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    Pharmaceutical & Bioprocessing

    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:

    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
    • ExCell® Irradiator
      For ultra-precision, repeatability, and speed, the ExCell Irradiator can be used in different stages of the product development lifecycle including R&D samples, batches for clinical trials and stability and routine testing, as warranted.
      Learn more

    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

    News

    Cold Chain Infrastructure

    AVAILABLE AT OUR CORONA FACILITY

    In response to the increasing need for pharmaceutical processing of products that require strict temperature control, Sterigenics® is pleased to announce the installation and validation of a comprehensive Cold Chain infrastructure now available at its facility in Corona, California. This infrastructure is designed to maintain precise temperature conditions between 2-8 degrees Celsius, ensuring validated cold storage temperature precision, dosing control, mapping, and monitoring. This capability places the facility in a unique position to meet the growing demand for Feasibility Studies related to early-stage drug formulations. Importantly, it enables pharmaceutical manufacturers to assess the feasibility of Terminal Sterilization for their Drug Development requirements at the earliest stages of development.

    Brochures

    “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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