We have all heard of digital plants, but there is often little guidance for plant managers on how to transition to these futuristic 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, Giuseppe Menin, Industry Manager for Pharmaceuticals at COPA-DATA, gives his advice on how the industry can master digitalisation using scalable software. 

The 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 industry regulations. As a result, digitalization 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. 

Pre-digital plants describe facilities that are dependent on paper processing. Using a low level of automation and relying on basic programmable logic controller (PLC) mechanisms, level one facilities are at the starting point of digitalization. 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 short, yes. 

Pharmaceutical manufacturers are under increasing pressure to improve efficiency. Growing price competition, demand for personalized 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 reporting cannot guarantee the accuracy of their data. As a result, delivering complex pharmaceuticals and personalised medicine can become an impossible task. 

While automated hardware enables higher product throughput, it is useless without an effective communication system. Without machine-to-machine connectivity, an operator must still execute the command on several machines — log in, set recipe, start machine. To increase digital maturity, a manufacturer must increase a plant’s communication.

To solve this, plants have historically used manufacturing execution systems (MESs). However, being an expensive and longwinded process, it’s not commonly used in the pharmaceutical sector. Instead, manufacturers should choose a flexible approach to connectivity. Starting small and scaling up later.   

Let’s consider a theoretical pharmaceutical manufacturing facility as an example. While the plant uses isolated machinery for production, it does have an adequate level of compliance in terms of data integrity. As opposed to deploying a plant-wide MES, the plant manager could use a smaller management system to provide similar benefits in terms of control and efficiency. 

The line execution system can offer an operator a single point of control for a run of machinery by simplifying new-batch setup and automating recipe management. What’s more, by using an intelligent software platform to control these operations, like COPA-DATA’s zenon, this method can generate a centralised audit trail to record operations. Once this method has been tried and tested, the plant can begin to scale up its use of this software to include more machinery. Before you know it, the plant is on its way to reaching level three DPMM. 

In an ideal world, deployed software would provide a full and holistic view of the plant’s operation — from recipe management to the shop floor production systems, right through to medicine storage and transportation. However, in an environment where most pharmaceutical manufacturers are coasting at levels one and two of the DPMM, a scalable approach is more realistic. 

More information on scalable smart factory software for the pharmaceutical industry can be found on the COPA-DATA website: www.copadata.com.