Process understanding is not just a ‘nice to have’ – it is actually critical to achieve a state of operations where things are done right the first time, every time. In fact, with good process understanding, an organization stands to reap a number of impactful business benefits such as reduced time to market, better use of resources, elimination of wastage and perhaps most importantly and a no-surprises path to regulatory approval.
Process understanding can be quantified in terms of the scale-dependent and scale-independent aspects of a unit operation. Armed with good process understanding, an engineer can use data from laboratory experiments – typically collected in small scale equipment – to confidently scale up to manufacturing to support clinical trials and/or to larger scales.
The scale-dependent aspects of a unit operation can be quantified conveniently using computational/first-principles models. This step – “Asset Digitalization” – results in a “digital nameplate” for the process asset under consideration, such as a crystallizer, a bioreactor, a tablet press or a granulator. Similar to a physical nameplate, the digital nameplate provides details on the capabilities of the asset or “process metrics” – in terms of expected mixing times, heat transfer capabilities, gas-liquid mass transfer effectiveness etc. – as a function of process conditions and material properties.