Scale up of API

The manufacturing Process of Active pharmaceutical ingredients (API) pharmaceutical process development process definition & objective is explained in detail. Different scale up perspectives will be explained for the pharmaceutical process development.

What parameters mainly changes during the scale up related to length, time and mixing are explained. Chemical process safety prevention is better to take care during the development stage and safe process development during the scale up. Effect of various process parameters like cooling capacities for different vessels and adiabatic temperature different for different vessels studies have been carried out. For most highly exothermic reaction which kind of risk assessment studies need to do that is mentioned. How calorimetry is being used for the calculation of heat of reaction mixture (Q) explained in detail. How calorimetry is directly or indirectly being used for mass transfer, heat transfer, mixing, concentration and dosing speed calculation. It also shows how this thing being connected to rate of reaction explained in detail. Case study relevant to this is explained in detail with graphs and related results. Batch reactor scale up designing from process side is explained with one of the case study for batch kind of stirr tank reactor with 4-balde pitch blade turbine. Drying scale up calculation is shown for one of the case. This thing is explained with the conclusion. Paper includes relevant references.