Technology Comparison

Gamma

Ethylene Oxide

Electron Beam

Process Type

Continuous

Batch

Batch

Continuous

Process Phases

Exposure

Pre-conditioning
Exposure
Aeration

Exposure

Process Description

Radioisotope-generated gamma rays

Humidity, low-temperature, gaseous process

Accelerated electrons

Total Processing Time

Hours: time varies based on dose requirements

Hours: time varies based on product material

Minutes: time varies based on dose requirements

Product Release

Dosimetric

Biological indicators or Parametric release

Dosimetric

Penetration

Complete

Complete

Complete, depending on density, material thickness and product orientation

Material Compatibility

Most materials

Plastics need to be evaluated

Avoid acetyls, Teflon^® and polypropylene

Nearly all materials

Most materials

Plastics need to be evaluated

Avoid acetyls, Teflon and polypropylene

Product Handling

Aluminum carriers/totes with product placed in pre-determined loading pattern

Off-carrier processing

Traditional: pallets are transferred between stages via fork truck or conveyor system

EOExpress^® processing: entire process takes place in the sterilization chamber

Conveyor system: uses trays on rollers for processing of boxes and bulk materials

Reel-to-reel system: designed to process various types of wire, cable, and tubing

Residuals

None

Ethylene oxide and ethylene chlorohydrin

None

Uses

Sterilization, accelerated aging and materials modification

Sterilization

Sterilization, cross linking and materials modification

Maintaining Sterile Claim

Quarterly dose audits

Validation must be performed at least once every two years with traditional processing, and at least once a year when using parametric release

Quarterly dose audits