The next phase of EtO replacement will not be won by technology selection alone. It will be won by those capable of industrializing complex sterilization processes.
In a previous article, “Reshaping the future of sterilization”, we explored the progressive shift from Ethylene Oxide EtO sterilization toward alternative sterilization technologies, with particular focus on the rise of vaporized hydrogen peroxide as a credible pathway for medical device sterilization.
That discussion was about transition. This one looks at complexity: the factor that determines whether this sterilization modality can be translated into a validated industrial process.
Because the challenge is no longer only identifying an alternative to EtO. It is understanding how sterilization processes behave when they interact with sensitive materials, intricate geometries, multilayer packaging and configurations that cannot be reduced to a standard condition.
Moving beyond EtO shifts the focus from technology selection to process governance. The challenge is not selecting a sterilant, but it is governing how that sterilant behaves across complex devices.
Manual ATMP manufacturing can be controlled at limited scale. But as demand grows, its fragility becomes structural.
It begins with operator-dependent steps and repeated transfers, where consistency relies on human execution across a process that must remain tightly controlled.
The applications presented throughout this article show how complexity changes the way sterilization processes must be developed, verified and transferred to production.
Only under these conditions, the ability to experimentally develop and industrialize sterilization processes becomes the determining factor in achieving reliable and reproducible performance.