5
*As of June 2026
The right sterilant for today’s medical devices
Delivers reliable sterility that is compatible with complex materials and packaging
- Nitrogen dioxide is a sterilant with strong microbicidal properties (degrades microbial DNA)
- Broad compatibility with many device materials (e.g. polymers, metals, bioresorbables, and adhesives)
- Compatible with commonly-used sterile barrier packaging: Tyvek® pouches, Tyvek® - Mylar® pouches, and Thermo Formed (PETG) with Tyvek® lids (not compatible with cellulosic materials such as paper and cardboard)
- Low sterilant concentration (1–20 mg/L)
- Ultra-low temperature sterilization (≈10–30 °C; NO₂ is a true gas with a boiling point at 21°C)
- Non-condensing gas sterilant means greater efficacy in lumens
- Less oxidative than traditional oxidizing sterilants like hydrogen peroxide and peracetic acid
Enables customization by product type
- Adjustable critical process parameters including: NO2 concentration, dwell time, RH, vacuum depth / chamber pressure, and temperature
Speeds time-to-market
- Short overall cycle times (6–12 hours)
- Rapid aeration (because it is a non-condensing gas sterilant)
- Shorter sterilant exposure (typically less than one hour; raising relative humidity reduces cycle time: 40–80% relative humidity provides rapid lethality)
- Sterilized batches can be handled packaged/shipped immediately
Confidence
- Technology used in multiple FDA/EMA-authorized products
- No sustainability or EPA concerns
- Non-carcinogenic, non-cytotoxic, non-teratogenic residual profile (residuals often not measurable; no increase in cytotoxicity observed)
Support
- In-house expertise & support
- Consultation / guidance on ISO 14937, protocols, verification, validation
- Data collection & documentation support
Supports development through to commercialization
- In-house expertise & support, including expert microbiology and material compatibility team
- Systems available in multiple chamber sizes, including pilot equipment
- Proven technology; track record with customers
- Meets all appropriate quality and regulatory standards: ISO 13485 certificate of registration, ISO 14937 compliance, EU Regulatory compliance (CE), 21 CFR Part 11 / EU Annex 11 compliance
Supports sustainability goals
- Lower societal and environmental burden than ethylene oxide (EtO) sterilization
Effective
Delivers reliable sterility that is compatible with complex materials and packaging
- Nitrogen dioxide is a sterilant with strong microbicidal properties (degrades microbial DNA)
- Broad compatibility with many device materials (e.g. polymers, metals, bioresorbables, and adhesives)
- Compatible with commonly-used sterile barrier packaging: Tyvek® pouches, Tyvek® – Mylar® pouches, and Thermo Formed (PETG) with Tyvek® lids (not compatible with cellulosic materials such as paper and cardboard)
- Low sterilant concentration (1–20 mg/L)
Works where other approaches don't
- Ultra-low temperature sterilization (≈10–30 °C; NO₂ is a true gas with a boiling point at 21°C)
- Non-condensing gas sterilant means greater efficacy in lumens
- Less oxidative than traditional oxidizing sterilants like hydrogen peroxide and peracetic acid
Customizable
Enables customization by product type
- Adjustable critical process parameters including: NO2 concentration, dwell time, RH, vacuum depth / chamber pressure, and temperature
Supply chain efficient
Speeds time-to-market
- Short overall cycle times (6–12 hours)
- Rapid aeration (because it is a non-condensing gas sterilant)
- Shorter sterilant exposure (typically less than one hour; raising relative humidity reduces cycle time: 40–80% relative humidity provides rapid lethality)
- Sterilized batches can be handled packaged/shipped immediately
Regulatory readiness
Confidence
- Technology used in multiple FDA/EMA-authorized products
- No sustainability or EPA concerns
- Non-carcinogenic, non-cytotoxic, non-teratogenic residual profile (residuals often not measurable; no increase in cytotoxicity observed)
Support
- In-house expertise & support
- Consultation / guidance on ISO 14937, protocols, verification, validation
- Data collection & documentation support
Enables product development
Supports development through to commercialization
- In-house expertise & support, including expert microbiology and material compatibility team
- Systems available in multiple chamber sizes, including pilot equipment
Low risk, reliable partner
- Proven technology; track record with customers
- Meets all appropriate quality and regulatory standards: ISO 13485 certificate of registration, ISO 14937 compliance, EU Regulatory compliance (CE), 21 CFR Part 11 / EU Annex 11 compliance
Sustainable
Supports sustainability goals
- Lower societal and environmental burden than ethylene oxide (EtO) sterilization
Noxilizer’s proprietary terminal sterilization process
“The NO2 sterilization process is completed in a vacuum chamber and begins with evacuation of the air in the sterilization chamber. After evacuation, the sterilization chamber is filled with the sterilization process gases which consist of NO2 and humidified air. For most medical devices and drug delivery devices that can tolerate a deep vacuum” of 150 mbars, “the chamber is evacuated to a relatively low vacuum pressure (e.g., 20 mbar; see figure below).
Some drug delivery devices, such as prefilled syringes, are susceptible to piston” (plunger) “movement during the sterilization cycle, due to the influence of the evacuated pressure, which causes the gases in the prefilled syringe to expand. The movement of the syringe piston may allow for the contamination of the syringe contents with both microorganisms and sterilant gas. To address this issue, a shallow-vacuum cycle has been developed. This type of shallow-vacuum cycle uses a much higher minimum process pressure (e.g., about 500 mbar minimum process pressure) compared to typical minimum process pressure levels used with deep vacuum cycles.”
Excerpt from Ray N, et al. Drug Delivery Device Design and Compatibility with Nitrogen Dioxide Gas Sterilization. Pharmaceuticals (Basel). 2025 Dec 8;18(12):1869. doi: 10.3390/ph18121869. PMID: 41471358; PMCID: PMC12736310:
With the NO2 process, both deep vacuum and shallow-vacuum cycles have similar process stages. These stages are described below and illustrated in the figure below. The process stages are:
Evacuation
Humidity Addition
Relative Humidity (RH) is added to the chamber until the desired percentage is reached, typically between 40% RH and 80% RH.
NO2 Injection
Pressurization
NO2 Exposure Stage
Aerations
†ISO 14937:2009; Sterilization of Health Care Products—General Requirements for Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices. International Organization for Standardization: Geneva, Switzerland, 2009.
Graph of pressure (mbar) vs. time (minutes) for an example deep vacuum NO2 sterilization cycle.
Rapid aeration — hours vs. days
Nitrogen dioxide’s low boiling point allows for rapid aeration. 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. (Noxilizer has short overall cycle times of 6–12 hours.) 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 batches can be handled and packaged/shipped immediately without any health risk concerns for employees.
Every spore batch & every BI lot are fully characterized, supporting validated, reproducible sterility
Biological indicators designed for confidence
When sterilization validation is critical, the quality and consistency of the biological indicator matter. At Noxilizer, we take a scientifically rigorous approach to biological indicator manufacturing by characterizing every spore production batch before application and every finished biological indicator lot after application to the carrier.
This dual-stage characterization provides exceptional lot-to-lot consistency, predictable resistance profiles, and greater confidence that the biological indicator accurately challenges the sterilization process.
A higher standard for biological indicators
Designed specifically for NO2 sterilization
Noxilizer biological indicators utilize Geobacillus stearothermophilus spores with a population greater than 106 CFU on proprietary quartz carriers engineered for nitrogen dioxide sterilization applications.
Key features include:
- Characterization of every spore production batch
- Characterization of every finished biological indicator lot
- Fully characterized resistance profiles
- Lot-to-lot consistency verification
- 12-month shelf life
- Transport stability validation
- Up to 48-hour post-exposure hold time
- 42-hour reduced incubation capability
- Complete quality documentation and traceability
Why customers choose Noxilizer biological indicators
Our rigorous characterization program helps customers:
- Increase confidence in cycle development and validation
- Reduce variability during qualification studies
- Support regulatory submissions with robust scientific data
- Improve process control and monitoring
- Accelerate sterilization program execution
Proprietary, validated, resistometer-measured biological indicators (BI)
Material compatibility
NO₂ is compatible with many materials
Don’t see a material on this list?
We would be happy to provide you with more information about material compatibility.
Packaging compatibility
NO₂ is compatible with commonly-used sterile barrier packaging, including:
- Tyvek® pouches
- Tyvek® – Mylar® pouches
- Thermo Formed (PETG) with Tyvek® lids
Noxilizer’s process is not compatible with cellulosic materials such as paper and cardboard. Due to incompatibility of cellulosic materials, consideration needs to be given to labels and inserts that are included during sterilization. Those items can be assembled after sterilization as part of final packaging.
RESOURCE — TO LEARN MORE:
Drug delivery device design and compatibility with NO2 gas sterilization
Resource: Ray N, et al. Pharmaceuticals (Basel). 2025 Dec 8;18(12):1869. doi: 10.3390/ph18121869. PMID: 41471358; PMCID: PMC12736310.
RESOURCE — TO LEARN MORE:
NO2 sterilization follows log-linear microbial inactivation kinetics using Geobacillus stearothermophilus biological indicators
Richards T, et al. PDA J Pharm Sci Technol. 2025 Aug 1;79(4):379-390. doi: 10.5731/pdajpst.2024.012997. PMID: 40523727.
RESOURCE — TO LEARN MORE:
Biological indicators and process challenge devices for nitrogen dioxide sterilization
Lisco D, et al. Biomed Instrum Technol. 2026;60(2):19-31. doi: 10.2345/0899-8205-60.2.19. Epub 2026 May 5. PMID: 42085597; PMCID: PMC13143232.
End-to-end sterilization services and support
Noxilizer offers support for companies’ products from development through commercialization
Material and packaging
Noxilizer assigns a team who will partner with you to address material selection and packaging and labelling questions regarding sterilization during the product development process. These experts are experienced materials scientists, engineers, and microbiologists. Working together, Noxilizer can help minimize the uncertainty in your product’s success.Research & development studies
Expose & return
- Noxilizer exposes a small number of product samples to NO2 sterilization and returns them to the customer to allow an assessment of any impact on structure, form, fit, function, etc.
- Consult on material and device compatibility
- Enables customer assessment of medical and combination drug device functionality and drug integrity
Feasibility
- Vacuum integrity testing to assess plunger movement
- Identification of worst-case (most challenging) locations and testing using biological indicator–based process challenge devices
- Colorimetric assay
- Ingress (for biologic drug product primary containers)
- External residuals (testing for NO2, aligned with ISO 10993-7 methods)
- Final packaging consulting
Scaling
- Custom tote and rack design based on final packaging
- 1-Pallet chamber full load scale up
- Production volume protocol development
- External process challenge device comparative resistance
Process definition
- Demonstration of sterilization process
- Demonstration of sterilizer capability
Validation per ISO 14937*
- Microbiological performance qualification
- Process performance qualification
- Commercial product stability
- Clinical sample testing
- Load-mapping or pre-conditioning*
* Noxilizer is compliant with ISO 14937 and ISO 11135 standards.
Regulatory consulting
Noxilizer offers consulting for customers preparing for regulatory submissions.
These services range from consulting with a customer’s regulatory team, to preparing FDA pre-submission meeting requests and information packages, to supporting the customer’s 510(k) and BLA processes.
