BIOCOOL LYO-3E Production-Scale Freeze Dryer
| Brand | BIOCOOL |
|---|---|
| Origin | Beijing, China |
| Model | LYO-3E |
| Instrument Type | Standard Shelf-Type Freeze Dryer |
| Application Scope | Production-Scale |
| Lyophilization Area | 3 m² |
| Ultimate Vacuum | <3 Pa |
| Condensate Capacity (24 h) | 60 L/24 h |
| Cold Trap Temperature | <−70 °C |
Overview
The BIOCOOL LYO-3E is a production-scale, shelf-type vacuum freeze dryer engineered for reproducible, scalable lyophilization of thermolabile biopharmaceuticals, herbal extracts, functional food ingredients, and advanced nanomaterials. It operates on the fundamental principle of sublimation—removing water from frozen samples under deep vacuum while maintaining product integrity through precise thermal control. Designed for continuous batch processing in pilot or small-volume manufacturing environments, the LYO-3E integrates robust mechanical architecture with programmable process automation to support GMP-aligned workflows without requiring full CIP/SIP capability. Its −70 °C cold trap, high-capacity condensation system (60 L/24 h), and 3 m² shelf area enable efficient drying of up to 6,300 vials (Ø22 mm) per cycle—making it suitable for clinical trial material production, nutraceutical scale-up, and analytical reference standard preparation.
Key Features
- Programmable freeze-drying control system with fully automated cycles—from pre-freezing and primary drying to secondary drying and controlled inert gas backfilling.
- Shelf temperature range: −55 °C to +110 °C, with uniformity ±1.5 °C across all shelves; constructed using certified orbital welding to ensure zero leakage and long-term vacuum integrity.
- Integrated vacuum regulation system enabling dynamic pressure control during both sublimation and desorption phases—minimizing collapse, foaming, or blow-out of delicate formulations.
- Triple-mode pulse backfill system (slow/medium/fast) optimized for particulate, fibrous, or porous dried products—reducing active ingredient loss during nitrogen or argon repressurization.
- Real-time monitoring at 50 ms sampling frequency for shelf temperature, chamber pressure, and condenser temperature—with full data logging and timestamped event tracking.
- Industrial-grade 10.1″ capacitive touchscreen HMI with intuitive navigation; no manual required for routine operation or recipe recall.
- 2,000-user-configurable process protocols stored locally; supports version-controlled recipe import/export via USB.
- Onboard calibration functions for shelf temperature sensors and vacuum transducers—traceable to NIST-traceable references—to maintain measurement accuracy over extended service life.
Sample Compatibility & Compliance
The LYO-3E accommodates a broad spectrum of sample formats including glass vials (Ø22 mm), trays, and custom stainless-steel containers. It supports aqueous and low-concentration organic solvent systems (with optional solvent trap). While the economic configuration does not include Clean-in-Place (CIP) or Steam-in-Place (SIP) functionality, its construction materials (316L stainless steel chamber, electropolished shelves) and sealed hydraulic actuation meet baseline requirements for ISO 13485-compliant device manufacturing and USP lyophilization guidance. The system complies with IEC 61000-6-2 (EMC immunity) and IEC 61000-6-4 (EMC emission) standards. Optional upgrades—including dry vacuum pumps, cascade refrigeration units, and organic solvent condensers—enable compliance with OSHA PEL and ACGIH TLV limits for volatile compound handling.
Software & Data Management
The embedded control firmware supports audit-trail-enabled operation per FDA 21 CFR Part 11 requirements when paired with optional PC remote monitoring software (up to 1.5 km range via Ethernet or fiber-optic link). Process data—including shelf temperature profiles, chamber pressure curves, and condenser load trends—are exported in CSV or XML format for integration into LIMS or MES platforms. The freeze-dry curve review function allows overlay comparison of historical batches to assess consistency and identify deviations. Optional add-ons include freeze-point determination modules (for eutectic temperature mapping) and electronic batch record (EBR) generation tools compatible with Annex 11 validation frameworks.
Applications
- Biopharmaceutical development: Stabilization of monoclonal antibodies, vaccines, and recombinant proteins under non-denaturing conditions.
- Traditional Chinese medicine (TCM) processing: Preservation of volatile oils, glycosides, and heat-sensitive alkaloids without degradation.
- Functional food & nutraceutical manufacturing: Retention of probiotics, enzymes, polyphenols, and omega-3 fatty acids post-drying.
- Nanoparticle formulation: Lyophilization of liposomal, polymeric, and metallic colloids for long-term storage stability.
- Diagnostic reagent production: Stabilization of ELISA kits, lateral flow assay components, and PCR master mixes.
- Research-scale material science: Preparation of aerogels, porous ceramics, and catalyst scaffolds via lyophilized templating.
FAQ
What is the maximum batch capacity of the LYO-3E in standard vials?
The system accommodates up to 6,300 Ø22 mm vials per batch when loaded at standard density.
Does the LYO-3E support automated stoppering?
No—the LYO-3E is a non-stoppering configuration. For integrated stoppering, consider the LYO-3SE variant.
Can the system handle solvents other than water?
Yes—with optional organic solvent condenser and dry vacuum pump upgrades, it supports acetone, ethanol, and tert-butanol-based formulations.
Is remote diagnostics supported out-of-the-box?
Remote monitoring is available as an optional module; basic local HMI operation requires no external connectivity.
What calibration standards are supported?
Temperature sensors are calibrated against ITS-90 traceable references; vacuum sensors support Pirani/capacitance manometer calibration per ISO 20487.
