Shanghai SUNGO Lab
Hefei SUNGO Lab
Validation and qualification of all common sterilization methods
Sterilization validation is critical to the safety of sterile medical devices. We validate ethylene oxide, radiation and steam sterilization processes, covering process qualification, sterilization residue testing and cleaning and disinfection validation, confirming that the process is effective and that product safety is not compromised.
Sterilization of health-care products - Ethylene oxide
Sterilization of health care products - Radiation
Sterilization of health care products - Moist heat
Cleaning validation of health care products
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Biological evaluation of medical devices - Ethylene oxide sterilization residuals
Dose setting, dose audit and dose distribution validation
Half-cycle and fractional-positive sterilization qualification
Ethylene oxide residue determination by gas chromatography
Heat distribution, heat penetration and biological indicator challenge
Spore survival / kill studies to verify sterilization effectiveness
Cleaning effectiveness qualification and residue testing for reusable devices