Combining Stainless Steel and Single-Use

As part of a major expansion at a pharmaceutical production site in Germany, ZETA was tasked with automating both stainless steel and single-use systems for the manufacture of injectable and infusion drug solutions. The project involved a stainless-steel preparation plant with mobile vessels and a CIP/DIP/SIP station, developed in-house by ZETA, alongside a single-use filtration system from an external supplier. ZETA’s responsibility was to integrate both systems into the customer’s Siemens PCS7 process control system, ensuring seamless operation, GMP compliance, and production flexibility.

Integrating two fundamentally different technologies – stainless steel and single-use – into a unified automation environment requires a high degree of customization. The automation system had to support redundancy (S2), meaning all components needed to be compatible with dual-controller setups, both physically and in software logic. This placed stringent demands on component suppliers and system architecture. Additionally, the mobile nature of the single-use filtration units introduced complexity in docking, undocking, and system recognition. These units needed to be interchangeable and adaptable in their operation, requiring intelligent identification and control mechanisms. The project also had to align with the customer’s strict programming standards and integrate into a broader, highly complex automation landscape, including MES connectivity for real-time production and logistics data.

ZETA delivered a robust, future-ready automation solution based on Siemens PCS7 with SIMATIC Batch, fully aligned with the client’s programming standards. The system was implemented as a virtualized, redundant server-client architecture, enabling both stainless steel and single-use systems to operate on the same controller. This design ensured high reliability and minimized downtime through intelligent redundancy strategies. To meet S2 redundancy requirements, ZETA ensured that all components were physically and logically compatible with dual-controller configurations, placing a strong emphasis on system resilience and operational continuity.

To manage the complexity of mobile, interchangeable single-use filtration units, ZETA developed a smart connector coding system that transmitted both power and signals. This enabled automatic identification of each unit, allowing for safe docking, undocking, and flexible operation. The automation software supported recipe-based batch control in accordance with ISA-S88 standards, ensuring scalability and adaptability across production processes. Additionally, ZETA built a seamless interface to the client’s Manufacturing Execution System (MES), enabling real-time data exchange and supporting IT/OT convergence. This integration supported optimized production control and logistics, while reducing project lead times by minimizing interface complexity.