Implementation of the ETO Sterilization Process
Eto Sterilization is conducted using a eto sterilizer located in a dedicated facility. Outside the sterilization room, control equipment regulates the process according to established parameters and requirements.
Composition of Agents Used in the ETO Sterilization Process
The agents employed in sterilization consist of either pure ethylene oxide or mixtures of carbon dioxide and nitrogen.
Precautionary Measures for Ethylene Oxide
Ethylene oxide (EO) gas must be handled, stored, and used with extreme caution due to its highly toxic nature, flammability, and explosion risk at concentrations as low as 2.6% in air.
Steps Involved in the Sterilization Process
The eto sterilization process comprises two critical steps:
Preconditioning
Preconditioning involves achieving the necessary humidity and temperature levels prior to introducing the load into the chamber, ensuring effective sterilization unaffected by internal environmental factors.
Sterilization Cycle
The EO sterilization process includes the following elements:
Influence of Load Chamber
The configuration of the load within the chamber affects:
- Heat distribution patterns
- Humidity levels
- EO gas penetration
- EO gas removal
Design of Load Configuration
The load configuration should be designed to facilitate the sterilization process by:
- Removing air
- Aiding heat penetration
- Eliminating humidity
- Ensuring EO removal during and after the process
Process Characterization & Safe Delivery of Sterilization Processes
Process characterization defines the range of variables required by ISO 11135 and identifies four key process variables, which must be documented at every stage of the sterilization process:
Phase
Covers variables associated with each phase of the process.Pre-conditioning
Involves time, temperature, humidity, and transfer time.Sterilization Cycle
Includes exposure time, temperature, humidity, EO concentration, and pressure.Aeration
Pertains to time and temperature during the aeration or gassing phase.