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Blog Series Part 3 – The role of Automation and MES in Digital Manufacturing

Posted on February 13, 2020 by

David Staunton, Global Services Director & Ryan McInerney, Technical Consultant

The role of Automation and MES in Digital Manufacturing, part of our: ‘Life Sciences 4.0, Revolutionising Life Sciences Manufacturing Through Connected Systems & Data’ blog series

Automation and MES have the potential to play a pivotal part in the role out of digital manufacturing or Life Sciences 4.0. The Food and Drug Administration (FDA) provided criteria for the acceptance of electronic records, electronic signatures and handwritten signatures executed to electronic records as equivalent to paper in the Part 11 regulations in 1997. This allowed for the first significant uptake of Automation and MES in the pharmaceutical industry. Since then projects have delivered incremental (sometimes significant) improvements in efficiency, quality, reliability and safety. However, in the context of Life Sciences 4.0, Automation and MES strategies could effectively eliminate human error and delay from manufacturing – preventing waste and upping efficiency. The financial benefits are significant.

The role of Automation in Digital Manufacturing

In a survey conducted by Zenith, respondents were asked about automation; 42% of participants said they are currently ‘very automated’ and 12% ‘automated wherever possible.’ In five years 50% want to be ‘very automated’ and 23% ‘automated wherever possible’. The desire for automation is clear as it offers several operational benefits – faster, more reliable and ultimately cheaper processes – but its adoption has been a decade long and a gradual process.

The potential that Life Sciences 4.0 holds for automation is massive with individual management processes throughout manufacturing expected to become automated. A simple example is the approach to a temperature gauge giving a higher than expected reading during manufacture. An automated system could detect this reading, interpret event data against previous information and decide upon a course of action to rectify the situation. This would negate the need for an operator to intervene and make an assessment on the required course of action and carry out said action.

The time saving for each event will often be minimal, but when scaled across an entire factory or at the enterprise level – the impact becomes significant. Future developments will also allow machine learning algorithms to adjust manufacturing lines and production scheduling much more quickly than with human intervention. New developments will also pave the way for predictive maintenance and the opportunity to identify and correct issues before they happen.

The role of MES in Digital Manufacturing

While MES systems are becoming more widely adopted, they have added more complexity to manufacturing environments. This has brought about implementation challenges. In response, long-term thinking sits at the forefront of every project to ensure that the process is cost effective and continuously delivers value.

With the shift from paper-based processes to intelligent electronic systems, accelerated by Life Sciences 4.0, MES systems will give more meaningful business insight, remove room for error, and enable resources to be better used.  For example, instead of just measuring the downtime of a piece of equipment for overall equipment effectiveness (OEE), MES can provide batch, cleaning, maintenance and operator inputs as context for the downtime to allow for detailed trend analysis and precise preventative measures to be put in place.

As better approaches to recording and accessing data in real-time are adopted, production both in single plants and across global facilities will be completely revolutionised by increasingly sophisticated and more connected MES systems.

In the next blog in our Life Sciences 4.0 Series we look at the power of IoT and connecting everything together, as well as creating context and more depth of data.

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