Related Experiment Video
Updated: May 16, 2025

A Novel Inhalation Mask System to Deliver High Concentrations of Nitric Oxide Gas in Spontaneously Breathing Subjects
Published on: May 4, 2021
Nitrogen Dioxide Sterilization is a New State-of-the-Art Sterilization Technology to Control Contamination Risks From
Annick Gillet1, Aaron DeMent2, Erik Haghedooren3
1Sterigenics, Oak Brook, IL agillet@sterigenics.com.
Abstract:
Prefilled Devices and Combination Drug Products, particularly those with integrated fluid paths or for specific Therapeutic Areas like Ophthalmology, may require final sterilization. Nitrogen Dioxide is a ground breaking novel sterilization technology designed to suit sensitive Prefilled Devices and Combination Drug products. This innovative sterilization process runs at ambient temperature and uses very low sterilant concentration. A SAL ≤10-6 is achieved in a few minutes of exposure, making this new technology highly efficient, without penetrating the drug reservoir. A case study will be shared, illustrating a validated process. This new modality will provide manufacturers with a new gas alternative to consider for their drug product to help ensure product safety for use in patients.
More Related Videos
Related Concept Videos
Methods of Sterilization II: Chemical Methods
Using chemical sterilization rather than heat to clean out equipment is recommended. It eradicates and removes all bacteria,...
Methods of Sterilization I: Physical Methods
Steam sterilization uses non-toxic, low-cost moist heat in the form of saturated steam under pressure, which is fast, microbicidal, and sporicidal, and quickly warms and penetrates fabrics. Autoclaves, or steam sterilizers, expose each item to direct steam contact for a predetermined time at the necessary...
Oxygen Delivering System II: Venturi Mask and Transtracheal Oxygen
Venturi Mask
The Venturi mask, named after the Venturi effect, is designed to deliver precise oxygen concentrations. It consists of a large tube with an oxygen inlet that narrows down, causing a pressure drop that pulls air in through adjustable side ports. The mask is a lightweight,...
Cleaning, Sterilization, and Disinfection
Cleaning
The cleaning process usually involves using water with detergents or enzymatic cleaner and removing foreign material from objects and surfaces, including organic material such as body fluids or inorganic material like soil. Cleaning is performed before high-level disinfection and sterilization because foreign materials on the cover of the devices interfere with process...
Transmission-based Precautions II: Airborne and Protective Environment
Airborne precautions:
Use airborne precautions when treating patients known or suspected to have diseases that spread through the air—for example, tuberculosis or measles. These organisms are present in smaller droplets expelled by an infected person and...
2° Amines to N-Nitrosamines: Reaction with NaNO2

