TABLETING 77
Continuous processing will require a change in mindset for controls and automation, explains Dr Hubertus Rehbaum
TheHOT TOPIC C
ontinuous processing for secondary manufacturing in pharma remains one of
Continuous processing has great potential for more efficient and cost-effective manufacturing of tablets
the hottest topics currently being discussed. Academia, industry and governmental institutions have embraced this development, working towards solutions from both the technological and regulatory perspective. Although from an economics point of view, continuous processing has great potential for more efficient and cost-effective manufacturing of tablets, the authorities and specifically the FDA pursue improved safety and product quality. With the pharmaceutical industry being extremely conservative, this paradigm change from batch to continuous requires a re-thinking for all the stakeholders that are part of the manufacturing process.
in pharma manufacturing
Despite some pharmaceutical companies taking the
engineering and implementation into their own hands, it is the machine suppliers that are challenged to translate concepts and regulatory requirements into industrially viable solutions, setting new standards for future production of solid dosage forms. In this respect, one of the major tasks on the pathway towards fully continuous production lines is the significantly increased complexity of the automation system, with the necessary control logic embedded. For reference, key words such as model predictive control, traceability and supervisory control systems are often used in this context. Until now, the process machines for batch manufacturing rely on local PLCs and PID control
loops, both very familiar to the pharmaceutical industry. However, the complexity of full continuous production systems exceeds the capabilities of these well-established technologies, calling for new methodologies. Instead of standalone
PLCs with HMIs, different architectures with distributed control structures and more advanced software platforms take a leading role in controlling both the production process and moreover the final product quality.1
Examples of such
implementations can be found in various test installations around the globe, either in pharmaceutical companies or on the demonstration systems of machine suppliers. Ahead of all, academia has presented pioneering solutions, implementing complex control
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