Sterilization Parameters: formaldehyde
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| formaldehyde | low_temperature_steam | 1e-6 | 180 | 60 | 120 | sub-atmospheric_100-200_mbar | Low-temperature steam and formaldehyde (LTSF) sterilization — European hospital setting | EU MDR 2017/745; EN 14180 | 80 | 73 | 73 | Used in Europe for heat-sensitive devices; limited use in US; better material compatibility than EtO; toxic gas — requires validated aeration; not used for liquids |
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