Industry 4.0 began as an acknowledgement of the growing role of digital and automated tools for both the possibilities they presented and the way they transformed approaches to operations, processes, and data. First coined in 2011, the term spoke to the advent of a new era of innovative digital and data-driven technologies that would lead to new visions centred around agility, interconnectivity, and end-to-end holistic designs.
The evidence of the movement is seen across the life sciences industry: big data, machine learning, AI, robotics, and automation are all reshaping the conversations around operational infrastructure, efficiency, and best practices.
ISPE created the term Pharma 4.0 (trademarked) as a way to crystallise where the trends and innovations of Industry 4.0 intersect with the challenges and priorities of the life sciences Industry. They identified that the movement towards automation, digitisation, and comprehensive data frameworks should collectively work towards higher standards of drug product quality, where holistic, regulatory robust drug processes deliver innovative treatments to patients in the shortest time possible.
Regulatory bodies, to their credit, have played a pivotal leadership role by spearheading key initiatives
Comparatively, our industry has been slower than others in implementing Industry 4.0 practices and technology. And with good reason; the efficacy and quality of sterile manufacturing solutions take time to develop and validate. Regulatory bodies, to their credit, have played a pivotal leadership role by spearheading key initiatives to emphasise and support developing technologies (for example, the FDA’s Emerging Technology Program and EMA’s Quality Innovation Group).
So, where does the industry find itself currently? How do manufacturers balance the clear direction of our industry towards automation and digitisation with current operational and regulatory demands?
Digital evolution of fill-finish solutions
The engine of Pharma 4.0 is the principle and methodology ascribed in the concept of the Internet of Things (IoT), a transparent, interconnected network of broadly applicable advanced and smart technologies.
The capabilities presented by IoT applications are what makes a holistic vision of pharmaceutical manufacturing possible. IoT references the previously unconnected facets of an operation—people, data, robotics, functions, processes, and monitoring—enabling them to work together. IoT empowers and augments these factors in a unified fashion where data is tabulated, accessible, and comprehensive, and monitoring and feedback can occur in real time.
A central aspect of the IoT relationship in the context of pharmaceutical manufacturing is the role of the operator. Human input will always be a valuable part of the manufacturing process. Ideally, Pharma 4.0 solutions should focus on practical ways to empower operators by removing risk and streamlining or altogether eliminating time-intensive procedures. In practice, this enables an approach to quality previously not accessible to pharmaceutical manufacturing, which has paved the way for many of the innovative medicines we see today.
Evaluating approaches to digitisation and automation
Drug product manufacturers should consider the following questions when evaluating the possible implementation of Pharma 4.0 solutions.
Are you utilising a modular, multi-product approach?
The emphasis on Pharma 4.0 has a clear correlation with the rise of modular, standardised technologies. The expectations surrounding new drug products and, in many cases, the necessary processing requirements are contingent on
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