BIOCOOL FD-1D-50+ Laboratory Benchtop Freeze Dryer
| Brand | BIOCOOL |
|---|---|
| Origin | Beijing, China |
| Manufacturer Type | Authorized Distributor |
| Country of Origin | China |
| Model | FD-1D-50+ |
| Instrument Type | Stoppering Freeze Dryer |
| Application Scope | Laboratory Use |
| Lyophilization Area | 0.08 m² |
| Ultimate Vacuum | <9 Pa |
| Condensate Capacity (24 h) | 3 L |
| Cold Trap Temperature | −55 °C |
Overview
The BIOCOOL FD-1D-50+ is a compact, benchtop stoppering freeze dryer engineered for reproducible, controlled lyophilization of heat-sensitive biological and pharmaceutical samples in research and quality control laboratories. It operates on the fundamental principle of sublimation—removing water from frozen samples under deep vacuum while maintaining sample integrity below the eutectic temperature. Designed for compatibility with standard 20 mm or 22 mm serum vials, this unit integrates a stainless-steel drying chamber, a high-efficiency cold trap, and an intelligent PLC-based control system to deliver precise thermal and vacuum management. Its −55 °C cold trap enables reliable condensation of ice from aqueous solutions, suspensions, and pastes with eutectic points above −20 °C—making it suitable for proteins, vaccines, enzymes, antibiotics, and diagnostic reagents.
Key Features
- Monolithic stainless-steel drying chamber: Seamless, welded construction eliminates joints and potential leak paths—ensuring long-term vacuum integrity and ease of cleaning.
- High-reliability refrigeration system: Equipped with an internationally certified hermetic compressor delivering stable cooling performance, low acoustic emission (<62 dB(A)), and extended service life.
- Cold trap pre-freezing capability: Allows full sample freezing prior to primary drying—critical for preserving structural morphology and minimizing collapse during sublimation.
- Dual PT100 temperature sensors: Monitor both shelf and sample temperatures in real time, supporting process validation and deviation detection per ICH Q5C and USP <1211> guidelines.
- Graphical lyophilization curve logging: Records shelf temperature, chamber pressure, and condenser temperature over time; data stored internally and exportable via USB flash drive.
- Intelligent hot-gas defrosting: Uses controlled R290 refrigerant flow to rapidly and safely melt ice without thermal shock to the cold trap or chamber seals.
- Inert gas backfilling: Integrated solenoid valve accepts nitrogen or argon for post-drying headspace purging—essential for oxygen-sensitive formulations and sterile packaging compliance.
- Stoppering mechanism: Motor-driven hydraulic ram enables uniform, programmable stopper compression into vials—supporting GMP-aligned batch documentation and container closure integrity testing.
Sample Compatibility & Compliance
The FD-1D-50+ accommodates standard 10–20 mL serum vials placed directly on the heated shelf. It supports lyophilization of aqueous solutions, colloidal suspensions, and viscous pastes with eutectic temperatures ≥ −20 °C. The system meets mechanical and electrical safety requirements per GB 4793.1–2019 (equivalent to IEC 61010-1) and complies with electromagnetic compatibility standards EN 61326-1. While not certified as Class A medical device, its architecture supports GLP/GMP-aligned operation when integrated with validated SOPs, audit trails, and electronic signatures (via optional software add-ons). Data logs are timestamped and non-editable—facilitating FDA 21 CFR Part 11 readiness when paired with secure network storage and user access controls.
Software & Data Management
The embedded HMI features a 7-inch resistive touchscreen with intuitive icon-driven navigation. All process parameters—including setpoints, actual values, alarms, and event timestamps—are logged at user-configurable intervals (1–60 s). Raw data exports as CSV files compatible with Excel, MATLAB, and statistical process control (SPC) platforms. Optional firmware upgrades support enhanced alarm logic, multi-stage ramp/soak profiles, and password-protected parameter locking—aligning with laboratory information management system (LIMS) integration needs. Internal memory retains ≥100 complete cycle records; external USB storage extends archival capacity indefinitely.
Applications
- Pharmaceutical R&D: Development and small-batch production of lyophilized injectables, monoclonal antibodies, and peptide therapeutics.
- Biotechnology: Stabilization of cell lysates, plasmid DNA, CRISPR reagents, and viral vectors.
- Academic Research: Preservation of microbial cultures, plant extracts, and enzyme preparations for long-term storage.
- Food Science: Dehydration of probiotics, flavor compounds, and functional food ingredients without Maillard degradation.
- Diagnostic Manufacturing: Preparation of dry-reagent strips, ELISA kits, and lateral flow assay components.
FAQ
What is the maximum vial loading capacity for the FD-1D-50+?
The unit accommodates up to 200 × 20 mm vials (or 150 × 22 mm vials) when using the standard shelf configuration.
Can the system operate under partial vacuum during freezing?
Yes—the vacuum pump remains active during pre-freezing, enabling simultaneous freezing and initial dehydration for certain low-viscosity formulations.
Is remote monitoring supported?
Not natively; however, RS485 Modbus RTU output allows connection to third-party SCADA or building management systems for status telemetry.
What maintenance intervals are recommended?
Compressor oil and refrigerant levels should be verified annually; vacuum pump oil must be changed every 500 operating hours or quarterly—whichever occurs first.
Does the unit include validation documentation?
Factory-installed IQ/OQ documentation is available upon request; PQ protocols must be developed by the end user in accordance with ISO 13485 or ASTM F2476-21.
