Sterilization Methods for Medical Packaging Safety
32 patents in this list
Updated:
Medical device sterilization requires complete elimination of microorganisms while preserving package and product integrity. Current methods face challenges with penetration depth, material compatibility, and process validation—especially for complex geometries where sterilant coverage may be incomplete or where temperatures above 50°C can damage sensitive components.
The fundamental challenge lies in achieving sterility assurance levels of 10^-6 while maintaining material properties and avoiding toxic residuals.
This page brings together solutions from recent research—including atmospheric pressure plasma systems, hybrid approaches combining hydrogen peroxide with UV or ozone, controlled vapor phase treatments, and targeted plasma activation methods. These and other approaches focus on practical implementation in medical manufacturing while meeting regulatory requirements for sterility validation.
1. Cold Plasma Sterilization Device with Parameter Adjustment Based on Object Surface Area and Volume
江苏容正医药科技有限公司, JIANGSU RONGZHENG MEDICAL TECHNOLOGY CO LTD, 2023
Cold plasma sterilization device for precisely sterilizing instruments and consumables by optimizing the plasma exposure parameters based on the surface area and volume of the object being sterilized. A controller determines the plasma release time, object rotation speed, and other parameters based on the object's exposed surface area and volume to provide targeted and effective sterilization. This addresses issues with overall disinfection not fully reaching contaminated areas. The device can be used for items like test tubes where fixed-point sterilization can be performed by moving the plasma nozzle to the specific location.
2. Low-Temperature Plasma Fusion Ultraviolet Sterilization Device with Integrated Plasma Airflow and 222nm UV Light System
NANJING AGRICULTURAL UNIV, NANJING AGRICULTURAL UNIVERSITY, NANJING SUMAN PLASMA ENGINEERING RES INSTITUTE CO LTD, 2023
Low-temperature plasma fusion ultraviolet sterilization device that uses a combination of low-temperature plasma and 222nm ultraviolet light to kill pathogenic bacteria and coronaviruses. The device has a plasma airflow generator, an ultraviolet generator, and an airflow circulation system. The plasma airflow is fused with 222nm UV light to create a sterilizing airflow that is sprayed onto surfaces to kill pathogens. The airflow is recycled through the system to improve sterilization efficiency and reduce ozone emission.
3. Plasma-Activated Water Vapor Sterilization System with Integrated or External Configuration
LOEWENSTEIN MEDICAL TECHNOLOGY SA, 2023
Sterilization system for medical devices like ventilators using plasma-activated water vapor. The system has a sterilization device with a plasma generator and water source to create the vapor. The vapor is conducted through the medical device like a ventilator's gas pass to sterilize it. The vapor can be pulsed or continuous. It flows through the entire pass, then waste treatment. The system can be integrated into the device or external.
4. Plasma Vacuum Sterilization Method Utilizing Hydrogen Peroxide and Organic Acid Composition with Variable Concentrations
2022
Plasma vacuum sterilization method for medical devices that uses a composition of hydrogen peroxide and an organic acid like lactic, citric, or acetic acid as the sterilizing agent. The hydrogen peroxide concentration is reduced to 20-45% and the organic acid concentration is 12.5-20% when the hydrogen peroxide is 20-45%, or 1-20% when the hydrogen peroxide is 45-50%. This reduces chemical load on device components while increasing bactericidal activity. Plasma activation oxidizes any remaining hydrogen peroxide and peracids.
5. Plasma-Based Medical Device Sterilization System with Dry Ionized Gas Chamber
UNIV SCIENCE & TECHNOLOGY CHINA, UNIVERSITY OF SCIENCE AND TECHNOLOGY OF CHINA, 2021
Plasma medical device disinfection and sterilization device using dry plasma instead of wet steam to prevent corrosion and provide complete disinfection. The device has a chamber with electrodes, compressed air is introduced and ionized into plasma at high voltage. The plasma is blown into a sterilization chamber to disinfect and sterilize medical equipment. The sterilized plasma is exhausted to balance pressure. This provides dry disinfection that avoids corrosion issues compared to wet steam sterilization.
6. Atmospheric Pressure Plasma Sterilization Device with Integrated Electrode Functionality
JIANGSU BONSS MEDICAL TECH CO LTD, JIANGSU BONSS MEDICAL TECHNOLOGY CO LTD, 2021
Atmospheric pressure low-temperature plasma rapid sterilization device that uses the instrument being sterilized as an electrode. The device allows rapid sterilization of sensitive medical devices without damaging them or requiring long cycle times. The sterilization chamber has an air inlet and an exhaust port. A power output end penetrates through the exhaust port. High-amplitude high-frequency pulsed DC voltage applied to the electrodes inside the chamber ionizes the gas (like ammonia) into a low-temperature plasma. This plasma breaks down charged particles and generates active oxygen to kill microorganisms. The device can sterilize quickly and efficiently at atmospheric pressure without pre-vacuum treatment.
7. Plasma-Based Sterilization System with Dielectric Gap and Controlled Precursor Gas Flow
3M INNOVATIVE PROPERTIES CO, 2020
Sterilization system using plasma to kill microbes and dry contaminated articles. The system has a plasma generator with electrodes, shield, and dielectric gap. An electric power source applies high voltage between electrodes. A sterilizing gas precursor containing water, oxygen, and nitrogen is fed to the gap. Plasma forms with acidic/oxidizing substances from the precursor. The precursor flow is kept below 150C on the shield. The plasma sterilizes contaminated articles by exposure. Dry gas flow dries articles. The system can have a conveyor to move articles through.
8. Sterilization Apparatus with Atmospheric Pressure Plasma Generator and Container for Large Articles
ARANN HEALTHCARE LTD, 2015
Sterilization method and apparatus using atmospheric pressure plasma to sterilize articles like medical devices, beds, and surfaces without the need for high temperatures or vacuum chambers. The method involves placing the article in a container, generating oxidizing plasma radicals at atmospheric pressure, and exposing the article to the plasma. The apparatus has a container, plasma generator, and means to provide the plasma to the container. It allows sterilization of articles too large for vacuum chambers, avoids issues with heat and chemicals, and uses atmospheric pressure plasma instead.
9. Sterilization Apparatus with Combined Hydrogen Peroxide and Ozone Delivery in Vacuum Chamber
KOREA BASIC SCIENCE INST, KOREA BASIC SCIENCE INSTITUTE, 2012
Medical device sterilization apparatus using hydrogen peroxide and ozone to improve sterilization efficiency and reduce processing time compared to conventional ozone sterilization. The apparatus introduces both hydrogen peroxide and ozone into a vacuum chamber to increase the amount of OH radicals for sterilization. A vacuum pump creates a sterile vacuum in the chamber. Hydrogen peroxide is sprayed into the chamber. Ozone is supplied. The chamber temperature is controlled. This allows uniform diffusion of the hydrogen peroxide and ozone into the medical device to sterilize it.
10. High-Pressure Steam Sterilization Device with Integrated Vacuum, Plasma, and Ozone Systems
2011
High-pressure steam sterilization device for medical equipment that uses a combination of vacuum, low-temperature plasma, ozone, and steam to provide fast and complete sterilization. The device has a chamber with filters, valves, sensors, and pumps to circulate and sterilize the air inside. It can selectively introduce vacuum, plasma, ozone, and steam based on the type of equipment being sterilized. This allows targeted disinfection of hard-to-reach areas and avoids over-sterilization of sensitive materials.
11. Vacuum Chamber Sterilization System with Cold Plasma and Ozone Gas Integration
2011
Vacuum medical sterilization system using cold plasma and ozone gas to disinfect and sterilize medical equipment. The system operates by evacuating the equipment chamber, introducing low temperature plasma and ozone gas, and applying pressure to penetrate hard-to-reach areas. Sensors monitor ozone concentration and chamber pressure. Filters remove impurities and bacteria from intake/outtake air. The system also has a decomposer to decompose ozone before release. A vacuum pump draws air into the chamber. The system connects to a suction unit.
12. Apparatus for Medical Sterilization and Drying with Dual-Stage Low-Temperature Plasma and Integrated Ozone Decomposition System
CHOI EUN KYUNG, 2010
Medical sterilization and drying apparatus using low-temperature plasma to prevent secondary infection in advance by drying, deodorizing, and sterilizing medical equipment, clothes, shoes, firefighting suits, etc. infected with bacteria using a nature-friendly low-temperature plasma. The apparatus has separate primary and secondary air sterilization stages followed by a heating stage for drying. It uses filters, ozone decomposition, UV, and low-temperature plasma to sterilize the air. An ozone generator, anion generator, and low-temperature plasma device sterilize the primary air. The apparatus has a chamber, inflow and outflow paths, filters, ozone decomposition, primary sterilization, pump, secondary sterilization, and heating stages.
13. Apparatus and Method for Sequential Sterilization Using Hydrogen Peroxide and Ozone with Integrated Decomposers
RENOSEM CO LTD, 2009
Method and apparatus for sterilizing medical instruments using a sequence of steps with hydrogen peroxide and ozone to maximize sterilization efficiency, reduce sterilization time, and lower cost compared to existing methods. The steps involve sequentially sterilizing the instruments with ozone, decomposing the ozone, vacuumizing, sterilizing with hydrogen peroxide, decomposing the hydrogen peroxide and ozone, and repeating the sequence as needed. The apparatus has components like an ozone compressor, vacuum accelerator, hydrogen peroxide vaporizer, and decomposers.
14. Plasma-Based Low-Temperature Disinfection Device with Nitrogen-Hydrogen Gas Circulation in Vacuum Chamber
SOCIETE POUR LA CONCEPTION DES APPLICATIONS DES TECHNIQUES ELECTRONIQUES - SATELEC, 2008
A low-temperature disinfection device for sterilizing medical and dental instruments that uses plasma generated by an electric field in a vacuum chamber. The device circulates a mixture of nitrogen and hydrogen through the vacuum chamber, generates plasma by applying an electric field, and then allows the discharged gas to contact the surfaces of the instruments being sterilized. The discharged gas contains reactive species like nitrogen and hydrogen atoms that can disinfect without damaging sensitive instrument materials. The low-temperature disinfection is achieved by using a vacuum to reduce oxidation risks. The device can also heat the instruments during sterilization using an autoclave or heating elements.
15. Device and Method for Sterilization Using Combined Hydrogen Peroxide, Ozone, and Plasma with Residue Decomposition
MIZUNO AKIRA OF, YUYAMA MFG CO LTD, 2007
Sterilization method and device using a combination of hydrogen peroxide, ozone, and plasma to sterilize medical instruments and materials without leaving harmful residues. The sterilization process involves supplying hydrogen peroxide and ozone to the chamber, exhausting the gas, and generating plasma to decompose any remaining hydrogen peroxide and ozone. This harmless sterilization approach provides sufficient sterilization without residual gases or long aeration times.
16. Sterilization Method Utilizing Low-Temperature Water Vapor Plasma at Sub-100 Torr Pressure
ABTOX INC, 2007
Sterilization method using low temperature plasmas generated from water vapor to sterilize articles without using hazardous gases or high temperatures. The plasmas are generated at low pressures below 100 torr and temperatures below 100°C. The plasmas effectively sterilize the articles by exposing them to neutral active species derived from water vapor. The low temperature and pressure conditions allow sterilization without damaging the articles or packaging. The exhaust gases after sterilization contain only water vapor and trace impurities. This addresses safety concerns with hazardous sterilization gases.
17. Hydrogen Peroxide Plasma Sterilization Process with Reduced Chamber Temperature for Sensitive Medical Products
CSL BEHRING GMBH, 2005
A modified hydrogen peroxide plasma sterilization process that allows sensitive medical products to be sterilized in their final packaging without degradation. The key innovation is maintaining the chamber temperature below 39°C during the entire process, compared to the typical 45°C used in existing plasma sterilization systems. This lower temperature prevents damage to temperature-sensitive products like biological drugs when sterilizing them in their final packaging. The modified process involves injecting hydrogen peroxide plasma into the chamber at reduced temperatures and shorter durations compared to conventional plasma sterilization. It allows effective sterilization of temperature-sensitive products without degradation or loss of activity.
18. Continuous Inline Sterilization Process for Medical Devices Using Monochromatic Ultraviolet Radiation with Specified Energy Density
BROWN-SKROBOT SUSAN K, EBEL JAMES A, ENNS JOHN B, 2005
A novel continuous, inline sterilization process for medical devices using monochromatic ultraviolet radiation. The process involves exposing the medical devices to UV radiation with a Dvalue of at least 23.7 mJ/cm2 for Bacillus spores. This allows sterilization without the need for high-temperature, pressure processes. It works by using UV sources like lasers or lamps to deliver the required energy density to inactivate microorganisms. The devices can be transmissive to UV or enclosed in partially-transparent containers. The UV sources are selected based on the device's UV transmission. Multiple sources may be needed for opaque devices. The process enables rapid, inline sterilization of devices like contact lenses without the time-consuming, costly autoclaving steps.
19. Cold Plasma Generation System for Sterilization of Medical Devices in Sealed Bags
C R I T T MATERIAUX DEPOTS ET, CRITT MATERIAUX DEPOTS ET TRAITEMENT DE SURFACE, 2004
Sterilizing medical devices using cold plasma generated inside sealed bags to preserve sterility during packaging. The devices are placed in a sealed bag containing a gas or gas mixture, then subjected to cold plasma induced by reducing the pressure inside the bag and chamber. This sterilizes the devices inside the sealed bag without exposing them to external contaminants during packaging. The low-pressure plasma generation allows sterilization inside sealed bags.
20. Plasma-Based Sterilization Process Utilizing In Situ Generated Biocidal Species with Controlled Oxygen Flux
CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE, ECOLE POLYTECHNIQUE DE MONTREAL, UNIVERSITE DE MONTREAL, 2004
Sterilization process using plasma to sterilize medical instruments and accessories without damaging heat-sensitive materials. The process involves exposing objects to a plasma containing sterilizing species generated in situ when a gaseous flux containing 0.5-20% atomic oxygen is exposed to an electric field. The plasma source creates biocidal species that destroy microorganisms, even though the base gas has no inherent sterilizing properties. The objects are sterilized outside the plasma zone to avoid exposure.
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