Noxilizer has developed a sterilization process based on nitrogen dioxide, NO2. This proprietary sterilization technology has application in two large market segments: life science manufacturing and hospital reprocessing.

Noxilizer Technology for Life Science Manufacturing

In the life science manufacturing market, the development of next-generation medical devices, drug-device combination products, bioresorbable implants and collagen scaffolds is constrained by current sterilization technologies. Ethylene oxide and radiation sterilizers all leave excessive sterilant residuals or destroy the chemical, biologic and mechanical properties of products.

Today, Noxilizer provides contract sterilization services to companies that are developing and marketing these next generation products. The demonstrated advantages of the Noxilizer technology used in industrial applications include:

• Better penetration into complex medical devices;
• No aeration time required leading to improved efficiency;
  
• Proven material compatibility with therapeutic molecules and biomaterials;
  
  
• Wide range of cycle parameters permitting optimization of sterilization process for specific products (cycles can be designed without humidity and vacuum); and,
  
• No cytotoxic residues after sterilization cycle.
  
  

To use the Noxilizer technology in the development or manufacturing of your medical device is no different than using other sterilization processes. Noxilizer would complete the required testing and supply that unique data to the device manufacturer for their regulatory submission. In addition, Noxilizer will maintain the Device Master File for our sterilization systems at the FDA.

Noxilizer operates in accordance with the GMPs (21CFR820) and is capable of conducting GLP (21CFR58) studies.

To read more about the Noxilizer technology, please refer to the following two peer-reviewed journal publications:

Link to Biomedical Materials
Link to MD&DI

Noxilizer Technology for Hospitals

In the hospital sterilizer market, today’s low temperature or gas sterilization technologies are inadequate. Noxilizer has developed a method that may result in a commercial product that can rapidly, reliably, and safely sterilize reusable medical devices in the hospital central sterilization department.

The key advantages that Noxilizer is targeting are:

• Lethal sterilization of rigid endoscopes and flexible lumens with significant penetration into lumens or hollow channels;
• Effective, yet gentle sterilization across a broad range of materials used in reusable diagnostic and surgical instruments;
  
• No cytotoxic residues reducing the potential for worker injuries (skin burns); and
  
• Short overall sterilization cycle time leading to increased efficiency and improved turnaround time between procedures.

Over the last year, Noxilizer has optimized the process of sterilization using nitrogen dioxide as the gas sterilant. Below is a picture of our first potential commercial unit.

Disclaimer: Noxilizer does not have regulatory clearance to sell units in the hospital market in the United States or any other market. The company is engaged in development only and will submit for regulatory approval in the next 12 – 15 months.