Electron Beam Sterilization

1. Electron Beam Sterilization Presented by John Newman & Nicole Coons

3. E-Beam Technology Electron Beams � aka Cathode Gun, Electron Gun, or Electron Accelerator Made up of electrodes � cathodes (negative electrodes) and anodes (positive electrodes) sealed in a vacuum chamber Electrons are generated when cathode is heated (by passing current thru cathode) Electrons are accelerated by an electric field and moved out of the vacuum chamber The Electron Beam (or E-Beam) becomes source of ionizing energy that can be used for multiple applications

4. E-Beam Technology E-Beams are either classified as high or low voltage High voltage accelerators achieve an average range of 0.5 � 10 MeV Low voltage accelerators achieve up to 0.3 MeV (300 KeV) Most electron beam installations worldwide are high voltage systems

5. 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

6. 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 to keep them running Require really large facilities to house equipment Result � very difficult and EXPENSIVE to integrate into a manufacturing process

7. E-Beam Technology Development of new compact e-beam guns (low energy) has allowed this efficient and clean energy source to be used in a wide range of industrial applications

8. TYPICAL EMITTER OR �GUN� Keep clicking to work through the basic operation theory Last clip produces the �lines� of electronsKeep clicking to work through the basic operation theory Last clip produces the �lines� of electrons

9. 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-linking polymer composites to improve thermal, mechanical, and chemical resistance properties Material degradation and recycling of materials Sterilization E-Beam processing breaks DNA chains leading to cell death; effective method for destroying all types of pathogens � viruses, fungi, bacteria, parasites, spores, molds

11. Sterilization / Aseptic Processing Aseptic � free of microbiological organisms / contaminants; maintains sterility Many drugs (such as vaccinations and bio-pharmaceuticals) require aseptic processing versus terminal sterilization All components (packaging, syringes, drug, etc.) MUST be sterile before entering the aseptic environment

12. Sterilization Traditional methods require batch processing and rapid transfer stations or Class A clean rooms to maintain product sterility before transferring into filling isolator Low energy e-beams allow surface sterilization of materials before entering the sterile environment; continuous feed processes

14. Advantages of E-Beam Sterilization

15. E-Beam Sterilization System

16. 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

17. Containment Challenges BYPRODUCTS CREATED FROM ELECTRONS PASSING THROUGH AIR AND MATTER: X-RAY RADIATION REQUIRES LEAD SHIELDING OZONE REQUIRES AIR HANDLING NITRIC ACID REQUIRES CORROSION RESISTANT MATERIALS

22. Current Concerns By-product generation - Nitric Acid & Ozone Effect of by-products on various drug products? No real time dose measurement system Effect of environmental conditions on sterilization results Other geometries pose challenges to this sterilize technique

23. Future Sterilization Applications

24. Summary Advances in E-Beam Technology allow for innovative application of ionizing energy Offers significant advantages over traditional sterilization 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

25. Questions & Answers