Process Chemistry Scale Up


Process Chemistry Scale Up

Processes developed at lab scale are scaled-up to kilo scale.

Capabilities
  • Scale-up of APIs from laboratory to non-validated kilo GMP scale with an output of 05 kg to 10 kg
  • Scale-up of laboratory processes to optimized manufacturing processes, which are:
    • Commercially and technically viable
    • Environment friendly
    • Safe
  • Obtain APIs of desired quality, including particle size and desired polymorph, to suit the requirements of our international customers
  • Customer support to address queries from regulatory authorities
  • Validation of processes in cGMP compliant, multi-purpose plant, on a commercial scale from 1 kg to 100 kgs
Infrastructure
  • Scale-up kilo laboratory to manufacture APIs /Intermediates up to 10 kg
  • Facilities to scale-up and study all types of chemical reactions including pressure reactions
  • Separate cGMP facility for isolation, drying and particle sizing of the finished APIs
  • Autoclaves to carry out high pressure reactions on a commercial scale
  • Facilities to carry out very low temperature (-80°C) reactions
  • Different types of drying facilities like Air Tray, Vacuum Tray, Fluidized Bed Driers and Rotacone Vacuum Dryer
  • Spray drying facility having an output of 1-2kg powder/hr
  • Particle sizing from laboratory to kilo and commercial scale operations
  • Multi-purpose plant consisting of 21 reactors ( GL & SS) with different types of agitators designed for various types of applications to manufacture APIs from 1 kg to 100 kgs





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