Sterilization Parameters: gamma_irradiation
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 | SAL | cycle pressure condition | dose kGy max (kGy) | dose kGy min (kGy) | dose kGy typical (kGy) | material compatibility notes | method description | notes | validation standard |
|---|---|---|---|---|---|---|---|---|---|---|
| gamma_irradiation | high_dose_35kGy | 1e-6 | ambient | 50 | 25 | 35 | Used when bioburden is elevated or material can tolerate higher dose; maximum radiation tolerance must be validated; 35 kGy commonly used for xenograft tissues and drug products | Gamma radiation — high dose (35 kGy) for high-bioburden products or maximum assurance | For tissue allografts per AATB guidelines; 25-50 kGy used for tissue banks; higher doses may compromise biomechanical properties of collagen-based allografts; tissue bank-specific validation required | ISO 11137-2:2013 |
| gamma_irradiation | substantiation_25kGy | 1e-6 | ambient | 35 | 25 | 25 | Conservative approach; 25 kGy applied without bioburden-based reduction; commonly used for custom/low-volume devices | 25 kGy substantiation method — dose verification without full VDmax bioburden characterization | Simpler validation than VDmax; no bioburden monitoring required; may be over-killing for low-bioburden products; suitable for drug-device combinations | ISO 11137-2:2013 Method 1 |
| gamma_irradiation | vdmax15 | 1e-6 | ambient | 25 | 10 | 15 | Lower dose for products with very low bioburden; must verify with quarterly bioburden testing; used for single-use devices with controlled bioburden | Gamma radiation sterilization — VDmax15 method; minimum dose 15 kGy for lower bioburden devices | Dose audit every quarter; VDmax15 applicable only if average bioburden ≤0.4 CFU per device; dose verification by dosimetry per ISO 11137-3 | ISO 11137-2:2013 |
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