Sean Costello, Director of Technical Operations
Innopharma Technology Group is at the forefront of developing technologies that enable pharmaceutical, food and chemical manufacturers to better understand their manufacturing processes.
A key focus of Research and Development efforts at Innopharma has been in the Process Analytical Technology (PAT) space. PAT has been defined by the US Food and Drug Administration (FDA) as a mechanism To “design, analyse, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA)”
The practical implementation of PAT involves the on-line or in-line integration of “smart technology” such as process control sensors to conventional process equipment and using the real-time data from the sensors to model and control the process.
Benefits of PAT Technology
The benefits of applying PAT technology in manufacturing include reduced downtime, improved yields, faster process development and scale up as well as faster technology transfer and process troubleshooting. All of these benefits lead to improved quality, efficiency and productivity in manufacturing at a time of increasing competition within the process industry.
Examples of successful PAT technologies which have been successfully developed and commercialised by the Innopharma Technology group include the Eyecon™ and Multieye™.
• Eyecon is a particle characteriser capable of real-time in-line and at-line particle size measurement. Eyecon is used to monitor particle size distribution and detect process endpoint during formulation development, scale-up, tech transfer and commercial manufacturing in processes such as granulation and coating.
• Multieye is a multipoint Near-Infrared (NIR) spectrometer designed for real-time in-line process monitoring. Multeye is an innovative concept incorporating a single sensor with four discrete channels which allow concurrent measurements from up to four positions overcoming the representative sampling limitations of single point devices. Multieye enables the measurement of chemical and physical parameters in various processes such as moisture, blend homogeneity, density, or segregation.
Several other technologies remain in development across the food, chemical and pharmaceutical sector. These include applications to characterise, monitor and control the production of infant formula during spray drying, chemical imaging for equipment cleaning validation, in-line monitoring of crystallisation processes during active pharmaceutical ingredient (API) manufacture and content uniformity measurement of tablets.
Harnessing of Big Data and The Internet of Things
Of course, the application of PAT leads to the generation of large and complex datasets also known as ‘Big Data’. By harnessing the storage, distribution and processing capacity of ‘The Cloud’ innovation opportunities for Innopharma Technology has progressed. Now it is possible to apply advanced analytic against PAT generated Big Data to help decode complex manufacturing process. This is possible by harnessing the Internet of Things (IoT).
The concept of IoT is one of the most significant trends in technology today and is creating a wave of excitement in the process automation industry. The IoT vision is of machine-to-machine (M2M) connectivity and of an instrumented driven world of intelligent sensors and actuators communicating across the Ethernet to improve performance and efficiency. IoT is about the creation of “Smart Devices” and processes.
Innopharma Technology and IoT
Innopharma Technology has joined the IoT revolution with a vision which involves coupling, sensing and control with Big Data and analytics to accomplish advanced levels of optimisation and efficiency. Innopharma Technology is driving this innovation through the development of SMART-GRAN™ a Self-Guided Fluidised Bed Granulation Solution targeted at the pharmaceutical, food, nutritional and cosmetics industries. The SMART-GRAN solution incorporates a suite of Process Analytical Technology (PAT) analysers for in-process monitoring and closed-loop control of the Critical Process Parameters (physical, chemical and moisture properties of the granulate) coupled with soft-sensoring, for obtaining consistent product quality and safety.
Through a cloud-based data management platform, the SMART-GRAN solution enables historical data to be available for Quality-by-Design process optimisation for gaining resource efficiencies for improved competitiveness. This enables 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 the industry to move to proactive manufacturing strategies that deliver predictable manufacturing performance.
Innopharma’s research efforts continue to result not only in some great technology but also in the growth of strong collaborative relationships with pharmaceutical, food and medtech companies, their process equipment manufacturers and also analytical technology partners. This places Innopharma in a unique position of understanding the needs of industry and focusing R&D effort to respond with solutions that make the best use of emerging technologies.
Secret of Success
What’s the secret of Innopharma’s success? Quite simply it’s their Winning Team! Their researchers are multi-disciplined, ranging from backgrounds in mechanical engineering and electronics to software development, physics, and biologics. The team are doctorate led experts with domain expertise and experience in industrial experience. The entire team are innovation-driven, with a spirit of collaboration which has a focus of commercialisation.
To read more about our current research activities click here