Private Label & OEM
Your brand, our science.
PuroGen engineers bespoke VHP sterilization and purification systems for partners who require validated capability without the burden of building it internally. The fastest path to a validated system is through the organization that invented one.
The Proposition
Validated sterilization capability — delivered, not developed.
Building a VHP sterilization platform from the ground up requires deep expertise in reagent chemistry, chamber dynamics, cycle development, material compatibility, and regulatory validation. The engineering timeline alone spans years. The regulatory pathway adds more.
PuroGen has already completed that journey — across multiple regulated industries, with a patent portfolio and validation heritage that spans three decades. Our private label and OEM programs give partners direct access to this institutional knowledge, delivered as a system engineered specifically for their requirements.
You are not licensing a product. You are partnering with the organization that invented the technology — and the engineering depth that comes with it.
Capabilities
Every engagement draws on PuroGen's complete engineering, validation, and manufacturing capability — not a subset.
Custom Engineering
System architecture designed to your specifications — chamber geometry, cycle parameters, material compatibility, and facility integration requirements defined collaboratively.
Validation-Integrated Development
IQ/OQ/PQ protocols, process documentation, and regulatory submission support built into every development cycle — not appended after the fact.
Manufacturing & Delivery
Complete fabrication, assembly, quality assurance, and commissioning. Systems delivered production-ready with full documentation and training.
30 Years
Continuous R&D in VHP sterilization and purification
IQ/OQ/PQ
Validation integrated from first specification through delivery
Full IP
Patent portfolio backing every system we build
Partnership Process
A systematic path from requirements to validated system.
Every stage is structured, documented, and designed to produce the evidence required for regulatory submissions in your target markets.
Inquiry & Scoping
Define requirements, constraints, and regulatory context.
We begin with a structured technical dialogue to understand your sterilization requirements, product portfolio, regulatory pathway, and operational constraints. This stage establishes the project scope, timeline expectations, and engagement structure — ensuring alignment before any engineering begins.
Key Outputs
Specification & Design
Collaborative system architecture and performance criteria definition.
PuroGen engineers work directly with your technical team to define system architecture, performance specifications, and acceptance criteria. Every specification is developed against regulatory requirements — not adapted to them after the fact. Design reviews are iterative and documented.
Key Outputs
Development & Prototyping
Engineering, fabrication, and iterative validation cycles.
System construction proceeds in parallel with validation protocol development. Prototype systems undergo cycle development testing to optimize parameters for your specific product portfolio. Each iteration is documented and traceable — building the validation evidence package from day one.
Key Outputs
Validation & Documentation
Complete IQ/OQ/PQ execution with regulatory documentation.
Full Installation Qualification, Operational Qualification, and Performance Qualification executed against pre-approved protocols. Biological indicator challenges, parametric monitoring, and process reproducibility studies produce the evidence package required for regulatory submissions in your target markets.
Key Outputs
Delivery & Commissioning
Installation, operator training, and ongoing technical support.
Systems are delivered with complete documentation packages, commissioned on-site by PuroGen engineers, and accompanied by comprehensive operator training. Post-commissioning support ensures sustained operational performance and provides a direct line to the engineering team that designed your system.
Key Outputs
Deliverables
What You Receive
A private label partnership with PuroGen delivers more than hardware. Every engagement produces a complete, validated, regulation-ready sterilization capability under your brand.
Your Branded System
Validation Package
Operational Readiness
Ongoing Partnership
Institutional Depth
The Difference Between a Supplier and an Inventor
Most contract manufacturers build to specifications provided by the customer. PuroGen writes the specifications — because we invented the underlying technology. Our private label partners benefit from direct access to the engineering team that developed SteriFlex, TheBOX, T10⁶, and Reactive Oxygen.
This means cycle development is informed by first-principles understanding of VHP chemistry and transport phenomena — not interpolation from a reference table. It means validation protocols reflect decades of regulatory engagement across FDA, Health Canada, and international standards bodies. It means technical challenges are resolved by the people who understand the science, not just the assembly.
When your sterilization requirements evolve — new materials, new product geometries, new regulatory markets — PuroGen's engineering depth ensures your system evolves with them. This is the structural advantage of partnering with the inventor.
The fastest path to a validated VHP system is through the organization that has already validated dozens.
Who We Serve
Built for regulated industries.
PuroGen partners with organizations that require validated sterilization capability without the burden of building it internally. Our private label and OEM programs serve business development leaders at life sciences companies, contract sterilization organizations expanding beyond EtO, and medical device manufacturers navigating the transition to VHP.
The common thread: these are organizations that recognize the fastest path to a validated system is through an organization that has already invented one — and has the regulatory track record to prove it.
Life Sciences Companies
Organizations seeking validated sterilization platforms for tissue processing, biologics, or pharmaceutical applications — branded under their own identity.
Contract Sterilizers
Service providers adding VHP capability to their offering — expanding beyond ethylene oxide with a proven, customizable platform.
Device Manufacturers
Companies bringing sterilization in-house with a system engineered and validated specifically for their device portfolio and regulatory pathway.
Begin a conversation.
Every partnership starts with understanding your requirements. Let's define the scope together.