BioCoool FD-1E-50+ Laboratory Freeze Dryer
| Brand | BioCoool |
|---|---|
| Origin | Beijing, China |
| Model | FD-1E-50+ |
| Instrument Type | Manifold Freeze Dryer |
| Application | Laboratory-Scale Lyophilization |
| Shelf Area | 0.12 m² |
| Ultimate Vacuum | <9 Pa |
| Condenser Capacity (24 h) | 3 L |
| Condenser Temperature (No Load) | −55 °C |
Overview
The BioCoool FD-1E-50+ is a benchtop manifold-type laboratory freeze dryer engineered for reproducible, controlled lyophilization of heat-sensitive biological and pharmaceutical samples. It operates on the fundamental principles of sublimation under deep vacuum and low-temperature condensation—removing water from frozen samples while preserving structural integrity, activity, and stability. Designed for routine R&D, QC, and small-batch processing in academic labs, biotech startups, and quality control environments, this system integrates a robust refrigeration architecture with precise vacuum management and real-time thermal monitoring to support method development aligned with ICH Q5C and USP <1211> lyophilization guidance.
Key Features
- Monolithic stainless-steel drying chamber: Seamless, welded construction ensures zero leakage and high mechanical strength—critical for maintaining stable vacuum and avoiding cross-contamination during multi-vial runs.
- High-efficiency dual-stage compressor system: Sourced from an internationally recognized OEM, delivering stable condenser performance at −55 °C (no-load) with low acoustic emission (<58 dB(A)) for quiet operation in shared lab spaces.
- Pre-freezing capability: The condenser can be activated prior to chamber loading, enabling rapid sample freezing directly on shelves or within vials—reducing thermal shock and improving ice crystal uniformity.
- Dual Pt100 temperature sensors: Monitor both shelf surface and sample core temperature in real time, supporting empirical validation of primary drying endpoints and compliance with FDA 21 CFR Part 11–compatible data logging (when paired with optional software).
- Lyophilization curve visualization & storage: Onboard PLC touchscreen displays dynamic pressure, condenser temp, shelf temp, and elapsed time; curves are timestamped and exportable via USB flash drive for audit-ready documentation.
- Hot-gas defrost system: Uses controlled refrigerant reversal for fast, residue-free condenser defrosting—minimizing downtime between cycles without requiring manual intervention or external heating elements.
- Inert gas backfill option: Equipped with original-imported solenoid-controlled gas inlet valve for post-drying nitrogen or argon purging—essential for oxygen-sensitive proteins, vaccines, and sterile powder formulations.
Sample Compatibility & Compliance
The FD-1E-50+ accommodates standard 10–22 mm OD glass vials mounted on its 10-port manifold. It is validated for aqueous solutions, suspensions, and pastes with eutectic temperatures above −20 °C—covering common applications such as enzyme preparations, monoclonal antibody intermediates, diagnostic reagents, and microbial cultures. While not certified to ISO 22000 or GMP Annex 1 out-of-the-box, the system supports GLP-compliant operation when configured with optional accessories including calibrated Pt100 probes, electronic logbooks, and audit-trail-enabled software modules. All electrical components meet CE/IEC 61010-1 safety standards; vacuum integrity complies with ASTM F2476-05 (Standard Practice for Determining Residual Moisture Content in Lyophilized Products).
Software & Data Management
Control is managed via an industrial-grade PLC with a 7-inch capacitive touchscreen HMI. The interface supports multi-step program creation (freeze, anneal, primary dry, secondary dry), real-time deviation alerts, and automatic cycle suspension upon vacuum loss or temperature excursion. Raw sensor data—including pressure (Pirani gauge), condenser temp, shelf temp, and runtime—is stored internally (up to 100 cycles) and exportable in .csv format via USB 2.0 port. For regulated environments, optional BioCoool LyoView™ PC software enables remote monitoring, electronic signature integration, and 21 CFR Part 11–compliant user access controls, change logs, and electronic records retention.
Applications
- Stabilization of labile biologics: Antibodies, cytokines, plasmid DNA, and viral vectors requiring long-term storage at ambient temperature.
- Preparation of calibration standards and reference materials for HPLC, ELISA, and mass spectrometry workflows.
- Routine dehydration of bacterial/fungal cultures for strain banking and microbiological assay development.
- Formulation screening of excipient blends (e.g., trehalose, sucrose, mannitol) under controlled drying rates.
- Small-scale production of lyophilized diagnostics kits, including lateral flow reagents and PCR master mixes.
FAQ
What types of flasks or vials are compatible with the FD-1E-50+ manifold?
Standard 10–22 mm outer diameter glass vials with rubber stoppers (e.g., 2R, 5R, 10R) are supported. Optional adapters allow use of serum bottles and scintillation vials.
Can the system operate continuously for extended periods?
Yes—the condenser and vacuum pump are rated for uninterrupted 24-hour operation; however, recommended maintenance intervals (e.g., oil changes, filter replacement) must be observed per the service manual.
Is the FD-1E-50+ suitable for GMP manufacturing?
It is designed for laboratory-scale process development and non-sterile R&D use. For GMP production, additional qualification (IQ/OQ/PQ), environmental monitoring, and integration with SCADA systems are required.
Does it support shelf temperature control?
No—this is a manifold-only configuration without heated shelves. Temperature control is limited to condenser and sample monitoring; shelf-based drying requires FD-1A or FD-1B series models.
What vacuum pump is recommended for optimal performance?
A 2 L/s two-stage rotary vane pump is included; for lower ultimate vacuum (<0.1 Pa), a hybrid turbo-molecular pump (optional) may be integrated with appropriate foreline protection.
