Pilot production scale (1–7 m²) for process scale-up and small-batch trial production, compatible with automated production lines.
cGMPFDA21 CFR Part 11EU GMP Annex 1
Key Features
Process scale-up & small-batch trial production
Shelf flatness <1.0mm, temperature uniformity <1°C
SCADA control system GAMP compliant, up to 1,000 recipes
Energy-saving control via compressor & vacuum pump management
Flexible arrangement design to suit plant layout
Optional Systems & Configurations
CIP/SIP Automatic Cleaning & Sterilization
Automatic Shelf Stoppering Under Vacuum
Automatic Loading/Unloading System (Row-by-Row)
API Auto-Dosing System
SCADA Control System (21 CFR Part 11)
Isolator / Cleanroom Flange Interface
Oil-Free Dry Vacuum Pump
Technical Specifications
| Parameter | LYOPRO-1.0 | LYOPRO-2.0 | LYOPRO-3.0 | LYOPRO-5.0 | LYOPRO-7.0 |
|---|---|---|---|---|---|
| Drying Capacity | 20 L | 40 L | 60 L | 100 L | 150 L |
| Shelf Area | 1.0 m² | 2.0 m² | 3.0 m² | 5.0 m² | 7.0 m² |
| Shelf Size (mm) | 600×450 mm | 900×600 mm | 900×600 mm | 1200×900 mm | 1200×900 mm |
| Number of Shelves | 4 | 4 | 6 | 5 | 7 |
| Vial Loading Quantity | 4,400 (φ16) | 9,000 (φ16) | 14,000 (φ16) | 20,000 (φ16) | 32,000 (φ16) |
| Inter-Shelf Distance | 90 mm | 90 mm | 90 mm | 90 mm | 90 mm |
| Shelf Cooling Temperature | -55°C | -55°C | -55°C | -55°C | -55°C |
| Condenser Temperature | -75°C | -75°C | -75°C | -75°C | -75°C |
| Ultimate Vacuum | ≤1 Pa | ≤1 Pa | ≤1 Pa | ≤1 Pa | ≤1 Pa |
| Installation Dimensions (mm) | 3000×1400×2200 | 3200×1500×2200 | 4000×1500×2200 | 4500×1750×2200 | 5000×1750×2400 |
| Weight | 2,000 kg | 3,500 kg | 4,500 kg | 7,500 kg | 8,500 kg |
| Power Consumption | 18 KW | 22 KW | 28 KW | 40 KW | 52 KW |
Applications
Process Scale-Up
Clinical Trial Material Production
Small-Batch Commercial Production
API Lyophilization
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