Pharmaceutical & medical
Transitioning to smarter pharma: How mature is your digital plant?
We have all heard of digital plants, but there is often little guidance for plant managers on how to transition to these more integrated facilities. For the pharmaceutical industry, the Digital Plant Maturity Model (DPMM) is providing a roadmap. But, with the majority of plants operating as digital silos, COPA-DATA’s Giuseppe Menin gives his advice on how the industry can master digitalisation using scalable software
T
he DPMM model was developed through a collaboration of 20 experts from eleven major biopharmaceutical
companies. The system was created to curate the different stages of maturity for a pharmaceutical plant; from paper-based operations, right through to fully automated and ‘adaptive’ plants of the future. The consensus is that pharmaceutical plants are largely in their digital infancy. Unlike other industry sectors, pharmaceutical
manufacturers must focus primarily on quality and compliance in order to adhere to regulatory authorities. As a result, digitalisation in the sector is lagging behind other areas, such as food and beverage and automotive. In fact, many are operating as so-called pre-digital plants or digital silos — levels one and two of the five stage DPMM hierarchy.
PrePArinG FOr The FuTure Pre-digital plants describe facilities that are dependent on paper processing. Using a low
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level of automation and relying on basic programmable logic controller (PLC) mechanisms, level one facilities are at the starting point of digitalisation. Level two plants, while slightly more advanced, are described as digital silos. These plants operate isolated machinery with very little plant-wide connectivity. The hierarchical DPMM model allows
companies to plot their state of digitalization and plan their steps to mature technologically. But, is this change necessary? In shor t, yes. Pharmaceutical manufacturers are under
increasing pressure to improve efficiency. Growing price competition, demand for personalised medicines and increasingly complex regulations are forcing the industry to adapt its operations or risk falling behind. Consider personalised medicine as an
example. Moving away from the one-size-fits- all approach to treatment, this trend sees medication customised at the manufacturing stage to tailor it to every patient’s individual
needs. However, moving from batch production to smaller runs of medicines brings sizeable manufacturing challenges. In fact, it is almost impossible to produce personalised medicine in a pre-digital plant. In the pharmaceutical plant of the future, digitalisation is essential.
SOFTWAre FOr SMArTer PhArMA Data integrity is one of best examples of why digitalisation is imperative for pharmaceutical manufacturers. Pre-digital plants and those reliant on paper-based operations and reporting cannot guarantee the accuracy of their data. As a result, complying to data integrity can becomes complicated, inefficient and expensive. While automated hardware enables higher
product throughput, it is useless without an effective communication system. Without ver tical and horizontal machine data integration, an operator must still execute the command on several machines — log in, set
January 2021 Instrumentation Monthly
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