Recent advances in sensor technology and machine learning have opened a new horizon in the use of Process Analytical Technology (PAT) in Oral-Solid Dose manufacturing. The next industrial revolution involves the automation of production
processes, and it’s coming to the pharmaceutical sector – Pharma 4.0.
Regulators across the world, including ISPE and the FDA, are encouraging Pharma manufacturers to adopt methods for real-time
process monitoring and automation. The move to automation promises improved manufacturing efficiency, reduced burden on time-consuming and costly laboratory analysis, fewer reworks, and less waste.
So how is this achieved? To automate a process, you need to know what your process is doing and how to adjust the process inputs accordingly. At Innopharma Technology, we have developed a suite of integrated tools to do
all of this for you.
You can monitor critical quality attributes in real-time using state-of-the-art PAT sensors such as the Multieye2 Near Infrared Spectrophotometer. This
sensor has been developed specifically with real-time in-line applications in mind. With extremely fast acquisition times, very high signal to noise, automated referencing, and multiple probe options, it is ideally
suited to monitoring production from granulation, roller compaction, drying, through to compaction, and tableting.
Our sensors integrate natively with a wide range of data historians and process control systems via OPC standard protocols, including our in-house developed advanced data platform for process development and automation,
SmartX, which reads in process-equipment
and sensor data, determines whether the quality attributes are within specification, and adjusts the critical process parameters accordingly, without requiring intervention from technical staff.
To achieve this, several reference runs are carried out to determine typical operating trends and to establish the influence of process parameters, as is typical during process development. We can use the same process
runs to train both SmartX and the Multieye2 NIR sensor, building calibration models and validating how well the models predict the critical quality attributes at the same time as mapping
out how the product evolves throughout the process and in response to combinations of the parameters. The result is a data-driven tool that significantly accelerates development, gives real-time process
data, and allows you to see how closely your process is tracking ideal process evolution. Here is our app note on our self-guided granulation process.