FAQ

Frequently Asked Questions

Technical and partnership questions organized by audience — from foundational VHP science to specific regulatory and process details.

General

Foundational questions about PuroGen's technology and applications.

VHP sterilization uses hydrogen peroxide in its gas phase to achieve microbial inactivation. The process operates at room temperature, leaves no toxic residue — decomposing only to water and oxygen — and is compatible with a wide range of materials including polymers, metals, and electronics. PuroGen's SteriFlex platform provides fully programmable parametric control over VHP processes.

Reactive Oxygen™ is PuroGen's proprietary advanced oxidation chemistry for surface decontamination and environmental bioburden reduction. It generates reactive oxygen species that rapidly inactivate microorganisms on contact while remaining compatible with sensitive materials and environments.

PuroGen's validated sterilization and decontamination systems serve multiple regulated industries: allograft tissue processing, medical device sterilization, pharmaceutical and cleanroom decontamination, semiconductor fabrication, biotechnology and life sciences research, and seed and agricultural genetics.

PuroGen invents validated process architectures — we don't adapt commodity equipment to meet specifications. With 30 years of development, a patent portfolio spanning multiple systems (SteriFlex™, TheBOX®, T10⁶®, Reactive Oxygen™), and a validation-first methodology, PuroGen brings the depth of the inventor rather than the breadth of a catalog.

For Device Manufacturers

Sterilization transition, regulatory pathways, and material compatibility.

VHP operates at room temperature with no toxic residue, eliminating the 12–72 hour aeration period required by EtO. VHP produces no carcinogenic byproducts and faces no EPA emission restrictions. The FDA reclassified VHP to Category A in January 2024, recognizing it as an established sterilization method on par with legacy modalities.

VHP sterilization is recognized under FDA Category A (January 2024) and ISO 22441. For device manufacturers, the pathway involves process validation (IQ/OQ/PQ), sterility assurance level demonstration (SAL 10⁻⁶), and biocompatibility testing. PuroGen integrates regulatory documentation into the development process from day one.

VHP is compatible with most common device materials including stainless steel, titanium, PEEK, polyethylene, polypropylene, silicone, and most medical-grade polymers. Material compatibility studies are a standard component of PuroGen's validation process. Specific compatibility can be assessed during the initial technical consultation.

Yes. VHP transition requires revalidation of the sterilization process, but the device itself typically does not require redesign. PuroGen has experience guiding manufacturers through EtO-to-VHP transitions, including regulatory submission support and parallel validation strategies that minimize disruption.

For Partners

Partnership models, co-development, and engagement structure.

PuroGen engages through three primary models: Direct Application (PuroGen deploys validated systems into your environment), Private Label & OEM (bespoke systems manufactured under your brand), and Strategic Collaboration (licensing, co-development, and deeper institutional arrangements). The appropriate model depends on the scope and nature of the engagement.

Co-development follows a structured pathway: requirements definition, collaborative system specification, engineering and prototyping, iterative validation cycles (IQ/OQ/PQ), and production-ready delivery with full documentation. Throughout the process, PuroGen's engineering team works alongside your technical staff to ensure the system meets both performance and regulatory requirements.

Yes. PuroGen's Private Label & OEM program delivers complete VHP sterilization and decontamination systems manufactured to your specifications, delivered under your brand with full validation documentation. Your brand, our science.

Licensing structures are tailored to the specific technology, application domain, and scope of use. PuroGen's patent portfolio covers multiple system architectures and process methodologies. Licensing discussions begin with a technical assessment and are structured to align mutual institutional objectives. Contact us to begin a confidential conversation.

Technical

Performance specifications, process parameters, and validation details.

PuroGen's SteriFlex platform achieves SAL 10⁻⁶, the standard required for terminal sterilization of medical devices and implants. This represents a one-in-a-million probability of a single viable microorganism surviving on a sterilized item — the same assurance level required of established methods like EtO and gamma irradiation.

VHP sterilization typically operates between 25°C and 50°C, making it a true low-temperature sterilization method. This range is compatible with heat-sensitive materials, electronics, and biological substrates that would be damaged by steam (121–134°C) or other thermal methods.

Cycle times depend on chamber volume, load configuration, target SAL, and specific process parameters. Typical cycles range from 30 minutes to several hours. SteriFlex's programmable parametric control allows cycle optimization for specific applications — balancing throughput requirements with validated sterility outcomes.

No. Hydrogen peroxide in the vapor phase decomposes to water (H₂O) and oxygen (O₂). There are no toxic residues, no aeration period required, and no environmental byproducts. This is a fundamental advantage over EtO, which requires extended aeration to remove carcinogenic residues.

Yes. VHP is recognized by the FDA as a Category A sterilization method (January 2024) and is covered by ISO 22441. PuroGen's validation methodology includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), with all documentation structured for regulatory submission.

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