The Challenge
In pharmaceutical production, Big Pharma faced the dilemma that highly complex systems became difficult to operate due to restrictive compliance requirements. At the same time, isolated robot systems (“black boxes”) led to massive problems with data consistency and maintenance.
- Operating Complexity: HMIs were overloaded and required deep programming knowledge for the simplest adjustments – even qualified operators relied on external service providers
- Compliance Risks: Lack of audit trails for parameter changes jeopardized data integrity according to 21 CFR Part 11 and threatened to lead to critical findings during FDA audits
- Interface Chaos: Difficulties in securely connecting machines to higher-level IT systems (MES/LIMS) led to manual data transfers and media breaks
- Separate Data Worlds: Robot data (positions, tools, jobs) was only available on the robot controller and not in the central PLC control – every adjustment required the teach pendant and specialized know-how
- Maintenance Inefficiency: Position adjustments after maintenance took hours instead of minutes because robot teach processes were cumbersome and error-prone
The consequence: High downtime, expensive external service calls, increased compliance risk, and frustrated production teams. A unified, intuitive operating concept was urgently required.
Our Solution
Pharmabotix developed “The Pharmabotix Way” – a radically simplified yet strictly regulated operating concept that breaks down the barriers between operator, robot, and IT systems.
Intuitive & Compliant HMI:
- 21 CFR Part 11 Compliance: Every interaction, especially parameter changes, is comprehensively logged in a protected audit trail
- Role-Based Login: Integration via Siemens UMC or RFID badge reader enables quick access according to the operator’s qualification (Operator, Technician, Administrator)
- Simplified Frontend: Points and positions can be adjusted via a graphical interface without a programming device – every change is automatically documented in the audit trail
- Smartphone-Like UX: Touch-optimized operation with intuitive symbolism, clearly structured menus, and real-time feedback massively reduces training time
Seamless Robot Integration via SRCI:
- Data Sovereignty on the PLC: Through the SRCI interface (Siemens Robot Communication Interface), the robot is directly projected onto the Siemens interface
- Central Management: Positions, jobs, tools, and frames are directly at the control level – this eliminates the need to use the robot’s teach pendant during operation
- Live Visualization: 3D view of the robot workspace with graphical teach mode directly in the HMI for intuitive position adjustments
Efficient Connectivity via OPC UA:
- Interfaces to Customer Systems: Standardized OPC UA servers enable secure data exchange with MES (Manufacturing Execution System) or LIMS (Laboratory Information Management System)
- Real-Time Synchronization: Seamless transmission of process data, alarms, and batch documentation for complete traceability
- Cybersecurity: Encrypted communication and certificate management according to OPC UA security standards protect critical production data
Project Gallery
4 Images