There’s a saying that the only constant in life is change. In terms of manufacturing technology, Industry 4.0 represents the most recent fundamental change, presenting a vision of smart manufacturing, near-complete automation, fully optimised processes and, ultimately, the “lights out” factory. Heather Coglaiti, Life Sciences Industry Leader, and Dan UpDyke, Strategic Marketing Manager at Rockwell Automation, report
Out of Industry 4.0 came Pharma 4.0 and, now, manufacturing is again looking ahead to Industry 5.0. But what could that look like and how might it be applied to pharmaceutical production?
Industry 4.0 has seen advanced technologies such as the industrial internet of things (IIoT), artificial intelligence (AI), machine learning (ML), cloud and cognitive computing being integrated into manufacturing ecosystems.
Interconnecting machines to seamlessly to automate processes, Industry 4.0 delivers tangible benefits in terms of consistent quality and manufacturing flow, improved productivity, reduced downtime, streamlined processes and decreased costs.
This advanced connectivity has provided enterprises with a greater insight and understanding of systems and workflows — driven by improved quantitative and qualitative data capture, analysis and contextualisation — resulting in more informed decision making.
Seeking to provide a framework to adapt Industry 4.0 innovations to the highly specialised pharmaceutical sector, the International Society for Pharmaceutical Engineering (ISPE) introduced Pharma 4.0 in 2017.1
Representing a holistic and digitised operational model, Pharma 4.0 combines elements such as improved data quality, increased visibility and transparency, driving opportunities for deeper cross-enterprise collaboration and delivering multiple benefits.
The integration of AI and ML, for example, adds intelligent, contextual analytics, enabling teams to better plan production, model different operational scenarios and perform predictive maintenance on plant and machinery. Furthermore, the ability to optimise product lines enables greater manufacturing flexibility, an important factor as personalised medicine and small-batch specialised therapeutics gain traction.
Manufacturers are now looking to the next operational step-change, Industry 5.0, a concept that first surfaced in 2017 and which the European Union defines as follows:
Essentially, Industry 5.0 focuses on adding value to people, society, the environment and sustainability. Unlike Industry 4.0, which revolutionised manufacturing technology on a digital and transformational level, Industry 5.0 is more opaque.
At its core is a continuation of Industry 4.0, leveraging advanced technologies and automating many repetitive “block and tackle” tasks, the onus being on supporting — not superseding — a newly empowered workforce in a meaningful way. The ISPE, has not, to date, created a Pharma 5.0 model, so what are some of the areas in which Industry 5.0 could benefit pharma manufacturers?
Freedom to innovate
Industry 5.0 refocuses on the added value that human expertise brings to design and manufacturing processes. Process automation enables humans and technology to work in harmony to design and deploy more efficient, intelligent, data-driven pharmaceutical manufacturing processes. Throughout the pharmaceutical product cycle, there are significant opportunities to refocus staff on higher value activities.
Consider, for example, paper-based records. From drug discovery through to product release, a significant amount of time was spent interacting with systems (recording, transferring and sharing data within cumbersome paper-based systems).
Digitising, automating and streamlining those processes makes that information available automatically and immediately to relevant stakeholders and allows scientists to focus on actual science.
In a market that’s increasingly driven by positive patient outcomes, liberating human imagination, creativity and curiosity to advance innovation and discovery in medicine, science and technology is key to delivering advanced therapeutics that can tangibly improve patients’ lives.
Room to grow
Employee well-being is a key tenet of Industry 5.0. The cost of employee churn, recruitment and training are significant, especially in a tight labour market wherein expertise is at a premium. Building long-term relationships with employees and empowering individuals to grow and develop within an organisation boosts in-house expertise.
It’s beneficial for business continuity, improves operations, morale and work quality, and encourages initiative and “outside-the-box” thinking. Greater co-operation between humans and advanced machines, software and technology can improve the employee experience and job satisfaction because people are operating in a higher value capacity.
Leveraging advanced technologies provides better insights, enabling staff to work smarter, optimise their time, drive process improvements and make better, more informed decisions. This is results in greater overall efficiencies and faster times to market, meaning patients have access to treatments sooner.
Transferability, flexibility, scalability
From a global manufacturing perspective, building a production network site by site, integrating with contract manufacturers and meeting different regulatory demands previously required significant manual effort. Industry 5.0 will continue the transition of pharma manufacturing to fully connected enterprise networks.
The implementation of advanced digital systems is key to driving continuous improvements. Creating a digital thread enables IIoT platforms and advanced technologies such as digital twins to be introduced, connecting processes, systems, products and equipment in a seamless, integrated flow of centralised data and insights captured across the manufacturing chain.
Data is shared securely, accurately and instantaneously, freeing up teams to focus more of their energy on refining and optimising manufacturing processes — regardless of location — rather than just simply ensuring that those processes work.
Within a digitised framework, flexible manufacturing processes can be modelled and transferred easily across an organisation’s manufacturing networks, with automatic adjustments made to meet location-specific regulatory and operational requirements (such as adding collaborative robots [cobots] and modular pieces of equipment that can be repurposed for different uses).
Maximising the utilisation of existing systems and capacity helps optimise time to value as there is no need to create novel manufacturing systems, new platforms or build new facilities.
Sustainability is a key focus of the Industry 5.0 model. As organisations look to manage environmental impacts, intelligent technology can monitor manufacturing systems, uncover inefficiencies and seek to optimise natural resources and energy consumption, adapting and evolving with the product mix.
Predictive intelligence will be able to support sustainability by monitoring batch production and making adjustments in real-time to ensure products meet defined specifications and parameters, reducing product waste.
Predictive maintenance, based on AI and ML outputs, can also support sustainability efforts by proactively alerting teams when plant or equipment is likely to require attention. This reduces the risk of unscheduled downtime when facilities are consuming resources but are not productive.
Manageable common-sense implementation
There will, of course, be challenges to address as the pharmaceutical industry seeks to adopt Industry 5.0. Drug manufacturers, ultimately, are tasked with being able to deliver positive healthcare results for patients and must weigh that against the risks of introducing new technologies and methodologies.
Industry 5.0 is not an off-the-shelf, one-size-fits-all single process. Rather, it’s a journey, an evolution of processes and systems that require a strategic, staggered approach to planning and preparation. Manufacturers must clearly define where they want to go and chart a pathway to get there.
A common-sense approach is to start with problems that are already understood and need to be solved as priorities. Where can beneficial value be shown quickly to build momentum and trust in the process?
It’s also important to not only consider the current problems to be solved but also plan for future needs, pre-emptively thinking about the agility and flexibility that solutions might demand. What is going to be required of the manufacturing processes and how can that agility and flexibility be designed from the start to be maximised as the industry evolves?
Industry 5.0 reflects the changing attitudes of society in terms of refocusing on the human experience, job satisfaction, environmental concerns and optimising resources — technological, natural and human — in a value-added, sustainable, long-term way.
Although those might seem lofty, vaguely defined goals, the key to maximising the benefits of Industry 5.0 is by building on the technological advances of Industry 4.0 to get the absolute best outcomes from every resource available.
As drug and therapeutic needs evolve, so must production. Manufacturers need to be more agile, more flexible and be able to scale operations up and down to meet specific therapy needs … because they’re delivering more specialised, targeted treatments for smaller patient populations.
Automation enables these needs to be met, augmented by human expertise that is free to operate in higher capacity functions such as creative design, innovation and scientific discovery.