Industry 4.0, Smart Manufacturing

Pharma TechOps USA Interview: Applying Innovative Technologies in Manufacturing

Interview with Oliver Kärst, Director Global Packaging Reliability Engineering, EMD Serono / Merck KGaA Darmstadt

In the run-up to the Pharma TechOps USA 2019, we spoke with Oliver Kärst, Director Global Packaging Reliability Engineering, EMD Serono /Merck KGaA Darmstadt about Merck‘s Digitalization Initiative and the biggest challenges for introducing innovative technologies into pharmaceutical manufacturing systems.

we.CONECT: What is your role in your company? Do you work in a defined team and how does it relate with other departments in the company?

Oliver Kärst: I am part of the Global Engineering & Technology team of the Healthcare Business Sector of Merck (or EMD Serono, as we have to call ourselves in the US). I work on Packaging Reliability topics which require strong interaction with operations, engineering, operational excellence, procurement and other functions. Together with my team we optimize the packaging components and work on line productivity of our packaging sites.

we.CONECT: In your presentation at Pharma TechOps USA you will be introducing the Digitalization Initiative at Merck and give an overview of its PLUSS program. As a brief summary, what does PLUSS stand for?

Oliver Kärst: PLUSS stands for “Preventing Losses Using Smart Sensors”. It is the first time in our company that we bring smart sensors to our production lines in order to predict downtimes and therefore prevent losses.

we.CONECT: On what scale has Merck‘s Digitalization Initiative been rolled out and what were the greatest challenges? Which benefits justified facing these challenges?

Oliver Kärst: Digitalization is a big topic for Merck (or EMD Serono in the US) since we believe that our competition of the future will not only come from the pharma industry but also from companies like Google and Amazon, who are already heavily investing. Therefore the Digitalization Initiative is driven by our CEO (Stephan Oschmann) on a very high management level. One of the biggest challenges I see, is that there still is some lack of standards in the digital world – which makes it difficult to apply innovative technologies in a regulated environment and bring them to the right scale. Also, it is not easy to justify the cases purely on financial calculation of the benefits we already know – you need to be a kind of evangelist to move topics / ideas forward.

we.CONECT: Most large manufacturing companies are running Industry 4.0 pilot projects but many of these projects fail to be implemented successfully. Only a few are actually rolled out on a large scale. What do you think are the reasons for such a low success rate? Is this also applicable to the pharmaceutical industry, which is known for its thorough evaluations?

Oliver Kärst: Again, I think there is still a lack of standard and the right potential is hard to quantify at the beginning (we all work more or less on fundamental research in the topics). If you purely look at the financial numbers, these kind of projects won’t fly initially (considering the relatively high investments in infrastructure etc.). Especially in the pharmaceutical industry, in a regulated environment it is difficult to start with a “beta version” where you can improve during usage – that’s not what our QA functions want to see.

we.CONECT: Has your company successfully implemented pilot projects which make use of IoT architecture? Do you have recommendations how to prevent ‘pilot purgatory’?

Oliver Kärst: Yes and no. We have run some pilots and are now exactly at this point to convince the management how to move forward. Our plan is to leverage some other projects which need to be implemented anyway for regulated topics like data integrity, and use the infrastructure of these systems – such that the future investments and therefore the risk of investment loss are relatively low. Knowing the right colleagues in IT and QA would also help, since both organizations live in a world of standards, procedures and specifications you better respect from the beginning.

we.CONECT: Does your company have a Predictive Maintenance strategy in place? What were the prerequisites to adopt this strategy? Are there any simple methods for gathering and analyzing data efficiently?

Oliver Kärst: In our global Maintenance Management System there is a standard drafted on predictive maintenance which will be rolled out in the sites soon. Some of the activities described in the standard are linked to the PLUSS project.

we.CONECT: Is the work force ready for Industry 4.0? How does your company make employees predisposed to use new technologies?

Oliver Kärst: We have a lot of digitalization initiatives going on. I think there is a good balance between programs which come “top down” and some entrepreneurial spirit out of the sites. All of these activities are bundled in organizational units dealing with digitalization. The constant dialogue helps to drive these programs – and promoting and sharing some great success stories help to increase the interest in these topics. On top we try a lot on the shop floor where the operators can provide input on the fly and feel “heard”.

we.CONECT: Looking into the future of the pharmaceutical manufacturing system, where do you see the most chances for maintenance & reliability to gain efficiency? What is the biggest challenge to be overcome?

Oliver Kärst: We are at the point where much more data is available. There are many solutions out there which can help to collect, contextualize and analyze the data. Using the data wisely (picking and analyzing the data which will help you to identify losses early in the process) will be key to gain efficiency. Furthermore, I see a lot of potential in using digital solutions to work much more efficient with machine suppliers. One of the biggest challenges I see is that both sides (customer and supplier) are not ready yet. Both parties still don’t have a common goal to run a machine as smoothly as possible but try to optimize in their own camp. On top of that there are many challenges around the topic of sharing data with the suppliers which need to be solved along the way.

we.CONECT: Thank you, Oliver, for the interview!

Join us at Pharma TechOps USA 2019!

On day one of the 2019 Pharma TechOps USA, Oliver Kärst will share his expertise and moderate discussions in the following sessions:

11.00 – 11.30: „Sensors & Sensor Networks for Condition-based Maintenance in pharmaceutical manufacturing plants
In this case study Oliver will address the following topics:

  • Merck Digitalization Initiative
  • Overview PLUSS (Preventing Losses Using Smart Sensors) Project
  • Proof of Concept Challenges and Results
  • Global Roll Out

15.45 – 16.45: In the afternoon, Oliver will be hosting the Challenge Your Peers session to discuss “IoT as a catalyst for paperless production

For more information on the event agenda and booking, click on the buttons below:

07 – 08 March | Marriott Marquis San Diego Marina, USA