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Although there are challenges to be addressed, the digital transformation of equipment has begun.
Digitalization is taking hold in many areas of the pharmaceutical industry. Pharmaceutical Technology spoke with Marcus Michel, CEO of ACG Engineering, about digitalization in pharmaceutical manufacturing equipment and ACG’s own digital transformation journey.
PharmTech: What trends do you see currently in use of digitalization/Industry 4.0 technologies for the equipment you supply to bio/pharma manufacturers?
Michel (ACG): Industry 4.0, or the ‘digital revolution’, is gaining momentum within the pharmaceutical industry. In particular, Big Data, artificial intelligence, cloud computing, continuous connectivity, and advanced analytics through the Industrial Internet of Things (IIoT) are being utilized by pharma and biopharma manufacturers to deal with issues, such as rising complexities, costs, remote connectivity, and regulations. Smart factories managed with data analytics and machine learning will lower pharmaceutical manufacturing costs, improve quality, and reduce capacity constraints. Ongoing advances in predictive analytics are enabling manufacturers to draw on vast pools of data, including information on resource consumption, machine performance, and storage conditions on shop floors to troubleshoot problems, optimize processes, and boost productivity.
With forward-thinking pharmaceutical companies expediting their plans for digital transformation following the COVID-19 pandemic, a few trends indicate the early stages of adoption of Industry 4.0 in the pharmaceutical manufacturing sector. These trends include smart connected machines and factories; the leap from a reactive to a proactive framework using data analytics; augmented and virtual reality (AR/VR) services, including remote machine maintenance, remote factory acceptance testing, and even installation and commissioning; additive manufacturing; process unit design; digital twin systems; and personalized medicine and the correct use of big data.
ACG began its digital transformation journey in 2017 with four broad objectives: 1) to use emerging digital technologies to transform manufacturing operations, 2) to enhance customer experience, 3) to build smart products and services, and 4) to create new business models. Reducing machine breakdowns and enhancing overall equipment effectiveness in capsule manufacturing were the key business drivers. While the current focus is on transforming operations, ACG is expanding into building smart connected products and services, developing customer experiences, and creating digital-led business models.
PharmTech: What do you see as the biggest obstacles to the implementation of these technologies?
Michel (ACG): The major challenges experienced by the pharmaceutical industry during this digital revolution are:
To completely capitalize on the potential of the IIoT, pharmaceutical manufacturers need to invest in an IIoT infrastructure that has the capacity to handle their high level of requirements. As data and network security are of paramount importance, manufacturers must also be prepared to integrate existing protocols with the latest security solutions. There must be a check on the data that is flowing out of the plants to the Cloud servers. Manufacturing shop floors typically house a wide variety of equipment and associated software, some of which are legacy systems and no longer enjoy vendor warranty. Therefore, IIoT relevant upgrades are crucial. However, these upgrades can be costly. Additionally, the workforce needs to be trained, upskilled, and educated on the importance of these technological advancements, as they are an integral part of this digital transformation.
PharmTech: What do you see as needs in workforce training or changing the business and work culture to adapt to these new technologies?
Michel (ACG): Building, deploying, and adopting Industry 4.0 initiatives requires a wide variety of technology and domain capabilities. Active collaboration with the original equipment manufacturers, continuous improvement cells, and hands-on training sessions will help in developing the required skill sets. Pharmaceutical manufacturers will have to work on developing a few core competencies, as well as flexibility, to be in the driver’s seat for successful adoption and implementation of digitalization and the technologies of the future. These competencies include:
PharmTech: What do you see as the future in adoption of digitalization technologies in bio/pharma manufacturing?
Michel (ACG): The Fourth Industrial Revolution is beginning to flourish within the pharmaceutical sector, which was reluctant to change before COVID-19 hit the world. Due to the pandemic, companies have realized the need for digitalization and are now focusing on a complete adoption of digital technologies. What does Industry 4.0 mean for the pharmaceutical industry? It means increased connectivity, higher productivity, simplification, and transparency in compliance, as well as consolidation and analysis of production information to optimally respond to manufacturing issues as they emerge.