EYELA FDU-2110 Benchtop Freeze Dryer

Overview

The EYELA FDU-2110 is a benchtop freeze dryer engineered for reproducible, low-moisture lyophilization of heat-sensitive biologicals, pharmaceuticals, and analytical standards in research and quality control laboratories. It operates on the principle of sublimation under high vacuum and cryogenic condensation: frozen samples are subjected to reduced pressure while maintaining the cold trap at −80 °C, enabling ice to transition directly from solid to vapor without passing through the liquid phase. This preserves structural integrity, enzymatic activity, and immunogenicity—critical for proteins, vaccines, probiotics, and diagnostic reagents. Designed and manufactured in Japan by Tokyo Rikakikai Co., Ltd. (EYELA), the FDU-2110 integrates precision refrigeration, real-time process monitoring, and fail-safe operational logic to meet GLP-compliant workflows and support validation-ready documentation.

Key Features

• −80 °C cold trap with SUS304 stainless steel chamber (Φ200 × 300 mm) ensures efficient water vapor capture and minimizes cross-contamination risk.
• Automated vacuum pump control: initiates pumping only when cold trap reaches target temperature and maintains active vacuum monitoring throughout the cycle.
• Dual-stage refrigeration system using R404A/R23 refrigerant blend delivers stable, deep-cold performance with high thermal efficiency and low ambient heat load.
• Hot-gas defrost function with automatic thermal cutoff prevents overheating during regeneration and enables rapid cold trap recovery between cycles.
• Motorized vacuum release valve equipped with a 0.2 µm hydrophobic membrane filter ensures sterile backfilling and eliminates sample oxidation or particulate ingress.
• Power failure recovery protocol delays vacuum pump restart post-outage to prevent sample boil-over, preserving sample morphology and yield.
• Front- and side-access design facilitates routine maintenance of vacuum lines, oil changes, and gasket inspection without disassembly.
• Integrated Pirani vacuum gauge (0.4–533 Pa range) and digital temperature display provide continuous, traceable process parameters.

Sample Compatibility & Compliance

The FDU-2110 accommodates standard glassware including Ø25–Ø50 mm vials, multi-port manifolds (optional), and flat-bottom flasks up to 1 L volume. Its −80 °C condensing capability supports lyophilization of aqueous solutions with eutectic points down to −45 °C, making it suitable for most biologics, bacterial cultures, and botanical extracts. The unit complies with IEC 61010-1 (Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use) and meets electromagnetic compatibility (EMC) requirements per IEC 61326-1. While not certified for GMP manufacturing, its operational logic—including vacuum/temperature logging readiness, power-loss hysteresis, and sterile air filtration—aligns with FDA 21 CFR Part 11 data integrity expectations when paired with validated external chart recorders or SCADA interfaces.

Software & Data Management

The FDU-2110 operates via an embedded microcontroller with no proprietary software dependency. All process variables—including cold trap temperature, chamber pressure, elapsed time, and vacuum status—are available as analog outputs (0–5 V or 4–20 mA) for integration with third-party data loggers (e.g., Omega OM-DAQ, Campbell Scientific CR1000) or LIMS platforms. Users may connect external strip-chart or digital recorders to monitor and archive lyophilization curves—critical for method development, batch record generation, and audit preparation. The control panel’s self-diagnostic function logs fault codes (e.g., “CT TEMP HIGH”, “VAC LEAK”) into non-volatile memory, supporting root-cause analysis during equipment qualification (IQ/OQ/PQ).

Applications

• Stabilization of monoclonal antibodies, recombinant enzymes, and cell lysates for long-term storage and transport.
• Preparation of calibration standards and reference materials in environmental and clinical chemistry labs.
• Lyophilization of microbial cultures (e.g., Lactobacillus, Bacillus) for strain banking and shelf-life studies.
• Drying of tissue sections, histological specimens, and botanical extracts where solvent residue or thermal degradation must be avoided.
• Process development for scale-up to pilot or production freeze dryers—FDU-2110 data informs primary drying endpoint detection and shelf temperature ramp profiles.

FAQ

What vacuum pump specifications are recommended for optimal performance with the FDU-2110?
A two-stage oil-sealed rotary vane pump with ≥135 L/min free-air displacement and ultimate vacuum ≤1 Pa is required. Pumps must be fitted with gas ballast and cold trap inlet filters to minimize oil backstreaming and moisture loading.
Can the FDU-2110 be used for organic solvent-containing samples?
No. The refrigeration system and cold trap are designed exclusively for aqueous-based systems. Solvents such as ethanol, acetone, or acetonitrile will degrade seals, contaminate the compressor oil, and exceed the condenser’s thermal capacity.
Is the cold trap removable for cleaning or servicing?
Yes—the cylindrical SUS304 cold trap is mounted on quick-release flanges and can be lifted out manually after system venting and warm-up, enabling thorough inspection and ultrasonic cleaning.
Does the unit support programmable multi-step drying protocols?
No. The FDU-2110 is a manually operated, fixed-parameter lyophilizer. Process sequencing (e.g., ramped shelf temperature, pressure-controlled drying) requires external controllers or manual intervention.
How is compliance with ISO 22000 or USP <1211> demonstrated using this instrument?
While the FDU-2110 itself does not hold certification, its documented performance (−80 °C trap stability, ≤0.2 µm filtered backfill, and vacuum repeatability) forms part of a broader validation package. Users must perform installation qualification (IQ), operational qualification (OQ), and process-specific performance qualification (PQ) per their internal SOPs and regulatory framework.