Digitalization in Pharmaceutical Manufacturing Equipment

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.

Digitalization trends

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:

• Infrastructure setup
• Integrating new information technology (IT) systems and updating existing systems
• Data sharing and management
• Cybersecurity risks
• Regulatory compliance
• Workforce upskilling.

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.

Workforce training

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:

1. Infrastructure. Industry 4.0 needs existing systems to be updated and, in some cases, entirely new IT infrastructure setups. Legacy systems are workhorses, but not high on data security, cybersecurity, and flexible communication protocols. Companies need tailored risk management systems, in addition to a strategy for cybersecurity across the organization and value chain.
2. Talent. Digitalization increases the need for companies to develop new skills at an individual associate level, as well as at an organizational level. To shorten the skill development timeline, recruiting a digitally acquainted workforce and virtual training through AR/VR applications are measures being adopted by companies. This is important in terms of improving quality since we are dealing with pharmaceutical products.
3. Business models. As horizontal integration will create transparency and flexibility across process chains—from procurement to production and maintenance—vertical networking opens doors to collaborate with customers and [original equipment manufacturers] to build new business models for product-based customized solutions and remote aftermarket services. Remote condition monitoring, data analytics, and sharing insights across the value chain will open avenues for different business models.
4. Business segments. Flexibility for adaptation will be different for different segments in an organization. R&D, services, warehousing, and production have great potential to adapt and benefit from this shift to new technologies. However, the business rules and set process standards make it difficult for warehousing, administration, and sales to transform.

Outlook

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.