BIOCOOL LYO-5SE Production-Scale Freeze Dryer
| Brand | BIOCOOL |
|---|---|
| Origin | Beijing, China |
| Model | LYO-5SE |
| Instrument Type | Shelf-Type Freeze Dryer |
| Application | Production-Scale Lyophilization |
| Freeze-Drying Area | 5 m² |
| Ultimate Vacuum | <4 Pa |
| Condensate Capacity (24 h) | 100 kg/24 h |
| Cold Trap Temperature (No-Load) | <−75 °C |
| Shelf Temperature Range | −55 °C to +110 °C |
| Shelf Count | 6+1 |
| Shelf Spacing | 100 mm |
| Control Interface | Industrial Touchscreen (HMI), Programmable Logic Controller (PLC) Based |
| Data Logging Frequency | 50 ms |
| Stored Protocols | Up to 2000 User-Defined or Predefined Lyo Cycles |
| Remote Monitoring Distance (Optional) | Up to 1.5 km |
| Calibration Capability | Temperature & Vacuum Sensors |
| Optional Accessories | Eutectic Point Tester, Dry Vacuum Pump, Cascade Compressor Unit, Extended Vacuum Pump Array, Organic Solvent Trap, Vacuum Oil Mist Filter |
Overview
The BIOCOOL LYO-5SE is a production-scale, shelf-type freeze dryer engineered for reproducible, scalable lyophilization of heat-sensitive biopharmaceuticals, herbal extracts, functional food ingredients, and advanced nanomaterials. It operates on the fundamental principle of sublimation under deep vacuum: frozen water in the product matrix transitions directly from solid to vapor phase without passing through liquid—preserving structural integrity, biological activity, and chemical stability. Designed for GMP-aligned manufacturing environments (though not certified for full FDA 21 CFR Part 11 compliance out-of-the-box), the LYO-5SE delivers robust thermal and vacuum control across its 5 m² drying area, enabling batch processing of up to 9,450 vials (Ø22 mm) per cycle. Its cold trap maintains ≤−75 °C under no-load conditions, ensuring efficient vapor capture even during high-moisture load cycles (100 kg/24 h), while the <4 Pa ultimate vacuum supports rapid primary drying kinetics and low residual moisture levels (<1.0% w/w typical with endpoint detection).
Key Features
- Programmable PLC-based control system supporting fully automated cycles—from pre-freezing and primary drying to secondary drying and controlled backfill—with adjustable ramp rates, hold times, and pressure modulation.
- Integrated freeze-dry endpoint detection system that automatically initiates a gravimetric or pressure-rise test during desorption drying to verify residual moisture compliance against user-defined thresholds.
- Vacuum regulation module enabling dynamic pressure control during both freezing and drying phases—critical for preventing boil-over, collapse, or foaming in viscous or low-viscosity formulations.
- Triple-mode pulse backfill system (slow/medium/fast) optimized for delicate particulate or fibrous materials, minimizing particle dispersion during atmospheric re-entry.
- Welded stainless-steel shelves fabricated via orbital TIG welding—leak-tested and validated for long-term integrity under thermal cycling and vacuum stress.
- High-resolution industrial HMI touchscreen (≥10″) with intuitive workflow navigation, real-time parameter overlays (shelf temp, chamber pressure, condenser temp), and alarm history logging—requiring no external documentation for routine operation.
- Comprehensive data acquisition: 50 ms sampling interval for temperature (RTD-based), pressure (capacitance manometer), and vacuum pump status; raw data exportable via USB or Ethernet (optional).
Sample Compatibility & Compliance
The LYO-5SE accommodates diverse sample formats including glass vials (Ø22 mm standard), trays, and custom containers mounted on its 6+1 heated/cooled shelves. Its −55 °C to +110 °C shelf temperature range supports both cryogenic pre-freezing and elevated secondary drying for amorphous or crystalline products. While the unit meets core ISO 22042:2016 requirements for freeze dryer performance verification and aligns with ASTM F2375–22 for lyophilization process characterization, it is classified as an “Economic Series” system—meaning it lacks integrated Clean-in-Place (CIP) or Steam-in-Place (SIP) functionality and is not pre-validated for FDA 21 CFR Part 11 electronic records or EU Annex 11 audit trails. Users requiring regulatory-compliant validation must perform IQ/OQ/PQ per internal SOPs and may integrate third-party data integrity modules.
Software & Data Management
The embedded control firmware supports storage of up to 2000 lyophilization protocols—including time-temperature-pressure profiles, alarm setpoints, and endpoint criteria—with password-protected access levels for operators, engineers, and administrators. Process data (shelf temp, chamber pressure, condenser temp, vacuum pump current) are logged continuously and timestamped with millisecond precision. Export options include CSV via USB drive or TCP/IP transfer to local network servers. Optional PC-based remote monitoring enables real-time supervision and alarm notification at distances up to 1.5 km using standard Ethernet infrastructure. Calibration logs for temperature sensors (per ASTM E2847) and vacuum transducers (per ISO 27874) are retained within the system database and support GLP-style traceability when paired with external document management systems.
Applications
The LYO-5SE serves laboratories and pilot plants engaged in process development and small-batch commercial production across regulated and non-regulated sectors. Typical applications include: terminal sterilization-free stabilization of monoclonal antibodies and recombinant proteins; lyophilization of traditional Chinese medicine (TCM) extracts with volatile active constituents; dehydration of probiotic cultures and enzyme complexes for nutraceutical delivery; production of porous nanostructured carriers for controlled drug release; and preservation of labile food-grade emulsifiers, natural pigments, and fermentation-derived flavor compounds. Its modular architecture permits integration into isolator-based filling lines or standalone cleanroom suites (ISO Class 5–7).
FAQ
Does the LYO-5SE support automated stoppering?
Yes—the “S” suffix denotes integrated hydraulic stoppering capability, allowing in-situ closure of vials under vacuum or inert gas after drying completion.
Can it handle organic solvent-containing formulations?
With the optional organic solvent trap and compatible dry vacuum pump configuration, the system safely condenses acetone, ethanol, or ethyl acetate vapors without cold trap contamination.
Is temperature mapping included in the standard commissioning?
No—thermal uniformity qualification (per ASTM F2943) requires separate IQ/OQ execution using calibrated thermocouples and is offered as a value-added service.
What maintenance intervals are recommended for the cascade compressor?
Compressor oil analysis and filter replacement every 2,000 operating hours; full service by certified BIOCOOL technicians annually or per usage log.
How is vacuum sensor accuracy maintained over time?
The system includes built-in zero and span calibration routines for the capacitance manometer, traceable to NIST standards when performed with certified reference equipment.
