Industries
Exploring alternatives to ethylene oxide (EtO)
NO₂ sterilization is increasingly recognized as a validated, sustainable alternative to legacy technologies like EtO, especially as industry demand grows for safer and more environmentally responsible and supply chain efficient methods.
Sterilization is under increasing environmental and regulatory scrutiny
Ethylene oxide +
- Significant regulatory pressure and litigation exposure
- Linked to health risks, including carcinogenicity concerns
- Facility shutdowns and constraints due to environmental compliance leading to limited access and rising costs
- Shutdowns are creating massive bottlenecks for remaining plants that sterilize 17B+ devices annually
Radiation (γ & x-ray) +
- Gamma sterilization depends on Russian-imported Cobalt-60, creating geopolitical risk
- Radiation requires massive electricity consumption, driving up costs and environmental impact — long-term sustainability concerns tied to energy usage
- Increasing scrutiny around infrastructure and scalability
Vaporized hydrogen peroxide (VHP) +
- Requires large volumes of water and consumables
- Operational and environmental burden at scale
Noxilizer delivers a next-generation terminal sterilization solution that’s safe, effective, efficient, and scalable, with several key advantages to EtO and alternative sterilization methods
Risk management
- A proven sterilant with a solid technical foundation and an established sterilization validation and regulatory pathway — commercialized since 2012
- Technology used in FDA/EMA-authorized products
- Proven biocompatibility: effective against a wide range of microorganisms
- Leaves none of the carcinogenic, cytotoxic or teratogenic residuals associated with EtO
- No harmful environmental emissions
- No plunger pistoning or sterilant ingress means drug and device integrity are maintained
- Lower societal and environmental burden than EtO sterilization
Supply chain efficiency
- Non-condensing sterilant and short cycles (short cycle times of 6‒12 hours, including aeration) reduce total manufacturing time and cost
- Multiple systems installed and running globally (Europe and Asia)
- Sterilized batches can be handled and packaged/shipped immediately
Choosing an alternative technology that is ideal for modern, sensitive products
Traditional terminal sterilization methods (i.e., ethylene oxide [EtO], gamma, heat) are designed for robustness and scale but often introduce compromise for prefilled syringes and biologic drug products:
High heat and radiation degrade proteins
High heat from EtO, steam, and VHP can lead to protein denaturation:
Ionizing radiation from x-ray and gamma can break the protein chains:
Pressure changes (due to vacuums) can force syringe plungers to move, allowing microbes and sterilant to contaminate the biologic drug products
This movement creates risks for:
HEADSPACE
Prefilled syringes have a small amount of gas-filled space between the product and stopper/plunger
PLUNGER MOVEMENT
When exposed to low pressure (vacuum), this air expands and then contracts when then pressure increases, forcing the plunger to move up and down
MICROBIAL PLUNGER VEILING
Veiling occurs when the plunger moves and traps microbes between the plunger and syringe wall, shielding them from sterilant
INGRESS
Plunger movement may pull sterilant into the drug itself and contaminate the biologic active ingredient
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