NO2 - Room Temperature Sterilization




The Noxilizer NOX FLEX Rapid Biodecontamination System is designed to decontaminate a wide range of equipment used in bio-pharmaceutical manufacturing.
It is a flexible, modular system, allowing confguration to meet a wide range of decontamination needs.
Designed to be integrated with isolators, lock-chambers or other sealed enclosures, the primary advantage of the system is the rapid process time compared with other chemical sterilants such as hydrogen peroxide vapor (HPV).
A secondary advantage, benefcial in some applications, is that the chemical sterilant employed, nitrogen dioxide (NO2).

Key Features
- Sterilant is a true gas, not a vapor allows rapid aeration to very low (ppb) levels, needed when handling chemically-sensitive materials
- Unique "On-Demand" technology generates nitrogen dioxide as needed, eliminating the need to deliver, store and manage sterilant on site
- Benchmark comparison: for isolator decontamination with identical lethality and process conditions, NO2 has a process time ~50% of HPV
- Example for NO2: 1 cu.m isolator, aeration to 1ppm, 45 minutes total process time (TPT), aeration to 0.1ppm (=100ppb), TPT approximately 60 minutes
- Example for NO2: Typical process time for lock-chamber decontamination <15 minutes
- Scalable to accommodate enclosures up to 10 cu.m. (350 cu.ft.)
- Generator module may be installed remote from equipment (e.g. 50m)
- Aeration by ventilation via scrubber (abator) module
- Gas concentration sensors for real-time process monitoring and safety
- User-friendly color touchscreen HMI

Advantages of NO2 Technology

- Room temperature process
- Safe and simple to use
- Faster process times compared with other methods
- Effective at low humidity levels: allows decontamination in moisture-sensitive environments
- Compatible with a broad variety of materials including all common materials of construction of isolators and lockchambers
- Low residuals: typically not measurable
- ideal when manipulating chemicallysensitive materials
Noxilizer has developed a room temperature nitrogen dioxide sterilization and decontamination technology that addresses many of the challenges associated with traditional methods of sterilization.
Only NO2 technology offers all the following benefits:

- Effective, room temperature sterilization and decontamination process
- Sterilization with or without vacuum, with humidification or limited humidification
- Faster processing time (no preconditioning)
- Maintenance of material properties for heat-sensitive products
- Flexible cycles for materials compatibility
- Safe and simple alternative to use in-house

NO2 is Rapid and Effective
NO2 is effective against a wide range of microorganisms. The primary mechanism of lethality is the degradation of DNA. Late outgrowth studies have shown no repair mechanisms for the DNA degradation.
White Paper: "Overview of Nitrogen Dioxide Sterilization Process," June 2012.

Data just-released demonstrates the effectiveness of NO2 as a sterilant with a reduction in endotoxins on temperature-sensitive prefilled, polymer syringes.
Testing has also been completed to demonstrate the decontamination and depyrogenation of a Weiler Engineering ASEP-TECH® BFS System with NO2. The results indicate this process offers: enhanced decontamination and depyrogenation capability with the increased safety of an automated process with no human intervention in the filling zone that can be easily validated.

NO2 Penetrates Complex Geometries
The boiling point of NO2 is relatively low, at 21°C, and Noxilizer employs sterilant concentrations that are well below the vapor pressure of NO2. The NO2 gas will not condense on devices, or as it travels down long lumens or into other complex geometries. Therefore, NO2 gas can sterilize medical devices with complex geometries. The video above demonstrates sterilization in a long lumen.

White Paper: "NO2 vs H 2O2 Lumen Testing Summary," August 2012.

Aerates Rapidly - Minutes vs. Days
Low boiling point, coupled with the low NO2 sterilant concentrations, translates into rapid aeration of the sterilization chamber and exposed products.
NO2 does not permeate materials to the same degree as other methods, greatly reducing the overall cycle time of the sterilization process and eliminating the lengthy post-sterilization aeration. This benefit applies to terminal sterilization using a batch process or high level decontamination in isolators.

Leaves Low Residue Levels - Non-carcinogenic, non-cytotoxic and non-teratogenic
The rapid aeration process results in fewer residues on product and packaging. Noxilizer's sterilant residues are non-carcinogenic, non-cytotoxic and non-teratogenic. Sterilized packages may be handled immediately after the cycle.

Key advantages over all other sterilization methods:

- Ambient cycle for vacuum-sensitive products
- Operates even at very low humidity for moisture-sensitive materials

Compatible with Common Packaging
Noxilizer's sterilization process is compatible with commonly used sterile barrier packaging. This includes: non-woven polypropylene, Tyvek® pouches, Tyvek®-Mylar® pouches and plastic tubs with Tyvek® lids. Noxilizer's process is not compatible with cellulosic materials such as paper and cardboard.