We implement customized process control systems (PCS) for safe, efficient, and GMP-compliant production processes.
Digital processes, secure systems, and reliable data are the foundation of modern bioproduction. Together with our partners, we combine engineering expertise with intelligent automation and IT systems to create holistic, future-proof solutions.
Fields
LIMS
Our LIMS solutions enable comprehensive capture, management, and analysis of laboratory data—digital, transparent, and regulatory compliant.
We support you in the selection, design, and implementation of a system that is optimally integrated into your laboratory and production processes. We consider GMP, GLP, and data integrity requirements as well as existing IT architectures and interfaces to ERP or PCS systems.
MES
With MES solutions, we connect production and IT into a comprehensive, transparent overall system. The goal is to efficiently control processes, ensure complete traceability, and sustainably increase productivity.
We support you in the selection, design, and implementation of an MES tailored to your requirements—from electronic batch records (eBR) to material and resource management, and integration into ERP, LIMS, and PCS structures. This creates digital production processes that ensure compliance, make data available in real time, and enable informed decisions.
SCADA
We implement SCADA systems for monitoring, controlling, and visualizing complex production processes in real time.
Data Historian
Our solutions for data acquisition and historization ensure complete and tamper-proof process documentation. They form the foundation for reliable analyses, continuous optimization, and regulatory compliance.
We integrate data historian systems seamlessly into your automation and IT landscape—from defining relevant data points to structured archiving, analysis, and visualization. This creates transparent data structures that reveal trends, enable early detection of deviations, and support informed decisions based on validated process data.
Engineering
I Hook-ups
Our I hook-ups ensure precise installation and mechanical and electrical connection of all sensors and actuators.
We define connection diagrams, installation situations, and interfaces between process engineering, mechanics, and automation—clearly structured and standards-compliant. We consider both functional requirements and maintainability, accessibility, and GMP aspects. The result is complete, traceable documentation and technically sound implementation—providing a reliable foundation for installation, commissioning, and qualification.
HAZOPs (Hazard and Operability Studies)
We support and facilitate HAZOP analyses to identify risks early and ensure sustainable plant safety.
Supplier Management
We handle technical coordination and processing with your suppliers—from specification and detailed clarification to timely integration into your project.
We review technical documentation, coordinate interfaces, facilitate clarification discussions, and consistently track deadlines and milestones. Our focus is on transparency, quality, and seamless integration into the overall project. This ensures that systems and components are not only delivered to specification but can also be commissioned efficiently and without disruption.
FAT / SAT
We plan, structure, and support Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to reliably demonstrate the function, quality, and GMP compliance of your systems.
During the preparation phase, we work with you to define clear test criteria, test plans, and acceptance criteria. During execution, we coordinate all stakeholders, document results in a traceable manner, and ensure that identified deviations are systematically addressed.
References
Boehringer Ingelheim Pharma GmbH & Co. KG
Upgrade of an existing sterile area (grade A) with implementation of a new RABS vial filling line with semi-automatic tub loading/unloading system
- Technical planning of a RABS vial filling line and the associated process workflows and support processes
- Technical construction management
- Conversion measures
- Commissioning
GSK Zoster (GSK Vaccines GmbH)
New facility for the production of cell culture-based vaccines
- General Planner
- Construction Management
- Commissioning (EPCM)
- Procurement
- Site Safety
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