In Summary
Results :
Successful integration with no production downtime. Compliant, traceable, and GMP-aligned process.
A client aimed to integrate two new 800L mobile vessels into its production line for monoclonal antibody-based vaccines. The project required seamless implementation in an active GMP-regulated environment while ensuring equipment standardization and full data integrity.
Context & Issues
RealDev was entrusted with leading a complex technical integration project within an active production environment, subject to strict regulatory compliance (GMP) and data integrity requirements. Our approach was based on rigorous planning, close coordination with stakeholders, and a structured execution methodology designed to minimize impact on ongoing operations.
We focused on:
- Standardizing automated systems in line with the client’s global strategy,
- Ensuring data traceability at every stage,
- And maintaining full compatibility with existing infrastructure.
Our Approach
1. Infrastructure Preparation
- Supervision of utility connections,
- Installation of a custom Harting socket column.
2. PLC Programming
- Development of automation logic using Siemens TIA Portal,
- Integration of new modules into the central control PLC,
- Alignment with the client’s standardization strategy.
3. Supervision and Data Collection
- Real-time data communication from new modules to the central controller, then to the IFIX supervision system,
- Full data historization to ensure traceability and regulatory compliance.
Recovery of existing data
Import of new data into the supervision systems
Deployed Solution
Results
Expected Outcomes
- A validated, compliant process aligned with GMP and data integrity standards
- Seamless equipment integration with minimal impact on production
Looking to optimize your production processes?
Whether you need to migrate existing systems, integrate new equipment, or ensure full compliance and validation, RealDev is your trusted partner in industrial automation and life sciences. Contact us today to discuss how we can support your project!