Truelab RF-6000A Automatic Infrared Hand Disinfector
| Brand | Truelab |
|---|---|
| Origin | Shanxi, China |
| Manufacturer Type | Authorized Distributor |
| Country of Origin | China |
| Model | RF-6000A |
| Dimensions (W×D×H) | 230 × 150 × 375 mm |
| Liquid Capacity | 1500 mL |
| Dispensing Volume per Cycle | Adjustable 1–5 mL |
| Sensing Distance | 8–250 mm |
| Power Supply | AC 100–240 V, 50/60 Hz, ±10% |
| Power Consumption | <60 W |
| Operating Temperature | 5–40 °C |
| Relative Humidity | ≤80% RH |
| Safety Class | Class I, Type B |
| Net Weight | 3.6 kg |
| Sensor Type | German-made infrared proximity sensor with ambient light immunity |
| Reservoir Material | Food-grade PE (polyethylene), hermetically sealed |
| Display | LED liquid-level indicator (full: 1500 ±10 mL |
| low | 100 ±15 mL) |
Overview
The Truelab RF-6000A Automatic Infrared Hand Disinfector is an engineered solution for controlled, touchless hand hygiene in regulated manufacturing and laboratory environments. Designed to comply with core operational hygiene frameworks—including GMP (Good Manufacturing Practice), HACCP (Hazard Analysis Critical Control Point), and QS (Quality Safety) standards—it operates on a validated passive infrared sensing principle: a high-stability German-sourced IR sensor detects hand presence within an adjustable 8–250 mm range, triggering precise metered dispensing without physical contact. This eliminates mechanical wear, reduces cross-contamination risk, and supports consistent adherence to hygiene SOPs in high-traffic production zones. Its architecture integrates fail-safe electronic actuation—no mechanical switches or arcing components—ensuring intrinsic safety in non-hazardous classified areas per IEC 60601-1 (Class I, Type B). The unit is not a medical device per FDA 21 CFR Part 820, but functions as a critical environmental control tool in pharmaceutical, nutraceutical, food processing, and cosmetic manufacturing facilities where personnel hand sanitation directly impacts product integrity.
Key Features
- Touchless operation via industrial-grade infrared proximity sensor with proven immunity to ambient lighting fluctuations and reflective surface interference
- Precision metering system with user-selectable dispense volume (1–5 mL per cycle), enabling optimization of disinfectant usage and cost control
- Hermetically sealed 1500 mL reservoir constructed from food-grade polyethylene (PE), compliant with EU Regulation (EC) No. 1935/2004 and US FDA 21 CFR §177.1520 for indirect food contact
- Integrated LED liquid-level indicator providing real-time visual feedback: full (1500 ±10 mL), low (100 ±15 mL), and empty states
- Universal power input (AC 100–240 V, 50/60 Hz, ±10%) with <60 W peak consumption—suitable for global facility deployment without voltage conversion
- Compact footprint (230 × 150 × 375 mm) and vertical wall-mount or countertop configuration support flexible integration into existing cleanroom pass-throughs, airlocks, and production line entry points
Sample Compatibility & Compliance
The RF-6000A is compatible with alcohol-based formulations (e.g., 75% v/v ethanol or isopropanol), quaternary ammonium compounds, and other WHO-recommended hand antiseptics meeting EN 1500 or ASTM E1174 efficacy standards. Its fluid pathway design prevents residue buildup and supports routine cleaning validation per ISO 14644-3. The unit itself carries no CE marking as a standalone medical device, but conforms to EMC Directive 2014/30/EU and Low Voltage Directive 2014/35/EU when installed per manufacturer instructions. It supports audit readiness for GMP Annex 1 (sterile manufacturing), FDA 21 CFR Part 211 (pharmaceutical CGMP), and BRCGS Food Safety Issue 9 Section 4.11.3 (hand hygiene controls).
Software & Data Management
The RF-6000A is a standalone electromechanical system with no embedded firmware, network interface, or data logging capability. All operational parameters—including dispense volume and sensor sensitivity—are set manually via DIP switches or potentiometers during commissioning. This design prioritizes reliability, electromagnetic robustness, and regulatory simplicity in environments where IT validation (e.g., FDA 21 CFR Part 11, Annex 11) would introduce unnecessary complexity. Maintenance records, calibration logs (sensor response verification), and disinfectant lot traceability remain the responsibility of site QA/QC teams per internal SOPs.
Applications
- Pre-entry sanitation at Grade C/D cleanroom access points in API and finished-dose pharmaceutical manufacturing
- Hand hygiene enforcement stations in ready-to-eat (RTE) food processing lines subject to USDA-FSIS or EU Regulation (EC) No. 852/2004
- Operator disinfection checkpoints in cosmetic fill-finish areas governed by ISO 22716 (GMP for cosmetics)
- Supporting GLP-compliant laboratory animal facilities where personnel hygiene directly affects study validity
- Integration into HACCP critical control points (CCPs) for pathogen mitigation in dairy, meat, and beverage production
FAQ
Is the RF-6000A certified as a medical device under FDA or MDR?
No. It is classified as an environmental hygiene control equipment—not a medical device—and does not require FDA 510(k) clearance or EU MDR certification.
Can the unit be validated for use in sterile manufacturing?
Yes. While the device itself is not sterilizable, its materials, dispensing repeatability, and compatibility with sporicidal agents support IQ/OQ protocols per ISO 13485 and EU GMP Annex 15.
What maintenance is required for long-term reliability?
Quarterly verification of sensor response time (<0.5 s), visual inspection of reservoir seals, and annual replacement of the IR sensor module per manufacturer service bulletin.
Does it support integration with building management systems (BMS)?
No. It lacks digital communication interfaces (e.g., Modbus, BACnet). Optional dry-contact output for status signaling is available upon request.
Is the reservoir compatible with hydrogen peroxide-based disinfectants?
Not recommended. Prolonged exposure to >5% hydrogen peroxide may degrade the PE reservoir and elastomeric seals; consult Truelab technical support before use.
