Tailin HTY-V1000A Remote-Pipe-Transported Vaporized Hydrogen Peroxide (VHP®) Sterilization System
| Brand | Tailin |
|---|---|
| Origin | Zhejiang, China |
| Manufacturer Type | OEM Manufacturer |
| Origin Category | Domestic (China) |
| Model | HTY-V1000A |
| Reagent Capacity | 10 L |
| Airflow Rate | <200 m³/h |
| Sterilization Volume | 1000–1500 m³ |
| Vaporization Temperature | ≤160 °C |
| Dehumidification RH | <85% |
| Filter Efficiency | 99.99% (HEPA H14) |
| Sterilant | 35% Food-Grade Hydrogen Peroxide Solution |
| Log Reduction | ≥6-log (Geobacillus stearothermophilus spores) |
Overview
The Tailin HTY-V1000A is a fully integrated, remote-pipe-transported vaporized hydrogen peroxide (VHP®) sterilization system engineered for terminal biodecontamination of large-scale, high-containment environments—including BSL-3 and BSL-4 laboratories, isolators, cleanrooms (ISO Class 5–8), and pharmaceutical manufacturing suites. It operates on the principle of controlled thermal vaporization: liquid 35% food-grade hydrogen peroxide is flash-vaporized at ≤160 °C using a proprietary five-channel VHPS™ (Vaporized Hydrogen Peroxide Sterilization) module, generating a stable, sub-micron aerosol with consistent vapor-phase concentration and uniform spatial distribution. Unlike liquid disinfection or low-concentration fogging, VHP® achieves rapid, residue-free microbial inactivation via hydroxyl radical (•OH) generation—reactive species that oxidize essential cellular components including lipids, proteins, and nucleic acids. The system interfaces directly with facility HVAC infrastructure, enabling centralized delivery through pre-installed ductwork to ensure homogeneous exposure across complex geometries and hard-to-reach zones.
Key Features
- Five-channel VHPS™ flash-vaporization module: Enables high-throughput, energy-efficient conversion of 35% H₂O₂ solution into dry, cold VHP® vapor with minimal condensation risk and enhanced material compatibility.
- Automated process orchestration: Integrated control of pipe-line insulation, trace heating, carrier gas pressurization (compressed air or nitrogen), vapor injection rate (6–100 g/min), and environmental conditioning (RH <85%, temperature monitoring).
- Modular, skid-mounted architecture: Compact footprint (1600 × 600 × 1950 mm) with 15 kW 380 V three-phase power requirement; designed for integration into existing utility corridors and mechanical rooms.
- Full lifecycle engineering support: Includes containment-compatible materials compatibility assessment (per ISO 14971 and ASTM E2999), IQ/OQ/PQ protocol development, on-site commissioning, and validation documentation aligned with EU GMP Annex 1, USP , and FDA 21 CFR Part 11 requirements.
- Real-time vapor concentration monitoring: Optional integrated H₂O₂ sensor array (0–1000 ppm range) with data logging for audit-ready process records and automated cycle pass/fail evaluation.
Sample Compatibility & Compliance
The HTY-V1000A is validated for use with standard cleanroom construction materials—including stainless steel (316L), anodized aluminum, epoxy-coated walls, PVC flooring, and HEPA/ULPA filter media (H14 class, ≥99.995% @ 0.3 µm). It complies with ISO 14644-3 for cleanroom testing, ISO 14698-1 for biocontamination control, and EN 17125 for chemical decontamination efficacy. All sterilization cycles are developed and verified against Geobacillus stearothermophilus biological indicators (ATCC 7953), achieving ≥6-log reduction under worst-case load conditions. The system supports GLP/GMP-compliant operation with electronic signature-enabled audit trails, user access levels, and tamper-proof cycle logs.
Software & Data Management
The embedded PLC-based control interface provides intuitive touch-screen navigation with multilingual support (English, Chinese, Spanish). Process parameters—including injection mass, vapor dwell time, relative humidity, ambient temperature, and real-time H₂O₂ ppm—are logged at 1-second intervals and exportable in CSV or PDF format. Optional software modules enable remote monitoring via Ethernet/IP or Modbus TCP, integration with SCADA systems, and automated report generation compliant with 21 CFR Part 11 (electronic records and signatures). Cycle data archives include operator ID, timestamp, equipment ID, and deviation flags—ensuring full traceability for regulatory inspections.
Applications
- Terminal decontamination of BSL-3/BSL-4 laboratory suites prior to maintenance or decommissioning.
- Periodic bio-decontamination of aseptic processing isolators and RABS in sterile drug manufacturing.
- Emergency response decon of facilities exposed to select agents (e.g., viral vectors, recombinant pathogens).
- Validation of HVAC ductwork integrity and airflow uniformity during cleanroom qualification (IQ/OQ).
- Supporting ISO 13485-certified medical device packaging line sterilization challenges where ethylene oxide alternatives are required.
FAQ
What biological indicator is used for cycle validation?
Geobacillus stearothermophilus spores (ATCC 7953) on stainless steel carriers, placed at geometrically worst-case locations per ISO 14644-3 Annex D.
Can the system be integrated with building management systems (BMS)?
Yes—via Modbus TCP or Ethernet/IP protocols; digital I/O signals support interlock with HVAC dampers, exhaust fans, and door access controls.
Is residual H₂O₂ decomposition included in the cycle?
The system supports catalytic decomposition (using Pt/Pd catalysts) or passive aeration; post-cycle residual levels are verified to <1 ppm using calibrated electrochemical sensors.
Does the unit require external cooling water or chilled air?
No—vapor generation is thermally self-contained; only compressed air/nitrogen and 380 V/15 kW electrical supply are required.
How is material compatibility assessed prior to first use?
Tailin performs ASTM F1640-compliant accelerated aging tests on client-submitted samples, evaluating discoloration, weight loss, tensile strength change, and surface morphology via SEM.
