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research article

A semantic-driven approach for maintenance digitalization in the pharmaceutical industry

Wu, Ju  
•
Zheng, Xiaochen
•
Madlena, Marco
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October 15, 2025
International Journal of Pharmaceutics

The digital transformation of pharmaceutical industry is a challenging task due to the high complexity of involved elements and the strict regulatory compliance. Maintenance activities in the pharmaceutical industry play an essential role in ensuring product quality and integral functioning of equipment and premises. This paper first identifies the key challenges of digitalization in pharmaceutical industry and creates the corresponding problem space for key involved elements. A semantic-driven digitalization framework is proposed aiming to improve the digital continuity of digital resources and technologies for maintenance activities. This framework aligns with Quality 4.0 principles and supports the industry's pursuit of zero manufacturing defects. A case study is conducted to verify the feasibility of the proposed framework based on the water sampling activities in Merck Serono facility in Switzerland. A tool-chain is presented to enable the functional modules of the framework. Some of the key functional modules within the framework are implemented and have demonstrated satisfactory performance. As one of the outcomes, a digital sampling assistant with web-based services is created to support the automated workflow of water sampling activities. The implementation result proves the potential of the proposed framework to solve the identified problems of maintenance digitalization in the pharmaceutical industry.

  • Details
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Type
research article
DOI
10.1016/j.ijpharm.2025.125981
Scopus ID

2-s2.0-105011855411

PubMed ID

40738268

Author(s)
Wu, Ju  

École Polytechnique Fédérale de Lausanne

Zheng, Xiaochen

Southern University of Science and Technology

Madlena, Marco

Merck Serono

Kiritsis, Dimitris  

École Polytechnique Fédérale de Lausanne

Date Issued

2025-10-15

Published in
International Journal of Pharmaceutics
Volume

683

Article Number

125981

Start page

125981

Subjects

Digitalization

•

Maintenance automation

•

Pharma 4.0

•

Pharmaceutical industry

•

Quality 4.0

•

Semantic technology

•

Zero Defect Manufacturing

Editorial or Peer reviewed

REVIEWED

Written at

EPFL

EPFL units
EPFL  
FunderFunding(s)Grant NumberGrant URL

Energy-aware Factory Analytics for Process Industries

EU H2020

825030,869951

Available on Infoscience
August 20, 2025
Use this identifier to reference this record
https://infoscience.epfl.ch/handle/20.500.14299/253217
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