Consider a conventional tablet-manufacturing factory. The ingredients are blended, granulated, compressed, and coated in discrete steps. Each of these needs its own ‘clean room’ with dedicated equipment and a low concentration of airborne particles. After each step, the material is stored, and samples are taken and tested in the laboratory for quality.
In the end, you get a ‘batch’ of tablets, lending the process its moniker ‘batch manufacturing’ — a process that is over 50 years old and used to make nearly all pharmaceuticals.
Such a factory covers a large geographical area, has extensive air-conditioning and ventilation systems, requires regular maintenance and employs plenty of labour, while frequent testing puts a “load” on the laboratory, says Mumbai-based drug industry consultant Kaushik Desai. Further, a batch, decided by the size of the equipment, takes months to produce.
But what if these operations were integrated into a connected and compact manufacturing system in a single room? Ingredients would enter at one end and tablets removed at the other. Quality would be monitored by Process Analytical Technology (PAT), sophisticated analytical tools using sensors and probes connected to the manufacturing line and software to analyse and manage data. One instance of a PAT tool is Near-Infrared Spectroscopy (NIR) — using near-infrared radiation to analyse the composition or characteristics of materials in real time.
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