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

Reza Vatankhah Barenji; Yagmur Akdag; Barbaros Yet; Levent Oner

doi:10.1016/j.ijpharm.2019.06.036

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

Int J Pharm. 2019 Aug 15:567:118445. doi: 10.1016/j.ijpharm.2019.06.036. Epub 2019 Jun 18.

Authors

Reza Vatankhah Barenji¹, Yagmur Akdag², Barbaros Yet³, Levent Oner²

Affiliations

¹ Department of Industrial Engineering, Hacettepe University, 06800, Beytepe, Ankara, Turkey. Electronic address: reza.vatankhah@hacettepe.edu.tr.
² Department of Pharmaceutical Technology, Faculty of Pharmacy, Hacettepe University, 06100, Sıhhiye, Ankara, Turkey.
³ Department of Industrial Engineering, Hacettepe University, 06800, Beytepe, Ankara, Turkey.

PMID: 31226474
DOI: 10.1016/j.ijpharm.2019.06.036

Abstract

Industry 4.0 aims to integrate manufacturing operations into a seamless digital whole by incorporating flexibility, agility, re-configurability, and sustainability. The result of this integration is a "smart factory" that is more lean, agile, and flexible in operations. There are valid reasons, and perhaps requirements, for pharmaceutical industries to embrace smart factory and to "borrow" the concept of Industry 4.0 to give rise to "Pharma 4.0" (i.e., the pharmaceutical version of Industry 4.0). This paper proposes a cyber-physical-based PAT framework called CPbPAT for implementing smart manufacturing systems in the pharmaceutical industry. The framework has been developed using an agent-based system and is presented by a standard system modeling language called the Unified Modeling Language (UML). The pharmaceutical manufacturing system shown in "Quality by Design for ANDAs" is used as a case study to illustrate the application of the proposed framework.

Keywords: Cyber-Physical System; Industry 4.0; Multi Agent System; PAT; Pharma 4.0; Pharmaceutical Technology; QbD; RTRT.

MeSH terms

Computer-Aided Design
Drug Industry
Technology, Pharmaceutical / methods*