacturing company with over 30 years of experience serving the medical, veterinary, cosmetic, and biotech research industries. The company specializes in freeze-drying (lyophilization) services ranging from pilot-scale to bulk production, with capacity exceeding 60,000 lyophilized vials per day. Core service offerings include customized formulation development with excipient selection, liquid and dry filling operations, and biomaterials processing (chitosan, cellulose, collagen, and related compounds). Quality BioResources provides end-to-end contract manufacturing support from early-stage research through scaled production, ensuring quality-driven outcomes for clients across regulated and non-regulated segments. The company maintains quality assurance protocols and operates from its Seguin, Texas facility. As a contract manufacturer, Quality BioResources serves as a scalable manufacturing partner for organizations requiring specialized lyophilization expertise without in-house infrastructure.

C.G. Laboratories, Inc. is a multi-service medical device contract manufacturer and testing laboratory founded in 1983 and headquartered in Granbury, Texas. The company specializes in medical device decontamination, contract packaging, laboratory testing, sterilization validation, and environmental monitoring. With over 40 years of operational experience and 19,000 square feet across two facilities, C.G. Labs serves the medical device, tissue, and dental industries. The company is FDA-registered and ISO 13485:2016 and MDSAP accredited. Core competencies include microbiological analysis, regulatory testing, reusable medical device validation, water testing, air microbial monitoring, and IFU development. C.G. Labs offers customizable decontamination and sterilization services with turnaround times exceeding 72-hour performance objectives, end-to-end contract packaging (sterile and non-sterile), and comprehensive validation support including process validation and equipment qualification. The laboratory team collectively has over 90 years of medical device industry experience.

Intech Partners, LLC is a Houston-based manufacturer of radiation protection and shielding products founded in 2003. The company specializes in lead-free and lead-containing radiation shielding solutions for medical, industrial, nuclear, and security applications. Intech designs and manufactures composites, alloys, and polymers for nuclear and gamma radiation shielding; lead-free and lead curtain shielding for NDT (non-destructive testing) and security scanners; custom barriers and curtains for medical facilities and work areas; and bismuth and tungsten custom fabrications. The company serves architecture and engineering firms, manufacturers, government agencies, and medical organizations including major healthcare systems (Johns Hopkins, Kaiser Permanente, MD Anderson), national laboratories (Lawrence Livermore, Los Alamos, Sandia), and federal agencies (FBI, DOE, NASA). Products comply with ASTM, FDA, NFPA, UL94, and Priority Pollutant Metal specifications. Intech maintains local warehousing, production, and fulfillment capabilities in the Houston area, enabling rapid material sourcing and custom fabrication. The company advises on x-ray system design, permitting, and shielding architecture for OEM manufacturers and provides inventory of over 50 types of lead-free radiation shielding materials in stock.