Single-use devices that cannot tolerate heat or radiation are typically sterilised with ethylene oxide gas — a slower, more closely monitored process than autoclaving, run in sealed chambers with a defined dwell time, aeration period and biological indicator check.
Because our EO line sits on the same premises as assembly and packing, a batch does not leave the building and wait in a queue at a third-party steriliser. That single change is usually the difference between a two-week lead time and a five-week one.
Every cycle is logged against the batch number, along with the biological indicator result, before the batch is released for dispatch.