A leading global pharmaceutical manufacturer built a new chemical synthesis production unit entirely from scratch, no prior automation, no recipe system, no digital infrastructure. Everything was designed and implemented according to the client’s specifications, with the goal of full automation and GMP-compliant digitalization from the first batch.
The starting point
The facility required integrating approximately 130 work units, reactors, vessels, manifold stations, centrifuges, dryers, into a single cohesive system, while development was already underway before the building itself was complete.
Beyond standard automation, the ambition was to remove manual confirmation from the production workflow entirely. Rather than operators working from printed instructions and filling out paper batch reports after each phase, the goal was a system where the workflow advances automatically based on verified process data, and documentation is generated without manual intervention.
Two layers, one integrated system
Metronik delivered the solution across two complementary layers.
The automation layer, built on Siemens TIA Portal and iFIX SCADA, governs the physical operation of the plant: machine control, valve management, interlocks, and process sequencing across all work units.
The digitalization layer is MePIS. MePIS PDM captures process data in real time, providing full GMP-compliant traceability across every production step. MePIS RM manages the recipe lifecycle, defining, versioning, and maintaining recipes in accordance with GMP specifications. Recipe execution is carried out through iFIX SCADA and the underlying PLC architecture, with MePIS RM as the governing recipe layer. Above both sits the MePIS Batch Module, which orchestrates batch execution across multiple work units simultaneously.
Together, these two layers turn a collection of standalone automated work units into a fully integrated, GMP-compliant production system.
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The freely configurable factory
The client designed the facility around a manifold-based multi-connectivity concept: rather than fixed piping that predetermines production routing, any unit can be connected to any other, with routing defined and changed through software. Metronik developed the PLC algorithm to realize this, reading the requested configuration, validating the connection, opening the correct valves, executing the transfer, and performing an automatic CIP rinse on completion. The facility currently runs three simultaneous product campaigns and can scale further as production demands grow.
Because construction and development ran in parallel, Metronik used Siemens PLCSIM to build a virtual commissioning environment. Most control sequences and interlocks were tested before physical hardware was accessible. Validation was structured unit by unit, allowing manufacturing to begin on qualified units while the rest of the facility was still being commissioned.
MePIS as the orchestration engine
The MePIS Batch Module orchestrates batch progression through two mechanisms. A data-verified workflow gate monitors a specific real-time process data tag at defined points in the production sequence; the workflow advances only when a pre-defined value is confirmed. A report-driven workflow trigger uses the availability of a completed batch report for a specific unit as the signal to proceed to the next phase.
Both mechanisms remove manual confirmation from the critical path, with the batch driven forward by verified production data through a single configurable interface.
Results
The facility entered live production before full plant validation was complete. The system runs three simultaneous product campaigns; if a unit fails, production reroutes automatically without interrupting the campaign. System performance has remained stable across all ~130 integrated work units.
The solution has also significantly reduced batch release times. Replacing manual paper-based documentation with automated, data-driven batch reporting creates the infrastructure for a continuous push toward instant batch release.
Interested in building a fully automated and digitalized pharmaceutical production facility? Get in touch with sasa.sokolic@metronik.si.
