FD-30L-TP Freeze Dryer
The Vikumer FD-30L-TP is our largest stoppering type lyophilizer, it has a total shelves area of 29.7 square meters for product loading. Control of the lyophilization process is by PC software that meet 21CFR Part11. Reference production capacity as following:
2R
OD16mm *114576Pcs
6R
OD22mm *60588Pcs
10R
OD24mm *51150Pcs
Parameters
| Shelves Area | 29.7m2 |
| Shelves Temp. | -55C to +70C |
| Ice Condenser | -85C, 600L |
| Final Vacuum | <1Pa |
| Installed Size | 2300*8000*3500mm |
| Power | 105Kw |
Main Features
Shelves
11 + 1 Plates, Total area 29.7m2.
Condenser
External condenser with isolator.
Control
PC Software, Meet 21CFR Part11.
Design
Meet cGMP, with super craftsmanship.
Configuration
Customizable based on URS.
Technical Details
Designing Applications
The Vikumer pharmaceutical lyophilizers are cost effective freeze drying solutions, which can be addressed to all pharmaceutical lyophilization applications. Include both injectable formulation freeze drying and bulk material freeze drying.
Offer standard configuration as well as customized accessories and functions. Here is the summary of our standard machines.
Machinery Structure
Drying Chamber and Door
Pressure vessel rated rectangular shape drying chamber. Stainless steel 316L made and surface mirror polished. Inner corners are rounded for easy cleaning.
Hinged door is fully Insulated, with viewing port. Door decoration panel for clean room mount is stainless steel 304 made.
External Condenser
Both condenser chamber and condensing coils are S/S316L made, surface mirror polished. Condenser bottom is sloped for water easy draining.
Isolate of the condenser is a butterfly valve, pneumatically operated.
Shelves and Trays
Flexible shelf module, hydraulic stoppering device. All plates are mirror polished roughness better than 0.6um, flatness better than 0.5mm/m.
Construction
Condenser and drying chamber connect can be vertical or horizontal. Drying chamber is rectangular, condenser chamber can be cylindrical or rectangular shape.
System Specifications
Vacuum System
The vacuum pumps installed in pharmaceutical freeze dry system is 2-stage oil sealed pumps and roots pump combination.
Each vacuum pump has individual isolation valve, and is pneumatically operated. Capable of automatic close once electric interrupt.
Refrigeration System
Water cooling method, Bitzer 2-stage compressor system.
Shelves Heating System
Fluid circulates inside sandwich type plates, which can be heated or chilled. Brazed plate heat exchanger and fluid transfer pump is installed to guarantee the evenly temperature of shelves.
Controller and Measuring Apparatus
Temperature Sensors
PT100A probes for fluid, shelves, products and condenser coils temperature measure and control.
Vacuum Gauges
Pirani type vacuum gauges for drying chamber and vacuum system.
Controller
Based on PC, PLC and user friendly HMI. Meet 21 CFR PART 11 guidelines.
- Users and authorization management.
- Batch report generate and auto save.
- Freeze drying recipes management.
- Graphic display system working status.
- Real-time freeze drying curve.
- Automatic and semi-automatic working.
- Alarms and debug model.
Valves
All the valves that use to isolate air and water are pneumatically operated, which include:
- Vacuum pumps isolate, vacuum adjust, vacuum break.
- Condenser isolation valve.
- CIP and SIP related valves.
- Condenser defrost water supply/draining/overflow.
Options and Accessories
- Backup units for key parts (compressor, vacuum pump, fluid pump)
- Dry type vacuum pumps.
- PC control and software authorization.
- CIP, SIP
- Variable shelves spacing.
- Pneumatic door lock.
- Door lock sensor.
- Capacitive vacuum gauge.
- Air filters.
- Lyophilizer documents (Validation package IQ, O/PQ, FAT etc.)