Pharma 4.0: what are the building blocks of tomorrow’s pharmaceutical manufacturing processes?

What does the future of pharmaceutical manufacturing hold? From Internet of Things to remote communication: let’s have a closer look at the technologies that, according to us, will be pivotal in Pharma 4.0.

1. Internet of Things (IoT)

The Internet of Things incorporates devices equipped with sensors, software and other technologies to link data together and exchange it with other devices.

Such devices monitor and control various aspects of your manufacturing process, such as the following, among others:

• temperature
• humidity
• pressure
• …

These data are collected in real time.

In this filling machine, for example, we are constantly monitoring the amount of airborne particles, such as dust and microorganisms. This data is used to ensure the air quality of the air flows in the different grade zones.

2. Artificial Intelligence (AI)

AI algorithms analyze the data collected by the IoT and other devices.

They identify patterns and trends. Pharma 4.0 uses these insights to optimize your manufacturing processes and improve the quality of your product.

Inspection

We see enormous opportunities for automating certain inspection tasks, such as checking for bacterial growth in Petri dishes, to name one. This check is typically carried out by a laboratory technician.

But this kind of work is precisely the forte of AI combined with vision technology. Vision paired with an algorithm that can draw from a vast database excels at these classifying tasks. What is within specification and what is not? What is deemed correct and incorrect? AI does this faster and more accurate.

The advancement of vision-based technology has already made an impact on bin picking in pharma. We expect the same for everything that has to do with inspection.

3. Big Data Analytics

Thanks to automation and digitization, we have more data available than ever.

Big Data Analytics helps us to process and analyze these large quantities of data. That leads to insights on how to further optimize your processes.

Our take on these three Pharma 4.0 building blocks

Digital transformation extends beyond a single machine. A machine itself is too limited to bring together the complete context of your company. It is only by centralizing all data – production orders, raw material flows, planning… – that we can create an overarching context within your organisation.

But IoT, AI and Big Data Analytics not only go beyond the level of one machine. They transcend your machinery altogether.

Yes, the data itself is captured on the production floor. And yes, that requires the integration of sensors, among others, in the actual machines. But to put all that data to work, you need to align all departments involved. And that means looking beyond your machinery.

This graphic visualizes the different levels of Pharma 4.0.

Level 0 and 1 is your machinery. At those levels, it’s about the manufacturing processes. A sensor that signals that a certain component is available for further handling. A PLC that controls a robotic arm to transfer a certain component from point A to point B.

Level 4 is management. The level of business planning and logistics. On this level, the MES and the ERP bring together all the data from separate sources. Making it possible to manage your stock, make up the weekly planning…

The goal is to use data to make decisions that have the best possible results in the shortest time. With actions being taken automatically without human intervention.

This is not achieved overnight.

Integration of these three Pharma 4.0 building blocks are part of a constant improvement process. This model shows the different steps of this process, based on the development path to Industry 4.0.

The different steps

1. Computerisation: the various information sources within the company are still isolated.
2. Connectivity: the various data sources (ERP, OT, IT, etc.) are connected and can share data.
3. Visibility: providing real-time insight into all relevant data within the company, enabling decisions to be made based on actual real-time data. This data is called the digital shadow.
4. Transparency: insights can now be gained from the digital shadow. By analyzing the data, knowledge is gathered that allows complex and quick decisions to be made.
5. Predictive capacity: the company can predict different future scenarios, based on the analysis of the digital data and select the most likely one. This is a very important step in making the right decisions more rapidly.
6. Adaptability: the step to automatic actions and decisions in response to changing circumstances.

4. Robotics and automation

Robotics and automation streamline your production processes and reduce the number of manual actions.

From all building blocks in Pharma 4.0, this is the one that is closest to VINTIV’s core business. We have designed and built numerous machines that clearly show how automation can help you take the step to Pharma 4.0.

This is what we bring to the table.

We could go on and on about this particular Pharma 4.0 building block. But we think it’s more interesting to introduce three different ways of looking at robotics and automation.

It can be done

Customization can be the answer to challenges that off-the-shelf solutions cannot solve. Like a robot gripper specifically tailored to your product. Or a custom pump and drum to handle even the most challenging material, as for this syringe filling machine for dental restorative composite.

Keep what’s good

Robotics and automation in Pharma 4.0 do not always imply completely new.

Sometimes, it makes more sense business wise to opt for a retrofit. These two cases prove that point:

• Retrofitting a packing machinery at a healthcare company
• Customized loading system in a standard isolator and freeze-dryer

Not always for innovation’s sake

A customized machine helps you strengthen your market position and secure knowledge within your company.

But innovation is not always the driver. In some cases, customization is the answer to legislation. An answer to a stricter GMP, for example.

5. Cloud storage

Cloud storage makes it possible to store and manage various types of data. Such as data on

• clinical trials,
• genomic data,
• patient data,
• manufacturing data
• and data on the supply chain.

The data are available in real time. Security is generally provided by a combination of encryption, access controls and other security measures.

6. Blockchain

Blockchain is seen as an important link in

• improving the safety of medicines,
• decreasing counterfeiting and fraud,
• improving supply chain efficiency
• and guaranteeing adherence to regulations.

The strengths of blockchain in Pharma 4.0:

• Veracity: transactions are certified by an immense network of computers,
• Transparency: transactions are publicly accessible, for example public files drawn up by a notary,
• Independence: with decentralisation, there is no central power that can influence or alter the transactions,
• Safety: data recorded on the blockchain are shielded by encryption and cannot be lost due to redundancy.

7. Remote communication technologies

Finally, remote communication technologies as part of Pharma 4.0.

Obviously, teleconferences, videoconferences and virtual collaboration tools allow you to contact stakeholders in the value chain in real time and all over the world. From researchers and physicians to patients and regulators.

But how does that translate to Pharma 4.0 machinery?

Remote assistance

A major benefit is remote access. And more specifically, remote assistance. This is the ability to log in remotely and perform initial diagnostics and troubleshooting. Remote access allows us as a machine developer to take over your installation remotely, when your operator needs help.

From our experience, 80% of the issues can be solved remotely and within a few hours.

Result: simplified maintenance and improved availability. And on top of that:

• No travel costs for service technicians
• Quick start of troubleshooting
• Secure remote access via VPN

This Pharma 4.0 building block has become a matter of course in nearly every machine we build.

Reach out

Need help integrating one of these technologies in your machines? Or do you want to know what benefits these innovations could bring to your processes? Let’s talk.