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The scale-up of microbial fermentation processes is essential in industrial biotechnology, allowing the transition from laboratory-scale experiments to commercial-scale production while aiming to maintain product yield and quality. This process requires meticulous adjustment of equipment design, process parameters, and contamination control strategies to accommodate increasing culture volumes.At the laboratory scale, cultures are typically maintained in 1 to 10-liter glass or autoclavable...
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Scale Up of Pan Coating Process Using Quality by Design Principles.

Anjali M Agrawal1, Preetanshu Pandey2

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Summary
This summary is machine-generated.

Scaling up pharmaceutical pan coating involves managing complex variables. This review details macroscopic and microscopic scale-up strategies for reproducible and robust coating processes.

Keywords:
coatingprocess analytical technology (PAT)processingquality by design (QbD)solid dosage formtabletthermodynamicsunit operations

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Area of Science:

  • Pharmaceutical Technology
  • Chemical Engineering
  • Process Scale-up

Background:

  • Pan coating is crucial in pharmaceutical and food industries.
  • Scale-up presents challenges due to numerous interdependent process variables.
  • A systematic approach is needed for effective process scale-up.

Purpose of the Study:

  • To review strategies for scaling up pan coating processes.
  • To categorize pan coating variables for systematic scale-up.
  • To highlight the importance of microscopic scale-up in a Quality by Design framework.

Main Methods:

  • Categorization of process variables into pan-related, spray-related, and thermodynamic-related factors.
  • Review of macroscopic and microscopic scale-up strategies.
  • Discussion of modeling and process analytical technology (PAT) tools.

Main Results:

  • Identified key variables influencing pan coating scale-up.
  • Presented distinct macroscopic and microscopic scale-up approaches.
  • Emphasized microscopic scale-up for enhanced process understanding and reproducibility.
  • Reviewed advanced tools for fundamental process insight.

Conclusions:

  • Systematic breakdown of variables and strategic scale-up approaches are essential for robust pan coating.
  • Microscopic scale-up, aligned with Quality by Design, ensures process reproducibility.
  • Modeling and PAT tools are vital for deeper understanding and successful scale-up.