Hanuo FD-2B Benchtop Freeze Dryer with Shelf Heating and Stoppering Function

Overview

The Hanuo FD-2B is a benchtop, pilot-scale freeze dryer engineered for reproducible lyophilization of thermolabile biologicals, pharmaceuticals, and research-grade materials under controlled vacuum and precise shelf-temperature conditions. It operates on the principle of sublimation—removing water from frozen samples via primary drying (ice-to-vapor transition under deep vacuum) followed by secondary drying (desorption of bound moisture). Unlike passive cooling systems, the FD-2B integrates electrically heated shelves that enable active, programmable thermal control across all three tray levels—critical for optimizing drying kinetics, preserving structural integrity of proteins or live cells, and ensuring batch consistency in preclinical formulation development.

Key Features

• Shelf heating system with independent temperature control (range: ambient to +60 °C), enabling full cycle optimization including annealing, primary drying ramping, and isothermal holds
• High-efficiency condenser operating at ≤ −70 °C, fabricated from stainless steel with optimized surface geometry for uniform ice deposition and minimal vapor path resistance
• Ultimate vacuum capability of < 13 Pa achieved via dual-stage rotary vane pump (pump not included), compatible with optional oil-free vacuum solutions for GMP-aligned workflows
• Large backlit LCD interface supporting up to 32-step programmable freeze-drying protocols, with real-time display of shelf temperature, chamber pressure, condenser temperature, and elapsed time
• Integrated stoppering mechanism (press-seal function) allowing sterile closure of vials post-drying without breaking vacuum—essential for aseptic processing of clinical trial batches
• Rugged stainless-steel chamber and door seal designed for repeated sterilization cycles; conforms to ISO 13485 design principles for medical device manufacturing support

Sample Compatibility & Compliance

The FD-2B accommodates standard Φ200 mm sample trays (3-layer stackable configuration) and supports direct vial loading (up to 100 × 10 mL vials per cycle). Its 0.1 m² drying area and 1.0 L total liquid capacity suit small-batch lyophilization of monoclonal antibodies, plasmid DNA, bacterial cultures, diagnostic reagents, and botanical extracts. The system meets baseline requirements for ASTM F2337–21 (Standard Practice for Validation of Freeze Drying Processes) and supports documentation traceability aligned with FDA 21 CFR Part 11 when paired with external audit-log-enabled data acquisition software. All wetted surfaces are electropolished 316L stainless steel, facilitating cleaning validation per ICH Q5C and EU Annex 1 guidelines.

Software & Data Management

While the FD-2B features embedded curve programming and local data logging (time-stamped temperature/pressure values stored internally), it includes an RS-232 port for integration with third-party SCADA or LIMS platforms. Users may export protocol files and session logs in CSV format for offline analysis in MATLAB, Python (Pandas), or commercial statistical process control tools. Optional PC-based software (sold separately) provides real-time remote monitoring, alarm notification via email/SMS, electronic signature capture, and automated generation of IQ/OQ-ready validation reports compliant with ISO 9001 and ISO/IEC 17025 frameworks.

Applications

• Pre-formulation stability studies of biologics under variable shelf-ramp profiles
• Lyophilization cycle development for Phase I/II clinical trial materials
• Preservation of microbial cultures, enzymes, and diagnostic calibrators without cryoprotectant dependency
• Dehydration of nanomaterial dispersions and liposomal suspensions while retaining colloidal integrity
• Small-volume production of reference standards for analytical laboratories (e.g., USP, EP, JP monographs)
• Academic research in food science (e.g., probiotic viability retention), tissue engineering (extracellular matrix scaffolds), and forensic sample archiving

FAQ

Does the FD-2B include a vacuum pump?
No—the FD-2B requires an external vacuum pump. A 4–6 m³/h two-stage rotary vane pump is recommended; oil-free alternatives are supported for cleanroom applications.
Can the shelf heating be calibrated independently per layer?
No—shelves are heated uniformly as a single zone. For multi-zone thermal profiling, consider the FD-2D variant with separate heating circuits.
Is the stoppering function compatible with rubber stoppers of varying durometers?
Yes—the pneumatic press mechanism adjusts force dynamically and accepts standard ISO 8362-compliant stoppers (durometer range: 45–65 Shore A).
What is the maximum allowable load weight per shelf?
Each Φ200 mm tray supports up to 3.5 kg gross weight (including tray mass); total chamber load must not exceed 10.5 kg.
How often does the condenser require defrosting during continuous operation?
Defrosting is manual and typically required after every 2–3 full-capacity cycles (6 kg ice accumulation), depending on initial moisture content and freezing rate of the product.