A pharmaceutical manufacturing facility in Sweden transitioned from manual batch processing to an automated formulation environment coordinated between MES and process control. The previous setup relied on manual procedures and paper-based documentation, limiting consistency and traceability.

KeyPlants Automation implemented SIMATIC PCS 7 with SIMATIC Batch and integrated it with PAS-X MES using MSI messaging. This enables the PAS-X Master Batch Record to orchestrate batch execution while PCS 7 performs equipment-level control.

The project was delivered while process definitions were still evolving. A Siemens SIMIT simulation environment enabled early validation of control logic and operator training ahead of commissioning. The system was delivered in approximately seven months and provides a foundation for scalable, recipe-driven production.

The Challenge

• Process design continued to evolve late into the project, requiring parallel automation development
• Late platform selection compressed the original delivery timeline
• PAS-X to SIMATIC Batch integration via MSI messaging was new to the delivery team
• Single-use equipment required integration into structured batch control
   

Solution Approach

The solution established a coordinated MES–DCS architecture where PAS-X manages production workflows and PCS 7 executes batch operations.
 

Batch applications were structured using ISA-88 principles to support modular and maintainable recipe execution. MSI messaging enabled direct interaction between PAS-X and SIMATIC Batch, allowing MES-driven orchestration of process steps.

To manage evolving requirements and limited early access to equipment, a Siemens SIMIT simulation environment was used to validate automation logic, test integrations, and prepare operators prior to commissioning.
 

Implementation and Assurance

Delivery followed structured engineering, testing, and validation phases including Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and system qualification.
 

Simulation and early integration testing reduced commissioning risk by validating both control logic and MES interaction before deployment. The system was delivered as a GMP-critical control system with full validation documentation.
 

Results and Benefits

Implementation of the system resulted in several operational improvements: 
 

• MES-orchestrated batch execution with coordinated control and workflow management 
• Removal of paper-based batch documentation
• Improved traceability and visibility of batch execution
• More consistent and controlled process operation

Engineering and maintenance benefits included:
 

• Standardized automation structures
• Improved diagnostics and troubleshooting

• Reduced testing and commissioning effort

   

Differentiators  

• MSI-based integration between PAS-X MES and SIMATIC Batch 
• Automation development executed in parallel with evolving process design
• Simulation-driven validation and operator preparation 
• Simulation-driven validation and operator preparation 

Key Learnings and Future Outlook

Key lessons from the project include:

• Simulation enables parallel engineering Early validation of control logic and integrations, despite incomplete process definitions, reduced commissioning risk and accelerated decision-making.
   
• Early MES–automation alignment is critical Defining the interaction model between PAS-X and PCS 7 early ensured stable batch orchestration and avoided late integration issues.
   
• Structured batch design drives scalability ISA-88-based design enabled modular, reusable batch logic, supporting efficient future expansion.
   
• Cross-functional collaboration is essential Close coordination between process, automation, and MES teams enabled parallel development without compromising quality or timelines.

The resulting architecture provides a scalable foundation for future expansion, allowing new recipes, units, and integrations to be added with limited impact.