Low Temperature - Biodecontamination - Sterilization


Product: RTS


The Noxilizer RTS Series is a range of free-standing, room temperature sterilizers with working capacities extending from 360 to 5,000 liters.
The RTS Series sterilizers use nitrogen dioxide (NO2) gas as a sterilant at room temperature. The rapid process, typically 2 to 3 hours, may be used in-house, in-line with production.
Flexible cycle parameters allow sterilization of, for example, preflled syringes, drug-delivery devices/containers and heat or moisture-sensitive equipment.

Key Features:
- Robust stainless steel chamber with usable working capacities from 360 to 5,000 liters (12.7 to 177 cu.ft.)
- Single or double door, pass through models
- Typical room temperature process cycle time 2 to 3 hours, load to unload (vacuum process, suitable for most packaged devices)
- Non-vacuum/ambient pressure process also available, suitable for pressure-sensitive products
- Variety of cycles (recipes) easily customized to user needs
- Printer for process record/batch documentation
- Abator scrubs efluent gas after use
- Variety of sensors to monitor and ensure safety
- System validated to IEC 61010 requirements
- Chemical and biological indicators (CIs, BIs), and tunable process challenge devices (PCDs) available
- CE marked

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.