MODEL: LP (50 to 300kg/Batch)
MAIN FEATURES
Process Control
- Lyophilization process
CIP → SIP → Loading → Freezing → Primary Freezing → Secondary Freezing - Manual control
- Pre-Freeze → 1st/2nd Drying process parameter setup.
- Process is completed manually by user verification.
- Automatic control
- Select recipe. Parameters of Pre-Freeze → 1st/2nd Drying process are automatically set up.
- Process is completed by P-rise test system inside the chamber after the whole process is finished.
Recording parameters
- Sample temperature
- Shelf temperature
- Condenser temperature
- CIP, SIP data
- Vacuum level
Drying Chamber
- Surface roughness: Less than 0.4 µm
- Cooling speed: Within 60 minutes from 20°C to ~-40°C (1°C/min)
- Shelf temperature uniformity: Less than ±1.5°C
Cold Trap Chamber: Condenser
- Cooling speed: Within 30 minutes from 20°C to ~-70°C
- Defrosting System: Hot gas solenoid method, fast defrosting by steam and hot water
Vacuum System
- Pull down time: Within 45 minutes from 760Torr to 100mTorr.
- Eventually lowers to less than 20mTorr.
- Primary Vacuum Tester:
- Automatic vacuum tester before starting the freeze-drying process.
- Protection for Vacuum Pump:
- Automatic gas ballast system for protection from condensation and oil contamination.
Remark
- SCM
- SCM stands for Stoppering, CIP, and SIP: premium full-function series.
- bGMP/cGMP/SCADA
- bGMP (Bulk Good Manufacturing Practices): Standard of process and quality control complying with pharmaceutical material production requirements.
- cGMP (Current Good Manufacturing Practice): Standard of quality control on pharmaceutical goods by the US FDA (Food and Drug Administration).
- SCADA (Supervisory Control And Data Acquisition): Supervisory Control And Data Acquisition system.
- CIP testing method
- Spray with Riboflavin solution (10g/L).
- After the CIP process, no residue must be found using an Ultra Violet device.
SPECIFICATION
| LP50 | LP100 | LP200 | LP300 | LP500 | |
| Totally ice capacity | 50 liters | 100 liters | 200 liters | 300 liters | 500 liters |
| Vial quantity (10ml Standard) | 6,700 ea | 13,300 ea | 27,300 ea | 41,000 ea | 69,500 ea |
| Condenser temperature | Below -85°C | ||||
| Shelf temperature | -45(-55°C) to +80°C | ||||
| Shelf areas | 3.2m² (0.4m²/EA) | 6.4m² (0.8m²/EA) | 13.2m² (1.2m²/EA) | 19.8m² (1.8m²/EA) | 33.6m² (2.5m²/EA) |
| Shelf quantity | 8 + 1 | 11 + 1 | 14 + 1 | ||
| Material | STS 316 (Chamber/Shelf) / Calibration service | ||||
| Shelf Dimensions (WxDxH mm) | 500 x 800 x 18 | 805 x 1005 x 18 | 1005 x 1205 x 25 | 1210 x 1510 x 25 | 1510 x 1650 x 25 |
| Ext. Dimensions (WxDxH mm) | 1450 x 2003 x 2140 | 1600 x 2415 x 2210 | 2970 x 2855 x 2160 | 3500 x 3390 x 2375 | 3516 x 4616 x 2347 |
| Electrical | 380/400/440/480V 3Ph 50/60Hz | ||||
| Refrigeration system | 7.5HP x 2EA | 10HP x 2EA | 30HP x 2EA | 40HP x 2EA | 30HP x 4EA |
| Vacuum Vol. (LPM) | 841 | 1,600 | 4,000 | 6,680 | 14,000 |
OPTIONS:
- Pizza door with automatic loading/unloading system
- Stoppering system
- CIP system
- SIP system
- Loading/Unloading System
- Dual-safety system
- Isolation system
- Monitoring system
- Validation support
