Along with increasing market and regulatory pressures, the industry needs to keep pace with the latest manufacturing practice. Alan Johnston, Siemens Industry, reviews the trends as predictions about the influence of the next industrial revolution gather pace
Since the dawn of the industrial revolution, technology has been the prime enabler of productivity in manufacturing. From early mechanics in the 18th century wool industry through the introduction of electrical energy to support mass production nearly 200 years ago, to the advent in recent decades of factories exploiting intelligent manufacturing technology to drive growth in the automotive and electronics sectors, so production advancement has had technology at its heart.
The next productivity leap in manufacturing is on the horizon and this fourth industrial revolution has been coined by experts as ‘Industry 4.0’. Put simply, it builds upon existing work that is developing smarter factories for the future; productivity hubs that will use higher levels of distributed intelligence through miniaturised processors, storage units, sensors and transmitters embedded in all conceivable types of machines, unfinished products and materials, as well as smart tools and new software for structuring data flows around a manufacturing facility.
The long-term thinking behind the notion of Industry 4.0 makes use of embedded technology and refers to this as Cyber Physical Systems that have both a computational element and physical interaction with the real world. Deploying such new technologies and processes will, according to estimates, lead to a 30% increase in industrial productivity.
While the journey to Industry 4.0 will take time, nonetheless it poses important questions for those charged with planning current and future manufacturing performance in the pharmaceutical and life science sectors. Indeed, these are real questions of relevance for the more than 4,000 companies currently operating in the sector across the EU.
The sector is continuing to focus upon key objectives such as asset value, protecting investments, seeking reductions in manufacturing costs, safeguarding product quality and ensuring patient safety at all times. It is also having to do this against a background of slowing growth forecasts, competitive pressures from low-cost manufacturing operations, reduced blockbuster product pipelines and ever more regulatory scrutiny.
The questions raised by Industry 4.0 are not just about blue sky thinking decades away from reality. They pose challenges to the companies of today, therefore all areas of a manufacturing functionality come under the spotlight. How is the organisation structured? Are the business processes appropriate for a more challenging future? What about the status of current production processes and equipment, backed by a need for increasing numbers of skilled personnel?
These questions touch all areas of the pharmaceutical and life science manufacturing experience and the unknown factor is whether companies across the sector are considering such issues today to help formulate a more secure and prosperous future. It is clear from all respected sources that embracing the notion of dynamic change and applying it to current thinking and practice will, in time, separate the manufacturing winners and losers. The particular needs of the sector can be highlighted. They are access to and the intelligent use of accurate and timely data; consistent quality in product design and manufacture, speed to market and validation transparency to satisfy regulatory pressures. These are the foundation blocks for any successful pharmaceutical manufacturing process. All such areas can be supported, enhanced and improved through current available technology solutions also linked to the performance philosophies ingrained in the notion of Industry 4.0.
With speed to market essential, the design, development and qualification of new products through a capability to model in a ‘virtual world’ and use of simulation tools to aid the speed and accuracy of drug development from the laboratory to full scale manufacturing, can drive a leap in productivity possibilities.
This can encompass clean and sterile area modelling; environmental monitoring such as airflow, temperature and humidity profiles; and movement of operations and manufacturing staff. Simulation can cover the physical and process engineering aspects, as well as the offline functional testing of the automation system. This supports the overall qualification process during delivery and also maintains the validated state during operations. Likewise, the true integration of technologies and systems to support access to data integrity both in real time, as well as historic data management, to drive quality control, repeatability assurance and product safety, can be a strategic game-changer for pharma and life science manufacturers.
Linked with visualisation functionality across the operational plant and business processes, it is clear that automation technology as it exists today can help companies achieve a new-found production vision for the future. Intelligence-driven tools such as Product Life Cycle Management and Manufacturing Execution Systems can be the key building blocks in this critical area.
From an operations perspective, the possibilities of a broader digital system can permit a pharmaceutical manufacturing facility to achieve ever greater data-based information accessibility by helping to remove information barriers – something of particular relevance when having to abide with tough regulatory responsibilities.
Automation technology as it exists today can help companies achieve a new-found production vision for the future
Such systems and technologies are proven to optimise business and manufacturing performance. They satisfy essential product consistency and accuracy objectives through the use of quality tools such as Process Analytical Technology (PAT) and Quality by Design (QbD). Repeatability of the manufacturing process and improved yields and waste reduction are just some of the key benefits afforded through a strategic objective to access the right data at the right time and, critically, to be in a position to transform data into actionable information. This includes patient safety, product integrity and traceability through serialisation and track and trace functions, as well as continuous manufacture and real time release.
Achieving such an objective, which will be a pre-requisite for any company wishing to adhere to the long-term vision of Industry 4.0, challenges today’s pharmaceutical and life science operations. Can companies today honestly say they are reaping the proven benefits that such technology can deliver? I don’t mean in 20 years’ time, but here and now.
It is clear that current technology developments can ably support today’s manufacturers in vital areas such as quality, information access and use and safety. For those pharmaceutical manufacturers grappling with more competitors, regulation and a need for new products, early engagement with automation technology vendors can help accelerate the journey to better manufacturing performance outcomes, including measurable production and process efficiency improvements.
Industry 4.0 sets out a pathway to dynamic change with the strategic use of technology at its heart. Solutions to add value already exist today and can underpin a long-term vision. Pharmaceutical and life science companies keen to protect their present and secure a successful future really cannot afford to ignore what is happening. Industry 4.0 and all it entails is coming, whether they like it or not.