Journal
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 159, Issue -, Pages -Publisher
ELSEVIER
DOI: 10.1016/j.ejps.2021.105717
Keywords
Pharmaceutical technology; Machine vision; PAT; Crystallization; Granulation; Film coating
Categories
Funding
- OTKA [FK-132133, KH-129584]
- National Research, Development and Innovation Fund of Hungary [FIEK_16-1-2016-0007]
- Gedeon Richter's Talentum Foundation
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This paper introduces the analysis of images acquired by a digital camera with visible illumination and its applications in pharmaceutical manufacturing as a Process Analytical Technology (PAT). The development of machine vision and conversion to continuous manufacturing have accelerated the use of digital image analysis methods, enabling more comprehensive analysis and prediction of product quality attributes.
The goal of this paper is to give an introduction to analysis of images acquired by a digital camera with visible illumination and to review its applications as a Process Analytical Technology (PAT) which has great potential in pharmaceutical manufacturing. By utilizing in-line analytical techniques, it is possible to monitor the quality of all the material leaving a processing unit and to create models capable to predict product quality attributes, which are otherwise measured by cumbersome off-line techniques. The rapidly developing machine vision has proven its versatility in numerous applications and it has great potential as an in-line analytical tool. The ongoing conversion of the pharmaceutical industry from batch to continuous manufacturing accelerated the development of digital image analysis methods in the last decade. Among numerous other benefits, continuous technologies, equipped with digital image analysis, enable detecting disturbances in the material flow, and analyzing the products comprehensively. The purpose of this work is to give an insight into the currently available image analysis methods in the characterization of powders, crystallization, granulation, milling, mixing, tableting, film coating, in vitro dissolution testing, and residence time distribution measurements by highlighting some of the most relevant examples of application.
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