Science
Research, Validation & Intellectual Property
Original research, validated platforms, and a patent portfolio that reflects deep expertise in sterilization science.
Patent Portfolio
Invented at the Bench, Protected in the Portfolio
Four patented technology platforms — each addressing a distinct sterilization challenge, each the result of original R&D rather than acquisition.
SteriFlex®
VHP Sterilization Platform
Parametric VHP sterilization with adjustable dwell times, reagent dosing, vacuum profiles, and humidity control for medical device and tissue processing applications.
T10⁶®
Supercritical CO₂ Processing
Non-irradiated sterilization of biological tissue using supercritical carbon dioxide. Achieves SAL 10⁻⁶ while preserving osteoinductivity and mechanical integrity.
TheBOX®
Enclosed VHP Chamber
Patented enclosed sterilization chamber designed for integration into cleanroom, laboratory, and manufacturing environments with automated cycle management.
Reactive Oxygen™
Advanced Oxidation Chemistry
Proprietary reactive oxygen species formulation for surface decontamination and environmental bioburden reduction in controlled environments.
Validation Heritage
Evidence, Not Claims
PuroGen's validation portfolio reflects decades of systematic testing, regulatory submission, and clinical application — the kind of evidence base that due diligence teams are built to evaluate.
SAL 10⁻⁶
Sterility assurance level validated across multiple platforms and applications
30+ Years
Continuous R&D in sterilization science, tissue processing, and VHP technology
US & Canada
Regulatory approvals for non-irradiated tissue products in both markets
4 Platforms
Patented technology systems spanning VHP, scCO₂, and reactive oxygen chemistry
Validation Domains
Sterility Assurance
SAL 10⁻⁶ validated across multiple biological indicators, organism challenges, and load configurations. The gold standard for terminal sterilization.
Material Compatibility
Comprehensive testing across polymers, metals, electronics, composites, and biological tissues. Documentation of material properties pre- and post-sterilization.
Biological Integrity
Preservation of osteoinductivity, osteoconductivity, growth factors, and mechanical properties in processed allograft tissue. Clinical outcome correlation.
Regulatory Framework
Standards, Guidance & Regulatory Recognition
The regulatory landscape for VHP sterilization has matured significantly. PuroGen's platforms are aligned with current and emerging regulatory requirements.
January 8, 2024
VHP reclassified from Category B (novel) to Category A (established) sterilization method by the U.S. Food and Drug Administration. Recognized alongside steam and ethylene oxide.
2024
International standard for sterilization of health care products using vaporized hydrogen peroxide. Provides the regulatory framework for VHP validation and quality management.
2024–2026
Environmental Protection Agency mandating 90% reduction in ethylene oxide emissions from commercial sterilization facilities. Driving industry transition to alternative modalities.
Ongoing
FDA guidance documents supporting VHP as a viable sterilization modality for medical devices, including parametric release and biological indicator testing protocols.
Classification Framework
Understanding FDA Sterilization Categories
The FDA classifies sterilization methods into three tiers based on the maturity of scientific evidence, published literature, and regulatory precedent. This framework directly impacts the validation pathway and regulatory burden for device manufacturers.
Established
Methods with extensive published literature, validated biological indicators, and well-defined regulatory pathways. Reduced burden of demonstrating method suitability.
Includes: Steam, Dry Heat, EtO, Radiation, VHP (as of January 2024)
Developing Evidence
Methods with a growing evidence base but no recognized consensus standard. Higher regulatory burden — manufacturers must build the case for method suitability.
Includes: Ozone, Nitrogen Dioxide, Chlorine Dioxide
Novel
Methods still undergoing foundational research. No established regulatory pathway. Significant burden of proof required for any submission.
Includes: Supercritical CO₂ (for most device applications), other novel approaches
Why This Matters in the U.S.
VHP's move from Category B to Category A means the FDA now recognizes VHP as having sufficient scientific evidence and regulatory precedent to support streamlined validation pathways. For device manufacturers, this transforms VHP from an alternative requiring novel justification into an established method requiring only process-specific validation — the same standard applied to steam, EtO, and irradiation.
Why This Matters Internationally
ISO 22441 is not a U.S.-specific standard — it is an international consensus standard recognized by EU Notified Bodies under MDR 2017/745, Health Canada, TGA (Australia), and regulatory authorities across Asia-Pacific. Device manufacturers validating against ISO 22441 produce documentation accepted globally — enabling market access in the EU, U.S., and beyond from a single validation framework.
Technical Resources
Technical Briefs & Documentation
Detailed technical documentation for evaluation by engineering, regulatory, and business development teams.
VHP Sterilization: Mechanism of Action
Technical overview of gas-phase hydrogen peroxide oxidation, microbicidal activity, and decomposition kinetics.
SteriFlex Platform Specifications
Engineering specifications, parametric control ranges, and integration requirements for the SteriFlex sterilization platform.
Material Compatibility Guide
Comprehensive compatibility data for VHP sterilization across polymers, metals, electronics, and composite materials.
Non-Irradiated Tissue Processing
T10⁶ and SteriFlex validation data for allograft tissue sterilization — biological integrity preservation and sterility assurance.
EtO Transition Planning Guide
Strategic framework for medical device manufacturers evaluating VHP as an ethylene oxide replacement.
Regulatory Pathway Overview
FDA Category A classification, ISO 22441 compliance requirements, and validation protocol considerations for VHP adoption.
Technical Due Diligence Starts Here
PuroGen welcomes rigorous evaluation. Our validation heritage, patent portfolio, and regulatory alignment are designed to withstand the scrutiny of serious partners.