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Processes 2018, 6(5), 53; https://doi.org/10.3390/pr6050053

A Systematic Framework for Data Management and Integration in a Continuous Pharmaceutical Manufacturing Processing Line

1
Department of Chemical and Biochemical Engineering, Engineering Research Center for Structured Organic Particulate Systems (C-SOPS), Rutgers, The State University of New Jersey, Piscataway, NJ 08854, USA
2
Department of Electrical & Computer Engineering, Rutgers, The State University of New Jersey, Piscataway, NJ 08854, USA
3
Johnson & Johnson, Co., Cork, Ireland
4
Janssen Research & Development, Spring House, PA 19002, USA
*
Author to whom correspondence should be addressed.
Received: 28 March 2018 / Revised: 3 May 2018 / Accepted: 4 May 2018 / Published: 10 May 2018
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Abstract

As the pharmaceutical industry seeks more efficient methods for the production of higher value therapeutics, the associated data analysis, data visualization, and predictive modeling require dependable data origination, management, transfer, and integration. As a result, the management and integration of data in a consistent, organized, and reliable manner is a big challenge for the pharmaceutical industry. In this work, an ontological information infrastructure is developed to integrate data within manufacturing plants and analytical laboratories. The ANSI/ISA-88.01 batch control standard has been adapted in this study to deliver a well-defined data structure that will improve the data communication inside the system architecture for continuous processing. All the detailed information of the lab-based experiment and process manufacturing, including equipment, samples and parameters, are documented in the recipe. This recipe model is implemented into a process control system (PCS), data historian, as well as Electronic Laboratory Notebook (ELN) system. Data existing in the recipe can be eventually exported from this system to cloud storage, which could provide a reliable and consistent data source for data visualization, data analysis, or process modeling. View Full-Text
Keywords: data management; continuous pharmaceutical manufacturing; ISA-88; recipe; OSI Process Information (PI) data management; continuous pharmaceutical manufacturing; ISA-88; recipe; OSI Process Information (PI)
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Cao, H.; Mushnoori, S.; Higgins, B.; Kollipara, C.; Fermier, A.; Hausner, D.; Jha, S.; Singh, R.; Ierapetritou, M.; Ramachandran, R. A Systematic Framework for Data Management and Integration in a Continuous Pharmaceutical Manufacturing Processing Line. Processes 2018, 6, 53.

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