|#||Ethylene Oxide||Gamma||Electron Beam||X-ray|
|Methodology||Penetration of sterilant gas into packaged product||Irradiation of product using photons from radioisotope||Product sterilized using ionizing energy from electron beam||Products sterilized using ionizing energy from Rhodotron electron beam|
|Efficacy||Process efficacy confirmed by biological indicators and/or process monitoring||Process parameters confirmed by dosimetry||Process parameters confirmed by dosimetry||Process parameters confirmed by dosimetry|
|Penetration||Requires gas permeable packaging and product design||Good penetration complete even at high densities (> 0.4 gm/cc)||Efficient penetration at bulk densities between 0.05 – 0.30 gm/cc||Excellent penetration for all product types|
|Material Compatibility||Requires gas permeable packaging and product design||Good penetration complete even at high densities (> 0.4 gm/cc)||Efficient penetration at bulk densities between 0.05 – 0.30 gm/cc||Excellent penetration for all product types|
|Turnaround Time||Days: Conventional = 9-10 days. EOExpress® = one day||Hours: time varies based on dose requirements||Minutes: time varies based on dose requirements||Hours: time varies based on dose requirements|
|Process||Complex process: Variables include exposure time, temperature, humidity and EO concentration Non-process variables impacting lethality include load density, packaging, and winter shipping conditions.||Simple process: Variables include time in the cell and isotope load||Complex process: Variables include scan height, processing speed, number of passes, and orientation to the beam||Moderately complex process: Variables include processing speed, number of passes and number of pallets on conveyor|
|Product Handling||Traditional processing: pallets are transferred between stages via fork truck or conveyor system EOExpress® processing: entire process takes place in the sterilization chamber||Aluminum totes/pallets with product placed in pre-determined loading pattern||Aluminum carriers with product placed in pre-determined loading pattern, or boxes placed directly onto conveyor||Products processed via pallets, in predetermined loading pattern|
Ethylene Oxide Master File Pilot Program FAQ
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Study on the Impact of EO Concentration on Product Residuals
A study was carried out to compare the impact, if any, of EO concentration on product EO residual levels determined in accordance with ISO10993-7.