LYODRY Mitte Classic Series Benchtop Freeze Dryer

Overview

The LYODRY Mitte Classic Series Benchtop Freeze Dryer is a pilot-scale lyophilization system engineered for reproducible, scalable freeze-drying of heat-sensitive biologicals, pharmaceuticals, and research-grade samples. Based on the fundamental principles of sublimation under controlled low-pressure and cryogenic conditions, this system operates by freezing the sample to below its eutectic temperature, then reducing chamber pressure to enable direct phase transition from ice to vapor—bypassing the liquid phase entirely. The dual-model configuration (LSMC55 and LSMC85) provides flexibility in condenser performance: the LSMC55 achieves a minimum condenser temperature of –55 °C, suitable for aqueous formulations with moderate volatility; the LSMC85 extends capability to –85 °C, enabling efficient capture of low-vapor-pressure solvents (e.g., tert-butanol, ethyl acetate) and high-concentration protein solutions. With a total condensate capacity of 44.5 L per 24 hours and an ultimate vacuum level below 20 Pa, the system supports robust batch processing across diverse sample formats—including bulk trays, serum vials, glass flasks, and ampoules—without requiring external vacuum controllers or auxiliary chillers.

Key Features

• Integrated touchscreen HMI with real-time monitoring of vacuum (displayed simultaneously in mbar, Torr, and Pa) and temperature (°C/°F), supporting multi-unit readability for cross-laboratory standardization
• Hot-gas auto-defrost system significantly reduces cycle downtime between batches—condenser defrost completes in ≤15 minutes without manual intervention or water drainage
• Front-access stainless steel (AISI 304) condenser with bottom-mounted drain port ensures rapid, residue-free condensate removal and minimizes risk of cross-contamination
• Modular chamber architecture accommodates interchangeable drying accessories: acrylic drying chambers, shelf-mounted manifold systems, stoppering-compatible drying cabinets, and custom-fit tray assemblies
• Locking casters and compact footprint (945 × 700 × 950 mm) allow flexible placement on standard laboratory benches or integration into cleanroom utility zones
• Pre-engineered vacuum interface compatible with common oil-free scroll pumps (recommended pumping speed ≥12 m³/h) and optional helium leak detection ports for validation protocols

Sample Compatibility & Compliance

The Mitte Classic Series is routinely deployed in academic laboratories, contract development and manufacturing organizations (CDMOs), and early-phase biopharmaceutical units where process consistency and audit readiness are critical. Its mechanical design and control architecture align with foundational requirements of ISO 22042 (freeze-drying equipment), ASTM F2667 (lyophilization cycle development), and FDA guidance on Process Validation (Stage 3: Continued Process Verification). While not pre-certified as 21 CFR Part 11 compliant out-of-the-box, the system’s data logging firmware supports export of time-stamped, user-attributed event logs—including vacuum ramp rates, shelf temperature profiles, and condenser load events—which may be integrated into validated electronic lab notebook (ELN) or LIMS platforms. All wetted surfaces are electropolished stainless steel, facilitating cleaning validation per ICH Q5C and EU GMP Annex 15 criteria.

Software & Data Management

The embedded operating system records all critical process parameters at configurable intervals (1–60 second resolution) to internal flash memory. Data exports are generated in CSV format via USB-A port, preserving column headers, timestamps (ISO 8601), and unit annotations. Optional Ethernet connectivity enables remote status monitoring and alarm notification via SMTP or Modbus TCP—supporting centralized facility management systems. Audit trail functionality includes operator login tracking, parameter change logs with before/after values, and automatic timestamping of start/stop commands. No cloud storage or third-party telemetry is enabled by default; all data remains resident on-device unless explicitly exported by authorized personnel.

Applications

• Stabilization of monoclonal antibodies, vaccines, and plasmid DNA for long-term storage and transport
• Preparation of sterile reference standards and certified reference materials (CRMs)
• Drying of microbial cultures, enzyme preparations, and diagnostic reagents without activity loss
• Processing of botanical extracts and nutraceutical formulations while preserving thermolabile phytochemicals
• Method development and scale-down modeling for commercial lyophilization cycles (e.g., mapping collapse temperature, optimizing primary drying rate)
• Teaching and training in pharmaceutical sciences, food engineering, and materials chemistry curricula

FAQ

What is the difference between the LSMC55 and LSMC85 models?
The LSMC55 features a single-stage condenser rated to –55 °C, optimized for standard aqueous buffers and saline-based formulations. The LSMC85 integrates a two-stage cascade refrigeration system achieving –85 °C, required for low-eutectic-point solvents and high-concentration biopolymer solutions.
Can this system be used for terminal sterilization of dried products?
No—this is a lyophilization unit only. Terminal sterilization requires separate autoclave or gamma irradiation processes. The system supports aseptic loading/unloading when integrated with isolator or RABS environments.
Is the vacuum pump included with the system?
No. A compatible oil-free scroll vacuum pump (minimum 12 m³/h displacement, ultimate vacuum ≤1 × 10⁻² mbar) must be selected separately and installed per manufacturer guidelines.
Does the system support programmable shelf temperature control?
Yes—both models offer fully programmable shelf heating/cooling profiles with up to 10 segments per cycle, adjustable ramp rates (0.1–5.0 °C/min), and hold steps with precision ±0.5 °C.
How is calibration traceability maintained?
Temperature sensors (PT100 class A) and vacuum transducers (capacitance manometer) are factory-calibrated against NIST-traceable standards. Calibration certificates and SOP templates for periodic verification are supplied with each unit.