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    Electron Beam

    Sterilization

    Presented by

    John Newman & Nicole Coons

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    Overview

    E-Beam Technology Examples of Various Applications Sterilization & Aseptic Processing

    Advantages of E-Beam Sterilization Advances in E-Beam Sterilization Features Containment Challenges Current Challenges

    Future Applications Summary Questions

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    E-Beam Technology

    Electron Beams aka Cathode Gun, Electron Gun, orElectron Accelerator

    Made up of electrodes cathodes (negative electrodes)

    and anodes (positive electrodes) sealed in a vacuumchamber

    Electrons are generated when cathode is heated (bypassing current thru cathode)

    Electrons are accelerated by an electric field and movedout of the vacuum chamber

    The Electron Beam (or E-Beam) becomes source ofionizing energy that can be used for multiple applications

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    E-Beam Technology

    E-Beams are either classified as high or lowvoltage

    High voltage accelerators achieve an averagerange of 0.5 10 MeV

    Low voltage accelerators achieve up to 0.3 MeV(300 KeV)

    Most electron beam installations worldwide arehigh voltage systems

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    E-Beam Technology

    Voltage controls the energy of the electrons (depth of penetration) Current controls the number of electrons emitted from the cathode

    (dose) The higher the voltage the greater the surface penetration The higher the current the greater the dose received Low energy electron radiation does not penetrate very deep into

    materials Most of the electron energy is deposited on the surface perserving

    the bulk material and never reaching internal products

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    E-Beam Technology Historically, systems have

    been Very large, expensive and

    complex to maintain Required large, cumbersome

    vacuum pumping equipment Required large, high voltage

    power supplies Required in-house engineering

    and maintenance expertise tokeep them running

    Require really large facilities tohouse equipment

    Result very difficult andEXPENSIVE to integrate intoa manufacturing process

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    E-Beam Technology

    Development of new compact e-beamguns (low energy) has allowed this

    efficient and clean energy source to beused in a wide range of industrialapplications

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    TYPICAL EMITTER OR GUN

    electron cloud

    Accelerator

    Filament

    Ti FoilWindow

    AccelerationZone

    Atmosphere

    HermeticallySealed

    VacuumChamber

    Cu

    Faceplate

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    Applications E-Beam Processing is used for 3

    primary industrial purposes: Cross-linking of polymer based

    products

    Curing inks, cross-linking of rubber

    tires, curing adhesives, cross-linkingpolymer composites to improvethermal, mechanical, and chemicalresistance properties

    Material degradation and recyclingof materials

    Sterilization E-Beam processing breaks DNA

    chains leading to cell death;effective method for destroying alltypes of pathogens viruses, fungi,bacteria, parasites, spores, molds

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    Typical Emitter Configurations

    Stacked to address widerapplications

    Opposing to create uniformspatial treatment

    Opposing to treatboth sides of webin-line

    Arrayed to treat3-dimensional

    products

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    Sterilization / Aseptic Processing

    Aseptic free of microbiological organisms /

    contaminants; maintains sterility

    Many drugs (such as vaccinations and bio-pharmaceuticals) require aseptic processingversus terminal sterilization

    All components (packaging, syringes, drug, etc.)MUST be sterile before entering the asepticenvironment

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    Sterilization

    Traditional methods requirebatch processing and rapidtransfer stations or Class Aclean rooms to maintain

    product sterility beforetransferring into filling isolator

    Low energy e-beams allowsurface sterilization ofmaterials before entering thesterile environment;continuous feed processes

    Aseptic Manufacturing

    Sterile Product

    Product Packaging

    Aseptic

    Environment

    Sterile Transfer

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    E-Beam Sterilization &Syringe Tub Transfer into Filling Isolator

    Tubs in Section1 Emitter Section2 Pealing Filling and Closing Tubs out

    E-Beam Tunnel Isolator System

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    Advantages of E-Beam SterilizationKey Advantages

    Reduces risk compared totraditional methods

    Faster cycle time

    Eliminates operatordependencies

    Enables real timemonitoring

    Simplifies validation Allows for longer filling

    campaigns

    Sterile Transfer

    AsepticFilling

    Operation

    e-

    e-

    e-

    e-

    e-

    e-

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    E-Beam Sterilization System

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    Advances in Features Maintains Class A sterile environment from the e-beam

    source on

    Controlled unidirectional HEPA filtered downward airflow

    Straight through transport (versus a labyrinth type

    transport) Conveyor system minimizes particle contamination and

    maintains continuous product control

    Independent, stand alone unit with dedicated PLC

    controls and decontamination system Accessible for maintenance and manual cleaning

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    Containment Challenges

    BYPRODUCTS CREATED FROM ELECTRONSPASSING THROUGH AIR AND MATTER:

    X-RAY RADIATION

    REQUIRES LEAD SHIELDING

    OZONE

    REQUIRES AIR HANDLING

    NITRIC ACID

    REQUIRES CORROSION RESISTANT MATERIALS

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    E-Beam Decontamination

    Tunnelproduction modeSIS

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    E-Beam Decontamination

    Tunneldifferential pressure

    SIS

    -10Pa +25 Pa +30-35 Pa +35 Pa>15 Pa0Pa

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    E-Beam Decontamination

    Tunnelzone concept during

    production SIS

    Class D Class D Class AClass AClass D/A Class A

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    E-Beam Decontamination

    TunnelH2O2

    decontaminationmode

    SIS

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    Current Concerns

    By-product generation - NitricAcid & Ozone

    Effect of by-products onvarious drug products?

    No real time dosemeasurement system

    Effect of environmentalconditions on sterilizationresults

    Other geometries posechallenges to this sterilizetechnique !

    O3

    e-+

    O2

    O3

    O2O2

    ?N2

    NOx

    H2O

    HNO3

    O2

    O3

    e-+

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    Future Sterilization Applications

    TRANSDERMAL / WOUNDDRESSINGS

    BLISTER PACKS FORM FILL SEALPACKAGING

    SYRINGES / SYRINGECOMPONENTS

    VIAL STOPPERS

    VIALS OPHTHALMICS

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