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TH5 process
controller

For decades, process controllers were designed around a single objective: executing a validated process. Today, pharmaceutical manufacturers expect far more from the same automation platform.

Beyond deterministic process execution, pharmaceutical manufacturers increasingly rely on the same automation platform to support validation, data integrity, cybersecurity, electronic records, plant connectivity, continuous software evolution.

Rather than stacking up new features on a traditional process controller we redesigned its architecture from the ground up.

The result is TH5: a system engineered not only to execute the process, but to become the technological foundation of our Technology Hub.

 

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SEPARATING RESPONSIBILITIES TO PRESERVE PROCESS INTEGRITY

One of the fundamental architectural choices behind TH5 was to separate deterministic process execution from visualization, data management and enterprise connectivity. 
Traditional process controllers gradually accumulated new responsibilities as pharmaceutical digitalization evolved. Validation, electronic records, cybersecurity, enterprise connectivity and operator interfaces were progressively added to the same software environment, increasing lifecycle complexity.

TH5 follows a different architectural philosophy.

Instead of concentrating every function inside a single controller, it distributes responsibilities across dedicated architectural layers, each designed for a specific purpose. This architecture allows every layer to evolve independently while preserving deterministic process execution and validated process behaviour.

Each layer has a clearly defined responsibility, allowing the platform to evolve without compromising process integrity.

EVERY PROCESS CONTROLLER REFLECTS A SERIES OF ARCHITECTURAL DECISIONS

Some prioritize software flexibility, ohers focus on hardware integration or machine-level automation.

TH5 allows the digital platform to evolve throughout the equipment lifecycle while preserving deterministic process execution.

This philosophy shapes every architectural decision behind TH5 and provides the foundation for the Platform Applications of the Technology Hub through six principles:

Deterministic process execution remains isolated from digital services.

Process knowledge becomes reusable engineering assets through Phase Groups.

Validation is developed together with the software platform.

Open industrial technologies simplify enterprise integration.

Human-centred interaction improves usability and reduces operator errors.

Lifecycle-driven architecture supports long-term software evolution.

PROVEN BY NUMBERS

Up to 45% shorter validation time compared with GAMP Category 5 software.
-65/75% operator Errors reduction measured during shopfloor operator shadowing
0 additional engineering days for MES, SCADA and Historian integration
-40/50% training time reduction measured at Fedegari Tech Centers

TH5 PROCESS CONTROLLER FEATURES

DETERMINISTIC PROCESS EXECUTION

TH5 separates deterministic process execution from visualization and enterprise communication.

Critical process logic remains inside Siemens or Rockwell PLCs, ensuring predictable execution, certified safety functions and real-time performance independently of higher-level software services.

This separation protects validated process behaviour while allowing visualization, reporting and connectivity functions to evolve without affecting the core automation.

Technical evidence 

  • Siemens & Rockwell PLCs, hardware and software layer
  • Dedicated Safety PLC/CPU

  • SIL3 / PLe safety levels 

PHASE GROUPS

Fedegari Phase Groups standardize validated process logic into reusable software modules.

Instead of repeatedly engineering similar control sequences, validated execution strategies become reusable building blocks that simplify software maintenance, change control and future application development.

Existing Thema4 applications can be recreated using the same engineering philosophy while preserving validated process behaviour.

Technical evidence 

  • Standardized Phase Groups
  • Reusable process logic

VALIDATION PLATFORM

TH5 is engineered as a GAMP® 5 Category 4 software.

Software development, validation activities and Change Control are managed together, providing the complete documentation package required to support equipment qualification while reducing validation effort throughout the project lifecycle.

Technical evidence

  • GAMP® 5 Category 4
  • FDS / SDS
  • IQ / OQ
  • Traceability Matrix
  • Kneat integration

HUMAN USER EXPERIENCE

TH5 follows ISA-101 HMI principles and adopts WCAG accessibility guidelines, although these are not required for industrial equipment.

The interface was validated through operator usability testing to improve readability, consistency and operator confidence across different manufacturing environments.

Technical evidence

  • ISA-101 compliant 
  • WCAG compliant 
  • IQ / OQ
  • Responsive Web HMI user interface
  • Operator usability testing 

OPEN INDUSTRIAL ARCHITECTURE

TH5 combines industrial PLCs, an embedded SQL database and standard communication technologies rather than proprietary middleware.

This simplifies integration with MES, SCADA, Historians and enterprise systems while supporting both physical and virtual deployment.

Technical evidence

  • OPC UA 
  • SQL Database
  • IQ / OQ
  • MES / SCADA
  • Historian

PLATFORM LIFECYCLE

TH5 has been engineered to accommodate software maintenance, cybersecurity updates and future Platform Applications while preserving validated process execution and system integrity throughout the equipment lifecycle.
Its architecture allows the platform to evolve without redesigning the underlying process controller.

Technical evidence

  • Windows 11 IoT LTSC 
  • Built-in cybersecurity capabilities
  • Controlled software evolution
  • IT/OT integration

WHEN SHOULD YOU CHOOSE TH5 PROCESS CONTROLLER?

TH5 delivers its greatest value when the process controller becomes a strategic component of the manufacturing platform rather than simply the controller of a single machine.

PRESSURE CONTROL
In saturated steam sterilization, pressure governs steam conditions. Controlling pressure supports temperature uniformity and repeatable process behavior. 
±0.5°C UNIFORMITY
Temperature standard deviation is a key indicator of process behavior. The tighter the deviation, the greater the stability and repeatability across the entire load. 
DRY-LOADS
Critical components 
emerge sterile, dry and ready for immediate use. 
CANISTER PROVEN
We support advanced  canister-based transfer strategies while preserving filter integrity, drying performance and sterile transfer conditions.

When lifecycle complexity becomes a project risk.

When validation timelines cannot delay production.

When process data must be available across the manufacturing ecosystem from day one.

When operator adoption must be be fast and consistent across facilities. 

When long-term maintainability becomes more important than proprietary architectures.

When safety, cybersecurity and compliance must be engineered into the platform rather than added later.

When batch release times directly impact manufacturing performance.

FREQUENTLY ASKED QUESTIONS

Why did Fedegari integrate WCAG principles into TH5?

Although not required for industrial automation systems, TH5 adopts WCAG accessibility principles to improve readability, consistency and operator interaction.

Combined with ISA-101HMI guidelines, this approach simplifies operator training, reduces the likelihood of human error and promotes a consistent user experience across different facilities.

How does TH5 protect process integrity?

TH5 protects process integrity by separating deterministic process execution from visualization, data management and enterprise connectivity.

Role-based access control, electronic records, audit trails and cybersecurity functions are integrated into the platform while ensuring that validated process execution remains isolated from higher-level software services.

How does TH5 support data integrity?

TH5 provides controlled user management, auditability and electronic records designed to preserve the reliability and traceability of process data throughout its lifecycle.

Every action is recorded, process data remain attributable and protected, and electronic records support compliance with pharmaceutical data integrity requirements.

How does TH5 support manufacturing data management?

TH5 combines an embedded SQL database with open industrial communication technologies to make process information available beyond the equipment itself.

Process records, alarms, audit trails and operational data can be shared with MES, SCADA, Historians and other enterprise systems, supporting connected manufacturing without relying on proprietary communication architectures.

How do Phase Groups differ from recipes?

Recipes define the process parameters to be executed, such as temperature, pressure and exposure time.

Phase Groups define the validated execution logic that governs how those parameters are applied. A single Phase Group can therefore support multiple recipes while maintaining the same validated process strategy.

What are Phase Groups?

Phase Groups are pre-validated execution modules that standardize recurring process strategies into reusable software building blocks.

Instead of repeatedly engineering and validating similar control sequences, the same validated execution logic can be reused across multiple recipes and applications, reducing engineering effort, simplifying change control and supporting software evolution throughout the equipment lifecycle.

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