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    As a manufacturer, we understand your need to deliver trusted sterile medical devices to your customers and end users around the globe. Medical devices are complex, so the choice of sterilization technology must take into consideration the device’s design, material, product packaging, and final packaging. To achieve your sterilization goals, you may require Ethylene Oxide (EO or ETO), Gamma, Electron beam (E-Beam), X-ray, or Nitrogen Dioxide (NO2) technologies.

    With decades of sterilization expertise, Sterigenics offers a choice of modality through our global integrated network of state-of-the-art facilities.

    How can Sterigenics’ expertise help you?
    • Customized solutions to ensure secure, safe, and effective processing
    • A global integrated network of facilities located near your manufacturing or distribution hubs
    • High-quality and consistent processes that exceed safety standards
    • Industry Expert Advisors to assist in solution development, validation, and testing
    • Expedited product processing services
    • One partner for all your sterilization modality requirements and access to Sotera Health’s leading portfolio of best-in-class products and services from sister companies Nelson Labs and Nordion

    Technologies used to sterilize medical devices

    • EO offers a wide range of material compatibility except for moisture- and temperature-sensitive materials. For manufacturers whose product is particularly radiation sensitive, EO can be an effective sterilization modality.
    • Gamma offers a wide range of polymer compatibility with some limitations due to oxidation effects. Product can be shipped to the final user as soon as it exits the Gamma irradiation facility.
    • E-beam offers a wide range of polymer compatibility with some limitations due to oxidation effects. For manufacturers whose goal is production of sterile product of low density or product packaged in small, uniform packages, E-beam can be an effective sterilization modality.
    • X-ray offers a wide range of polymer compatibility with some limitations due to oxidation effects. X-ray can be an effective sterilization modality for product of high density, in large volumes and in its final packaging.
    • NO2based sterilization offers ultra-low temperature, minimal pressure requirements, no cytotoxic residuals, and fast cycle times.

    Since there are many considerations when sterilization is the required outcome, it’s best to collaborate with sterilization experts to ensure your unique product goal is achieved.


    For over 20 years, H&H Medical Corporation has been partnered with Sterigenics bringing emergency trauma products to the United States Military. Their operations have run like clockwork with the predictability that is critical to our business - enabling us to respond to immediate needs when events happen, whether globally or at home. Our ability to quickly manufacture and sterilize products is a crucial element to our success and our partnership with Sterigenics enables us to do just that.

    From dose auditing and packaging to sterilization and validation they continue to have our product safety and goals in mind. Being partnered with Sterigenics means I have one less thing to worry about when running a small business.

    Paul X. Harder, JD President

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    Innovation in Medical Device Technology

    Rapid innovation in medical device technology and booming demand in healthcare has fueled the growth of Connected / Wearable Healthcare Devices often battery-powered to improve product quality and patient outcomes.

    Connected/Wearable Devices Treated with Terminal Sterilization Include:

    • Pacemakers
    • Continuous Glucose Monitoring
    • Implantable Cardioverter Defibrillators
    • Insulin Patch Pumps
    • Implantable Cardiac Monitors
    • Temperature Sensing Patch
    • Large Volume Injector
    • Connected Wound Care
    • Connected Neurostimulators (eg., Deep Brain Stimulators, Gastric Electric Stimulators, Sacral Nerve Stimulators, Vagus Nerve Stimulators)
    • Smart Orthopedic Implants (eg., Knee, Hip)
    • Ethylene oxide (EO) sterilization is used for medical devices due to its high compatibility with most materials used in the manufacture of medical devices and effectiveness. However, due to concerns with EO ignition, medical devices that store energy should first undergo a full safety assessment by experts prior to EO sterilization. Our sister business, Nelson Labs and its Expert Advisory Services team is available to conduct these assessments as well as consult in the design process to guide the device design to minimize ignition potential within the finished product.

    • stored-energy

      Stored Energy Device Safety Assessment

    Medical Device Cybersecurity

    As medical devices become more connected, they are increasingly vulnerable to cyberattacks raising concerns about patient safety.

    Ensure your product is protected from cyberattacks

    • SaMD Consulting
    • Management Plan
    • Gap Assessment
    • Cyber Risk Analysis
    • Threat Modeling and Analysis
    • Security Requirements
    • IFU Labeling Guidance
    • Quality Assurance Services
    • ISO 62304
    • ISO 27001
    Connected Medical Device

    Get Your Sterilization and
    Validation Project Started Today