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There are several common root causes for high levels of residues after exposure to the ethylene oxide sterilization process.
Materials - some materials, such as natural materials like cellulose and cotton, are highly absorbent and will retain gas molecules more than others. Certain types of plastics have also shown a high absorption rate when exposed to EO processing. Packaging - breathable packaging is required for EO processing, allowing gas molecules to pass through. Packaging with a minimal or obstructed breathable surface area, such as a large adhesive label, will not allow the gas to move as freely across the breathable barrier. Load configuration - the volume, density, and overall configuration of the load on a pallet can impact the ability of gas removal after processing.
Fortunately, most residue issues can be addressed by adjusting existing sterilization parameters or considering the following methods when developing new sterilization parameters:
Nitrogen washes - Adding nitrogen after the EO gas has been evacuated from the chamber will dilute the EO in the headspace of the chamber, reducing the residues left behind. Increasing the number of Nitrogen washes and performing them at a deeper vacuum can be beneficial. Added heat - keeping as much heat in the chamber as possible after the sterilization process aids in off-gassing. This can be achieved by increasing the processing temperature set point or adding a moisture conditioning phase after the EO has been removed. Extended aeration - transferring the load into a heated aeration cell after the in-chamber process aids in further off-gassing. The industry average for a typical aeration time is 6 to 24 hours, but some devices may require no heated aeration or a longer period.&nbsp; Load configuration - leaving pathways or "chimneys" throughout each pallet can assist with off-gassing, especially if the load is dense.&nbsp;
For those experiencing residue issues or anticipating challenges with a new device, consulting with a sterilization provider is recommended to discuss minimizing the effects of the ethylene oxide sterilization process. Additionally, test methods for analyzing EO residues will vary depending on the device, so contacting a laboratory service provider to ensure that the correct test methods are employed is beneficial.

The Common Root Causes Of Eo Gas Residue And The Methods Of Residue Reduction

Publish Time：2023-11-01