Tailin HTY-V150 Vaporized Hydrogen Peroxide (VHP®) Sterilization System
| Brand | Tailin |
|---|---|
| Origin | Zhejiang, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | HTY-V150 |
| Quotation Range | USD 14,000–70,000 |
| Air Flow Rate | 20 m³/h |
| Sterilization Volume Capacity | ≤150 m³ |
| Vaporization Temperature | ≤100 °C |
| Dehumidification Target RH | <85% |
| Filtration Efficiency | 99.99% (HEPA H14) |
| Sterilant | 35% Food-Grade Hydrogen Peroxide Solution |
| Microbial Log Reduction | ≥6-log (Geobacillus stearothermophilus spores) |
Overview
The Tailin HTY-V150 Vaporized Hydrogen Peroxide (VHP®) Sterilization System is an engineered solution for terminal decontamination of enclosed critical environments. It operates on the principle of flash vaporization—introducing 35% food-grade hydrogen peroxide solution into a high-velocity heated airstream at ≤100 °C, generating a stable, uniformly dispersed VHP vapor phase. This vapor penetrates complex geometries and porous surfaces, where reactive hydroxyl radicals (•OH) oxidize essential cellular components—including lipids, proteins, and nucleic acids—resulting in irreversible microbial inactivation. Unlike thermal or ethylene oxide methods, the HTY-V150 achieves sterilization under ambient temperature conditions with no toxic residue, making it suitable for routine use in GMP-regulated pharmaceutical cleanrooms, BSL-2/3 biosafety laboratories, vivariums, and isolator pass-through chambers.
Key Features
- Compact & Mobile Architecture: Weighing approximately 45 kg with integrated casters and ergonomic handle, the HTY-V150 supports flexible deployment across multiple controlled zones without permanent installation.
- Controlled Vapor Generation: Precision metering pump delivers hydrogen peroxide at adjustable rates from 1 to 7 g/min, enabling process optimization for varying chamber volumes and humidity profiles.
- Integrated Dehumidification Support: Designed to operate effectively when ambient relative humidity is maintained below 85%, ensuring optimal VHP condensation kinetics and biocidal efficacy.
- High-Efficiency Filtration: Equipped with H14-class HEPA filtration (≥99.99% @ 0.1–0.2 µm), capturing residual VHP aerosols and particulates during aeration, meeting ISO 14644-1 Class 5 air cleanliness requirements post-cycle.
- Electrical Compliance: Rated for 220 V ±22 V, 50 Hz ±1 Hz input; power consumption capped at 2.5 kW (10 A), compatible with standard industrial single-phase circuits.
Sample Compatibility & Compliance
The HTY-V150 is validated for compatibility with common cleanroom materials including stainless steel (316L), polycarbonate, silicone elastomers, epoxy-coated surfaces, and most pharmaceutical-grade polymers. It does not degrade HEPA filters, PVC flooring, or epoxy resin countertops under standard cycle parameters. The system supports validation protocols aligned with ISO 14937, ISO 11135 (for VHP-based processes), and EU Annex 1 (2022) requirements for sterilization of non-sterile manufacturing areas. While not FDA-cleared as a medical device, its operational parameters meet the technical basis for qualification under USP , PDA Technical Report No. 35, and PIC/S PI 036-2 for aseptic processing environment decontamination.
Software & Data Management
The HTY-V150 features a programmable logic controller (PLC)-based interface with real-time cycle logging. Optional VHP concentration monitoring (via electrochemical sensor) provides continuous ppm-level feedback, enabling closed-loop control and automated endpoint determination. All cycle data—including injection rate, vapor dwell time, RH history, and aeration duration—are timestamped and exportable in CSV format. Audit trails comply with ALCOA+ principles; data integrity safeguards include user authentication, electronic signatures, and immutable storage—facilitating compliance with FDA 21 CFR Part 11 and EU Annex 11 for computerized systems used in GxP environments.
Applications
- Decontamination of ISO Class 5–8 cleanrooms and supporting utility corridors in API and finished dosage form manufacturing facilities
- Terminal sterilization of biosafety cabinets, laminar flow hoods, and animal housing isolation units prior to maintenance or reclassification
- Routine disinfection of laboratory equipment rooms, sample preparation suites, and quarantine areas handling high-consequence pathogens
- Validation support for barrier systems (RABS, isolators) requiring rapid, repeatable, and residue-free microbial reduction
- Emergency response decontamination following suspected contamination events involving spore-forming organisms (e.g., Bacillus or Geobacillus spp.)
FAQ
What biological indicator is recommended for cycle validation?
Geobacillus stearothermophilus spores (ATCC 7953 or equivalent), immobilized on stainless steel carriers, are the standard challenge organism per ISO 11135 and PDA TR35 for VHP process qualification.
Can the HTY-V150 be integrated with building management systems (BMS)?
Yes—via optional 4–20 mA analog output or Modbus RTU communication, allowing remote start/stop commands and status monitoring within centralized facility control platforms.
Is operator training required before first use?
Yes. Tailin provides documented SOP development support and on-site or virtual operator qualification training covering safety protocols, cycle parameter selection, alarm response, and maintenance procedures per IEC 62366-1.
Does the system require external compressed air or nitrogen supply?
No. The HTY-V150 generates its own high-velocity carrier airflow using an internal centrifugal blower; only electrical power and liquid H₂O₂ supply are needed.
How is residual hydrogen peroxide removed after the sterilization cycle?
A dedicated catalytic aeration phase decomposes residual VHP into water vapor and oxygen; exhaust air passes through the integrated H14 HEPA filter before release, ensuring workplace exposure remains below OSHA PEL (1.0 ppm TWA) and NIOSH REL (0.1 ppm STEL).
