You're transforming medicine.
We're preserving product integrity.

The only ultra-low temperature, low-pressure nitrogen dioxide (NO₂) sterilization platform designed to protect your prefilled syringes and biologic drug-device combination products from ingress and protein degradation.

You’re advancing medical innovation.
We’re optimizing supply chain efficiency.

Shorter sterilization cycles, combined with no need to off-gas, accelerates batch release and supply chain timelines.

You’re creating life-changing products.
We’re offering an EtO alternative.

NO2 sterilization delivers sterility assurance leaving none of the carcinogenic, cytotoxic or teratogenic residuals associated with ethylene oxide (EtO).

Trusted by
industry leaders

Companies partnering with Noxilizer include Fortune 150 biotech companies, pharmaceutical companies, and medical device manufacturers

Sterilization platform of choice

Multiple prefilled syringe products committed to using NO2 sterilant

Proven regulatory success

Approvals & authorizations of customer products from FDA, EMA, and Health Canada

13

Years offering proven lab services creating bespoke sterilization protocols

Our Certifications

ISO 13485 Certificate of Registration
ISO 14937 Compliance
EU Regulatory 
Compliance (CE)
21 CFR Part 11 / EU 
Annex 11 Compliance

Which best describes you?

Ophthalmic
prefilled syringe

Biologic drug-device 
combination product

Medical Device

Exploring alternatives to ethylene oxide

The right sterilant for today's medical innovations

Noxilizer, with its proprietary NO2 sterilization technology, opens new avenues for innovation by offering an efficient and scalable alternative to traditional sterilization methods, with several key advantages that make it particularly effective in the sterilization of ophthalmic prefilled syringes, biologic drug-device combination products, and other medical innovations that are compromised by traditional sterilization technologies.

Effective

  • Delivers proven sterility without material damage
  • Compatible with complex materials and packaging

Works where other approaches don't

  • Preserves sensitive drugs and devices
  • Maintains drug stability in combination products
  • Minimizes risk of plunger movement

Customizable

Enables customization by product type

Supply chain efficient

  • Speeds time-to-market
  • Flexibility

Regulatory Readiness

  • Confidence – Lower regulatory and submission risk
  • Support – Expert support for filing

Enables product development

  • Supports development through commercialization

Low risk, reliable partner

Sustainable

Supports sustainability goals

Support from R&D
to commercialization

Consulting and expert advice

Materials, packaging, labelling and R&D study design

R&D studies: early proof of concept through to validation

Expose and return, feasibility, scaling, process definition,
and validation 

Regulatory support

Expert consultation, data collection & documentation, and support for preparation of regulatory submissions

IP licensing

Preparation for submissions to reduce commercial risk

Contract sterilization vs. Capital install 

Coming soon in 2027

Contract sterilization

Fast turnaround. Release product in days, not weeks

  • 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 biological indicators 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

NO2 sterilization is the only method that allows my company to use a plastic syringe, which is the best choice for our drug and for our patients.

  • Nitrogen dioxide is a sterilant with strong microbial lethality (degrades microbial DNA/RNA)
  • 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
  • Effective surface sterilization that does not penetrate liquid drug
  • Low vacuum option (depth of vacuum is 7 to 760 Torr)
  • Adjustable critical process parameters including: NO2 concentration, dwell time, RH, vacuum depth / chamber pressure, and temperature
  • 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 and packaged/shipped immediately
Confidence
  • Technology used in 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
  • 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
  • Lower societal and environmental burden than ethylene oxide (EtO) sterilization