GMP compliant pilot type for clinical samples and process validation. Equipped with CIP automatic cleaning system.
cGMPFDA21 CFR Part 11
Key Features
CIP auto-cleaning; SIP steam or H₂O₂ sterilization optional
Stainless steel door, compatible with isolators & cleanroom flanges
Full GMP data compliance support
Wireless temperature probes & PAT sensor integration
Isolator/RABS integration for HPAPI handling
Seamless scalability to production-scale freeze dryers
Optional Systems & Configurations
CIP/SIP Automatic Cleaning & Sterilization
Isolator / Cleanroom Flange Interface
Automatic Stoppering System
Eutectic Point Detector
Wireless Temperature Probes
SCADA Control System (21 CFR Part 11)
Technical Specifications
| Parameter | LYOLAB-0.2G | LYOLAB-0.4G | LYOLAB-0.6G |
|---|---|---|---|
| Drying Capacity | 4 L | 8 L | 12 L |
| Shelf Size (mm) | 400×300 mm | 400×300 mm | 500×300 mm |
| Number of Shelves | 2 | 3 | 4 |
| Total Shelf Area | 980 cm² | 1,660 cm² | 2,460 cm² |
| Vial Loading Quantity | 500 (φ12) | 875 (φ12) | 1,300 (φ12) |
| Inter-Shelf Distance | 75 mm | 75 mm | 75 mm |
| Condenser Temperature | -50°C | -70°C | -70°C |
| Ultimate Vacuum | ≤3 Pa | ≤3 Pa | ≤3 Pa |
| Installation Dimensions (mm) | 1400×900×1800 | 1400×900×1900 | 1500×1200×1900 |
| Weight | 350 kg | 550 kg | 850 kg |
| Power Consumption | 4.5 KW | 5.5 KW | 8.5 KW |
Applications
Clinical Trial Material Production
Process Validation (IQ/OQ/PQ)
Sterile Formulation Development
HPAPI Containment & Handling
Ready to Find Your Ideal Lyophilization Solution?
Our engineering team will work with you to select the optimal freeze dryer configuration based on your product characteristics, production scale, and compliance requirements.
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