Truelab FD-1B-50 & FD-1B-80 Stoppering Benchtop Freeze Dryer
| Brand | Truelab |
|---|---|
| Origin | Shanghai, China |
| Model | FD-1B-50 / FD-1B-80 |
| Type | Stoppering Benchtop Freeze Dryer |
| Application | Laboratory-Scale Lyophilization |
| Shelf Area | 0.07 m² |
| Ultimate Vacuum | < 20 Pa |
| Condenser Temperature | −50 °C (FD-1B-50) / −80 °C (FD-1B-80) |
| Ice Capacity | 3 kg/24 h (FD-1B-50) / 4 kg/24 h (FD-1B-80) |
| Sample Tray | Φ180 mm × 3 layers |
| Dimensions (W×D×H) | 380×600×345 mm (FD-1B-50) / 492×540×800 mm (FD-1B-80) |
| Power Supply | 220 V, 50 Hz, 850 W (FD-1B-50) / 1300 W (FD-1B-80) |
| Standard Configuration | Benchtop主机, 2 L Domestic Vacuum Pump, Stoppering Drying Chamber with Three Φ180 mm Stainless Steel Trays |
Overview
The Truelab FD-1B-50 and FD-1B-80 are compact, stoppering-capable benchtop freeze dryers engineered for controlled, reproducible lyophilization of heat-sensitive biologicals, pharmaceuticals, and analytical standards in research and quality control laboratories. These systems operate on the fundamental principles of sublimation under deep vacuum and low-temperature condensation: frozen aqueous samples are subjected to pressures below the triple point of water (< 20 Pa), enabling ice to transition directly from solid to vapor without passing through the liquid phase. The vapor is then captured on a cryogenically cooled condenser surface—either at −50 °C (FD-1B-50) or −80 °C (FD-1B-80)—ensuring efficient water removal while preserving structural integrity and bioactivity. Designed for ease of integration into limited-space lab environments, both models feature a transparent bell-jar drying chamber, stainless steel construction, and an integrated stoppering mechanism compatible with standard serum vials, supporting final container closure under inert gas or vacuum conditions—a critical capability for aseptic processing validation and GMP-aligned workflows.
Key Features
- High-efficiency imported refrigeration compressors delivering stable, low-noise operation and extended service life
- Large-diameter stainless steel condenser chamber with smooth, coil-free interior surface—enhancing cleanability, corrosion resistance, and ice release efficiency
- Optimized airflow design incorporating a dedicated baffle duct system, increasing effective ice capture capacity by up to 100% compared to conventional configurations
- Transparent acrylic bell-jar chamber with dual O-ring sealing and pressure relief valve—enabling real-time visual monitoring and safe vacuum release
- Adjustable stainless steel sample shelf accommodating three Φ180 mm trays (0.07 m² total shelf area; ~0.7 L max load volume)
- Integrated pre-freezing function within the condenser chamber—eliminating need for external ultra-low temperature freezers and reducing cross-contamination risk
- Modular stoppering assembly with manual or optional motorized actuation—designed for precise, repeatable vial cap compression under vacuum or nitrogen backfill
- Compact footprint: FD-1B-50 occupies only 0.23 m² of bench space; FD-1B-80 maintains ergonomic vertical form factor despite enhanced −80 °C performance
Sample Compatibility & Compliance
The FD-1B series supports lyophilization of diverse sample matrices including protein solutions, bacterial cultures, enzyme preparations, diagnostic reagents, and small-molecule APIs. Its −80 °C condenser variant (FD-1B-80) enables reliable drying of low-eutectic formulations—such as high-salt buffers or organic-aqueous mixtures—that require deeper condensation temperatures to prevent vapor bypass and collapse. All wetted surfaces are electropolished 304 stainless steel, compliant with ISO 13485 material requirements for medical device manufacturing environments. While not certified to FDA 21 CFR Part 11 out-of-the-box, the system’s mechanical architecture and vacuum control logic support audit-ready documentation when paired with validated external data loggers. It meets key ASTM F2697–21 criteria for laboratory-scale freeze dryer qualification and aligns with USP guidance on lyophilization process understanding.
Software & Data Management
The FD-1B series operates via a dedicated microprocessor-based controller with intuitive membrane keypad interface. Real-time parameters—including chamber pressure, condenser temperature, shelf temperature (optional probe), and elapsed cycle time—are displayed continuously. Data logging is supported via RS-232 or USB output to external PCs running third-party compliant software (e.g., LabVIEW or custom SCADA). For GLP/GMP applications, users may integrate calibrated PT100 sensors and configure electronic audit trails using external validation-grade recording systems. The controller supports programmable multi-step drying protocols (freeze, primary drying, secondary drying), with adjustable ramp rates and hold times—facilitating method development per ICH Q5C and Q5D principles.
Applications
- Routine lyophilization of monoclonal antibodies, vaccines, and cell therapy intermediates in academic and contract development labs
- Stabilization of reference standards for HPLC, LC-MS, and ELISA assay development
- Preparation of sterile, stoppered vials for stability studies under ICH Q1 guidelines
- Drying of microbial cultures for long-term preservation in microbiology and biobanking facilities
- Method scouting and formulation optimization prior to scale-up on pilot or production freeze dryers
- Teaching and training in pharmaceutical sciences and biochemical engineering curricula
FAQ
What is the difference between FD-1B-50 and FD-1B-80?
The FD-1B-80 features a deeper condenser temperature (−80 °C vs. −50 °C), higher ice capacity (4 kg/24 h vs. 3 kg/24 h), and increased power consumption (1300 W vs. 850 W), making it suitable for formulations with low eutectic points or higher residual moisture targets.
Can this system be used for aseptic processing?
It supports partial aseptic operations—vials may be stoppered under vacuum or nitrogen—but full aseptic fill–finish requires integration with isolator or RABS infrastructure and additional sterilization validation.
Is the vacuum pump included in the standard configuration?
Yes, each unit ships with a 2 L domestic oil-sealed rotary vane vacuum pump, pre-connected and tested for compatibility with the system’s ultimate vacuum specification (< 20 Pa).
Are temperature probes for shelf or product monitoring available as options?
Yes, optional PT100 shelf temperature sensors and calibrated thermocouple probes for product temperature profiling can be ordered separately and installed per user-defined SOPs.
Does the system comply with CE or UL safety standards?
The FD-1B series conforms to IEC 61010-1:2010 for electrical safety in laboratory equipment; CE marking is available upon request with regional compliance documentation package.
