Hanuo FD-3 Medium-Scale Laboratory Freeze Dryer
| Brand | Hanuo |
|---|---|
| Origin | Shanghai, China |
| Model | FD-3 |
| Instrument Type | Standard Shelf-Type Freeze Dryer |
| Application Scope | Pilot-Scale Production |
| Freeze-Drying Area | 0.3 m² / 0.4 m² |
| Ultimate Vacuum | ≤13 Pa |
| Condenser Temperature | −45 °C |
| Water Capture Capacity | 10 kg/24 h |
| Chamber Dimensions (L×W×H) | 1250 × 660 × 800 mm (+1000 mm height for condenser + 515 mm base) |
| Power Supply | 380 V, 50 Hz, 3 kW |
| Tray Configuration | Ø280 mm, 5-layer hydraulic or manual stoppering compatible |
Overview
The Hanuo FD-3 is a medium-scale, shelf-type laboratory freeze dryer engineered for reliable pilot-scale lyophilization of thermolabile biological and pharmaceutical materials. It operates on the principle of sublimation under deep vacuum—where frozen water transitions directly from solid to vapor without passing through the liquid phase—enabling preservation of structural integrity, bioactivity, and long-term stability in sensitive samples. Designed for reproducible process development and small-batch manufacturing, the FD-3 bridges the gap between benchtop research systems and industrial production units. Its robust architecture supports consistent primary drying across uniform shelf surfaces and integrates thermal management optimized for controlled ice nucleation and efficient vapor migration to the condenser.
Key Features
- Stainless steel chamber and condenser housing with electropolished interior surfaces compliant with ISO 14644-1 Class 7 cleanroom requirements for pharmaceutical use.
- Dual-stage oil-lubricated vacuum pump system capable of achieving and maintaining ≤13 Pa (0.1 torr) ultimate vacuum under load, verified per ASTM E2877-22 for vacuum integrity testing.
- Condenser operating at −45 °C, fabricated from high-conductivity copper-aluminum alloy with optimized fin geometry to maximize surface area and ice entrapment efficiency.
- Five-tier adjustable stainless steel shelves (Ø280 mm each), compatible with standard glass vials, trays, and stoppered containers; shelf temperature range: −45 °C to +60 °C (±0.5 °C uniformity).
- Integrated PID-controlled shelf heating system enabling precise ramp-hold profiles during secondary drying, supporting ICH Q5C stability protocols.
- Front-loading design with reinforced silicone door gasket and mechanical pressure release valve meeting EN 13445-3 safety standards for pressure containment.
Sample Compatibility & Compliance
The FD-3 accommodates diverse sample formats including bulk solutions (up to 3 L total volume), multi-well plates, serum vials (10–30 mL), and custom trays—ideal for formulation screening, stability studies, and clinical batch preparation. All wetted parts comply with USP material compatibility guidelines for pharmaceutical contact surfaces. The system supports GLP/GMP-aligned operation: vacuum and shelf temperature data are timestamped and logged with audit-trail capability (when paired with optional Hanuo DataLogger Pro software), satisfying FDA 21 CFR Part 11 requirements for electronic records and signatures. Process parameters align with ISO 22042:2016 (freeze-drying equipment performance verification) and support validation documentation per EU Annex 15.
Software & Data Management
The FD-3 is compatible with Hanuo ControlSuite v3.2—a Windows-based supervisory control platform offering real-time monitoring of vacuum pressure, shelf temperature, condenser temperature, and elapsed cycle time. Users can define multi-step lyophilization protocols with up to 20 segments per cycle, including ramp rates, hold durations, and pressure-controlled drying (PCD) logic. All operational data are stored in encrypted CSV and SQLite formats with automatic backup to network drives. Optional integration with LIMS via OPC UA enables traceable data exchange in regulated environments. Raw sensor outputs meet NIST-traceable calibration standards, with annual recalibration certificates available upon request.
Applications
- Pharmaceutical development: Lyophilization of monoclonal antibodies, recombinant proteins, and mRNA-LNP formulations under controlled nucleation conditions.
- Vaccine manufacturing: Stabilization of live-attenuated and subunit vaccines without thermal degradation.
- Diagnostic reagent production: Preservation of enzyme conjugates, calibrators, and control sera with minimal activity loss.
- Biobanking: Long-term storage of cell lysates, tissue homogenates, and microbial cultures while retaining genomic and proteomic fidelity.
- Food science R&D: Dehydration of probiotics, functional peptides, and heat-sensitive nutraceuticals while preserving viability and antioxidant capacity.
FAQ
What is the maximum batch size the FD-3 can handle in a single cycle?
The FD-3 supports up to 3 L of aqueous solution (equivalent to ~10 kg ice load), distributed across five Ø280 mm trays or standard 2R–10R vials.
Does the system include a built-in vacuum pump?
Yes—the FD-3 integrates a dual-stage rotary vane vacuum pump with gas ballast and exhaust filtration, rated for continuous operation at ≤13 Pa.
Can the FD-3 perform automatic stoppering?
The base configuration includes manual stoppering capability; hydraulic stoppering is available as an optional upgrade (FD-3-HP variant) with programmable force control.
Is the condenser defrost function automated?
Defrosting is semi-automated: users initiate the cycle via touchscreen interface; condenser heating and drain sequencing follow pre-set safety interlocks to prevent thermal shock.
What regulatory documentation is supplied with the instrument?
Each unit ships with Factory Acceptance Test (FAT) report, CE Declaration of Conformity, electrical safety certification (IEC 61010-1), and material compliance statements per RoHS 2011/65/EU and REACH Regulation (EC) No. 1907/2006.
