An ever-increasing number of businesses, particularly in the oral solid dosage (OSD) sector are boosting their competitiveness by shifting toward continuous processing techniques
In this context, is it possible for manufacturers and processors that are not yet ready for continuous or cannot move away from batch-based approaches to thrive? The short answer is yes, thanks to process analytical technology (PAT). Martin Gadsby, Director at Optimal Industrial Technologies, looks at how PAT can bring batch-oriented plant to the next level of productivity.
Many process businesses are seeking the multiple benefits offered by continuous flow systems, such as higher product quality, consistency, efficiency and productivity. Yet, batch manufacturing is still widely used and is likely to remain a mainstay for many.
In effect, a continuous approach is not necessarily a panacea that can be applied to any type of plant. For example, the treatment of certain substances and live cultures, as well as specific reaction routes, can currently only occur in batches.
In these situations, manufacturers and processors are not bound to traditional product quality, efficiency and productivity levels. In fact, they can significantly improve their processes because key technologies that contribute to making continuous processing so attractive are now also available for batch systems.
More precisely, the main functional tool allowing plant to run continuous processes is PAT, which minimises the interruptions and process downtime associated with quality control and testing. The technology achieves this by offering a fully integrated system to conduct real-time, at-line, online or inline measurements of critical quality attributes (CQAs) on raw and in-process materials.
The power of PAT is not limited to eliminating the downtime associated with physicochemical analysis. The technology leverages multivariate analysis (MVA) and chemometric models to provide a unique, live and constant insight into how critical process parameters (CPPs) affect end product quality.
All the data and knowledge generated by PAT, including quality predictions, is collected, sorted and presented in a clear and immediate way to plant operators by robust and easily accessible PAT knowledge management platforms, such as Optimal’s synTQ.
The interface empowers manufacturers to adjust their manufacturing processes on the fly in accordance with the results obtained as well as set up automated process control mechanisms to meet set quality standards at all times.
For example, many batch production processes still rely on the precise management of process parameters such as temperature, pressure, pH, material morphology, etc., to achieve optimum results. This applies whether you are running a bioreactor, forming crystals or running a distillation column; and, inevitably, each batch will be slightly different.
By setting up a PAT system that delivers precise live insights and a control framework based on real-time quality, operators in the manufacturing and processing industry can maximise the quality and consistency of their end products.
In addition, they can minimise waste associated with out-of-specification materials, dramatically reducing costs while improving energy and resource efficiency.
The ability to build-in quality checks throughout the entire process ensures compliance and maximises traceability. This is one of the main reasons why PAT is strongly promoted by regulatory bodies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Advanced PAT knowledge managers can also help businesses to define and test PAT methods before processing any material on the physical manufacturing plant. This is the case with the Digital Twin function within synTQ, for example, which offers a cyber-physical system to effectively develop and test a process data flow.
In practice, this tool enables users to run partial or complete PAT methods, virtually, without requiring any real-time data. As the PAT knowledge management software has access to historic instrument data and prediction models, together with additional data, it allows the testing and refinement of the PAT methods offline; later, it can be used to generate more knowledge and improve the quality predictions.
Thus, the digital twin can be used to refine or optimise the process whilst reducing material and energy consumptions as well as waste generation.
The picture presented clearly shows how enhanced productivity, efficiency and product quality are easily accessible to PAT users. For example, large molecule manufacturers have reported how the adoption of PAT has tripled their batch productivity of an upstream biotech process. Although the process was not upgraded to continuous, the PAT framework sets the foundation for future adoption.
Ultimately, all the substantial benefits offered by comprehensive PAT set-ups give batch-driven manufacturing and processing plants the opportunity to thrive in an increasingly competitive market. All it takes is the will to embrace this innovative technology and the support of a reliable PAT and knowledge management specialist.
By relying on skilled and experienced PAT specialists, such as Optimal, businesses in the manufacturing and processing sector can benefit from crucial support in planning, implementing and using appropriate PAT strategies to fully reap the benefits of this technology.Photo caption: PAT helps batch-oriented manufacturers to enhance productivity, efficiency and product quality.