Our Expertise
From concept to validated system – comprehensive engineering services for pharmaceutical automation. We deliver end-to-end solutions that meet the highest GMP standards.
Documentation & Validation
Comprehensive documentation and validation services that ensure your automated systems meet all regulatory requirements. Our experienced team creates comprehensive qualification packages that accelerate approval processes and minimize project risks. We follow industry best practices and leverage our deep GMP knowledge to deliver documentation that meets both internal quality standards and external audits.
From User Requirements Specifications (URS) to final validation reports, we provide end-to-end documentation services that create a complete audit trail for your automated systems.
- Design Qualification (DQ) and risk analysis documentation
- Installation Qualification (IQ) protocols and execution
- Operational Qualification (OQ) and Performance Qualification (PQ)
- User Requirement Specifications (URS) and Functional Specifications (FS)
- Validation Master Plans (VMP) and traceability matrices
- Change management and deviation management procedures
Design Engineering
Expert mechanical and process-oriented design that seamlessly connects functionality with GMP compliance. Our design engineers leverage decades of experience in the pharmaceutical industry to create innovative automation solutions that optimize production flows while maintaining the highest quality standards. We transform complex requirements into practical, manufacturing-ready designs.
Each design is optimized for cleanroom environments, easy maintenance, and long-term reliability to ensure your investment delivers value over years.
- 3D-CAD modeling and detailed engineering drawings
- Process P&ID development and optimization
- Cleanroom-compatible equipment design and layout planning
- Material flow analysis and cycle time optimization
- Ergonomic design for operator safety and efficiency
- Design for Manufacturing (DFM) and Assembly (DFA)
Software Engineering
Customized software solutions for automation control and data management that drive operational excellence. Our software engineers develop robust, validated applications tailored to your specific process requirements. From PLC programming to advanced SCADA systems and database solutions, we create software that enhances productivity while ensuring complete traceability and compliance.
We specialize in creating intuitive HMI interfaces that empower operators while adhering to the strict data integrity standards required in pharmaceutical manufacturing.
- PLC programming
- HMI development with 21 CFR Part 11 compliance
- Database design and data management systems
- Recipe management and batch control software
- Electronic batch records (EBR) and data historians
Interfaces & Integration
Professional integration services that connect your automation systems with MES, ERP, LIMS, and other enterprise systems. We create seamless data flows that eliminate manual data entry, reduce errors, and provide real-time transparency across your entire operation. Our integration specialists have extensive experience with industry-standard protocols and customer-specific interface development.
From simple data exports to complex bidirectional integration with multiple systems, we ensure your automation solution fits perfectly into your existing IT infrastructure.
- MES integration for production tracking and genealogy
- ERP connectivity (SAP, Oracle, Microsoft Dynamics)
- LIMS integration for quality data and test workflows
- OPC UA/DA server and client implementation
High-precision Robotics for demanding environments
Vendor-independent integration of the latest robotic systems for pharmaceutical and biotech applications. From high-precision 6-axis robots over fast SCARA systems to collaborative cobots – we select and integrate the optimal robotic technology for your specific process requirements while adhering to strict cleanroom and sterility standards.
Our robotic solutions are fully compatible with ISO-classified cleanrooms and VHP decontamination procedures, while adaptive gripping technology provides maximum flexibility for various handling tasks.
- 6-axis robots, SCARA, and delta systems for high-speed applications
- ISO Class 5 cleanroom compliance and VHP compatibility
- Collaborative robotics (cobots) for safe human-machine interaction
- Adaptive gripping technology with force-moment control
- Vision-guided positioning and inline quality control
- Vendor-independent integration (Yaskawa, KUKA, Fanuc, UR, Stäubli)
Additional Expertise needed?
Discover our strategic consulting services and simulation solutions for plant planning, process optimization, and feasibility studies.