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