Dosage Development Scale Up


Dosage Development Scale Up

At the scale-up facility we manufacture batches of Solid Oral dosage forms and injectables for bio studies, clinical trials and various regulatory submissions.

Capabilities
  • Handling of all unit processes normally used for manufacture of solid oral and parenteral dosage forms.
  • Scale-up of formulations from laboratory to pilot scale (100,000 units).
  • Manufacture of pivotal and validation batches for submission.
  • Totally automated cGMP production facilities.
  • Manufacture and packaging of batches of solid oral dosage forms intended for clinical / bioequivalence studies.
  • Technical support with expertise in formulation development, process optimization, engineering, quality assurance & quality control with analytical instruments.
Infrastructure
  • cGMP facility equipped with:
    • Building Management system (BMS) for complete monitoring of environmental temperature, humidity and pressure.
    • Rapid mixer granulators
    • Fluid bed processor with top spray & Wurster facility.
    • High-speed rotary tablet presses
    • Completely automated tablets film coating machines
    • Alu/Alu (cold form blister) and PVC/PVDC
    • Automated bulk counting, filling and packaging line for oral solids
    • In-process instruments like Moisture Analyzer, Automated Hardness Tester, Roche Friabilator, Bulk Density Testing Apparatus, Torque Tester and Ultrasonic Sieve Shaker
  • cGMP facility for manufacture of sterile products





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