p34 e beam powerpoint

7/31/2019 P34 e Beam Powerpoint

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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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Tunneldifferential pressure

SIS

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


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Tunnelzone concept during

production SIS

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


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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
http://images.google.com/imgres?imgurl=http://img.alibaba.com/photo/51217159/Injections_Vial_Stoppers.summ.jpg&imgrefurl=http://www.alibaba.com/showroom/Butyl_Rubber_Stopper.html&h=100&w=100&sz=3&hl=en&start=13&tbnid=vVxdcYKXV9A0aM:&tbnh=82&tbnw=82&prev=/images%3Fq%3Dvial%2Bstoppers%26hl%3Den%26rls%3DGGLG,GGLG:2005-46,GGLG:enhttp://images.google.com/imgres?imgurl=http://www.tecmedica.com.br/osc/images/358%2520%2520Curativo%2520Duoderm%2520Borda%2520Quadrada%2520CONVATEC%2520922.jpg&imgrefurl=http://www.tecmedica.com.br/osc/product_info.php%3Fproducts_id%3D1408%26osCsid%3Da51c711c4fe9be0939eec07923711d6d&h=480&w=400&sz=46&hl=en&start=21&tbnid=1mVfVHn5UCuh4M:&tbnh=129&tbnw=108&prev=/images%3Fq%3DDUODERM%26start%3D20%26ndsp%3D20%26hl%3Den%26rls%3DGGLG,GGLG:2005-46,GGLG:en%26sa%3DNhttp://images.google.com/imgres?imgurl=http://www.51greenco.com/products/08_eye_drop_Bottles/06_PE_Eye_Drop_Bottles.jpg&imgrefurl=http://www.51greenco.com/products/08_eye_drop_Bottles/eye_drop_Bottles.html&h=443&w=591&sz=43&hl=en&start=3&tbnid=jyKN1q3i_NFSxM:&tbnh=101&tbnw=135&prev=/images%3Fq%3DEYE%2BDROP%2BBOTTLE%26hl%3Den%26rls%3DGGLG,GGLG:2005-46,GGLG:enhttp://images.google.com/imgres?imgurl=http://www.olivermedical.com/images/Rollstock.jpg&imgrefurl=http://www.olivermedical.com/rollstock.php&h=260&w=259&sz=36&hl=en&start=13&tbnid=wuK9i7MeG__WiM:&tbnh=112&tbnw=112&prev=/images%3Fq%3DFORM%2BFILL%2BSEAL%2BMATERIAL%26hl%3Den%26rls%3DGGLG,GGLG:2005-46,GGLG:enhttp://images.google.com/imgres?imgurl=http://images.jupiterimages.com/common/detail/02/91/22189102.jpg&imgrefurl=http://www.jupiterimages.com/itemDetail.aspx%3FitemID%3D22189102&h=232&w=250&sz=10&hl=en&start=3&tbnid=SVZAw6T2TBDgYM:&tbnh=103&tbnw=111&prev=/images%3Fq%3DBLISTER%2BPACK%26hl%3Den%26rls%3DGGLG,GGLG:2005-46,GGLG:enhttp://images.google.com/imgres?imgurl=http://www.germes-online.com/direct/dbimage/50043021/Tubular_Glass_Vial_for_Pharmaceutical_Packaging.jpg&imgrefurl=http://www.germes-online.com/catalog/54/1085/229769/sell_tubular_injection_vials.html&h=360&w=360&sz=10&hl=en&start=9&tbnid=L05K2HWfNhUnHM:&tbnh=121&tbnw=121&prev=/images%3Fq%3DVIALS%26hl%3Den%26rls%3DGGLG,GGLG:2005-46,GGLG:enhttp://images.google.com/imgres?imgurl=http://www.global-b2b-network.com/direct/dbimage/50316493/Sterile_3_Piece_Syringe_For_Single_Use.jpg&imgrefurl=http://www.global-b2b-network.com/b2b/41/939/page12/&h=360&w=360&sz=19&hl=en&start=154&tbnid=y5hq1ayPdSF54M:&tbnh=121&tbnw=121&prev=/images%3Fq%3DSYRINGE%26start%3D140%26ndsp%3D20%26hl%3Den%26rls%3DGGLG,GGLG:2005-46,GGLG:en%26sa%3DN


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Summary

Advances in E-Beam Technology allow forinnovative application of ionizing energy

Offers significant advantages over traditionalsterilization processes

Fast - Delivers sterilizing dose in milliseconds

Highly Effective - Lowers risk

Fewer process variables to validate and control

Real time monitoring of critical emitter conditions

Can be used to facilitate both sterile transfer and in-line sterilization


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Questions &

Answers

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