Ethylene Oxide (EO) sterilisation is a commonly used process in the sterilisation of Medical Devices, and combination medicine-devices. The EO sterilisation process is suitable when the products are sensitive to heat, ruling out any heat sterilisation. Sterility occurs when an EO gas molecule diffuses through the cell wall and cell membrane of microbes, where it reacts with various cellular components, including DNA, RNA, and proteins. The reactive gas molecules cause damage to the DNA, disrupting the cell's ability to replicate and leading to cell death. The gas molecules also disrupt protein function and denature enzymes, which can further inhibit the microorganisms' ability to survive and reproduce. The sterilisation process requires the simultaneous control of four interdependent parameters: gas concentration, temperature, relative humidity, and time of exposure to ensure that the microorganisms are exposed to a lethal dose of gas for a sufficient time, which is necessary for effective sterilisation.
The introduction of a sterilisation process requires thorough planning, attention to detail and pre-validation studies to ensure that the sterilisation process can be implemented with minimum risk of failure.
Submit the form below to access the full SeerPharma White Paper that provides an overview of “points to consider” when developing and validating the Ethylene Oxide Sterilisation process. The points addressed are more relevant when considering an “Overkill” approach.
