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Clinical Trial Manufacturing

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Released By Jubilant HollisterStier CMO

CTM Sterile Filling Capabilities

  • IMA Life Sterifill 100 (MAC) filler
  • Servo driven allowing adjustments from outside of the filler barrier via the HMI panel
  • Programmable filling nozzle allows “bottom up” filling
  • Peristaltic pumps integral to the filler allows for quick change over and control of the filling process
  • Automatic filling with ISO5 stoppering environment
  • 2mL to 20mL vials
  • 200 liters compounding capacity
CTM Lyophilization
  • 30 ft2 IMA Edwards Lyofast 3 Freeze Dryer
  • Cold shelf loading at -45 °C
  • Room dehumidification
  • CIP / SIP
  • 2mL to 20mL vials
  • All hydraulic cylinders are protected/isolated
Automatic batch reports generated for:
  • Freeze drying
  • SIP and CIP
  • Defrost
  • Bellow leak rate
  • System leak rate

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