Digital batch card and batch tracing: a successful project from the medical technology sector

Hello Marco and Roman. Great to have you here. I am very pleased that you took the time today. Marco, I’ll start with you. How are you and where can I reach you?

Marco

I’m in the office, and I am doing very well. There is still quite a bit to do before the long weekend, and I am looking forward to this podcast with you and Roman.

When you say office, where exactly are you located?

Marco

In Frauenfeld, in beautiful Switzerland.

In Switzerland, fantastic. Greetings to your colleagues. Roman, where can I reach you right now? How are you?

Roman

I am also fantastic. I am looking forward to the discussion ahead. I am in Rapperswil, directly on Lake Zurich, with the best view of the lake, which is why I am doing so well.

That sounds wonderful. I am excited to learn more about your joint project today. Marco, maybe you can start with an introduction to Innomat, about yourself, and your customers. You have brought an exciting case today. You are the CTO, and Innomat is specialized in software. You have your own product, the Kalisto IoT solution, with various modules. It can be operated locally and in the cloud, with various interfaces for ERP data and other data that your customers use. You also have a subsidiary, Asprotec AG. Did I get that right?

Marco

Right. At Innomat, we aim to seamlessly connect people and machines and bring them into synergy. We support companies in networking systems, whether it’s machine-to-machine or machine-to-higher-level systems, such as ERP systems. We want to help customers use the data intelligently and provide integrators and end customers with the best solution for the required system. For this purpose, we have developed a framework called Kalisto IoT. With it, we have various possibilities to implement interfaces, collect data, evaluate data, and implement logical sequences for customers. In this case, the project was implemented by Asprotec, a subsidiary of ours specializing in industrial automation, connecting everything from sensors to control systems to ERP and MES systems.

Before we move on to the joint project with Weidmann, one more question. You mentioned the connection between OT and IT. I like to ask about use cases. I think we will hear more practical examples shortly. Can you give us an overview of the use cases you are implementing today? Are these classic technologies or business use cases like condition monitoring? What kind of use cases do you implement with customers?

Marco

There are various applications. We work a lot in transferring order data from ERP to the industrial world and tracking batches and production data back to ERP. We have also implemented this in this project.

Okay, check out Innomat’s projects, they are very exciting. I will link them in the show notes. We want to talk about your project today, so I’m glad you’re here, Roman. Can you tell us why you are both here together? How did the project come about? How did you meet? Is there a story behind it?

Roman

Our paths crossed during the project. I joined later. It was fascinating to see the speed at which the project progressed. In a short time, the solution was presented and the first milestones were reached before I joined and could see the first implementations.

Roman, let’s talk about you and Weidmann because what you do is exciting. You are a Swiss injection molding system supplier, mainly for medical technology and pharma. You manufacture various products, such as packaging and container closures. On your website, you can see the product groups. You produce various products for these industries.

Roman

We have long experience in injection molding, especially in medical technology. Weidmann specializes in manufacturing high-quality, customized plastic and microplastic injection molding solutions, adhering to the smallest tolerances, which is very demanding in the plastics industry, and producing these products in large quantities. Our products are used in the fields of pharmaceutical diagnostics and medical devices. Our service begins in product development, through tool procurement and production, to the final product in the end packaging, sterilized or not, depending on customer requirements.

You have been doing this for a long time, about 70 or 80 years, and are part of a larger group. It’s not just you, but a whole conglomerate of companies behind it.

Roman

Weidmann Medical is a subsidiary of the Weidmann Group. Our big sister is Weidmann Electrical Technology, which offers solutions in insulation technology for transformers. We are part of that. We are in Rapperswil and have recently expanded our capacity, built a new plant, and have been in production since the beginning of the year.

When you are at your plant on-site, regarding your project, are these production facilities with cleanrooms? What are the customer requirements? What does your plant look like, and what machines do you have there?

Roman

Exactly, we operate in the medical technology field. There are many requirements for the environmental conditions of a cleanroom. Our entire production takes place in a cleanroom, which is about 1200 square meters. For this project, we use seven injection molding machines and a packaging line. Everything is highly automated, with no manual labor on the products. The parts are transported fully automatically from one system to another. Customer requirements are based on medical technology standards.

You are also pioneers in digitalization. Can you explain your vision for digitalization and IoT? What is your vision for your customers regarding digitalization?

Roman

Being based in Switzerland, it is almost a must for us to have a high degree of automation. Additionally, digitalization must continually advance. Especially in the medical field, which is very documentation-heavy, we want to automate processes and establish a future-proof organization. Customers desire seamless batch traceability and ensured quality. For this, we need technologies that provide a transparent supply chain, allowing us to trace products at any time. This should be implemented in a simple and understandable surface technology.

Are these the main use cases you implemented in the joint project? Is it about batch traceability and quality? What was the goal of your project?

Roman

One goal is the degree of automation. The system in our cleanroom can create transport orders for our trolleys using the digital batch card technology. The products are placed in trolleys, and an automated transport system moves them from one system to another until they reach the packaging line. The digital batch card recognizes when a system is faulty and adjusts accordingly. This way, we create redundancies and continue production without stopping an entire line, which is a significant benefit during downtimes. Additionally, we can see in the box which products are from yesterday, the day before, or last week, using a combination of batch numbers and material batch numbers. Everything is traceable.

Yes, it’s a digital batch card that contains various products and order data. The data is transferred digitally, which also digitally maps the documentation for your customers and optimizes processes. Did I understand that correctly?

Roman

Exactly, you can say that when a trolley is filled with products, there is a digital card with all the data such as batch number, timestamp, when it was produced, and from which system to which system it went. All intermediate steps are documented, and we can ensure where the products come from and see where delays occurred and what caused issues between the system interfaces.

[12:23] Challenges, potentials and status quo – This is what the use case looks like in practice

Perhaps let’s summarize the business case again. It’s about the digital batch card, which enables batch traceability for your customers and makes the data usable in interfaces or for your customers. Marco, can you summarize the business case from your perspective? You work with various customers. What is the business case from your view?

Marco

This involves the management of the trolleys, the transport trolleys and communication with the various systems. In two lines with three injection molding machines, we bring an empty cart to the first machine, which is then loaded. We receive the order data from the ERP and link it with the parts on the trolleys. The machine tells us how many parts were placed on the trolley. The trolley then goes into storage for a settling period and then to the next two machines until everything is loaded. We also receive the order from the ERP for traceability and book it in the ERP when we pick up the trolley. Finally, the loaded trolley goes to a packaging machine, and we report the order back to the ERP. This way, the customer has complete traceability in the ERP. The digital batch card supports our process and can be used by the customer for evaluations. Coordinating the orders, the automated transport system, and the tracking are part of the project.

A clear business case that saves time and money in the long run by automating manual processes. Transferring data from the injection molding machine to the packaging machine and back to the ERP is a big advantage. A question about regulations: In the medical industry, regulations play a big role. Roman, you mentioned batch traceability. What challenges do you face in this context?

Roman

You can distinguish it from a normal operation by the fact that our testing phase is much longer. The qualification and validation of the system, ensuring that the data correctly flows from the ERP to the digital batch card and back, and protecting the data from manipulation are the biggest challenges.

What other data sets are relevant? I want to understand which data is important for this project. I heard material bookings, machine orders, and inventory bookings. These are data from the ERP and live data. What data types do you process?

Marco

There are different types of data. On the one hand, the data records from the ERP that run via an SAP interface – IDoc. On the other side, there are machine exchange data that we capture via OPC UA. The machine informs us about its status, what is needed, and what was produced. Additionally, there is an interface with data for the automated transport system that runs via a REST API. We have three different interfaces and bring them together so that there is no media break, and the data runs smoothly through the system.

Yes, that’s a technical challenge, handling these different interfaces, which you solve with your Kalisto IoT framework, right?

Marco

Exactly.

[17:38] Solutions, offerings and services – A look at the technologies used

Okay, maybe we should look at the solution and technology you used. Markus already mentioned it. Can you summarize what the solution can do and what products you used?

Marco

The base system is the Kalisto IoT system, which runs in the backend with an SQL server as the data storage where we store the data. For this project, we developed customer-specific modules that can be integrated into Kalisto. These modules map the interfaces, handle the logic and data storage. The collected data is formatted in a readable way, and it is possible to map batch mixtures on a trolley. If multiple batches are on a trolley, the system can map this.

I understand, okay. You said the data is captured via OPC UA. So, you take the data from the hardware, like the injection molding machine. You also have the interface to the ERP. Kalisto IoT allows you to use a module that links the data directly to SAP, right?

Marco

Exactly, when the machine tells us that it has molded 300 parts and placed them on the cart, we report that to the ERP on the corresponding production order. This way, we directly book the inventory in the ERP and reduce manual work.

You said at the beginning that you connect people and machines or both worlds. At the end, a worker stands at the line and wants to see and observe the data. Who operates the system? Roman, is it your team? What exactly do you see? How does the presentation of these use cases work?

Roman

The system is mainly operated by the automation department and technicians who check for errors or interruptions. If a product is defective, we can trace which trolleys are affected. The trolleys also go through cleaning intervals at a washing station. Through a web interface, you can manually manage orders and trace where each trolley and product is placed. The automation department currently operates the system. We are training the production staff to allow them to check the system and manually execute transport orders if necessary.

Super exciting. Super exciting. You have the example of when a trolley needs to be picked up and seeing the data digitally is a big advantage. There is also data analysis behind it. Marco, is that something you do with the team? Each customer has different use cases they want to implement. Do you handle that, or can your software do it with the modules?

Marco

We have a software framework that simplifies things for us. But in cases where we work with specific customer data, we build the system and check the customer’s needs. We then develop the interfaces according to their wishes. We don’t have to build everything from scratch. We have ready-made modules and framework templates that we can configure and connect the data to.

Very nice. Perfect. Then maybe the last question: Roman, are you satisfied? You chose Innomat. There are many solutions on the market, and Innomat brings many advantages and unique features. You have been operating with it for about a year now. How is it going? What is your impression?

Roman

It is going very well. We are highly satisfied. Already in the project phase, it went from the request to the solution very quickly. Innomat was very competent and could clearly implement our wishes. Now we have a tool that is easy to use and very stable. That is very remarkable.

Marco, these are the advantages of an open, modular system architecture, certain independence, and a nice interface that can be expanded with you. Kalisto can be used for different cases in the future, right?

Marco

Yes, definitely. Our aim with Kalisto from the outset was to cover customer-specific cases with a wide variety of interfaces and requirements. There are solutions for standard cases on the market, but we are often in cases where the customer needs something special that you can’t find directly on the market or doesn’t come with SAP out of the box.

Very nice. Very nice. I have many more questions, but we are coming to the end of the episode. Perhaps the last word: Are there best practices or pitfalls you would like to share? Many listeners have similar projects or want to implement such projects. Do you have any experiences or learnings you would like to share with the audience?

Roman

I believe the most important thing in such projects is knowing exactly what you want. What is the end application? What do you need and what don’t you need? You should think about it carefully and not only cover the ideal case but also consider “what if” scenarios. These points are always more difficult to solve afterward than if you know them from the start.

Very nice. Marco, any additions or does the direction Roman is taking fit?

Marco

That fits. What I have seen repeatedly is not wanting too much from the start. Consider where the end goal is and then proceed step by step. In this project, we first tackled the solution with the automated transport system and added the digital batch card in a second step. This way, the project isn’t overloaded and doesn’t fail. Having the right partner is also very important for the collaboration to work.

Yes, you have found that partner here.

Roman

That is a very important point. In theory, on the white paper, you may not always know exactly what you need and where to look. If you keep it open and write it conservatively, you can see in the project phase what is important and implement additional wishes later. That is a very good approach.

That is a nice closing word and a call for all those doing projects. At this point, I say thank you from my side. I could ask many more questions about this project, but that can be done afterward. Roman and Marco, I will put your LinkedIn contacts in the show notes so people can contact you. Thank you for presenting this project. Roman, it is exciting to see the direction you are taking as a Swiss injection molding system supplier with your history and immense expertise. It is exciting to see that you are a pioneer for your customers, increasingly focusing on digital and data in the future, ensuring they are secure, highly secure, and correctly provided with the appropriate framework. I found it interesting to understand the business case, the relevant data sets, and how you solve it with Kalisto IoT. Many thanks to both of you. It was great having you here today. I’ll give you the last word. Thank you for being a part of this.

Marco

Thank you for the conversation. It was very interesting to look at the whole thing.

Roman

Also, from my side, many thanks for the good guidance in this conversation and to Marco for the competent answers.

Thank you, and have a nice rest of the week. Take care. Thank you.

Roman

Okay, ciao.

Ciao!

Marco

Bye.