“Digital technology can help make processes even more reliable”

An interview with Jürgen Rothbauer

Many pharma companies were initially skeptical about digitalization, following the “never change a running system” principle. Yet Jürgen Rothbauer, Managing Director of Optima Pharma, sees a lot of potential in the phenomenon. In an interview with editor Jan Deiniger, he explains what opportunities it offers and how Optima Pharma is exploiting these to further improve process reliability for users.

Mr. Rothbauer, “digitalization” is the word on everyone’s lips. What role do you think it has to play in the pharmaceutical industry?

Digitalization has become a crucial component for the future. Without it, things will stop working. If, as a business, you find your own way of embracing digitalization – moving away from the theoretical aspect toward practical implementation – then it can offer significant added value
 

How has digitalization changed the pharmaceutical industry?

The pharma industry has traditionally taken a conservative stance toward digitalization. This has changed since companies have had to ward off cyber attacks and deal with production downtime. Changes to the drugs landscape have also forced companies to pay more and more attention to overall equipment effectiveness, or OEE, which was not previously the case.
 

Aside from cyber security, data integrity is another issue that keeps cropping up. Could you briefly explain what these two terms mean?

Data integrity means that data is only stored once rather than repeatedly, and in a secure way that makes it impossible to manipulate. And cyber security refers to all measures taken to protect a pharma company’s production systems against cyber attacks.
 

What cyber security measures does Optima Pharma use?

First of all, you need to coordinate your efforts with your customers when it comes to setting up systems. Our customers’ network structures vary, so we have several different solutions in place. The IT experts at the user’s end, who we coordinate our solutions with, are also playing an increasingly important role here. Across the board, the interfaces between pharma companies and Optima Pharma always need to be secured to a high standard.

Interview with Jürgen Rothbauer
“We believe that digital technologies harbor a lot of potential for the future
Jürgen Rothbauer, Managing Director Optima Pharma

Smart machine operator guidance is another key area

Interview with Jürgen Rothbauer
Mr. Rothbauer can fully understand the long-standing skepticism among pharmaceutical companies regarding the digital revolution. He illustrates how companies can benefit from digitalization in terms of reliability, a key issue in this particular industy.

Smart machine operator guidance is becoming increasingly important with the onward march of digitalization. Are there any solutions for this too?

Smart machine operator guidance is becoming essential because machinery in the pharma industry is growing more and more complex. The changes to the product landscape mean that machines are having to handle increasing numbers of containers, which is not easy to deal with. Then there’s the problem of finding skilled staff, who are proving harder and harder to come by.
 
We at Optima Pharma are therefore taking various measures. These include offering video tutorials, helping to carry out error analyses, and installing cameras that clearly show the sources of errors on the HMI. There is also a menu that guides operators and makes it easier for them to fix errors. We also have an information database that enables users to carry out keyword searches to find the right way to deal with errors.
We refer to all the measures introduced to help operators before and during production under the collective term “IPAS,” which stands for “Intelligent Production Assistant System.” It boosts process reliability by providing support for operators during the production process. The main priority is to prevent and eliminate faults. Operators need to be able to set up the machines so that they run without any errors. If an error does occur, however, it’s important that the machine makes the operator aware of this. Like many other digital technologies at Optima, IPAS forms part of the Optima Total Care lifecycle management system.

What are the components of IPAS?

The “smart operator guidance” helps operators with troubleshooting using tools such as video tutorials on the HMI. This is particularly useful for pharma companies that don’t yet have any experienced specialist operating staff on board. The “smart failure log” provides support for carrying out error analyses, for example by means of camera monitoring. “Smart changeover” is a way of making format changes more secure by checking individual format parts – a function that significantly enhances process reliability. “Digital documentation” assists operators by providing technical information to help them fix errors more quickly and efficiently.

When it comes to managing production data Optima uses OPAL



Ever shorter production cycles call for efficient maintenance planning. Are there any digital solutions that can help with this?

More and more monitoring systems are being built into the machines to detect wear and tear at an early stage. These include, for example, monitoring the drives for overheating and correct torque transmission or using vibration sensors. Operators are therefore alerted to any weak spots early on, so they can order replacement parts in good time and plan maintenance intervals accordingly.
 

“Big data” is something of a buzzword: Companies are amassing huge quantities of production data. How can this be put to good use?

When it comes to big data, we distinguish between two kinds: production- and maintenance-related data. Production-related data means the online data that is continuously collected for each container. To give a concrete example, each syringe filling is measured and, if any measurements exceed the set limits, the machine makes the necessary adjustments automatically or triggers an alarm. Data is therefore used directly in this case. We take a very precise approach here to ensure that we only collect the process data that will guarantee appropriate product quality. This data forms the basis for batch reports and official inspections.
As far as maintenance data is concerned, there is still a lot of uncertainty over what types and quantities of data are actually useful. The main focus here is on avoiding data garbage and unnecessary faults, which are often caused by having a large number of maintenance sensors. It’s important to ensure that the machinery stays reliable.  
Interview with Jürgen Rothbauer

Does Optima already have a solution in place for managing production-related data in a useful way?

Like the other business units at Optima, we use the OPAL line management software for this. This records production data, including OEE, and links data at ERP level with that at manufacturing level. You can also connect multiple machines and system components across one or several lines in a horizontal network, which allows users to organize complex production processes more efficiently and reliably. Like many other digital technologies, OPAL is part of the Optima Total Care package. This extensive service portfolio ensures efficiency and reliability throughout the lifecycle of Optima systems and is being developed further.


It sounds like Optima is well prepared for the digital revolution. What are your objectives for Optima Pharma in this respect?

The aim for Optima Pharma is to integrate the existing solutions into the machines and thus continue to build up experience. We intend to use this as a basis for gathering further ideas for a large-scale integration of our digital technologies. This will require a huge amount of development work, which we will need to incorporate into our projects gradually to begin with. And it goes without saying that we would need to use these solutions to build trust among our customers first and dispel any concerns about the new technologies going forward. We believe that digital solutions harbor a lot of potential for the future across the board.
 
Process reliability, which is so important in the pharma industry, is an area where digitalization offers great opportunities in particular. Each process step can be monitored and the machine can respond as intelligently as possible without the operator needing to intervene at all. This self-learning and self-adjusting aspect is where the main opportunity lies for our customers, and of course for us too.



Thank you for talking to us, Mr. Rothbauer.

How Optima is harnessing the opportunities offered by digitalization

“We believe that digital technologies harbor a lot of potential for the future,” says Jürgen Rothbauer, Managing Director of Optima Pharma, in his interview. Machines that react intelligently, learn new things, and adjust themselves help to improve process reliability and minimize product losses even further.

Smart machine operator guidance is another key area. For this the company uses IPAS, its intelligent production assistant system, to prevent and eliminate faults.

When it comes to managing production data, Optima Pharma supports its customers with the help of the OPAL line management software, which forms part of the Optima Total Care Lifecycle-based services package.

Interview with Jürgen Rothbauer
In his interview, Jürgen Rothbauer takes the time to explain Optima Pharma’s digital strategies.

 This report will bee published in the Optima Magazin o-com pharma/life science 04 | 2018.

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