Biopharma Grade Machines (cGMP) - idexindia

Biopharma Grade Machines (cGMP)

LAB SCALE M-110P

LAB SCALE M-110P

  • cGMP ready
  • Minimum sample size of 36 ml
  • Processing pressures up to 2068 bar (30,000 psi)
  • Product flow rate up to 120 ml/min (100 ml/min on 50 Hz model)
  • Meets ASME-BPE compliance standard
  • Provides a 7″ HMI color touch screen control
  • Offers the highest shear rate
  • Guarantees scalability
  • Meets CE marking requirements
  • Offers customizable options to suit every application

PILOT SCALE M-110EH

PILOT SCALE M-110EH

  • cGMP
  • Has small batch capability-minimum sample size of 200 ml*
  • Achieves processing pressures up to 2068 bar (30,000 psi)
  • Produces product flow rates up to 320 ml/min at 2068 bar (30,000 psi) or 450 ml/min at 1724 bar (25,000 psi)
  • Is validatable under 21 CFR to cGMP
  • Meets CE compliance standards
  • Has cost-effective production capability
  • Assures batch-to-batch process repeatability
  • Features a low product holdup volume (180 ml*)
  • The system has motor starter and process interlocks
  • Sanitary-grade and BPE-compliant product paths, instruments and valves are also available

M-700 SERIES

M-700 SERIES

  • cGMP
  • Achieves processing pressures up to 689, 1379 or 2068 bar (10,000, 20,000 or 30,000 psi)
  • Produces product flow rates up to 7.56 lpm (2.0 gpm) (Model M-7125) or up to 15.12 lpm (4.0 gpm (Model M-7250)
  • Features a low product holdup volume (less than 5 liters depending on heat exchanger)
  • Is small batch capable (minimum 6 liters)
  • Guarantees scaleup from lab and pilot Microfluidizer®processors
  • Validatable under 21 CFR to cGMP (enhanced and basic models)
  • Requires no equipment takedown for CIP process
  • Safely processes thermally sensitive materials
  • Process reproducibility across batches
  • Contains only sanitary-grade and BPE-compliant product paths, instruments and valves

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