UltraNox™ 2.0: The next generation of NO2 sterilization
The RTS™ 1600 sterilizer design helped establish nitrogen dioxide (NO2) sterilization as a proven solution for sensitive pharmaceutical, biotechnology, and medical device products. The UltraNox™ 2.0 represents Noxilizer’s next-generation sterilization platform—engineered specifically for commercial manufacturing, operational excellence, and long-term scalability.
UltraNox™ 2.0 combines the proven benefits of NO2 sterilization with enhanced automation, improved process control, advanced safety systems, modern data management, and manufacturing-ready architecture designed to support the demands of today’s regulated production environments.
Designed for commercial success
UltraNox™ 2.0 was developed for organizations moving beyond development and validation into routine commercial manufacturing. Every aspect of the platform has been designed to improve operational efficiency, support regulatory compliance, and provide the reliability required for long-term production programs.
Whether supporting prefilled syringes, biologics, combination products, ophthalmic therapies, or advanced medical devices, UltraNox™ 2.0 delivers a sterilization platform built for commercial growth.
Why manufacturers choose UltraNox™ 2.0
Protecting sensitive products
UltraNox™ 2.0 leverages the unique advantages of NO2 sterilization, including:
- Ultra-low temperature operation (10–30 °C)
- Compatibility with biologics, combination products, and prefilled syringes
- Low-vacuum process options that reduce product stress
- Reduced risk of plunger movement, stopper displacement, and sterilant ingress
- Rapid aeration and low residuals
- Typical cycle completion in as little as 6–12 hours
These capabilities make NO2 sterilization an ideal solution for products that may be challenged by traditional sterilization technologies.
Enhanced process control and repeatability
UltraNox™ 2.0 incorporates next-generation control technologies that improve process consistency and operational confidence.
Key advancements include:
- Closed-loop humidity control
- Enhanced humidity and NO2 monitoring
- Improved process repeatability
- Increased cycle consistency across manufacturing campaigns
- Greater visibility into critical process parameters
- Increased uniform distribution of sterilant
- Improved lethality & significant sterilization efficacy improvement
Modern automation and data management
Today’s manufacturing environments require more than sterilization performance. They require data integrity, operational visibility, and seamless integration.
UltraNox™ 2.0 provides:
- Enhanced reporting and data management capabilities
- Improved automation architecture
- Expanded connectivity and integration options
- Greater flexibility for enterprise environments
- Improved electronic record support and operational oversight
Built-in safety and operational confidence
Multiple layers of protection help safeguard personnel, products, and facilities throughout every sterilization cycle.
Enhanced safety features include:
- Advanced interlock architecture
- Improved residual gas monitoring
- Enhanced process oversight
- Automated alarm management
- Expanded safety monitoring capabilities
Designed for manufacturing integration
UltraNox™ 2.0 is engineered to fit seamlessly within modern pharmaceutical, biotechnology, and medical device manufacturing facilities.
The platform supports:
- Commercial production environments
- Validation and quality system requirements
- Manufacturing scalability
- Enterprise automation strategies
- Long-term facility planning and growth
From proven technology to commercial platform
The RTS™ 1600 demonstrated what NO₂ sterilization could achieve. UltraNox™ 2.0 is designed to help manufacturers realize its full commercial potential by delivering:
- Enhanced automation and controls
- Improved process repeatability
- Greater operational efficiency
- Modern manufacturing integration
- Expanded reporting and data capabilities
- Enhanced safety architecture
- Long-term production scalability
The strategic
choice for the future
For organizations developing the next generation of biologics, prefilled syringes, drug-device combination products, ophthalmic therapies, and advanced medical devices, UltraNox™ 2.0 provides the performance, control, scalability, and confidence needed to support commercial success.
The UltraNox™ 2.0 sterilizer is industrial production equipment intended for installation and qualification within the customer’s manufacturing process. It is not a medical device and is not placed on the market for the sterilization of medical devices within the meaning of MDR Annex VIII, Rule 16.
Flexible automation and software solutions designed around your infrastructure
Scalable from development to commercial production
Built for regulated manufacturing
Whether operating as a standalone sterilization system or as part of a global manufacturing network, Noxilizer’s software platform is designed to support regulated environments with secure user management, electronic records, audit trails, data integrity, and integration with enterprise systems.
Automation that fits your environment
Our control system architecture is designed to support your operational, quality, and IT requirements—today and as your organization grows. Noxilizer systems are available in four levels of automation and connectivity, enabling customers to select the solution that best aligns with their infrastructure, cybersecurity policies, and data management requirements.
Level 1: Standalone operation
Ideal for facilities seeking a simple, self-contained solution. The system operates independently with no reliance on external networks or IT infrastructure, providing reliable local control and data management.
Level 2: Network connected
Designed for facilities that require local network connectivity. This configuration supports secure data backup, remote printing, and streamlined data transfer while maintaining operational simplicity.
Level 3: Enterprise integrated
A fully customized solution that integrates seamlessly with your manufacturing and quality systems. Centralized user management, secure data distribution, and enterprise reporting capabilities help support compliance, operational visibility, and standardized workflows across the organization.
Level 4: Virtualized enterprise platform
Our most advanced automation architecture delivers maximum flexibility, scalability, and cybersecurity. The SCADA environment is hosted within the customer’s secure virtual infrastructure, enabling centralized system management, simplified maintenance, disaster recovery support, and deployment across multiple manufacturing locations using thin-client operator interfaces.
Engineered to protect people, products, and processes
Multiple layers of protection.
One reliable sterilization platform.
UltraNox™ 2.0 is engineered to deliver safe, repeatable, and compliant NO2 sterilization through a comprehensive safety architecture that protects personnel, products, and facilities throughout every stage of the sterilization process.
Combining sealed-chamber containment, automated process controls, continuous monitoring, intelligent alarm management, rapid aeration, and facility-level safeguards, UltraNox™ 2.0 provides the confidence manufacturers need to operate in highly regulated environments. The system incorporates CE-marked and UL-listed components, further supporting reliability, quality, and operational confidence.
Engineered for safety, reliability, and compliance
Safety is built into every aspect of the UltraNox™ 2.0 platform. Multiple independent layers of protection work together to maintain process integrity, minimize operator exposure, and ensure sterilization cycles are executed within validated operating parameters.
Because NO2 sterilization can be performed at low sterilant concentrations and under low-vacuum conditions, UltraNox™ 2.0 also helps reduce mechanical stress on pressure-sensitive products while delivering robust sterilization performance.
Key safety features
Built-in redundancy for critical operations
UltraNox™ 2.0 incorporates redundant safety and monitoring systems to provide an additional layer of operational assurance, including:
- Dual door sealing systems and mechanical interlocks
- Redundant pressure, temperature, humidity, and NO₂ monitoring
- Fail-closed valve architecture designed to automatically isolate sterilant pathways
- Independent low-level NO2 monitoring in operator-accessible areas
- Mechanical pressure protection devices
- UPS-backed control systems to preserve operation and data integrity during power disturbances
- Independent electronic data recording and audit trail protection
- Confidence for Regulated Manufacturing
Whether supporting feasibility studies, validation programs, or commercial production, UltraNox™ 2.0 delivers the safety, reliability, and process control required by pharmaceutical, biologic, and medical device manufacturers. Multiple layers of protection, continuous monitoring, and built-in redundancies help ensure safe operation while supporting regulatory compliance and product quality.
How the Noxilizer UltraNox 2.0 works
STEP 1:
Create sterilizing gas
STEP 2:
Sterilize equipment
The sterilant spreads within the chamber, condensing on surfaces and activating its microbial-killing effect.
STEP 3:
Vent & exhaust
Graph of pressure (mbar) vs. time (minutes) for an example NO2 sterilization cycle.
Figure adapted from Ray N, et al. Pharmaceuticals (Basel). 2025;18(12):1869.
Critical parameters
Every critical parameter (except for time) is measured with redundant sensors:
1 sensor for measurement and control and 1 sensor for confirmation.
The purpose of two separate probes is to prevent the failure of one sensor from causing an out-of-specification process from being erroneously accepted. Comparing two separate temperature sensors will detect that one of the sensors has failed. A dual element temperature probe can be used to meet this need.
NO2 concentration (1-20 mg/L)
Relative humidity (40-80%)
Total dwell time
(20-40 mins)
Temperature 10-30°C
Process pressure
(Deep vacuum [25 mbar],
Near ambient [500 mbar])
Prefer contract sterilization?
Coming soon in 2027
Streamlined sterilization solution
On-demand, turn-key, 1-stop sterilization option
- Strategically located near major pharmaceutical and CDMO hubs — next to Baltimore Washington International Airport (I-95/I-295)
- Door-to-door processing in as little as 2 days
- Short sterilization cycles (6–12 hours)
- Integrated release testing & batch documentation
- On-site final packaging capability
Lower product risk. A resilient sterilization partner built for supply assurance
- 5 Sterilization systems enabling commercial-scale capacity exceeding 12.5 million prefilled syringes annually
- Cold-chain enabled with on-site cold storage
- Redundant BI manufacturing & backup power systems
- Full safety, maintenance, environmental, and qualification management
Built to sterilize customers' pharmaceutical and combination products within their own validated production process
- ISO 13485:2016 certified
- CE Mark compliant*
- ISO 14937:2009 aligned
*CE marked as industrial equipment (Machinery Directive 2006/42/EC, EMC, Low Voltage, and Pressure Equipment Directives as applicable)
End-to-end partnership from feasibility through commercial production
- 13+ years of low-temperature sterilization expertise
- In-house microbiology laboratory
- Materials science support team
- Development, validation, and routine processing support
Need more information?
Our team can provide you with more information about our system.
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