Noxilizer Inc.06.02.16
Noxilizer, Inc., a company advancing the NO2-based sterilization process for pharmaceutical, biotech and medical device manufacturers, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a medical device terminally sterilized using its nitrogen dioxide sterilization process.
"Receiving a, FDA clearance marks a pivotal milestone for Noxilizer," said Lawrence Bruder, Noxilizer CEO. "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."
Watch the video below to learn more about Noxilizer's NO2-based sterilization process:
Nitrogen dioxide gas sterilization is unique because it sterilizes at ultra-low temperature (10 degrees to 30 degrees Celsius) and functions with or without vacuum and humidity, according to Noxilizer. Such factors are important for the growing number of biotech drugs and temperature-sensitive medical devices being released to market. Noxilizer’s nitrogen dioxide sterilization also allows companies to safely bring sterilization back in house, greatly reducing process time, leading to turnaround times of two to three days and operational cost savings of 50 percent or more.
"The FDA spent considerable time and due diligence evaluating the nitrogen dioxide sterilization process, mechanism of action and validation approach," added Bruder. "Based on work already underway, Noxilizer is very excited that this approval is the first of many more."
With this clearance, Noxilizer has established a pathway to 510(k) approvals for nitrogen dioxide sterilized devices in the industrial medical device market.
Noxilizer Inc. provides an ultra-low temperature nitrogen dioxide process that offers many benefits over traditional sterilization methods. Noxilizer sells sterilization and biodecontamination equipment to pharmaceutical, biotech and medical device manufacturers and also offers contract sterilization services at its Baltimore, Md., facilities. The company has offices in the United States, United Kingdom and Japan.
"Receiving a, FDA clearance marks a pivotal milestone for Noxilizer," said Lawrence Bruder, Noxilizer CEO. "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."
Watch the video below to learn more about Noxilizer's NO2-based sterilization process:
Nitrogen dioxide gas sterilization is unique because it sterilizes at ultra-low temperature (10 degrees to 30 degrees Celsius) and functions with or without vacuum and humidity, according to Noxilizer. Such factors are important for the growing number of biotech drugs and temperature-sensitive medical devices being released to market. Noxilizer’s nitrogen dioxide sterilization also allows companies to safely bring sterilization back in house, greatly reducing process time, leading to turnaround times of two to three days and operational cost savings of 50 percent or more.
"The FDA spent considerable time and due diligence evaluating the nitrogen dioxide sterilization process, mechanism of action and validation approach," added Bruder. "Based on work already underway, Noxilizer is very excited that this approval is the first of many more."
With this clearance, Noxilizer has established a pathway to 510(k) approvals for nitrogen dioxide sterilized devices in the industrial medical device market.
Noxilizer Inc. provides an ultra-low temperature nitrogen dioxide process that offers many benefits over traditional sterilization methods. Noxilizer sells sterilization and biodecontamination equipment to pharmaceutical, biotech and medical device manufacturers and also offers contract sterilization services at its Baltimore, Md., facilities. The company has offices in the United States, United Kingdom and Japan.