Preconditioning
Establishing the required environmental conditions before ETO exposure.
ETO Sterilisation
Cleanse.
Protect.
A controlled low-temperature sterilisation pathway for suitable heat-sensitive medical products and materials.
01
Low-Temperature Sterilisation
A Process for Suitable
Heat-Sensitive Products
Ethylene oxide sterilisation uses ETO gas to address microorganisms, including spores and viruses, through a controlled sterilisation cycle.
Because the process does not rely on the high temperatures associated with some other sterilisation methods, it can be suitable for selected medical products and materials that require a lower-temperature approach, including certain plastic and rubber components.
ETO sterilisation depends on controlled conditions, defined exposure and thorough aeration before products proceed onward.
02
The ETO Cycle
Three Connected
Process Phases
The exact cycle depends on the medical product and approved process requirements. Each phase has a distinct role in the complete sterilisation pathway.
Sterilisation
Exposing the product to the sterilising agent under defined process conditions.
Aeration
Removing remaining gas and allowing absorbed ETO to dissipate from the product.
Controlled cycle / Product safetyProduct-Specific Planning
Sterilisation Considered as Part of Manufacturing
Product materials, packaging, configuration and intended process must be considered together when preparing a suitable sterilisation pathway.
- 01
Product Review
Understanding materials, construction and packaging.
- 02
Process Preparation
Organizing the load and approved cycle requirements.
- 03
Cycle Control
Managing the defined preconditioning, exposure and aeration phases.
- 04
Documentation
Maintaining relevant process and quality records.
Process Considerations
Protecting Products That Require a Lower-Temperature Approach
Material compatibilityProduct configurationPackaging suitabilityDefined cycle conditionsThorough aerationProcess documentation
Plan Sterilisation Early
Connect Product Design, Packaging,
and Sterilisation Requirements
Ask about GMI sterilisation processes and product compatibility.