TH5 PROCESS CONTROLLER
One of the fundamental architectural choices behind TH5 was to separate deterministic process execution from visualization, data management and enterprise connectivity.
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Technology Hub
Pharmaceutical equipment is expected to operate for decades. Digital expectations evolve every year.
Cybersecurity requirements, data integrity, software validation, connectivity, digital manufacturing and AI capabilities continue to expand what automation platforms are expected to deliver.
Twenty years ago, a process controller was expected to execute a validated cycle.
Today, manufacturers expect the same platform to support process execution, electronic records, user management, cybersecurity, software validation, plant connectivity and long-term software maintenance.
The process itself has not become harder to control. What has changed is the digital ecosystem surrounding it. The challenge is therefore no longer simply controlling the process but ensuring that the technology surrounding the process can continuously evolve without compromising compliance, validation or operational continuity.
A DIGITAL PLATFORM DESIGNED TO EVOLVE WITH PHARMACEUTICAL MANUFACTURING
Automation should evolve without becoming more complex.
We believe new manufacturing requirements should not be addressed by continuously adding newer features around the process controller. They should be supported by a common technology foundation capable of evolving throughout the equipment lifecycle.
The role of automation is no longer limited to controlling the process, but it has become the digital foundation that enables compliant, connected and continuously evolving pharmaceutical manufacturing.
Discover the platformProcess equipment should not become digitally obsolete before reaching the end of its operational life.
At the heart of the Technology Hub is TH5, the evolved process controller adopted across every new Fedegari machine. Around this common foundation, new platform capabilities are developed within the same architecture.
This allows new technologies to become part of the platform rather than separate software systems, preserving process governance, validation strategy, system integrity and regulatory compliance.
Future-ready architecture
The Technology Hub provides a common software architecture where new capabilities can be introduced without redesigning the automation platform, supporting continuous evolution throughout the equipment lifecycle.
Built for compliance
Validation, electronic records, audit trails and software lifecycle management are developed as integral capabilities of the platform, allowing compliance to evolve together with pharmaceutical regulations.
Cyber resilience
Cybersecurity functionalities are developed as part of the platform architecture rather than as an additional software layer, allowing security requirements to evolve while preserving system integrity, operational continuity and regulatory compliance.
Protected process knowledge
Validated process expertise is transformed into reusable software building blocks (phase groups) allowing process logic to be standardized, maintained and continuously evolved while preserving process consistency.
RESOURCE INTELLIGENCE
The Technology Hub already governs process execution. Resource Intelligence extends that capability by transforming utility consumption into process insight.
PLATFORM VIRTUALIZATION
Our Platform Virtualization, powered by TH5, transfers SCADA, web HMI, SQL database, Batch Management and electronic records from the dedicated BoxPC to a virtual machine within the customer’s governed IT/OT infrastructure, while the machine PLC remains local, preserving deterministic process execution independently from the virtual environment.
DIGITAL VALIDATION - POWERED BY EBR
Our digital validation application generates the electronic record directly from the process data produced through the process controller, organizing the evidence according to the actual execution of the cycle.
GOLDEN CYCLE
Golden Cycle converts the temperature and pressure behaviour established during validation into a configurable reference profile, with acceptance boundaries defined throughout the cycle.
PARAMETRIC RELEASE
Our Parametric Release application extends the Technology Hub with the digital capabilities required to apply the customer’s validated release criteria to every production cycle.