|#||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|
Radiation Verification Dose Transfer
Industrial radiation facilities are designed to achieve a dose uniformity inside a process load between the sterilization (minimum) dose and the maximal acceptable dose established during the validation process. To demonstrate continued effectiveness o
Radiation Dose Setting: Single Lot vs. Full Validation of Minimum Sterilization Dose
This TechTip will explain the differences between single lot validations and full validations of minimum sterilization dose, and outline the advantages and disadvantages of each of these approaches to dose setting.
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.