Validation
System Validation & Regulatory Documentation
Controlled disclosure document. Intended for compliance review, technical due diligence, and regulatory assessment by qualified parties.
Regulatory Classification
Applicable Standards and Recognition
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, dry heat, ethylene oxide, and irradiation as an established terminal sterilization modality.
2022
International consensus standard for sterilization of health care products using vaporized hydrogen peroxide. Provides IQ/OQ/PQ validation framework, process development requirements, and quality management protocols. Referenced by FDA, EU Notified Bodies under MDR 2017/745, Health Canada, and TGA.
Applicable
ISO 22441 harmonization enables CE marking assessment by EU Notified Bodies using the same standards-based pathway applied to EtO (ISO 11135) and steam (ISO 17665) — without novel method justification.
2024–2026
EPA finalized rules requiring 90% reduction in ethylene oxide emissions from commercial sterilization facilities. Provides regulatory context for VHP adoption as an established alternative.
Technology Lineage
22+ Years of VHP Operation Under FDA Regulation
PuroGen has operated VHP sterilization systems under FDA regulation for human tissue since 2003 — over two decades before the FDA's 2024 Category A reclassification. The regulatory milestone confirmed what PuroGen's validation data had demonstrated for years.
SteriFlex, PuroGen's parametric VHP sterilization platform, was developed for allograft tissue processing applications requiring the simultaneous achievement of SAL 10⁻⁶ sterility and preservation of biological integrity. This constraint-first development produced a validation heritage not available from vendors whose VHP capability originates in commodity decontamination equipment.
Declared Validations
Completed Studies and System Validations
The following validation studies have been completed. Full study reports, protocols, and raw data are available under NDA/CDA to qualified parties.
Methodology
Validation Methodology Framework
PuroGen's validation methodology follows ISO 22441 and is structured to support regulatory submissions across multiple jurisdictions simultaneously.
Installation Qualification
Equipment installation verification
Utility and infrastructure confirmation
Sensor calibration documentation
As-built configuration record
Operational Qualification
Empty chamber cycle studies
Process parameter mapping
Cycle repeatability demonstration
Parameter range validation
Performance Qualification
Representative product load studies
Biological indicator challenges
SAL 10⁻⁶ demonstration
Sterility testing per USP / ISO
Documentation
Documentation Governance
Full validation reports, study protocols, raw data, and supporting documentation are maintained under PuroGen's quality management system. Access is provided to qualified parties under executed Non-Disclosure Agreement (NDA) or Confidential Disclosure Agreement (CDA).
Documentation is structured for multi-market regulatory submissions. Packages are available formatted for FDA 510(k)/PMA, EU MDR technical documentation, Health Canada, and TGA submissions.