Noxilizer announces FDA 510(k) clearance of medical device sterilised using nitrogen dioxide
Accelerating the firm's pharmaceutical, biotech and medical device submissions globally
Noxilizer, a Baltimore, MD, US-based firm advancing an NO2-based sterilisation process for pharmaceutical, biotech and medical device manufacturers, has received a 510(k) clearance from the US Food and Drug Administration (FDA) for a medical device terminally sterilised using Noxilizer’s nitrogen dioxide sterilisation process.
The firm says receiving this clearance is a 'pivotal milestone'.
Lawrence Bruder, CEO of Noxilizer, said: 'This clearance confirms that nitrogen dioxide sterilisation is another option for companies – especially for those products, such as pre-filled syringes, drug delivery systems and medical devices – that face challenges with ethylene oxide, gamma radiation or other conventional sterilisation methods.'
Noxilizer says nitrogen dioxide gas sterilisation is unique because it sterilises at ultra-low temperature (10–30°C) and functions with or without vacuum and humidity, which are important factors for the growing number of biotech drugs and temperature-sensitive medical devices.
The firm’s nitrogen dioxide sterilisation also allows companies to safely bring sterilisation back in house and reduce process time, leading to turnaround times of 2–3 days and operational cost savings of 50% or more.
