Frequently Asked Questions

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.

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.

In January 2024, the FDA reclassified VHP from Category B (novel) to Category A (established). This means VHP now has the same regulatory standing as steam, dry heat, EtO, and radiation. For device manufacturers, it reduces the burden of demonstrating method suitability and provides a well-defined validation pathway through ISO 22441.

Category A recognition means you can reference an established body of scientific evidence and regulatory precedent when submitting VHP-sterilized devices. The validation pathway follows ISO 22441 and standard IQ/OQ/PQ protocols. You no longer need to justify VHP as a method — you need to validate your specific process, which is the same requirement applied to EtO and irradiation.

Yes. The combination of Category A regulatory clarity, ISO 22441 validation frameworks, and PuroGen's custom system engineering makes in-house VHP sterilization a defined project rather than an experimental one. PuroGen designs, builds, validates, and commissions systems tailored to specific device portfolios and facility requirements.

Sterilization revalidation typically requires 12-24 months of process development, validation runs, and regulatory submission — regardless of the alternative method. PuroGen supports parallel validation strategies that allow EtO and VHP processes to run concurrently during the transition period, minimizing production disruption.

ISO 22441:2022 is the international consensus standard for sterilization of health care products using vaporized hydrogen peroxide. It provides the validation framework — including requirements for process development, equipment qualification, and performance qualification — that manufacturers follow to demonstrate their VHP process meets regulatory requirements. Critically, ISO 22441 is not a U.S.-specific standard. It is recognized by the FDA, EU Notified Bodies under MDR 2017/745, Health Canada, TGA, and regulatory authorities globally.

Yes. Under EU MDR 2017/745, Notified Bodies assess sterilization processes against harmonized ISO standards. ISO 22441 provides VHP with the same standards-based assessment pathway that EtO manufacturers use through ISO 11135. Manufacturers validating against ISO 22441 produce documentation that supports CE marking without requiring novel method justification — the same standard applied to established sterilization methods across the EU.

Yes. ISO 22441 is an international consensus standard recognized across regulatory jurisdictions. A validation program structured against ISO 22441 produces documentation that supports FDA 510(k)/PMA submissions, EU CE marking under MDR 2017/745, Health Canada device licensing, and TGA (Australia) submissions. PuroGen structures validation documentation for multi-market regulatory use from the outset.