Population balance-enabled model for batch and continuous crystallization processes

Ajinkya Pandit*, Rahul Bhambure, Vivek V. Ranade

*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceedingChapter

1 Citation (Scopus)


Crystallization is a critical unit operation in manufacturing of various active pharmaceutical ingredients and drugs. Irrespective of the large-scale use of crystallization in pharmaceutical manufacturing industry, crystallization is still considered as an art. Recently, quality by design (QbD) is gaining industry acceptance as an approach toward development and commercialization of the pharmaceutical drug molecules. In QbD, the unit operations and the process are designed and controlled to deliver specified quality attributes consistently. The proposed chapter is motivated by the necessity of the prediction of crystallization events like onset of the crystallization, nucleation, and growth during crystallization of active pharmaceutical ingredients. The chapter demonstrates the integrated use of population balance modeling framework for developing a fundamental understanding of the kinetic aspects of crystallization and correlating the developed understanding for scale-up and design for the crystallization processes. Efforts are made to discuss the impact of various critical process parameters like metastable zone width, scale effects, and residence time on crystal size during batch and continuous modes with the help of couple of case studies. The presented model and approach will be useful for implementing QbD for crystallizers.

Original languageEnglish
Title of host publicationChemical Engineering in the Pharmaceutical Industry
Number of pages29
ISBN (Electronic)9781119600800
ISBN (Print)9781119285496
Publication statusPublished - 13 Apr 2019

Publication series

NameChemical Engineering in the Pharmaceutical Industry
PublisherJohn Wiley & Sons, Inc.

Bibliographical note

Publisher Copyright:
© 2019 John Wiley & Sons, Inc.

Copyright 2021 Elsevier B.V., All rights reserved.


  • Crystallization
  • Growth
  • Nucleation
  • Particle size distribution
  • Population balances

ASJC Scopus subject areas

  • Engineering(all)
  • Chemical Engineering(all)


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