The Baltimore, Md.-based company touts NO2 sterilization as “unique” as it sterilizes at low temperatures, between 10-30°C, and functions without a vacuum or humidity. Noxilizer says those aspects of the NO2 based sterilization make it ideal for temperature sensitive medical devices and biotech drugs.
“Receiving a FDA clearance marks a pivotal milestone for Noxilizer. This clearance confirms that nitrogen dioxide sterilization is another option for companies – especially for those products, like prefilled syringes, drug-delivery systems and medical devices — that face challenges with ethylene oxide, gamma radiation or other conventional sterilization methods,” CEO Lawrence Bruder said in prepared remarks.
The FDA clearance establishes a pathway to 510(k) approvals for other devices sterilized by NO2, the company said.
“The FDA spent considerable time and due diligence evaluating the nitrogen dioxide sterilization process, mechanism of action and validation approach. Based on work already underway, Noxilizer is very excited that this approval is the first of many more,” Bruder said in a press release.