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Digitalization involves a lot more than just the collection and networking of data. It means that many tools can be used to help pharmaceutical manufacturers achieve their goals. The focus is on maximizing plant availability and high production reliability. To achieve this, Optima Pharma is pursuing three principal strategies.
One good reason to use digitalization methods is that products are becoming more and more customized. The impact is even more marked with high-priced products manufactured using complex machines or systems. This means that numerous pharmaceutical companies are now showing great interest in the optimization possibilities that can be opened up by digitalizing production. The automation experts at Optima Pharma have been developing the tools to do this for some time, consistently focusing on the customer benefits. Heiko Ellwanger, Director Automation Technology, stresses: "We are interested in concrete use cases which create a commensurately major advantage for our customers." In particular, advances in system availability could be achieved using digitalization tools. In the past, an important goal has been maximum yield (minimum waste) with high output, and this is now achievable even more than before with the help of certain digitalization products. Further requirements arise from customized medicine. There are three aspects of digitalization that are generating sustainable benefits in pharmaceutical production: firstly, what is known as "Manufacturing Intelligence". It involves the comprehensive generation and management of the data that is produced in the course of production. Aspect number two is the support provided during the production process to minimize operator risks. The third aspect relates to improvements in maintenance. Here digitalization has a particularly positive effect on maintenance planning, and also brings with it economic and ecological advantages.
More than in any other industry, manufacturers in the pharmaceutical sector have an obligation to ensure product safety and to provide proof of it. Pharmaceutical companies ensure that this is true for every syringe, cartridge, ampoule or vial by recording and storing all the relevant production data. The shift towards more personalized medicine makes this even more important. Especially in critical process steps, the traceability of process data means that the transparency needed for product quality can be ensured. The basic purpose of digitalization is to make data available, to store it appropriately and to be able to reproduce it in an orderly, contextualized way. This means that the historical data for each individual product can be traced right from the raw materials, through production and filling right up to delivery. This is a bonus in terms of safety, not just for patients, but also for the manufacturer.
A variety of digitalization tools are designed to make life as easy as possible for system operators and technicians. Support that leads to fewer mistakes or helps them to carry out their tasks faster and more reliably has several positive effects. The process of machine changeover between individual production batches or cycles can be relatively prone to errors. Especially when isolators are being used, a defect that is only discovered during the decontamination cycle is very time consuming. This does not just torpedo production planning, particularly with products that have to be filled within a specific time frame. Reduced plant availability also significantly reduces output and hence profits in highly priced products.
With the need for numerous interventions by the operator during production, format changes, line clearance, etc., it is therefore necessary to "lead the operator by the hand" using a range of digital tools. The level of support can be adapted to the operator's level of training and knowledge. This can be done by simply showing them the SOP (Standard Operating Procedure) on the machine HMI or even by showing them what to do step by step with the aid of augmented reality glasses in their field of vision. This dramatically minimizes potential errors. Digital instruments can also be used to record the activities actually being performed. This is particularly helpful when questions about the precise procedure arise in the post-production phase.
Quite a lot of the data which is generated anyway in the course of production or that can be additionally collected as required can be used in the long term for maintenance. The relevant operators or modules of the machine are monitored with special sensor technology on the basis of a weak-point analysis. Presenting the trend development of certain parameters, when combined with expert knowledge, makes it easier to predict when a component will reach the end of its life cycle – and take action before it happens. Predictive maintenance and servicing do not just involve identifying the optimum time to make replacements. It means that the maintenance schedule can be planned in a targeted manner. Furthermore, components are no longer changed unnecessarily or too early, and that is to be encouraged in the interests of sustainability. But above all, predictive maintenance is an effective way of preventing unplanned plant shutdowns and machine failures.
The potential of digitalization is by no means limited to these three aspects. However, over the past two years, there are use cases that have already been rolled out in several Optima Pharma projects. Above all, the pharmaceutical industry's desire is to make processes as transparent as possible. Due to broad data acquisition and structured storage, it is possible, for example, to get to the bottom of errors afterwards in order for them to be eradicated in the future. For example, where a product in the quality laboratory does not meet the required specifications. When all factors affecting quality are available as a data collection, a successful analysis is possible, and any errors can be corrected. This idea is not a radically new one, but it can only be implemented if there is enough computing power.
Software and hardware, IT and OT (Operation Technology) play a twin role. Data acquisition is just as important as graphic representation. In the near future, artificial intelligence (AI) will also play a key role. Heiko Ellwanger explains: "A specialist is frequently able to interpret new trends. With AI that has been properly trained, a machine operator is also able to do this." For example, a torque curve of an engine can be used to predict a component failure. Or even more importantly, in the pharmaceutical sector: Using trend graphs showing specific process values such as temperatures and pressures, it is possible to identify the critical status of the entire process, which could otherwise lead to outof- spec products. The specialist, or alternatively the AI, can initiate timely countermeasures.
Digitalization plays an increasingly important role in changeover and line clearance. For example, product paths are exchanged or emptied and packaging materials are removed. Finally, the system is cleaned and sterilized before the next cycle can be performed. Marcel Biedermann, Project Engineering Manager at Optima Pharma, says: "There are massive risks here that can severely affect the production process. So we also support the operator here using digital technology." With the aid of virtual techniques, they can identify critical points more quickly, for instance. The most important thing is to guide them digitally through the SOP as specified by the customer.
Cameras also have a role to play. When they are placed within the system, they allow the machine interior to be observed. This means that the production manager can always keep an eye on the process from their office. If necessary, they can quickly intervene. High-speed cameras also provide clarity when looking back at recordings. With camera support, critical processes can be precisely analyzed during machine setup or in the event of a malfunction. All the services that offer digital production support will be successively enhanced. An important part of this is Operation Support, which supports operators with video tutorials. For instance, the tools for error analysis, for example with the aid of cameras, are grouped together under Data Management. Changeover Support encompasses the services for a more secure format changeover, and with "Digital Documentation", Optima Pharma provides support for technicians and operators with comprehensive technical information including circuit diagrams, P&ID schematics, operating instructions, etc.
The customer is not the only one who benefits from digitalization. Even Optima Pharma itself benefits. "The CSPE package is essential for our engineering," says Ellwanger. CSPE stands for Comprehensive Scientific Process Engineering, and it covers a wide range of tools that act as catalysts from the concept phase and integrated FAT to the operation and modernization phases. As well as digital engineering and simulation, the engineers are also using virtual reality to build up a picture of the plant at an early planning stage. Some customers have already benefited from the digital mockup, which has proven to be particularly useful in the COVID-19 pandemic. Finally, what takes place in the CSPE Center is not digital and virtual at all: an integrated FAT (iFAT) that merits its name – thanks to the provision of process heat, demineralized water and compressed air. In the wake of the COVID-19 pandemic with its strict travel restrictions, iFATs have already been provided with virtual technology that has enabled customers to be "live" at every step without the need to travel.
All CSPE instruments are designed to achieve the shortest possible time to market. Depending on the project, they can speed them up by up to six months. "First and foremost, the customers benefit from this, and so of course the patients do too," says Biedermann. After all, if a newly approved drug comes onto the market earlier every week, that's worth a lot to everyone involved. The knowledge gained by Optima Pharma's planners and engineers with every CSPE cycle cannot be underestimated. Biedermann reports: "We are becoming increasingly successful in optimizing processes and speeding up commissioning."
This in turn creates added value for the customer. Just like digital instruments for production provided by Optima Pharma. "For us, digitalization is not an end in itself, it's not just some playground where we want to sound out the limits," emphasizes Ellwanger. "All the digital tools always need to deliver a benefit to the customer. Once we recognize this, we will be able to implement the possibilities of digitalization quickly and convincingly."
