From sensors and software to data-based services throughout production, Industry 4.0 solutions are opening new potentials in terms of transparency, quality, safety and efficiency. In the pharmaceutical industry, especially complex processes must be adhered to, and stringent requirements upheld. Nobody can do this alone.

Humans, machines, processes and IT. In the factory of the future, everything and everyone is connected. Intelligent manufacturing is the answer to a rapidly changing market environment. Products are becoming more individualized, production processes more complex, and batches smaller. Manufacturers can address these challenges by reorienting their production, ensuring that it can quickly and continuously adapt to changing requirements. The basis for the digital transformation lies in the smart use of the virtually boundless amounts of available data. 

Pharma: a special case
Compared to many other industries, pharmaceutical production underlies more demanding regulations. Changes to production mean changes to the machines, processes and ultimately the product itself. To ensure consistently high product quality, authorities like the U.S. FDA and the EU Commission issue strict guidelines, such as those on Good Manufacturing Practice (GMP). Accordingly, companies have their fair share of reservations when it comes to implementing new and untried technologies.

Nevertheless, many pharmaceutical companies have already taken the first step toward digitization and are now engaged in its implementation. In this case, we are talking about serialization based on Track and Trace applications—at least, if a holistic solution is used. To adhere to all relevant legal guidelines, it is not enough to simply print a data matrix code on the folding carton. A holistic serialization and aggregation solution should include the connection between machines and software, ensuring that the entire process can be managed, and the data is constantly available. Only this way manufacturers and distributors alike have a clear overview of all process steps while simultaneously achieving the connectivity that is the hallmark of Industry 4.0.

Getting started step by step
The implementation of a serialization solution alone represents a huge challenge. However, in the next step, pharmaceutical companies face obstacles of a very different kind: while Track and Trace applications focus on the packaging, other instruments directly affect the production or filling process. Accordingly, pharmaceutical manufacturers have especially high demands when it comes to new Industry 4.0 solutions. They need the security of knowing that a given solution can be or has already been successfully implemented in the market.

Digitization projects can influence many processes and components. Hence, no one party can or should try to implement them alone. Instead, digitization is about bundling the respective expertise and experience on a cross-project basis. This can include participating in nationwide initiatives. Above all, however, machine providers, software manufacturers and process experts need to work together closely to reap the maximum benefits of Industry 4.0 for their customers. This does not mean they have to replace their entire machine park or abandon their current production philosophy. A step-by-step approach is often the more sensible alternative.

Making use of existing competencies
The first step is to make the existing data visible. For this purpose, Bosch designed its Pharma i 4.0 Starter Edition, which offers machine operators key functions for condition monitoring, event tracking and measuring Overall Equipment Effectiveness (OEE) on their PC or mobile device, including a complete audit trail for all user interactions. No matter whether anomalies or unexpected downtimes occur in the ongoing production, employees can access exactly the information they need, whenever and wherever they like, greatly simplifying their day-to-day work. The data gathered by the software can be subsequently analyzed and used as the basis for targeted process optimizations. This also includes historical data, which can be compared to real-time data and offers valuable insights into the development of central parameters, such as the OEE within a certain timeframe.

To make this possible, Bosch works with a software partner and applies the software according to the respective customer’s specific situation and needs. Thanks to the use of open standards, incorporating machines and lines from different brands does not mean reinventing the wheel. OPC-UA and the machine programming language PackML are primarily used as the standard for communication and data exchange. Adding further features, for instance the generation of Electronic Batch Records (EBR), is also possible. Here, too, all process steps are subject to strict regulations concerning electronic signatures, GMP-compliant processes and long-term data archiving.

Finding buried treasure
Once the data is available, the real challenge consists in identifying previously overlooked information and new potential for optimization. With the help of data analytics or data mining, huge amounts of data are assessed for effects and correlations using statistical methods. Usually, the data from two production batches is sufficient to draw initial conclusions. Yet the more data is evaluated, the more details come to light. The only equipment needed are sensors to gather the data, which can also be found on the majority of older machines, and the right tool for analyzing the data. The most important aspect, however, is the combination of extensive process expertise and IT know-how.

Here is a real-world example. A pharmaceutical manufacturer suddenly had an “out of specification” (OOS) batch. The data analysis revealed that a certain valve was responsible for the problem. Yet the valve had been ruled out in advance, as it was assumed to have no effect on product quality. The deeper correlations were analyzed, and a previously undetected causal chain became apparent. The analysis ultimately determined that the valve provided indirect evidence of an incorrect gas flow in the system, which would never have been detected otherwise. The problem was then easily solved by recalibrating the system.

From vision to reality
In the near future, such recalibrations could be even easier, thanks to Augmented Reality and Virtual Reality (AR and VR). For example, AR applications can guide employees through the process step by step, and be used to display calibration instructions and spare parts. This can considerably accelerate the process without the need for lengthy training. When more complex processes are involved that make training essential, it no longer has to take place in a classroom or on the shopfloor. VR applications produce 3D simulations of machines, which can be used under highly realistic conditions in virtual training sessions. Trainers can follow the simulation live and add helpful instructions as needed, while operators can practice safely and without stress, since any errors they make will have no direct consequences or interrupt the ongoing process.

Admittedly, some of these Industry 4.0 applications are still in an early stage of development. Nonetheless, the digital future is within our grasp, as essential devices like sensors are getting smaller and smaller, and components are becoming more affordable. To gradually make the vision of a connected pharmaceutical industry a reality in day-to-day production, strong partnerships are called for. After all, the challenges posed by digitization can only be successfully and sustainably overcome if machine manufacturers, software developers, process experts, and employees on the shopfloor work hand in hand.