Electron Beam Sterilization

Presented by

John Newman & Nicole Coons

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

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

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

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

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

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

TYPICAL EMITTER OR GUN

Accelerator Hermetically Sealed Vacuum Chamber Acceleration Zone Filament
electron cloud

Cu Faceplate

Atmosphere

Ti Foil Window

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

Typical Emitter Configurations

Opposing to create uniform spatial treatment

Stacked to address wider applications

Opposing to treat both sides of web in-line

Arrayed to treat 3-dimensional products

Sterilization / Aseptic Processing

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

Sterilization
Aseptic Manufacturing

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

Product

Packaging
Sterile Transfer

Aseptic Environment

Sterile Product

E-Beam Sterilization & Syringe Tub Transfer into Filling Isolator

E-Beam Tunnel Tubs in Section1 Emitter Section2 Pealing

Isolator System Filling and Closing Tubs out

Advantages of E-Beam Sterilization

Key Advantages

Reduces risk compared to traditional methods Faster cycle time Eliminates operator dependencies Enables real time monitoring Simplifies validation Allows for longer filling campaigns

Sterile Transfer

e-

e-

ee-

ee-

Aseptic Filling Operation

E-Beam Sterilization System

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

Containment Challenges

BYPRODUCTS CREATED FROM ELECTRONS PASSING THROUGH AIR AND MATTER:

X-RAY

RADIATION

REQUIRES LEAD SHIELDING REQUIRES AIR HANDLING

OZONE

NITRIC

ACID

REQUIRES CORROSION RESISTANT MATERIALS

E-Beam Decontamination Tunnel

production mode
SIS

E-Beam Decontamination Tunnel

differential pressure
SIS

0Pa

-10Pa

>15 Pa

+25 Pa

+30-35 Pa

+35 Pa

E-Beam Decontamination Tunnel

zone concept during production
SIS

Class D

Class D

Class D/A

Class A

Class A

Class A

E-Beam Decontamination Tunnel

H2O2 decontamination mode
SIS

Current Concerns
N2

O2

H2O

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

O2 O2

NOx O2

O3

?
+ eHNO3

O3

e-

O3

Future Sterilization Applications

SYRINGES / SYRINGE COMPONENTS VIALS OPHTHALMICS

TRANSDERMAL / WOUND DRESSINGS

BLISTER PACKS

FORM FILL SEAL PACKAGING

VIAL STOPPERS

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 inline sterilization

Questions & Answers