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Principal Scientist,  Process Research A Short Presentation Dec 2011  amcrasto@gmail.com
SCALE-UP--Definition ,[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Steps in Scale-Up
API Scale-Up During Research and Development ,[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object]
Process flow
[object Object],[object Object],[object Object]
[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Objective ,[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object]
[object Object]
[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Why conduct Pilot Plant Studies? ,[object Object],[object Object],[object Object]
A pilot plant can be used for ,[object Object],[object Object],[object Object]
[object Object],PARAMETERS Order of mixing of  components Mixing  speed Mixing  time Rate of addition of granulating agents,  solvents, solutions of drug etc. Heating and cooling Rates  Filters size  (liquids) Screen size (solids) Drying temp. And drying time
GMP CONSIDERATION   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
SRTM University, Nanded
Typical Distillation  Pilot Plant  Setup
DR  ANTHONY CRASTO
Automated  pilot plant , controlled with only one process control system for  production of recombinant technical enzymes
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Sugar Cane Crushing Cane Juice Sugar Process Molasses Bagasse Hydrolysate: Hexose, Pentose, Lignin Residues: Ash, Char Ethanol Fermentation Distillation Vinasse  Biomass Hydrogen Fermentation Methane Fermentation Hydrogen Process E. Power Methane Process Steam A B C D 10,000 t/day (1 sugar Mill) 3.000 t/day (50% moisture) Hexose 525 t Pentose 315 t Lignin 210 t Residues 450 t Gas for industry Raw material Gas Fuel
Pilot Plant Placement
LAYOUT 01-5 100L Vessel 01-1-1Tank for raw material preparation 01-1-6 Stirring device 01-1-4 Stirring device
01-3-1 Bioreactor 01-3-2 Circulation system 01-3-6 Flow monitor
[object Object],[object Object],[object Object],Eluent : A) methanol/water/TFA (50/50/0.1) B) methanol/TFA (100/0.1) 10-30%B (0-5 min), 30%B (5-10 min) Temperature : 25ºC for 50 X 4.6 mmI.D. ambient for 50 X 20 mmI.D. Detection : UV at 280 nm Sample : methanol extract of a commercial cayenne pepper (1 g cayenne pepper/3 mL)
Axial Compression Technology to semi-prep column (20 mm i. d. and 30 mm i. d.).  The column bed is compressed adequately by attaching the end assembly newly designed. It provides proper bed density  (10% higher than conventional columns) and bed uniformity. The combination of technology acquired by long our experience with DAC column, the advanced technique of slurry packing, and new hardware design offers an outstanding durability and efficiency  Column : 50 X 20 mmI.D. 5 µm Eluent : A) water B) methanol Gradient : 5%B-95%B Flow rate : 50 mL/min Pressure : ∼ 17MPa
Conclusion The various process considerations described in this article can help chemists understand and adopt a systematic and prospective approach in research and development to have documented and controlled synthetic processes.  This approach will help manufacturers meet product-quality objectives consistently and build a good basis for achieving the goals of prospective validation and scale-up activities.
References ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
https://sites.google.com/site/anthonycrastoscaleup/home

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Anthony crasto scaleup techniques & pilot plant

  • 1. Principal Scientist, Process Research A Short Presentation Dec 2011 amcrasto@gmail.com
  • 2.
  • 3.
  • 4.
  • 5.
  • 6.
  • 8.
  • 9.
  • 10.
  • 11.
  • 12.
  • 13.
  • 14.
  • 15.
  • 16.
  • 17.
  • 18.
  • 19.
  • 20.
  • 21.
  • 22.
  • 23.
  • 25.
  • 26.
  • 28. DR ANTHONY CRASTO
  • 29.
  • 30. Automated  pilot plant , controlled with only one process control system for production of recombinant technical enzymes
  • 31.
  • 32.
  • 33.
  • 34. Sugar Cane Crushing Cane Juice Sugar Process Molasses Bagasse Hydrolysate: Hexose, Pentose, Lignin Residues: Ash, Char Ethanol Fermentation Distillation Vinasse Biomass Hydrogen Fermentation Methane Fermentation Hydrogen Process E. Power Methane Process Steam A B C D 10,000 t/day (1 sugar Mill) 3.000 t/day (50% moisture) Hexose 525 t Pentose 315 t Lignin 210 t Residues 450 t Gas for industry Raw material Gas Fuel
  • 36. LAYOUT 01-5 100L Vessel 01-1-1Tank for raw material preparation 01-1-6 Stirring device 01-1-4 Stirring device
  • 37. 01-3-1 Bioreactor 01-3-2 Circulation system 01-3-6 Flow monitor
  • 38.
  • 39. Axial Compression Technology to semi-prep column (20 mm i. d. and 30 mm i. d.). The column bed is compressed adequately by attaching the end assembly newly designed. It provides proper bed density (10% higher than conventional columns) and bed uniformity. The combination of technology acquired by long our experience with DAC column, the advanced technique of slurry packing, and new hardware design offers an outstanding durability and efficiency Column : 50 X 20 mmI.D. 5 µm Eluent : A) water B) methanol Gradient : 5%B-95%B Flow rate : 50 mL/min Pressure : ∼ 17MPa
  • 40. Conclusion The various process considerations described in this article can help chemists understand and adopt a systematic and prospective approach in research and development to have documented and controlled synthetic processes. This approach will help manufacturers meet product-quality objectives consistently and build a good basis for achieving the goals of prospective validation and scale-up activities.
  • 41.