Solutions

Validated systems for regulated industries.

PuroGen deploys patented VHP platforms directly into regulated industries. Each vertical represents a domain where our invented systems solve a specific constraint.

Every system PuroGen deploys originates from the same invention methodology: regulation as design input, validation as method, documentation as architecture. The result is platforms that are not adapted to compliance — they are built from it.

Primary Verticals

Allograft Tissue Processing

PuroGen's deepest domain. Sustained invention in tissue processing has produced SteriFlex® and T10⁶® — validated sterilization platforms that achieve terminal sterility without compromising biological performance.

Non-irradiated tissue products approved for clinical use in the United States and Canada. The heritage that established PuroGen's regulatory-first approach to system design.

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Medical Device Sterilization

Vaporized hydrogen peroxide sterilization for medical devices requiring material-compatible, residue-free terminal processing. A direct alternative to ethylene oxide with validated efficacy and no toxic residuals.

FDA reclassified VHP sterilization to Category A (January 2024), recognizing it as an established sterilization method. PuroGen's systems were designed for this standard before it existed.

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Pharmaceutical & Biotechnology

Controlled environment decontamination and isolator bio-decontamination for pharmaceutical manufacturing and biotechnology research. Systems engineered for cleanroom integration and continuous validated operation.

cGMP-aligned systems that integrate with existing facility infrastructure. Validation documentation designed to satisfy regulatory audit requirements from the point of installation.

Cannabis & Hemp Purification

Validated Reactive Oxygen™ systems for microbial remediation and pathogen reduction in cannabis and hemp processing. Pharmaceutical-grade purification that eliminates contaminants while preserving cannabinoid and terpene profiles.

TheBOX® platform deployed across licensed facilities. Validated protocols for total yeast and mold reduction, aspergillus remediation, and post-harvest treatment without irradiation or chemical residuals.

Spice & Seed Purification

Pathogen reduction and decontamination systems for spice processing and seed treatment. Validated VHP and Reactive Oxygen platforms that achieve microbial safety without compromising flavor profiles, germination viability, or organic certification.

Food-safe sterilization addressing Salmonella, E. coli, and spoilage organisms. Systems designed for FSMA compliance and integration with existing processing infrastructure.

Emerging Applications

Domains where PuroGen's validated platforms are extending into new regulatory and performance requirements.

Emerging

Semiconductor Fabrication

Ultra-clean decontamination for fabrication environments where particulate and microbial control directly impact yield. VHP systems engineered for the precision demands of semiconductor manufacturing.

Emerging

Seed & Crop Genetics

Pathogen reduction and treatment systems for seed processing and crop genetics research. Extending pharmaceutical-grade control to agricultural science without compromising germination viability.

Platform Foundations

Every deployment across these verticals is built on PuroGen's core invented platforms — each patented, each validated, each representing a distinct advancement in purification science.

TheBOX®

Reactive Oxygen system

Reactive Oxygen™

Advanced oxidation platform

Discuss your requirements.

Every regulated environment has specific constraints. Tell us about yours.

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