Sterilization Parameters: plasma_low_temp
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| plasma_low_temp | argon_plasma | >4_log | 60 | 10 | 30 | atmospheric_low-pressure_plasma | Plasma-based cold sterilization — emerging low-temperature plasma methods (research/limited commercial) | Research phase; FDA has not cleared as sterilization modality | 35 | 20 | 20 | Research stage; applications for temperature-sensitive devices and combination products; generates reactive species (ROS, RNS); material compatibility under investigation |
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