Platform
SteriFlex™
Patented low-temperature VHP sterilization with complete parametric customization. The platform your company can license, private label, or co-develop.
SAL 10⁻⁶
Sterility assurance level — the gold standard for medical and pharmaceutical sterilization
Low-Temp
Room-temperature process preserves heat-sensitive materials and biological integrity
Patented
Original VHP technology developed from first principles — not acquired, not adapted
Full Control
Complete parametric customization — dwell times, dosing, vacuum, humidity
Parametric Customization
Engineered for Your Process
SteriFlex is not a fixed-cycle sterilizer. Every parameter is independently adjustable — creating a sterilization process tailored to specific device portfolios, material constraints, and regulatory requirements.
This level of control enables validation against specific organism challenges and load configurations, integrating seamlessly into existing quality management systems and validated production workflows.
Dwell Time
Adjustable exposure duration optimized for specific bioburden and load configurations
Reagent Dosing
Precise H₂O₂ concentration control for reproducible sterilization across every cycle
Vacuum Settings
Flexible vacuum profiles for enhanced vapor penetration into complex geometries
Humidity Control
High-humidity environment capability for materials requiring moisture management
Temperature Range
Low-temperature operation (25–50°C) protecting thermally sensitive substrates
Cycle Programming
Multi-phase cycle architecture for validation against specific organism challenges
Validated Applications
Proven Across Regulated Environments
SteriFlex has been validated for sterilization and decontamination across the most demanding applications in healthcare, pharmaceutical, and biotechnology settings.
Medical Device Sterilization
Endoscopes, catheters, implantables — validated EtO alternative for heat-sensitive devices
Pharmaceutical Manufacturing
Cleanroom decontamination, vaccine production lines, injectable fill-finish environments
Biotechnology Research
Cell cultures, tissue engineering scaffolds, recombinant DNA processing equipment
Biosafety Cabinets & Isolators
Complete chamber decontamination with zero toxic residue — no aeration downtime
Cryopreservation Equipment
Sterilization of containers and systems without thermal cycling of sensitive components
Allograft Tissue Transplant
Preserves osteoinductivity and osteoconductivity — biological integrity maintained
Bioreactors & Fermentation
Validated decontamination of complex internal geometries and multi-port systems
Laboratory Animal Facilities
Room-level and isolator decontamination with safe re-entry — water and oxygen byproducts
PPE & Protective Clothing
Material-compatible sterilization preserving barrier properties and structural integrity
Labware & Consumables
High-throughput sterilization of polymeric and composite laboratory materials
Integration
Designed for Existing Workflows
SteriFlex integrates into validated manufacturing and processing environments without requiring fundamental workflow redesign. The platform's parametric flexibility means it adapts to your existing quality system — not the other way around.
Whether replacing an ethylene oxide process, supplementing gamma irradiation, or establishing a new sterilization capability, SteriFlex provides the technical foundation for a smooth, well-documented transition.
License. Private Label. Co-Develop.
SteriFlex is available through multiple commercial pathways — from turnkey private-label manufacturing to deep strategic collaboration with PuroGen's engineering team.