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Quanta S Steam Sterilizable Freeze Dryers (SIP)

Freeze Drying Pharmaceuticals & Biotech Products

Depending on their use, there are a number of different freeze drying specifications to consider. If a lyophilizer is to be used in the pharmaceutical or biotech industries it is likely that sterilization between freeze drying runs is necessary.

     

View our brochure for the Quanta Production Freeze Dryers

Sterilization for Lyophilization of Biopharmaceuticals

Steam sterilization (SIP) is the most common form of sterilization in production lyophilizers. Steam sterilizable freeze dryers require a number of special design considerations. First, steam sterilizable freeze dryers have to be capable of maintaining a full vacuum. Secondly, they must be able to maintain high temperature and high pressures. With this two requirements in mind, Millrock Technology provides two design options: cylindrical or rectangular chambers so you can select the best fit, price and performance requirements for your application.

Our Pharmaceutical Freeze Dryers features include:

  • 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
  • Steam Sterilizable systems up to 200 sq ft
Typical Operations Specifications for Steam Sterilizable Freeze Dryers
Condenser Cool Down< 10 minutes to –50 C
Defrost Time< 30 minutes
Ultimate Vacuum5 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
Steam Sterilizable Freeze Dryers Features
Control System PLCOpto 22 or Allen-Bradley
Shelf Temperature Range-60C to +65C (+80C option)
Shelf Heat TransferHollow Fluid Filled
Shelf Material and Finish316L, 20 Ra or better
Shelf Area8 sq ft to 10 sq ft
Shelf AssemblyBulk or Hydraulic Stoppering
Condenser Temperature-75 C
Chamber ConfigurationCylindrical or Rectangular
Chamber RatingAMSE, IE: 25 PSI at 128 C
Condenser StyleCoil or Plate
CompressorsTwo StageCarlyle, Bitzer, Mycom (screw)
DefrostSteam
Vacuum PumpLeybold Rotary Vane or Dry Pumps
Vacuum ControlCapacitance Manometer with Solenoid/Needle Valve
Gas BackfillIncluded
Product SensorsOne per shelf standard
Water Ring PumpNash-Elmo
FrameWelded and Painted

For a complete list and comparison of all our Freeze Dryers, please visit our main Freeze Dryer page.