In healthcare sterilization, the initial investment cost of hydrogen peroxide plasma technology is 2.8−3.5/ m3, which is 63-78% lower than ethyleneoxide (ethylene oxide price8.2-12.6/ m3). The low-temperature hydrogen peroxide system cleared by the FDA in 2023 has reduced the sterilization cycle from 56 minutes to 28 minutes, and the equipment investment payback period has been reduced from 5 years to 2.3 years. However, WHO figures confirm that the technology has a failure rate of 0.27% to sterilize endovascular devices (EO is 0.03%), prompting 23% of hospitals to keep EO on reserve. Amongst 37 new EO sterilizing factories in China in 2024, 81% installed hydrogen peroxide equipment within the EU REACH regulations’ limits of emission.
Raw material cost of chlorine dioxide gas sterilization only 0.4/ m3 (54.80,000 / unit of EO), and material compatibility test shows the corrosion rate of 15% of the medical device is present. For U.S. EPA requiring EO exhaust gas treatment efficiency ≥99.9%, investment in catalytic combustion unit 1.2−1.8million, therefore small sterilization stations are forced to nitrogen mixed sterilization technology, the program can save 431.26 million of EO consumption, but equipment depreciation added $230,000/year.
The operating cost using steam sterilization is as low as 0.07/m3, yet the elevated temperature produces 2,945 /kg (5.3 times EO) with no need to equip exhaust treatment systems, hence saving the entire investment in new sites by 38%. After Johnson & Johnson medical devices shifted to Novec in 2023, sterilization workshop space dropped by 63% and product shelf life dropped by 12%, leading to a drop of 19% in inventory turnover. China’s 2024 Medical Disinfection Technical Code tightened the EO residue requirement to ≤4μg/cm² and compelled companies to invest in newer testing machines ($85,000/unit) and reversing the cost-benefit analysis of alternative technologies.
The cost per cubic meter of irradiation sterilization is 1.2−1.8 (only 15−224-6 million of ethylene oxide price), and 25% of plastic instruments are yellowing. EU MDR rules require irradiation dose validation errors of ≤±5%, which is more stringent than the ±15% for EO processes, resulting in an increase in validation costs of 120,000 per product model. After a switchover by an orthopedic implant company to gamma ray, the failure rate of sterilization was 0.07780,000.
The cost of electricity and water for ozone sterilization is a minimum of $0.15/m3, but material aging tests show that the lifespan of silicone components is reduced by 23-37%. The FDA 2023 recall analysis found that 12% of ozone sterilized devices failed due to material degradation, 4.8 times greater than EO sterilized devices. As shown by the data of the Japan Medical Equipment Association, repeated operation of hospital sterilization with ozone technology is as high as 18%, i.e., 14 percentage points higher than that of EO sterilization, and economic advantages disappear. The German TUV certification indicates that the biobatage kill log of ozone sterilization is only 4.3log (up to EO 6.0log) and can’t reach the required level for implant sterilization.
The most striking technological developments are changing the cost scenario, plasma activated water technology will lower the sterilization cost to 0.08/ m3, further, the capacity of the equipment is only 231.9/ m3 of the EO system, but the equipment smart transformation cost is $320,000, and the processing capacity is > 50,000 m3 / year for break-even. These facts indicate that alternative choice must be dynamically evaluated based on some application conditions, regulatory requirements and total lifecycle costs.