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    Clinics and physicians rely on manufacturers to ensure drug efficacy of active pharmaceutical ingredients (APIs) and sterility assurance across the supply chain—for the health and safety of their patients. As a manufacturer, we understand that your choice of sterilization modality is unique. Enhancing the aseptic manufacture sterility assurance level (SAL) of pharmaceuticals without affecting drug efficacy is a critical requirement of terminal sterilization.

    As pharmaceutical delivery has evolved, so have sterilization requirements. With the increase in drug-device combinations—like stents coated with a pharmaceutical preparation—sterilization processes must deliver a SAL of 10-6 without impairing the drug efficacy.

    Your products are cutting edge. So too are our approaches to pharmaceutical sterilization. Our advanced technology, dosimetry methods, and processing capabilities make it possible to sterilize devices while ensuring the safety and stability of your pharmaceutical and biologic products.

    With decades of sterilization expertise, Sterigenics offers choice of modality.

    Applications for sterilization of pharmaceuticals using radiation-based Gamma

    • Irradiation of ambient and frozen tissues
    • Nonproliferation by irradiation to stop cell growth in vaccine production
    • Decontamination of bio-hazard type products; for example, human serum
    • Virus removal from blood, serums, or other biologic products; for example, frozen products that require irradiation under cold chain management
    • Sterilization or decontamination of bulk APIs, excipients, or ingredients
    • Sterilization of drug-device products
    • Sterilization of hydrogels
    • Final sterilization of pharmaceutical products; for example, API-filled vials or syringes, which can be powder-filled, solution or suspension, gel or ointment

    Modalities used to sterilize pharmaceuticals

    • 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.
    • Ethylene Oxide (EO or ETO) 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.
    • Nitrogen Dioxide (NO2)-based sterilization offers ultra-low temperature, minimal pressure requirements, no cytotoxic residuals, and fast cycle times.

    Applications for sterilization of pharmaceuticals using gas-based Ethylene Oxide

    • External sterilization of pre-filled syringes, vials, or cartridges, where the goal is that EO does not reach the pharmaceutical product
    • Sterilization of bulk APIs
    • Sterilization of drug-device products
    • DNA removal

    Applications for sterilization of pharmaceuticals using gas-based Nitrogen Dioxide

    • External sterilization of pre-filled syringes, vials, or cartridges, where the goal is that NO2 does not reach the pharmaceutical product
    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
    • icon Brief overview of our terminal sterilization services for the Pharmaceutical Industry Download Brochure

    Contact Us To Get Your Project Started

    Contact Us or give us a call +1 (800) 472-4508