Sterilization Parameters: ozone
Sterilization process parameters for medical devices, pharmaceutical equipment, and healthcare facilities. Covers ethylene oxide (EtO standard/low-temp/hospital cartridge), gamma irradiation (VDmax15, VDmax25, substantiation 25 kGy, high dose 35 kGy), electron beam, X-ray, steam autoclave (gravity 121°C, prevacuum 134°C, liquid cycle, terminal, flash, prion), hydrogen peroxide plasma/vapor (VPHP, VHP, accelerated), dry heat (150°C/170°C/HVHA), low-temperature steam formaldehyde (LTSF), ozone, UV-C, and cold plasma. Parameters include temperature, exposure time, radiation dose, gas concentration, relative humidity, sterility assurance level (SAL), material compatibility, and validation standard references.
| sterilization method | process variant | cycle pressure condition | exposure time max min (min) | exposure time min min (min) | exposure time typical min (min) | material compatibility notes | method description | notes | temperature max C (°C) | temperature min C (°C) | temperature typical C (°C) | validation standard |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ozone | ozone_sterilization | 6-log | 180 | 60 | 120 | sub-atmospheric | Ozone gas sterilization (aqueous-phase and gaseous) for heat-sensitive devices | FDA 510(k) K040312 cleared (TSO3 SciCan Trios) | 30 | 4 | 20 | Compatible with stainless steel, titanium, most plastics; incompatible with silicone rubber, natural rubber, some adhesives; no toxic residuals — breaks down to O2; limited penetration into lumens |
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