Nitrogen Dioxide Sterilization for Medical Packaging Safety
15 patents in this list
Updated:
Medical device sterilization requires complete microbial inactivation while preserving material integrity. Traditional methods like ethylene oxide (EtO) sterilization pose environmental and safety concerns, while high-temperature steam can damage sensitive materials. Nitrogen dioxide (NO2) sterilization operates at concentrations between 9-100 mg/L and relative humidity levels of 10-90%, offering effective sterilization without the hazards of conventional approaches.
The core challenge lies in maintaining precise control of NO2 concentration, humidity, and exposure time to achieve sterility assurance levels while preventing material degradation and managing post-process gas remediation.
This page brings together solutions from recent research—including pulsed sterilization protocols, precursor gas systems utilizing N2O3 formation, plasma-assisted processes, and automated handling systems with integrated scrubbing technologies. These and other approaches focus on practical implementation in medical device manufacturing while addressing both sterilization efficacy and environmental safety.
1. Nitrogen Dioxide-Based Pulsed Sterilization Method for Medical Devices
NOXILIZER INC, 2023
A sterilization method using nitrogen dioxide (NO2) for medical devices that provides an alternative to high-temperature steam and hazardous gas sterilization methods. The method involves pulsed sterilization steps in a chamber containing the device. The steps include drying, humidifying, evacuating, introducing NO2, rinsing, and holding with monitored chemical concentrations. This controlled NO2 exposure sterilizes devices without toxicity issues of ethylene oxide or explosion risks of ETO.
2. External Sterilization Process for Pre-Filled Syringes Using Controlled Nitrogen Dioxide Exposure
アムジエン・インコーポレーテツド, AMJIEN INC, 2022
External sterilization of pre-filled syringes using nitrogen dioxide (NO2) to achieve high microbial reduction without discoloration. The method involves placing the syringe in a chamber, applying a vacuum, introducing NO2 for dwell times, purging, and venting. It achieves log reductions in microorganisms while minimizing NO2 absorption into plastics and preventing discoloration.
3. Sterilization Method Utilizing Precursor Gas Reactions for N2O3 Formation
NOXILIZER INC, 2020
Sterilization method using precursor gases like nitric oxide (NO), nitrogen dioxide (NO2), and water (H2O) that react to form the sterilizing molecule N2O3 on surfaces and in microorganisms. The method involves delivering controlled concentrations of these precursor gases to a sterilization chamber containing objects to be sterilized. The precursor gases are added in specific ratios to facilitate N2O3 formation without inhibiting sterilization. The chamber is humidified, the precursor gases are introduced, and the objects are exposed for sterilization. This provides effective sterilization with reduced damage compared to traditional sterilant gases.
4. Sterilization Method Utilizing Atomic Nitrogen with Sequential Conditioning and Transition Phases
SOCIETE POUR LA CONCEPTION DES APPLICATIONS DES TECHNIQUES ELECTRONIQUES, 2019
Method for sterilizing objects using atomic nitrogen from a nitrogen plasma to improve efficiency and reduce treatment time compared to conventional methods. The sterilization process involves conditioning the object in a plasma chamber with lower nitrogen concentration to weaken microorganisms before the actual sterilization step. This makes the sterilization more effective and prevents saturation of residual microbes. The conditioning phase may include lower pressure and temperature than the sterilization phase. After conditioning, the chamber is evacuated in a transition phase before the next nitrogen injection.
5. Sterilization Method Utilizing High Concentration Nitrogen Dioxide Gas with Controlled Humidity
SHEETS JOHN RICHARD, 2016
A sterilization method using high concentration nitrogen dioxide (NO2) gas to sterilize medical instruments and other articles. The method involves humidifying the sterilization chamber to 10-90% relative humidity, then filling it with 9-100 mg/L NO2 gas. This provides a sterilizing environment inside the chamber. The humidity and NO2 concentration are critical to achieve effective sterilization. The NO2 gas can be generated and stored in a compact system.
6. Apparatus and Method for Object Sterilization Using Gasified Nitrogen Oxide with Pressure Reduction and Recovery System
ENA CO LTD, 2015
A method and apparatus for sterilizing objects using nitrogen oxide gas. The method involves reducing the pressure inside a sealed space containing the objects, introducing nitrogen oxide liquid into the space, and allowing it to gasify to sterilize the objects. The apparatus has a nitrogen oxide liquid storage vessel, a decompressor to reduce space pressure, and a pump to introduce the nitrogen oxide into the space. This allows rapid, complete sterilization without high temperatures or pressures. The nitrogen oxide gas can be completely recovered after sterilization.
7. Nitrogen Dioxide Gas Sterilization System with Controlled Environmental Variables and Integrated NO2 Remediation
SHEETS JOHN RICHARD, 2012
Sterilization system using nitrogen dioxide (NO2) gas to sterilize objects without damaging them like heat or radiation methods. The system has a chamber to hold the objects, a NO2 source, a remediation mechanism to remove NO2 after sterilization, and a method to control variables like concentration, humidity, temperature, pressure, and duration. It also has options like automated object handling and exhaust cycles to further improve safety.
8. Nitrogen Dioxide Gas Sterilization System with Exhaust Scrubber and Moisture Control
SHEETS JOHN RICHARD, 2012
Sterilization system using nitrogen dioxide (NO2) gas to sterilize objects without damaging them. The system supplies NO2 gas to a sterilization chamber containing objects, then exhausts the NO2-containing gas. It removes NO2 from the exhaust stream using a scrubber filled with a processing medium. This prevents residual NO2 from contaminating the next cycle. The system also allows moist air to be introduced into the chamber during sterilization to prevent drying of sensitive objects. The NO2 concentration, humidity, temperature, pressure, exposure time, etc. are controlled to optimize sterilization while minimizing damage to the objects. The system can also automate loading and unloading of objects.
9. Sterilization Method Utilizing High Concentration Nitrogen Dioxide Gas with Controlled Humidity Levels
SHEETS JOHN RICHARD, 2011
Sterilization method using high concentration nitrogen dioxide (NO2) gas at controlled humidity levels to sterilize medical devices. The method involves humidifying the sterilization chamber to a relative humidity of 10-90% and filling it with 9-100 mg/L NO2 gas. This provides a sterilization effect for complex shaped devices like narrow tubes or intersecting surfaces that can't be fully sterilized by conventional methods. The humidity and NO2 concentration levels are chosen to ensure reliability without excessive gas volumes or humidity levels.
10. Sterilization System with NO2 Exhaust Purification via Ozone-Induced Conversion to N2O5 or HNO3
NOXILIZER INC, 2010
Sterilization system for medical instruments using high concentration nitrogen dioxide (NO2) gas that can efficiently and reliably purify the high concentration NO2 exhaust gas to make it harmless. The system has an ozone generator, a gas treatment section with ozone and NO2 adsorption and reaction to generate dinitrogen pentoxide (N2O5) or nitric acid, and an exhaust section. This allows exhausting the high concentration NO2 gas from the sterilization chamber and processing it to remove NO2 before releasing it into the atmosphere. The system uses ozone and NO2 reactions to convert NO2 into harmless compounds like N2O5 or HNO3.
11. Nitric Oxide and Nitrogen Oxides Generation System for Sterilization
SHEETS JOHN RICHARD, 2009
Sterilization using nitric oxide (NO) and other nitrogen oxides as disinfectants instead of traditional sterilizing agents like chlorine dioxide, ozone, or hydrogen peroxide. The method involves generating NO and nitrogen oxides by acidifying compounds that release NO, like carbon-based diazenium diolates, and mixing the gases with air. This produces a sterilizing agent gas with lower oxidizing properties than other sterilizers, making it safer and wider-rangely sterilizable. The gas can be generated in a chamber and used to sterilize objects like medical devices by exposure. The sterilization chamber is connected to a source of the NO-generating compound. The gas can also be scrubbed and reused. The NO and nitrogen oxides have lower explosion hazard than other sterilizers.
12. Nitric Oxide Gas Sterilization Method Using Concentration Gradients in Enclosed Environments
SYK TECHNOLOGIES LLC, 2009
Using nitric oxide gas as a sterilizing agent to replace traditional disinfectants like antibacterial soaps. The method involves exposing surfaces to high concentrations of nitric oxide gas in enclosed environments for sufficient times to kill microbes. The nitric oxide scavenges chemicals and attacks microbes due to its chemical reactivity. It does not require heat like autoclaving and provides superior sterilization compared to soaps. Concentrations of 500-1,000 ppm are used for skin and objects. Concentration gradients can drive diffusion to contact microbes.
13. Sterilization System with In Situ Nitric Oxide and Nitrogen Dioxide Gas Generation Using Nitrogen-Based Diazeniumdiolates
SHEETS JOHN RICHARD, 2008
Portable, safe, and efficient sterilization system using nitric oxide (NO) and nitrogen dioxide (NO2) gas mixtures. The system generates sterilant gases in situ without explosive risks. It employs compounds like nitrogen-based diazeniumdiolates that release NO upon acidification. The gases are generated in a separate chamber and delivered to the sterilization chamber. The gases sterilize objects like medical devices by disrupting microbial DNA and membranes. The gases can rapidly sterilize in seconds to minutes at lower concentrations than single-entity sterilants. The system avoids explosive risks of concentrated single-entity sterilants like chlorine dioxide.
14. Gas-Based Sterilization Method Utilizing Nitric Oxide Generation via Acidification of NO Donor Compounds
SHEETS JOHN RICHARD, 2007
A sterilization and disinfection method using gas to rapidly and effectively sterilize medical devices and materials without the risks and limitations of traditional sterilization methods like steam autoclaving. The method involves generating nitric oxide (NO) and other nitrogen oxides using a compound that releases NO upon acidification. The NO gas is generated in a separate chamber by adding water to a mixture of NO donors and acid activators. The gas is then transferred to the sterilization chamber containing the items to be sterilized. The NO and nitrogen oxides have antibacterial properties that sterilize the items. The method allows rapid, portable, and adjustable sterilization without the hazards of explosive or oxidative gases. The NO is removed before opening the chamber to limit exposure.
15. Localized Nitric Oxide Release System for Biofilm Disruption and Surface Application
PULMONOX TECHNOLOGIES CORP, 2007
Using nitric oxide gas to combat biofilms, which are bacterial communities that adhere to surfaces. The method involves applying nitric oxide-releasing materials to surfaces prone to biofilm formation, or surrounding biofilms with nitric oxide-releasing materials, to inhibit or eradicate biofilms. Nitric oxide can also be delivered topically to infected skin using a device that bathes the area with nitric oxide gas. This provides a localized, targeted approach to combat biofilms without systemic administration of nitric oxide.
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