p34 e beam powerpoint
TRANSCRIPT
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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
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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
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