Pharmaceutical
Pharmaceutical & Cleanroom Decontamination
VHP decontamination engineered for pharmaceutical manufacturing — validated process architectures for the most demanding regulated environments.
Approach
The inventor, not the catalog.
Pharmaceutical manufacturing environments present unique decontamination challenges — complex geometries, sensitive equipment, stringent regulatory documentation requirements, and the absolute necessity of validated outcomes. Commodity VHP providers sell equipment. PuroGen invents validated process architectures.
When your cleanroom has unique requirements — unusual chamber geometries, novel material combinations, integration with existing environmental monitoring — you want the organization that invented the technology, not one that resells it.
Applications
Validated for every critical environment.
PuroGen's VHP platforms are deployed across the full spectrum of pharmaceutical manufacturing environments.
Cleanroom Decontamination
Whole-room VHP decontamination for classified environments — achieving log-6 reduction across all surfaces without compromising HEPA filter integrity or damaging installed equipment.
Isolator Decontamination
Rapid, validated decontamination cycles for production isolators with uniform hydrogen peroxide distribution and verified decomposition before re-entry.
Aseptic Processing Environments
Environmental bioburden control for Grade A/B zones, ensuring aseptic conditions are maintained through validated, documented decontamination protocols.
Fill-Finish Areas
Decontamination of fill-finish suites and equipment between production campaigns. No residue, no aeration delays, no impact on product contact surfaces.
Lyophilizer Chambers
VHP decontamination of lyophilization chambers and associated transfer pathways — compatible with shelving, door seals, and condenser surfaces.
Methodology
Built for inspection readiness from day one.
PuroGen builds documentation into the process design from day one. Decontamination protocols are developed with IQ/OQ/PQ frameworks as design inputs — not afterthoughts applied to finished systems.
When validation is treated as a design input rather than a final checkpoint, the resulting system is inherently correct — not merely compliant.
cGMP Compliance
Process architecture aligned with current Good Manufacturing Practice requirements for pharmaceutical manufacturing, including 21 CFR Part 211 environmental controls.
FDA Expectations
Documentation structured for FDA inspection readiness — validated cycle development, biological indicator placement studies, and ongoing monitoring protocols.
Compatibility
Compatible with your existing infrastructure.
VHP is compatible with the materials found in standard pharmaceutical manufacturing environments — no facility modifications required.
HEPA Filters
No degradation over validated cycle parameters
Stainless Steel
316L and 304 — standard pharmaceutical surfaces
Electronics
Control panels, sensors, and monitoring equipment
Gaskets & Seals
EPDM, silicone, and standard cleanroom sealing materials
Polycarbonate
Windows, viewing panels, and enclosures
Epoxy Flooring
Standard cleanroom flooring systems
Discuss your cleanroom decontamination requirements.
Every pharmaceutical environment is unique. Our engineering team is available to discuss your facility's specific requirements.