Ethylene Oxide (EO) Sterilisation for Medical Devices

Ensuring Safe and Effective Ethylene Oxide (EO) Sterilisation for Medical Devices

Ethylene Oxide (EO) is widely used for sterilisation of medical devices due to its ability to eliminate microorganisms effectively, comparatively low temperature (routine 55°C) and low chance of changing material properties – unlike radiation.

Our Ethylene Oxide (EO) Validation Services

At Sabre Medical, we offer comprehensive sterilisation validation services tailored to your product requirements and batch sizes. Our expertise ensures compliance with relevant standards, allowing manufacturers to demonstrate the suitability of EO-sterilised products.
Sabre Medical provides a range of sterilisation validation services based on your device specifications. Our services include:

Custom Validation Protocols:

  • Defining products to be sterilised
  • Selecting test devices with appropriate justification
  • Listing relevant industry standards
  • Determining sample size requirements based on regulatory guidelines
  • Establishing acceptance criteria for all sterilisation cycles and testing

Validation Reporting:

  • Detailed record of all sterilisation cycles
  • Test method validations and results for bioburden, sterility/stasis, endotoxin, and EO/ECH residues
  • Documentation of loading configurations
  • Resistance study comparing the device and the Process Challenge Device (PCD)
  • Guidelines for ongoing cycle maintenance

Validated Cycle Specification:

  • Ensuring repeatability and consistency in device sterilisation

Audit Support and Consultation

  • We provide post-validation support and expert consultation to address any questions you may have, ensuring continued guidance even after the process is complete.

Sabre Medical Ethylene Oxide (EO) Sterilisation Compliance and Capabilities

Sabre Medical performs EO sterilisation validations in compliance with ISO 14937 for smaller loads using our in-house sterilisation systems. For larger loads, such as pallet-sized batches, we coordinate with external suppliers to conduct validations in accordance with ISO 11135.
As part of our validation service, we create custom protocols and reports for your device along with performing necessary packaging or processing in our Class 7 Cleanroom and we manage third-party testing as needed.

Typical Cycle parameters

A typical EO cycle consists of the following:

Preconditioning – bringing the load up to the required temperature and humidity in a 55°C, 50%RH oven, this portion of the cycle can take anywhere from 2 to 24 hours depending on the load configuration.
Exposure – the bag with product is placed inside the EO chamber with biological indicators and the gas is activated. Typically, this portion of the cycle is run at 54°C and >30%RH and will take 16 hours.
Internal Aeration – the bags are slit to release the gas and the load is left under temperature until the product is safe to remove from the chamber.
External Aeration/BI incubation – Biological incubators require 48 hours of incubation before the results can be assessed and product can be released to the customer.
While these are our standard parameters for sterilisation, during validation most of these can be modified to meet product requirements (e.g. cycle temperature lowered to prevent battery degradation or changing biological indicators to a short incubation style).

Ethylene Oxide (EO) Sterilisation Validation Process

A typical EO (Ethylene Oxide) validation process includes the following steps and tests: