Tailin HTY-V350 Vaporized Hydrogen Peroxide (VHP) Sterilizer

Overview

The Tailin HTY-V350 Vaporized Hydrogen Peroxide (VHP) Sterilizer is an engineered decontamination system designed for terminal sterilization of large-scale enclosed environments—primarily cleanrooms, isolators, biosafety cabinets, animal housing facilities, and laboratory containment suites. It operates on the principle of controlled vapor-phase delivery of hydrogen peroxide (H₂O₂) generated via flash vaporization technology. Unlike liquid or aerosol-based methods, VHP achieves uniform distribution as a true molecular vapor, enabling deep penetration into complex geometries and porous surfaces without condensation. The active biocidal species—hydroxyl radicals (•OH)—are generated in situ during vapor decomposition and react non-specifically with microbial proteins, lipids, and nucleic acids, resulting in rapid, residue-free inactivation of bacteria, spores, viruses, and fungi. This mechanism aligns with internationally recognized oxidative sterilization pathways validated under ISO 14937 and EN 17141.

Key Features

• VHPS™ (Vaporized Hydrogen Peroxide System) Flash Vaporization Module: Next-generation thermal flash evaporation core delivering ≥2× higher vapor output efficiency versus prior-generation modules; enables consistent saturation across volumes up to 400 m³ without localized condensation.
• Integrated Environmental Monitoring Interface: Supports real-time connection to NIST-traceable, tri-parameter sensors measuring H₂O₂ vapor concentration (ppm), relative humidity (%RH), and ambient temperature (°C); sensor calibration certificates provided with full traceability documentation.
• GMP-Compliant Control Architecture: Three-tier user permission system (Operator / Supervisor / Administrator) enforces role-based access control for parameter editing, cycle initiation, and audit log review; all actions timestamped and logged with immutable records.
• Uniform Distribution Design: Four independently controllable vapor outlets combined with integrated axial fans ensure 360° directional dispersion; computational fluid dynamics (CFD)-informed airflow patterns minimize dead zones and support ISO 14644-3 Class 5–8 environment compatibility.
• Full Lifecycle Validation Support: Includes pre-installation material compatibility testing (per ISO 10993-5), on-site Installation Qualification (IQ), Operational Qualification (OQ), and process-specific Biological Indicator (BI) challenge studies using Geobacillus stearothermophilus spores.

Sample Compatibility & Compliance

The HTY-V350 is validated for use with common cleanroom construction materials including stainless steel (304/316L), epoxy-coated walls, PVC flooring, HEPA filter housings, and polymeric gaskets. It complies with key regulatory frameworks governing pharmaceutical and biomedical facility operations, including EU GMP Annex 1 (2022), USP <797> and <800>, FDA Aseptic Processing Guidance, and ISO 14644-2:2015 for monitoring requirements. All sterilization cycles generate electronic records compliant with 21 CFR Part 11 for electronic signatures and audit trail integrity. Filter units meet ISO 14644-3 Class H14 specification (≥99.995% @ 0.3 µm).

Software & Data Management

The embedded control software provides cycle programming, real-time graphing of vapor concentration and environmental parameters, and automated report generation in PDF/CSV formats. Cycle data—including start/stop timestamps, setpoints, actual readings, alarm events, and user authentication logs—are stored locally with optional network backup. Audit trails are immutable and time-stamped; export functionality supports integration with LIMS or MES platforms via standard OPC UA or Modbus TCP protocols. Optional cloud-based remote monitoring (with TLS 1.2 encryption) allows off-site supervision while maintaining data sovereignty per GDPR and HIPAA-aligned policies.

Applications

• Terminal decontamination of Grade A/B cleanrooms and RABS in sterile pharmaceutical manufacturing.
• Decontamination of ABSL-2/ABSL-3 animal housing systems between study phases.
• Recovery of biosafety cabinets and laminar flow hoods following high-risk procedures.
• Pre-occupancy sterilization of new laboratory build-outs or after maintenance interventions.
• Emergency response disinfection in outbreak containment scenarios where rapid, non-corrosive bioburden reduction is required.

FAQ

What is the maximum recommended chamber volume for validated operation?
The HTY-V350 is validated for continuous, uniform sterilization in enclosed spaces up to 400 m³ under controlled environmental conditions (≤85% RH, stable ambient temperature). Larger volumes require multi-unit deployment or extended cycle times with additional validation.
Does the system support integration with building management systems (BMS)?
Yes—via Modbus TCP or dry-contact I/O interfaces, enabling interlock with HVAC dampers, door status sensors, and alarm relays per ISO 14644-4 requirements.
How frequently must the vaporization module be serviced?
Under normal operation (≤20 cycles/month), the VHPS flash module requires preventive maintenance every 12 months; service includes thermal element inspection, nozzle cleaning, and performance verification against factory baseline data.
Is third-party validation support available?
Tailin provides IQ/OQ protocol templates, on-site execution support by qualified validation engineers, and co-signature of final reports aligned with PIC/S TR13 and ASTM E2994 standards.
Can the unit operate with alternative concentrations of hydrogen peroxide?
No—the system is calibrated and safety-interlocked exclusively for 35% w/w food-grade hydrogen peroxide solution meeting USP/EP specifications; deviation invalidates validation and voids warranty.