Pilot/Production - Steam Sterilizable
Freeze Dryers used for processing pharmaceutical and viral products require sterilization between freeze drying runs. The most common form of sterilization is steam sterilization. Not only do steam sterilizable freeze dryers have to be capable of maintaining a full vacuum they also need to be capable of maintaining high temperature and high pressures, which requires special design consideration and construction. Millrock Technology provides steam sterilizable systems with either a cylindrical or rectangular chamber, to best fit the price and performance requirements of the application.
- All wetted components 316L stainless steel
- Validation port included
- Sterilization temperature: Controllable 121-125 degrees C
- Evacuation and drying: Water ring pump
- Insulation: High temperature CFC-Free foam with a stainless steel shroud around both chambers
- Filter: 0.2 micron Sartorius with integrity testing ports
- System cooling to ambient and drying in less than 2 hours using the refrigeration system and a liquid ring pump
- Slope to drain
- Cylindrical Chamber up to 80 sq ft
Typical Operations Specifications
| Condenser Cool Down | < 10 minutes to –50 C |
| Defrost Time | < 30 minutes |
| Ultimate Vacuum | 5 mT |
| Vacuum Pull-Down | < 20 minutes to 100 mT |
| Vacuum Leak Rate | < 3 x 10-2 mbar-liter/sec |
| Shelf Cooling (20 C to –40C) | <40 minutes |
| Shelf Heating | > 1 C/min |
Features
| Control System PLC | Opto 22 or Allen-Bradley |
| Shelf Temperature Range | -60C to +65C (+80C option) |
| Shelf Heat Transfer | Hollow Fluid Filled |
| Shelf Material and Finish | 316L, 20 Ra or better |
| Shelf Area | 8 sq ft to 10 sq ft |
| Shelf Assembly | Bulk or Hydraulic Stoppering |
| Condenser Temperature | -75 C |
| Chamber Configuration | Cylindrical or Rectangular |
| Chamber Rating | AMSE, IE: 25 PSI at 128 C |
| Condenser Style | Coil or Plate |
| Compressors | Two Stage Carlyle, Bitzer, Mycom (screw) |
| Defrost | Steam |
| Vacuum Pump | Leybold Rotary Vane or Dry Pumps |
| Vacuum Control | Capacitance Manometer with Solenoid/Needle Valve |
| Gas Backfill | Included |
| Product Sensors | One per shelf standard |
| Water Ring Pump | Nash-Elmo |
| Frame | Welded and Painted |
