Projects / Programmes
Machine vision system for in-line monitoring of high-shear granulation processes
| Code |
Science |
Field |
Subfield |
| 2.06.00 |
Engineering sciences and technologies |
Systems and cybernetics |
|
| Code |
Science |
Field |
| 2.02 |
Engineering and Technology |
Electrical engineering, Electronic engineering, Information engineering |
automated visual inspection, pocess monitoring, process analytical technology, high-shear granulation, machine vision, particle size analysis, deep learning, neural networks
Researchers (1)
| no. |
Code |
Name and surname |
Research area |
Role |
Period |
No. of publicationsNo. of publications |
| 1. |
36832 |
PhD Andraž Mehle |
Systems and cybernetics |
Head |
2020 - 2022 |
18 |
Organisations (1)
Abstract
The majority of pharmaceutical products on the market are tablets and capsules, which are produced through a series of complex unit operations. Starting from a mixture of drug and excipient powders, powder granulation is the core unit operation. The improvement of powder properties motivates the pharmaceutical industry to adopt granulation as a key intermediate process step in most tablet and capsule production processes. Granulation modifies the shape, size and density of powders to improve drug and excipient distribution, material handling, flow, compressibility and drug release. The attributes of granules obtained during the high-shear wet granulation step are thus critical to efficiency of the downstream processes and the quality of obtained tablets and capsules. In the last few decades, the industrial practice of pharmaceutical granulation has been dominated by the high-shear wet granulation process. High-shear wet granulation is a batch process that is controlled based on process parameters. The intermediate or end product quality is assured by determining the raw material properties, defining a fixed set of process parameters and testing the final quality on collected samples. Therefore, the quality is being tested and not built into the products. This approach inhibits efficient generation of process knowledge and imposes a status quo on future high-shear wet granulation process implementations. Despite over 50 years of research in granulation technology, the high-shear wet granulation process still depends on the practical knowledge of the operator and remained in some cases more of an art than science. This is mainly due to complex mechanisms involved in granule growth, a strictly regulated environment in the pharmaceutical industry sector and unavailability of thoroughly tested and reliable tools for in-line and real-time process monitoring of relevant granule properties. Few techniques are commercially available for in-line monitoring of high-shear wet granulation, which indicates that the process presents a complex and challenging condition for in-line control or even that existing solutions are not suitable for the purpose and have therefore not achieved broader commercial success. Our research hypothesis is that the visual appearance of granules contains sufficient information to indicate the state of the granulation process. This hypothesis is supported by practical findings such as routine visual assessment of granules by skilled process operators as aid in granulation process control and by industry recognized critical granule properties such as granule size distribution, morphology, porosity, etc. which can all be measured from the acquired visual information. Within the proposed research project, we aim to develop and evaluate a prototype machine vision system for in-line and real-time monitoring of high-shear wet granulation processes. By employing the system into a production-scale granulation equipment, critical visual properties of granules will become measurable in real-time throughout the granulation process. This will enable monitoring, understanding, controlling and optimization of high-shear wet granulation processes during process development, scale-up, technology transfer and production, which will result in significantly improved processes, assuring the quality and consistency of granules. This will reduce process development time and material consumption, the probability of rejected batches, the associated costs and environmental impact and generally provide more affordable drugs of better quality to the general public.
Most important scientific results
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Interim report
