Technology & services
End-to-end sterilization services and support
Noxilizer offers support for companies throughout the product’s development and commercialization.
Expert in-house microbiology and materials science team Sterilization testing to your requirements Testing services performed at our Hanover, MD facility Expert in-house microbiology and materials science team Sterilization testing to your requirements Testing services performed at our Hanover, MD facility
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
- 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 API 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
* Noxilizer is compliant with ISO 14937 and ISO 11135 standards.
Validation per ISO 14937*
- Microbiological performance qualification
- Process performance qualification
- Commercial product stability
- Routine processing and contract sterilization
- Clinical sample testing
- Load-mapping or pre-conditioning
* Noxilizer is compliant with ISO 14937and 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) process on behalf of a customer.
Companies that have selected NO2 as the sterilization method for the product*
1
FORTUNE 150 BIOTECH (US)
1
FORTUNE GLOBAL 200 BIOTECH (EU/US)
6
PUBLICLY-HELD BIOTECHS (EU, ASIA)
*As of January 2026.
Coming soon in 2027
Contract sterilization
Streamlined sterilization solution
On-demand, turn-key, 1-stop sterilization option
- Full on-site lab with expert in-house microbiology team; complete release testing & batch documentation
- On-site final packaging option
- All required consumables on-site
- Manage all safety, environmental, qualification, maintenance, etc.
Lower inventory costs
Rapid processing
- Door-to-door in a little as 2 days + short cycle times (7-11 hours) Supply-chain friendly location
Supply-chain friendly location
- Conveniently located next to the Baltimore Washington International Airport and I-95 / I-295, in close proximity to global pharmaceutical companies and some of the leading contract manufacturing organizations (CMOs).
Lower risk
Regulatory & quality compliance assurance
- ISO 13485:2016; CE Mark; ISO 14937:2009; FDA 21 CFR Part 820 Supply chain resilient
Supply chain resilient
- Significant capacity – 5 sterilization units each processing up to 2.5 million prefilled syringes per year
- Cold-chain enabled; on-site cold storage
- Multiple redundancies – BI manufacturing; back-up generator
Full life-cycle support
Expert R&D support to enable development through validation and on-going sterilization
- 13 years expert laboratory services
- On site materials science team
Sterilization equipment in your facility
- 1, 2 and 3 Pallet sterilizers
- Mezzanine and longitudinal configurations
- Installation–SAT, IQ, OQ, Validation, PQ
- Dedicated service engineers to support the warranty and provide planned maintenance and corrective service
Ready to talk?
Our team can provide you with more information.
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