Medical Device Sterilization Companies Compare 61 Companies
Compare medical device sterilization companies to find a partner that provides validated sterilization methods as part of your device manufacturing process. To maintain medical device safety and effectiveness, the FDA actively works with sterilization experts, medical device manufacturers, and other government agencies to ensure that both medical device manufacturers and sterilization facilities conform to FDA-recognized standards for sterilization. Explore the following medical sterilization companies to find a certified provider that offers the best sterilization technique for your unique medical device needs.
NAMSA delivers a comprehensive full spectrum of sterilization validation services tailored to ensure compliance, efficacy, and safety across your medical device lifecycle. From meticulous Bacteriostasis/Fungistasis Testing to comprehensive EO Residual Testing and advanced Bioburden Testing, our robust methodologies guarantee precise validation and optimization of EO Cycle Development. Leveraging our extensive expertise in Biological Indicator Sterility and Pharmacopoeia Sterility Testing, entrusting your sterilization processes to us means access to globally recognized experts, cutting-edge technology, and a commitment to accelerating your product's path to market with unparalleled precision and reliability.
Easter Services Inc. specializes in the comprehensive repair and refurbishment of all large autoclaves and sterilizers, offering an eco-friendly solution by reengineering the doors and chambers of old sterilizers with modern controls and piping. With attractive pricing and warranties comparable to new equipment, our refurbished sterilization equipment presents an excellent value proposition, ensuring reliability and performance. Certified by the FDA, our services guarantee not only cost efficiency but also adherence to the highest standards of safety and functionality, backed by a team of experts readily available for assistance and support for enhancing and maintaining your sterilization capabilities efficiently.
At Buxton USA, our predictive approach to sterilization solutions creates an environment where operational reliability and workflow efficiency are paramount, ensuring that your sterilizers and washers function impeccably day in and day out. Tailored to your facility's unique demands, our customization capabilities range from the positioning of machine gauges to door configurations, all designed to enhance flexibility and minimize downtime. With over 30 years of serving various facilities, our legacy is founded on building durable equipment that not only meets strict sterilization standards but also optimizes productivity through ingenious design and customer-centric support. Our approach takes the worry out of your workflow!
ETC Sterilization Systems specializes in providing customized sterilization services with a comprehensive range of Ethylene Oxide (EO) and steam sterilizers tailored to meet the diversified needs of the medical, pharmaceutical, and laboratory sectors worldwide. Our product lineup features cutting-edge control systems and includes both mini-bulk and bulk sterilizers, ensuring the highest efficiency and precision in sterilization processes. With our industry-leading expertise, dedicated support, advanced sterilizer control systems and custom-engineered chambers, informed by the deep expertise of seasoned professionals, we assist you in selecting the optimal sterilization solution to enhance operational outcomes and ensure compliance with global sterilization standards.
Air Safe, LLC, advances sterization services that specialize in cleanroom certification and controlled environment services with sterile preparations and sterile compounding facilities, catering to all types and sizes of cleanrooms, from compact single-filter rooms to extensive multi-filter facilities. Leveraging the latest standards and methodologies, including IEST and ISO 14644, we conduct comprehensive assessments encompassing air velocity, HEPA filter integrity, particle count, and room pressurization testing, along with optional services like viable environmental sampling and decontamination. Our commitment to upholding industry standards and our meticulous certification procedures ensure that your cleanrooms meet the strictest quality and performance criteria, fostering unparalleled safety and operational excellence.
American Cleanroom Systems' sterilization services offer specialized cleanroom solutions for the medical device sector, ensuring compliance with FDA GMP rules and supporting various classifications from ISO-5 to ISO-8 based on product criticality and sterility requirements. Our cleanrooms are engineered with advanced features such as FRP modular panels, proprietary ACS coved corners, and room-side replaceable HEPA fan filter units tailored to enhance the production of sterile, high-quality medical devices. By integrating robust environmental controls and precision cleanroom technologies with a strong focus on customizability, reliability, and comprehensive support, we deliver turnkey cleanroom solutions that empower you to achieve operational excellence and product integrity in your sterilization services, fostering both product safety and regulatory adherence.
Eagle Medical, Inc. offers a comprehensive suite of sterilization services, utilizing advanced modalities like Hydrogen Peroxide Gas Plasma, E-Beam, Gamma Beam Irradiation, and Ethylene Oxide Sterilization, to ensure full compliance with FDA and ISO standards. Our services are supported by state-of-the-art ISO 14644-1 Class 7 cleanrooms, meticulous validation processes, and extensive regulatory expertise to guarantee the highest level of sterility and safety for medical devices. With our tailored support, ongoing compliance assurance, and detailed process documentation, Eagle Medical ensures that your products meet stringent sterilization requirements with efficiency and precision.
DeRoyal Industries Inc. provides comprehensive sterilization services, leveraging an extensive array of manufacturing capacities, from textile products to complex medical devices, to ensure the highest standard of sterilization for OEM partners. Our ISO 13485:2016 and ISO 11135:2014-certified Royal Sterilization Services facility employs advanced technology and a straight-through process flow to maintain integrity between sterile and non-sterile products. With a focus on quality, efficiency, and compliance and supported by automated systems that continuously monitor all phases of sterilization, we deliver tailor-made sterilization solutions to meet your specific needs and assure unmatched quality and compliance.
Alcami Corporation provides industry-leading autoclave and sterilizer validation services, ensuring that critical sterilization equipment meets stringent operational and compliance standards. Our expert team, extensive experience and unwavering commitment to quality provides bespoke testing protocols, pre-qualification efficiency tests, and post-qualification verifications, leveraging cutting-edge equipment like thermocouples, wireless dataloggers, and biological indicators to certify the integrity of sterilization processes. By undertaking rigorous pre-qualification assessments and adhering to protocols aligned with globally recognized standards such as EN 285 and ISO 17665-1:2006, you benefit from our commitment to excellence and efficiency thereby enhancing the effectiveness and compliance of your sterilization processes.
Harmac Medical Products Inc. excels in providing comprehensive packaging and sterilization solutions tailored to ensure medical devices are safe and sterile upon reaching patients, leveraging a wide range of packaging materials and advanced sterilization methods such as Ethylene Oxide (ETO), Gamma Radiation, and Electron-Beam (E-Beam). Our collaborative approach includes re-designing packaging for cost efficiency and effectiveness while maintaining product integrity, in partnership with leading thermoforming companies and sterilization suppliers. Through our integrated service, we offer expertise in sterile barrier packaging, high-speed automation solutions, and rigorous packaging testing and validation processes to meet the critical demand for reliability in the medical industry, providing you with confidence in product durability and sterility.
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