Most national and international standards regarding bioburden, sterilization, or environmental testing refer to establishing alert and action levels to assist in demonstrating continued control over a … [Read more...] about Establishing Bioburden Alert and Action Levels
Nelson Labs
Current Regulatory Landscape for EO Residue Levels in Medical Devices
One of many crucial steps a single-use medical device takes on its journey from concept to commercial product is sterilization. Ethylene oxide gas sterilization, in particular, is one of the most … [Read more...] about Current Regulatory Landscape for EO Residue Levels in Medical Devices
Current Regulatory Landscape for EO Residue Levels in Medical Devices
One of many crucial steps a single-use medical device takes on its journey from concept to commercial product is sterilization. Ethylene oxide gas sterilization, in particular, is one of the most … [Read more...] about Current Regulatory Landscape for EO Residue Levels in Medical Devices