Technology & Services
End-to-end
sterilization services
and support
Noxilizer offers support for companies’ products from development through commercialization.
Material & packaging
consulting
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.
Proven regulatory success
Approvals & authorization of customer products from FDA, EMA, and Health Canada
Process overview
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
Fast turnaround. Release product in days, not weeks
- 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
Ready to talk?
Our team can provide you with more information.
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