Designing for Pharma 4.0

Pharma 4.0 is more than a buzzword.

It’s a bold vision for the future of pharmaceutical manufacturing. It promises smarter systems, seamless data and real-time decision-making. But to unlock its full potential, we must start with thoughtful design. 

Mags Dalton and Philip Ceary, Global Engineering Projects Technical Manager, AstraZeneca recently presented on this topic at the ISPE Annual Meeting and Expo 2025 in North Carolina. 

Start with the end in mind

Pharma 4.0 is about digital maturity. It’s about integrating technologies like IoT, robotics, cloud computing and augmented reality. These tools enable predictive maintenance, automated logistics and intelligent control systems.

“Pharma 4.0 isn’t just about technology - it’s about designing systems that learn, adapt and empower people to make smarter decisions,” Mags explains.

But technology alone isn’t enough. Success depends on how well we plan for it. That means defining clear goals, roles and responsibilities from day one. It means appointing an information manager and setting up governance frameworks that last. 

Build a connected facility

Designing a connected facility requires more than installing sensors. It’s about creating a digital ecosystem. Every piece of equipment, every control system and every data point must work together. 

Instrumentation, automation and ICT infrastructure must be designed to support interoperability. Workshops help align systems and teams. Integration of building management systems (BMS) and environmental monitoring systems (EMS) ensures seamless control. This isn’t just about efficiency and resilience. A connected facility can adapt, learn and improve over time.

Manage data like an asset

In Pharma 4.0, data is a strategic asset. It must be structured, tagged, and visualised. From design to operations, data flows through every phase of the project lifecycle. 

“When we treat data as a strategic asset from day one, we unlock visibility, traceability and performance across the entire lifecycle,” Mags advises. 

Early design must include:

• Tag naming strategies 
• Engineering data portals 
• Digital asset registers 
• Spare parts BOMs 
• CMMS integration plans  

These elements ensure that data is accessible, accurate and actionable. They support maintenance, calibration and performance monitoring. 

Visualise everything

Dashboards, digital twins and knowledge graphs bring data to life. They help teams understand what’s happening and why. 

Design must include control system architecture, historians and alarm configurations. Integration of engineering models supports real-time insights. Visualisation tools must be intuitive and powerful. This empowers operators, engineers and decision-makers alike. 

Learn from real projects

AstraZeneca’s Project Joyce offers valuable lessons. The team faced challenges aligning data formats across suppliers and systems. They chose to use individual tools for different data types. This preserved existing workflows but introduced inefficiencies.

To overcome this, they used knowledge graphs to connect data sources. This improved visibility and supported change management. It showed the importance of flexible design and strong governance.

Think long-term

Pharma 4.0 is not a one-time upgrade. It’s a continuous journey. Early design must support future growth. That means planning for mobile access, AR/VR training and predictive analytics.  

It means designing systems that can evolve. It means choosing standards like ISO 19650 and ISO 55000 to guide development. Most importantly, it means investing in people. Training, mentoring and onboarding are essential. Teams must understand the tools and the vision. 

Pharma 4.0 is transforming the industry. But transformation doesn’t happen by accident. It starts with smart design. 

By focusing on connectivity, data, visualisation and governance, we lay the foundation for success. We create facilities that are intelligent, agile and future-ready.

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