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
About the QuantaS Steam Sterilizable Production Freeze Dryer
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|
Note: Specifications subject to change without notice. All specifications based on 20C ambient on 60Hz.
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.
Number of vials is an approximation. Actuals can be provided as required.
Not sure which freeze dryer best fits your needs? Click here for our freeze dryer capacity calculator.
- Hydraulic Stoppering with Bellows Seal
- Bottom up or top down stoppering
- Isolation Valve
- Isolator interface
- Screw Refrigeration Compressors
- MKS Proportional Vacuum Control
- Clean-In-Place Piping and Control
- Electro-polished Shelves and Chamber
- Auto-Locking Doors
- Single Height Loading with Pizza Door
- Pass Through Design
- Cooling Jacket on Chamber and Door
- 21 CFR Part 11 Compliant Software
- Validation Documentation
- IQ/OQ Workbook
- Factory Acceptance Testing
- Site Acceptance Testing
Your Freeze Drying Partner
When you purchase a Millrock product, you get more than a freeze dryer. You get a long-term partner delivering industry-changing innovations, high-performing products, and on-call expert support.