QuantaS Steam Sterilizable Production Freeze Dryer

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

Specifications

Note: Performance specifications are estimates and may change based upon design. Specifications subject to change without notice. All specifications based on 20C ambient on 60Hz.

Control System 

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.

Vial Capacity

* Number of vials is an approximation. Actuals can be provided as required.

Available Options

• Cooling Jacket on Chamber and Door
• Clean-In-Place Piping and Control
• Pass-through Design
• Single Height Loading with Pizza Door
• Auto Load/Unload Options
• Internal Condenser or External Condenser
• Isolation Valve
• Bulk or Hydraulic Stoppering
• Bellows Seal on Hydraulic Stoppering
• Acrylic or Stainless Steel Door
• MKS Proportional Vacuum Control
• Water Ring Pump
• 21 CFR Part 11 Compliant Software
• Validation Documentation
• Factory Acceptance Testing
• Site Acceptance Testing
• IQOQ Workbook

Applications

• Pharmaceutical Freeze Drying
• BioTech Freeze Drying
• Microbiome Freeze Drying