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Non-Sterile
Production Freeze Dryer

Quanta™ Non-Sterile Production Freeze Dryer

Versatile Industrial Freeze Dryer

Pharmaceutical lyophilizers often require sterilization (SIP) between each cycle. However, Industrial Freeze Dryer applications often do not require sterilization. To accommodate the large range of requirements between each industry, Millrock Technology offers Non-Sterile Freeze Dryers in the following specifications:

  • 304L stainless steel for non-pharmaceutical applications.
  • 316L stainless steel for pharmaceutical applications.

Custom Designed to Fit Your Needs

Our lyophilizers can be custom designed to fit your specific application needs. Our condenser assemblies can be internal or external with the option of either bulk or stoppering style shelf assemblies. Cylindrical chambers are another option that offer cost savings and can be supplied up to 200 square feet in shelf area. Additionally, options such as: isolation valves, redundant compressors, redundant vacuum pumps, and clean-in-place (CIP) piping can also be provided.

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About the Quanta Non-Sterile Production Freeze Dryer

SPECIFICATIONS

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 with Optional Electropolish
Shelf Area 20 sq ft to 200 sq ft
Shelf Assembly Bulk or Hydraulic Stoppering
Condenser Temperature -75 C
Chamber Configuration Cylindrical or Rectangular
Chamber Rating Full Vacuum
Condenser Style Coil, Internal or External
Compressors Two StageCarlyle, Bitzer, Mycom (screw)
Defrost Hot Gas or Hot Water
Vacuum Pump Leybold Rotary Vane or Dry Pumps
Vacuum Control Pirani with Solenoid & Needle Valve
Gas Backfill Included
Product Sensors One per shelf standard
Frame Welded and Painted

 

Typical Operations Specifications for Non-Sterile Freeze Dryers

Condenser Cool Down < 10 minutes to –50 C
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 (may vary)
Shelf Heating > 1 C/min

 

Performance specifications are estimates and may change based upon design.

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.

Not sure which freeze dryer best fits your needs? Click here for our freeze dryer capacity calculator.

OPTIONS

  • 304 or 316L stainless steel
  • 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
  • Clean-in-Place piping and control
  • Single height door loading with pizza door
  • Pass-through design
  • 21 CFR Part 11 Compliant software
  • Validation documentation
  • IQOQ Workbook
  • Factory acceptance testing
  • Site acceptance testing
  • Water Ring Pump: Nash-Elmo

CONFIGURATION EXAMPLES

For example reference only.  Actual configurations may vary based on design for application needs.

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Millrock Technology:

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.