BIOCOOL LYO-15 Production-Scale Freeze Dryer
| Brand | BIOCOOL |
|---|---|
| Origin | Beijing, China |
| Model | LYO-15 |
| Instrument Type | Shelf-Type Freeze Dryer |
| Application | Production-Scale |
| Lyophilization Area | 15 m² |
| Ultimate Vacuum | <4 Pa |
| Condensate Capacity (24 h) | 320 kg/24 h |
| Cold Trap Temperature | <−75 °C |
| Compliance | GB150-2011, PED, ASME, FDA 21 CFR Part 11, GMP |
Overview
The BIOCOOL LYO-15 Production-Scale Freeze Dryer is an industrial-grade, shelf-type lyophilization system engineered for reproducible, scalable, and regulatory-compliant freeze drying of pharmaceuticals, biologics, diagnostics, and high-value functional ingredients. It operates on the fundamental principle of sublimation—removing water from frozen materials under controlled vacuum and low-temperature conditions—while preserving structural integrity, biological activity, and chemical stability. Designed for continuous batch processing in pilot-to-production environments, the LYO-15 integrates a robust stainless-steel chamber rated for full-range pressure cycling (−0.15 MPa to +0.5 MPa), precision-controlled shelf heating/cooling, and a high-efficiency condensation system capable of handling up to 320 kg of ice per 24-hour cycle. Its architecture supports both sterile manufacturing and non-sterile production workflows, with optional CIP (Clean-in-Place) and SIP (Sterilize-in-Place) configurations validated per ISO 13485 and EU Annex 1 requirements.
Key Features
- Shelf-based primary drying with ±1.0 °C temperature uniformity across 9+1 heated/cooled shelves (1200 × 1490 mm each), fabricated via orbital TIG welding and certified leak-free for 3-year warranty.
- Advanced process control system supporting fully programmable lyophilization cycles—including pre-freezing, primary drying, secondary drying, and automatic endpoint detection via pressure rise test (PRT) or product temperature monitoring.
- Integrated vacuum regulation module enabling dynamic pressure control during sublimation and desorption phases to suppress boil-over, vial deformation, and collapse—critical for sensitive monoclonal antibodies and live-virus vaccines.
- Pulse backfill system with three selectable rates (slow/medium/fast) to prevent particle dispersion during inert gas (N₂ or Ar) repressurization—optimized for lyophilized powders, granules, and fragile amorphous matrices.
- Industrial 15.6″ HMI touchscreen interface with intuitive workflow navigation; no manual reference required for routine operation or alarm response.
- Real-time data acquisition at 50 ms intervals for shelf temperature, product thermocouple signals, chamber pressure, condenser temperature, and vacuum pump status—fully traceable and exportable.
- Onboard storage for up to 2000 user-defined or factory-default lyo protocols, including versioned revisions and metadata tagging (operator ID, timestamp, audit trail).
- Full compliance with FDA 21 CFR Part 11: electronic signatures, role-based access control, immutable audit logs, and secure data encryption for all operational records.
Sample Compatibility & Compliance
The LYO-15 accommodates standard pharmaceutical vials (e.g., 22 mm diameter, up to 33,600 units per batch), serum bottles, trays, and custom containers compatible with its 15 m² shelf area. Its chamber geometry—featuring large-radius internal corners, mirror-polished 316L stainless steel surfaces (Ra ≤ 0.4 µm), and sloped floor design—meets stringent CIP/SIP validation criteria for residual moisture removal (<10 ppm) and bioburden reduction (Fo ≥ 12 at 121 °C). All wetted components undergo helium mass spectrometry leak testing (≤1 × 10⁻⁹ mbar·L/s), and pressure vessel fabrication adheres to GB150-2011, PED 2014/68/EU, and ASME Section VIII Div. 1 standards. Structural integrity is verified via industrial X-ray radiography of all weld joints.
Software & Data Management
The embedded BIOCOOL LyoControl™ software provides closed-loop PID control of shelf temperature (−75 °C to +80 °C), vacuum setpoints (0.1–100 Pa), and condenser load management. Process data—including real-time shelf/product temperature curves, pressure profiles, and energy consumption metrics—are logged in compliant .CSV and .PDF formats. Remote PC monitoring (up to 1.5 km via Ethernet or fiber-optic link) enables off-site supervision without compromising data security. Optional modules include: calibrated thermocouple and Pirani gauge calibration routines; co-located eutectic point determination (via integrated resistance measurement); and 21 CFR Part 11-compliant electronic signature workflows with dual-factor authentication.
Applications
The LYO-15 serves as a platform for GMP-aligned lyophilization development and commercial manufacturing in regulated sectors. Typical applications include terminal sterilization of injectables (e.g., antibiotics, oncology therapeutics), stabilization of labile biologics (recombinant proteins, mRNA-LNPs, viral vectors), preparation of diagnostic reagents (ELISA kits, PCR controls), and preservation of probiotics and nutraceuticals. Its modular design allows integration into larger aseptic filling lines, isolator systems, or standalone cleanroom suites (Grade C/D). The system is routinely deployed in contract development and manufacturing organizations (CDMOs), vaccine producers, and R&D centers conducting DOE-based lyo cycle optimization.
FAQ
What regulatory standards does the LYO-15 comply with?
The system meets GB150-2011, PED 2014/68/EU, ASME Section VIII Div. 1, and FDA 21 CFR Part 11 requirements. CIP/SIP variants support EU Annex 1 and ISO 13485 certification.
Is the LYO-15 suitable for organic solvent-based formulations?
Yes—when equipped with the optional organic solvent trap and cascade refrigeration unit, it safely handles acetone, ethanol, and tert-butanol-based formulations.
Can the system be validated for GMP production?
Absolutely—the LYO-15 ships with IQ/OQ documentation templates, FAT/SAT protocols, and full traceability for qualification against ICH Q5C, Q8, and Q9 guidelines.
What is the maximum batch capacity in standard 22-mm vials?
Approximately 33,600 vials per cycle, assuming single-layer loading on 9 shelves plus one condenser shelf.
Does the system support automated cycle development?
Yes—integrated process analytical technology (PAT) tools, including tunable diode laser absorption spectroscopy (TDLAS) and manometric temperature measurement (MTM), are available as configurable options for real-time drying endpoint prediction.
