Mill Rock – Steam Sterilizable Production Freeze Dryer
The QuantaS Steam Sterilizable Production Freeze Dryer supplies cGMP pharmaceutical freeze dryers with steam sterilization (SIP) and 21CFR part 11 for demanding applications in bio-pharmaceutical and pharmaceutical….
QuantaS™ Steam Sterilizable
Production Freeze Dryer
Pharmaceutical Freeze Drying in a Sterile Environment
The QuantaS Steam Sterilizable Production Freeze Dryer supplies cGMP pharmaceutical freeze dryers with steam sterilization (SIP) and 21CFR part 11 for demanding applications in bio-pharmaceutical and pharmaceutical applications.
Choosing the right freeze dryer is often pivotal to the production of a great product and to long term company success. At Millrock Technology, our collaborative approach to system selection, customization and design provides the best freeze dryer for your production needs. Our support lasts throughout the production freeze dryer life cycle to help ensure that your project starts successfully and remains successful.
Our Steam Sterilizable Production Freeze Dryers include:
- All wetted components 316L stainless steel
- Sterilization (SIP) 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
- Customized for your application needs
QUANTA-S STANDARD FEATURES
|Control System||Opto 22, Allen-Bradley (optional)|
|Shelf Temperature Range||-60C to 65C ( 80C option)|
|Shelf Heat Transfer||Hollow, serpentine, fluid filled|
|Shelf Material and Finish||316L stainless steel, 20 Ra or better. Optional electro-polish|
|Shelf Area||Up to 400ft2 (37 m2) total shelf area|
|Shelf Stack||Bulk or Hydraulic Stoppering|
|Product Probes||1 “T” type thermocouple/shelf|
|Condenser Temperature||-75C dry and empty|
|Chamber Configuration||Cylindrical or Rectangular|
|Chamber Rating||ASME 25psi at 125C|
|Compressors||Two Stage,Carlyle, Bitzer, Mycom (screw)|
|Vacuum Pump||Two Stage Oil Sealed Rotary Vane, Dry (optional)|
|Vacuum Control||Capacitance manometer, Proportional vacuum control (optional)|
|Water Ring Pump||Included standard|
|Frame||Welded and Painted|
Millrock Technology, Inc offers 21 CRF Part 11 control system that provides the necessary platform to meet the needs of cGMP freeze drying manufacturing. All data is stored in a secure SQL database to prevent manipulation. Program access is controlled through a multi-level password system to limit access to critical areas. New and modified data entry requires electronic signature that is level controlled to prevent unauthorized changes. All changes are logged in a change log database to provide a full audit trail that meets FDA requirements.