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 regulatory authorities. 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.
Preparing for the future
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 personalized medicine as an example. Moving away from the one-size-fits-all approach to treatment, this trend sees medication customized 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 personalized medicine in a pre-digital plant.
In the pharmaceutical plant of the future, digitalization is essential.
Software for smarter pharma
Data integrity is one of best examples of why digitalization 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 vertical and horizontal machine data integration, 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.
Scalable digitalization
Let’s consider a theoretical pharmaceutical manufacturing facility as an example. Operating with isolated machinery means it can be expensive to comply to 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 and compliance.
Following this approach, a line execution system can offer an operator a single point of control for a complete manufacturing line 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 line based user management, audit trail, data acquisition and reporting. Once this method has been tried and tested, the plant can begin to scale up its use of this software to include more machinery and manufacturing lines. 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 — full end-to-end value chain integration from suppliers to patients. However, in an environment where most pharmaceutical manufacturers are coasting at levels one and two of the DPMM, a scalable approach is more realistic.
