Sterilization is an essential requirement for the pharmaceutical, biotech and medical devices industries. Noxilizer has developed an ultra-low temperature nitrogen dioxide sterilization technology that addresses many of the challenges associated with traditional methods. NO2 is effective against a wide range of microorganisms. The primary mechanism of lethality is the degradation of DNA. Late outgrowth studies have no repair mechanisms for the DNA degradation.
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Nitrogen dioxide is a true gas. 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. It is a surface sterilant. Therefore, NO₂ gas can sterilize prefilled syringes, while maintaining drug integrity, and medical devices with complex geometries.
Nitrogen dioxide gas sterilization is ideal for sensitive biotech products and improves supply chain efficiency:
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.
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.
NO2 is less oxidative than traditional oxidizing sterilants like hydrogen peroxide and peracetic acid. Noxilizer has tested many medical device materials including metals, polymers, bioresorbables and adhesives. Compatible materials showed no increase in cytotoxic response. The true or ultra-low room temperature performance of the Noxilizer process allows temperature-sensitive materials to be processed.
Compatible Materials Stainless SteelPolyethylenePolyetherimideThermoplastic Elastomers AluminumPolypropylenePolycarbonate Gold (Plating)PET/PETGCyclic Olefins Glass/CeramicPolystyrenePVC* FluoropolymersPolysulfonesSilicone*This list is not exhaustive Viton (Gaskets)PEEK/PAEKHypalon*The specific type of material should be tested.
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.
Nitrogen dioxide, or NO2, is a gaseous air pollutant composed of nitrogen and oxygen and is one of a group of related gases called nitrogen oxides, or NOx. Nitrogen dioxide forms when fossil fuels such as coal, oil, methane gas (natural gas) or diesel are burned at high temperatures. NO2 and other nitrogen oxides in the outdoor air contribute to particle pollution and to the chemical reactions that make ozone. It is one of six widespread air pollutants for which there are national air quality standards to limit their levels in the outdoor air. NO2 can also form indoors when fuels like wood or gas are burned.
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Nitrogen dioxide causes a range of harmful effects on the lungs, including:
Scientific evidence suggests that exposure to NO2 could likely cause asthma in children.
A review of multiple studies found that elevated levels of NO2, as well as elevated particulate matter and sulfur dioxide, were strongly associated with heart and lung harm, affected pregnancy and birth outcomes, and were likely associated with increased risk of kidney and neurological harm, autoimmune disorders and cancer.
As of , human-made sources in the U.S. emit 7.64 million short tons of nitrogen oxides per year (down from 15 million short tons per year in ) mainly from burning fuels. Trucks, buses, and cars are the largest sources of NO2 emissions, followed by diesel-powered non-road equipment, industrial processes such as oil and gas production, industrial boilers and other movable engines, and coal-fired power plants. Emissions of nitrogen dioxide will decline as cleanup of many of these sources continue in future years.
Monitors show the highest concentrations of outdoor NO2 in large urban regions such as the Northeast corridor, Chicago and Los Angeles. Levels are higher on or near heavily traveled roadways.
It is important to note that NO2 and other nitrogen oxides are also produced from burning natural gas (methane), both outdoors and indoors. Outdoors, this can include gas-fired power plants and from facilities that extract, process or transport oil and gas if they burn it in flares or to power equipment. Indoors, appliances such as stoves, dryers and space heaters that burn natural gas, liquified petroleum gas (or LPG, which includes propane and butane) and kerosene can produce substantial amounts of nitrogen dioxide. If those appliances are not fully vented to the outside, levels of NO2 can build up to unhealthy levels indoors.
While everyone is at risk from health impacts of nitrogen dioxide pollution, those that live near the emission sources are at higher risk. Other vulnerable subpopulations at higher risk from nitrogen dioxide exposure include:
The good news is that for much of the nation, the outdoor air has much lower levels of nitrogen dioxide now than in previous decades. Under the federal Clean Air Act, more protective standards nationwide have helped drive down nitrogen dioxide emissions. Power plants, industrial sites and on-road vehicles are cleaner than they used to be, which has driven nationwide improvement in air quality. However, far too many people still breathe in unhealthy levels of nitrogen dioxide pollution.
Individuals can take steps to protect themselves on days with unhealthy levels of air pollutants and also ask policymakers at all levels of government to continue to require cleanup of air pollution.
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