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    Sterilization is a CRITICAL step in the manufacturing process to kill any bacteria and help ensure pharmaceuticals, biopharmaceuticals are safe to use.

    Sterigenics offers comprehensive terminal sterilization services of Drug Products including:

    • Lyophilized products
    • Dry powder
    • Pre-filled syringes
    • Nano-suspension
    • APIs
    • Excipients
    • Packaging systems
    • Single-use systems
    • Container-closure systems

    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

    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

    What is Bioprocessing?

    Bioprocessing is a cost effective and rapid manufacturing process designed to produce therapeutic substances by continuous or batch processing cells or cell components, viruses, or an entire organisms. Examples of Bioprocessing products include biopharmaceuticals: therapeutic proteins, polysaccharides, vaccines, antibiotics and diagnostics.

    How is the risk of contamination minimized?

    Controlling contamination in bioprocessing facilities is critical. In order to maintain the conditions required sterile systems and components are used including single-use systems (SUS), disposables, serum and serum-derived proteins.

    SUS include materials or assemblies used in the production of a drug substance or drug product that are discarded as waste after one or a few uses these include: disposable chromatography columns, bioreactor, storage bags for bulk solution, single-use assemblies, disposable centrifuges, filter cartridges, storage containers for buffers or intermediates, and filter capsules.

    What are the benefits of Single-Use Systems?

    The shift from fixed stainless steel to SUS has revolutionized the therapeutic market. Benefits of SUS include:

    • Elimination of cleaning and sterilization process
    • Elimination energy cost for steam generation
    • Elimination of “cleaning validation” cost
    • Reduced risk of contamination
    • Increased flexibility: Time saving between production batches
    How can Sterigenics’ expertise help you?

    5 Strategic Pharma Pillars that Deliver Reliability, Speed to Market, and Quality

    • Centers of Excellence: Prioritizing business continuity, security and controlled conditions to minimize your risk
    • Quality Systems: Focusing on regulations and processes that help ensure your pharmaceutical products are manufactured to a safe and consistent standard
    • Operational Expertise: Leveraging digital solutions, lean principles, processes and procedures to provide transparency and speed to market
    • Integrated Solutions: 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
    • Advisory Services: Employing pharma expert advisors committed to supporting you in the design and execution of the sterilization process and virus reduction/removal

    “Through their efforts, flexibility and collaboration, in 2019, Sterigenics has proven to be a key supplier in helping to avert a supply disruption of a critical life-saving vaccine.”

    Strategic Sourcing Director, A Top 10 pharmaceutical company

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    • 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