Community Research and Development Information Service - CORDIS


SMART-GRAN Report Summary

Project ID: 666588

Periodic Reporting for period 1 - SMART-GRAN (Development and Commercialisation of a Self-Guided Fluidised Bed Granulation Solution)

Reporting period: 2015-09-01 to 2016-08-31

Summary of the context and overall objectives of the project

Compared to other industries, the production performance of pharmaceutical plants is relatively low according to Duennibier, Riehle and Tups. The introduction of analytical technologies and sensors has been considered over the past fifteen years to bring greater understanding and control to pharmaceutical processes. The introduction of such technologies was termed Process Analytical Technology by the Food and Drug Administration (FDA) in 2004. PAT is a system for designing, analysing, and controlling manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. Central to PAT is improving final product quality through knowledge of the fundamental scientific principles behind it, and continuous online control of a process. The hypothesis behind PAT is that the quality of the products can and should be incorporated by process design and not by postproduction quality testing.
In pharmaceutical processes particles and granules play a key role in process efficacy and final product quality. The pharmaceutical manufacturing platform of fluid bed granulation is widely used, whereby powders are fluidized and a binder solution or suspension is sprayed onto the fluidized particles, creating liquid bridges which form agglomerates from the powder. However, the adoption of PAT to monitor and control this process is difficult, due to its dynamic nature. These physical and chemical variables can have a significant effect on final product behaviour such as blend homogeneity, drug absorption rates, product robustness, etc and thus overall product quality.

Overall Objectives
The overall objective is to develop and commercialise the world’s first Self-Guided Fluidised Bed Granulation Solution. The SMART-GRAN solution will incorporate a suite of PAT analysers for the in-process monitoring and closed loop control of the Critical Process Parameters coupled with soft-sensoring, for obtaining consistent product quality and safety. The ability of the system to confirm cleaning process success between batches will reduce equipment downtime, increase product throughput and lead to increased productivity. Through a cloud-based data management platform, the SMART-GRAN solution will enable historical data to be available for interrogation. This will enable intelligence-based manufacturing (IbM) concepts which focus on harnessing the complementary power of data, modelling, engineering and IT infrastructure by transforming data into knowledge and ultimately intelligence, to equip industry to move to proactive manufacturing strategies that deliver predictable manufacturing performance.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

A clear, comprehensive and realistic work plan was developed which is the basis for ensuring that the project’s R&D and exploitation goals are fulfilled. The overall plan is clearly linked to the objectives and is broken down into 8 work packages which are further broken down into tasks and subtasks, with clear outputs contributing to the fulfilment of the project milestones. The following work package breakdown was developed:
WP 1 System Specifications
WP 2 System Hardware
WP 3 System Software
WP 4 Cloud Architecture
WP 5 Integration and Control System
WP 6 Validation in Industry
WP 7 Gear Up to Market
WP 8 Project Management

With respect to the generation of the systems specifications, in order to accurately identify the need and specifications for the SmartGran technology a bottom-up approach was mobilised by consulting with industry stakeholders and carrying out research to obtain a clear understanding of the technological needs of the pharmaceutical manufacturing industry and also the specifications expected for these technologies. These consultations served to understand and detail the current needs and limitations of the process control technologies currently in use with FBG processes, which, if any soft sensor data is currently collected/monitored/analysed/stored, the reporting capabilities, if any, of FBG’s and the data generated by these equipment types.
In conjunction with the industry consultations, IPL personnel participated in a number of presentations and discussions on technological solutions and regulatory expectations for process monitoring/control with industry leaders and FBG equipment manufacturers.
The focus of this collaboration was to ensure that the tasks in WP2, WP3 and WP4 could be executed effectively and also provided guidance for the verification and validation of a fully integrated process monitoring, control and reporting solution for fluid bed granulation as well as understanding the current best practices for the fabrication and control of fluid bed granulation processes.
A review of the regulatory and standard landscape was carried out. Its influence on the proposed system development and its features, such as GAMP requirements for automated process and software structure, labelling, and revision control, the FDA 21 CFR part 11 compliance challenges for electronic data generation and protection and current regulatory guidelines for analytical technology validation, were all evaluated.
The regulatory bodies are very supportive and encouraging of the introduction of in-process monitoring and process control technologies. They are supportive of any initiative that will improve product quality.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The SMART-GRAN project will realize a new concept on self-guided fluidized bed granulation that will in the medium to long term benefit the pharmaceutical industry. Particle physics governs process variables such as flow, blending, granulation, compression and coating which can have a significant effect on final product behaviour such as blend homogeneity, drug absorption rates, product robustness, etc. Similarly, the chemistry variation (moisture & homogeneity) within the products has a critical effect on product quality. The development of a technology capable of monitoring physical and chemical parameters of the fluidized bed granulation process in real time will significantly increase process understanding and control thereby assuring product quality, lean operational costs, as well as patient safety.

Equipping the EU pharmaceutical industry with a technology that will enable them to safeguard product quality and safety, reduce costs, increase production throughput, meet with international good manufacturing practices, and facilitate quicker new product development, will undoubtedly contribute to increasing the competitiveness of these sectors at European level, as well as to safeguarding the futures of the 635,000 employed in the sector.

As FBG technology is an important manufacturing platform in numerous industries beyond the pharmaceutical sector, such as food and nutritionals. Improved monitoring and control of the physical and chemical characteristics of particles during food granulation processing will benefit the competitiveness of the European food industry, which is the cornerstone of the European economy and the lifeblood of our rural regions will also be significant. These benefits will be particularly felt in the case of the production of infant formula, powdered milk, nutritional product, whey product manufacture, whereby the uniform presence of various sugar/fat components within the granule as well as its size and structure is critical to the performance of the product

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