Medical Device Sterilization Companies Compare 101 Companies
Explore FDA approved sterilization services, equipment, and supplies used in the medical device manufacturing process. The FDA inspects medical sterilization facilities that employ both established and novel sterilization methods to confirm safe and effective processes in compliance with Good Manufacturing Practices (GMP) for all devices, parts, and equipment labeled as sterile. Ensure that you partner with a sterilization provider with experience in a wide array of device designs, materials, product packaging, and final packaging to meet your sterilization goals and comply with industry safety standards.
Air Safe, Llc
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.;
Eagle Medical, Inc
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
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.;
Harmac Medical Products Inc.
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.;
Ecolab
Ecolab's Central Sterile Program pioneers a holistic approach to instrument sterilization, harnessing the power of cleaning verification, monitoring, and standardized processes to enhance infection prevention measures in healthcare settings. Our program is meticulously designed to ensure process standardization and consistency, leading to improved cleaning results, faster throughput, and a reduction in the risk and financial implications of healthcare-associated infections (HAIs). By focusing on best-in-class operational efficiencies, world-class service and compliance with industry standards, we are committed to advancing the safety and success of healthcare facilities globally, ensuring every patient benefits from the highest standards of care, and protecting margins for your hospital.;
Ceutical Laboratories, Inc.
Ceutical Laboratories, Inc. provides expert sterilization services powered by cutting-edge methodologies, including Ethylene Oxide testing and Post Sterilization Testing, ensuring that medical devices meet the highest safety and quality standards. Our lab testing services support a broad range of needs across the pharmaceutical, nutraceutical, and medical device sectors, offering comprehensive analyses from raw material testing to product degradation studies. With our commitment to excellence, we offer unparalleled support and validation efforts, guaranteeing that each product not only complies with rigorous regulations but also retains its integrity and efficacy post-sterilization, ensuring the utmost safety for end-users.;
Dravon Medical Inc.
Dravon Medical Inc. provides sterilization services supporting the medical field with validated sterilization methodologies like autoclaves and EtO for devices such as the versatile A-Clamp. Our A-Clamps undergo rigorous cleaning, disinfecting, and sterilization processes guided by comprehensive testing data to ensure safety and efficacy. We are committed to delivering top-tier sterilization with detailed sterilization parameters and maintaining robust test data to guarantee the reliability and performance of our clamps in critical medical settings. Our commitment to quality extends to offering a range of clamp colors and configurations, supported by comprehensive sterilization guidelines and a limited warranty, ensuring you receive products that meet stringent medical standards and boost reliability in medical procedures.;
Plasma Etch Inc
Plasma Etch Inc. provides sterilization services with its innovative plasma cleaning technology, offering an environmentally friendly and chemical-free method to remove all organic matter from various surfaces, utilizing oxygen and/or argon in a vacuum chamber. Our systems provide unparalleled sterilization capabilities, including microbial contamination removal, ensuring thorough cleanliness without compromising material integrity—a level of uniformity and thoroughness that other sterilization methods simply can't compete with. Through our patented temperature control and versatile gas options, we enable enhanced bonding and adhesion characteristics on treated substrates, delivering superior sterilization results with the flexibility to cater to a wide array of material types.;
Steris Laboratoties
STERIS Applied Sterilization Technologies (AST) offers a comprehensive suite of sterilization services tailored to the medical device industry, harnessing advanced technologies such as gamma, electron beam, X-ray irradiation, and ethylene oxide. Our 40 years of expertise ensure a nuanced understanding of the complexities involved in medical device sterilization, offering our customers high-quality, cost-effective processing backed by our globally positioned, multi-technology facilities. We ensure the integrity of your sensitive medical devices, emphasizing stringent quality standards compliant with global regulations, and support rapid turnover and stringent quality demands with certified processes. In dedication to delivering superior customer care, we integrate a meticulous quality system that complies with stringent regulatory standards, offering you peace of mind and reliability in every sterile product journey.;
Nelson Laboratories, LLC
Nelson Laboratories, LLC offers a comprehensive suite of sterilization validation services tailored to ensure the safety, efficiency, and compliance of medical devices and products. Leveraging state-of-the-art methodologies, including Ethylene Oxide (EO) sterility testing, radiation sterility validations, and advanced bioburden and microbial identification processes, we provide reliable solutions designed to meet rigorous regulatory standards. Our expert support extends beyond testing, encompassing detailed risk assessments and advisory services to optimize sterilization processes and partner with you to navigate complex sterilization validation requirements, enhance product integrity and safety, and accelerate time to market.;
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