Biotechnology
Biotechnology & Life Sciences Research
Validated VHP decontamination for the environments where contamination isn't an inconvenience — it's a catastrophe.
The Problem
Contamination in biotech is not a quality issue. It is an existential one.
A single contamination event in a cell therapy production run can cost hundreds of thousands of dollars — not just in lost material, but in lost time, regulatory scrutiny, and patient impact. In BSL-3/4 environments, the stakes include human safety.
Prevention through validated decontamination is not optional. It is the foundation upon which every downstream process depends.
$500K+
Potential cost of a single contamination event in cell therapy manufacturing
SAL 10⁻⁶
Sterility assurance level achieved by PuroGen's SteriFlex platform
Zero
Toxic residues — VHP decomposes to water and oxygen only
Applications
Across the biotech spectrum.
PuroGen's VHP platforms serve the full range of biotechnology and life sciences research environments.
Cell Culture Facilities
Environmental decontamination for cell therapy production suites, stem cell laboratories, and primary cell isolation environments — where a single contamination event can destroy months of work.
BSL-2/3/4 Laboratories
Room-level and cabinet-level decontamination for biosafety laboratories handling infectious agents. VHP achieves validated sporicidal efficacy without the safety concerns of formaldehyde fumigation.
Bioreactor Sterilization
Surface decontamination of bioreactor vessels, ports, and transfer lines. Compatible with stainless steel, glass, and the polymeric tubing used in single-use bioreactor systems.
Fermentation Equipment
Decontamination between fermentation runs for pharmaceutical and industrial biotech applications — eliminating cross-contamination risk without thermal damage to temperature-sensitive components.
Tissue Engineering Labs
Cleanroom decontamination for scaffold fabrication, 3D bioprinting environments, and tissue maturation chambers where both sterility and material compatibility are critical.
SteriFlex for Biotech
Customizable parameters for different substrates and equipment.
Biotech environments are diverse — a cell culture cleanroom has fundamentally different decontamination requirements than a BSL-3 containment suite or a fermentation bay. SteriFlex's programmable parametric control allows each application to be optimized independently.
Adjustable dwell times, reagent concentrations, humidity control, and cycle sequencing mean that decontamination protocols can be tailored to the specific biological substrates, equipment types, and regulatory frameworks that define each environment.
Regulatory Alignment
PuroGen's decontamination protocols are designed for regulatory environments from the outset.
Cell & Gene Therapy
FDA guidance for cell and gene therapy manufacturing requires validated environmental controls. VHP decontamination meets these requirements with documented, reproducible efficacy.
GMP Compliance
PuroGen's decontamination protocols align with cGMP requirements for biological product manufacturing, including validated cycle development and ongoing environmental monitoring.
Biosafety Standards
VHP decontamination is recognized for use in BSL-3 and BSL-4 facility decontamination, meeting CDC/NIH biosafety guidelines for agent-specific inactivation.
Discuss your biotech decontamination requirements.
PuroGen works directly with biotech manufacturers, research institutions, and facility designers on validated decontamination solutions.