Insights
Insights & Perspectives
Thought leadership from the intersection of sterilization science, regulatory evolution, and validated process engineering.
FDA Reclassifies VHP to Category A: What It Means for Medical Device Manufacturers
The FDA's reclassification of vaporized hydrogen peroxide sterilization to Category A formally recognizes VHP as an established sterilization method — a validation of the science PuroGen has practiced for three decades.
The EtO Transition: Timeline, Implications, and Alternatives
EPA mandates for 90% ethylene oxide emission reductions are reshaping the sterilization landscape. Understanding the timeline and evaluating validated alternatives is no longer optional for device manufacturers.
Non-Irradiated Tissue Sterilization: 30 Years of Preserving Biological Integrity
From the first supercritical CO₂ processes to today's SteriFlex platform, PuroGen's approach to tissue sterilization has always prioritized what matters most: preserving the biology that makes the graft work.
Why Programmable Sterilization Matters for Next-Generation Biologics
As biologics grow more complex, sterilization must become more precise. Programmable parametric control isn't a feature — it's a necessity for the next generation of cell therapies, gene therapies, and engineered tissues.
Two Years After Category A: The VHP Adoption Landscape in 2026
The FDA's January 2024 Category A reclassification opened a defined pathway for VHP sterilization adoption. Two years later, the landscape has shifted — ISO 22441 has matured, EPA EtO deadlines are compressing, and the first wave of in-house VHP deployments is underway.
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