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Cyber-physical-based PAT (CPbPAT) framework for Pharma 4.0.

Reza Vatankhah Barenji1, Yagmur Akdag2, Barbaros Yet1

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Summary
This summary is machine-generated.

Industry 4.0 principles can enhance pharmaceutical manufacturing through Pharma 4.0. This paper introduces a cyber-physical-based Process Analytical Technology (CPbPAT) framework for smart pharmaceutical manufacturing systems.

Keywords:
Cyber-Physical SystemIndustry 4.0Multi Agent SystemPATPharma 4.0Pharmaceutical TechnologyQbDRTRT

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Area of Science:

  • Manufacturing Engineering
  • Pharmaceutical Science
  • Industrial Informatics

Background:

  • Industry 4.0 promotes integrated, flexible, and sustainable manufacturing via smart factories.
  • The pharmaceutical industry can benefit from adopting Industry 4.0 concepts, leading to Pharma 4.0.
  • Smart manufacturing offers enhanced operational efficiency and agility.

Purpose of the Study:

  • To propose a novel cyber-physical-based Process Analytical Technology (PAT) framework, termed CPbPAT.
  • To facilitate the implementation of smart manufacturing systems within the pharmaceutical industry.
  • To demonstrate the applicability of the CPbPAT framework using a pharmaceutical manufacturing case study.

Main Methods:

  • Development of the CPbPAT framework utilizing an agent-based system.
  • Modeling the framework using the Unified Modeling Language (UML).
  • Application of the framework to a pharmaceutical manufacturing system described in "Quality by Design for ANDAs".

Main Results:

  • The proposed CPbPAT framework provides a structured approach for smart pharmaceutical manufacturing.
  • The agent-based system and UML modeling ensure a robust and adaptable framework.
  • The case study illustrates the practical implementation and potential benefits of CPbPAT.

Conclusions:

  • The CPbPAT framework is a viable solution for implementing smart manufacturing in the pharmaceutical sector.
  • Adoption of Pharma 4.0 principles, enabled by frameworks like CPbPAT, is crucial for future pharmaceutical production.
  • The cyber-physical approach enhances PAT integration for improved pharmaceutical manufacturing.