Target
Upscaling production / production enhancement
Location
Belgium
Sector
Life Science
Duration
2 years (ongoing)
Budget
Confidential
Team
2 Project Manager
5 Project Engineer
Context
The client seeks to multiply production throughput by integrating into the two existing production lines, additional high-performance equipment:
Filling Units (FU)
Freeze & Thaw Units (FTU)
Highly Cusomized Automated
RealDev’s Mission
RealDev will act as the client’s engineering and validation partner, leading the entire lifecycle for each piece of equipment, in alignment with the V-cycle methodology:
Requirements Definition
- Draft and validate the User Requirements Specifications (URS) with the client.
- For the Automated Transfer Units, RealDev will facilitate workshops to support the client in defining precise and actionable requirements.
Design and Construction Oversight
- Ensure manufacturers fully understand and integrate the client’s expectations regarding automation, electrical connections, data integrity, and software configuration.
- Support the preparation of documentation including Data Integrity Assessment, Electronic Records and Electronic Signature Assessment, and Alarms List.
- Follow up on detailed design reviews and automation technical documentation.
Factory Acceptance Testing (FAT)
- Assist suppliers in preparing FAT protocols and technical documentation.
- Represent the client during FAT execution, ensuring conformity to specifications.
Installation and Site Acceptance Testing (SAT)
- Coordinate the installation of new equipment, especially the large-scale ATUs, during planned shutdown periods to avoid production disruption.
- Oversee integration with utilities (compressed air, electricity, gas, etc.) and perform on-site SAT.
Qualification and Validation
- Lead and support the IQ (Installation Qualification) and OQ (Operational Qualification) phases.
- Ensure that all required validation documentation is prepared and compliant.
Key Challenges and RealDev’s Added Value
1. Definition and Integration of Custom ATUs
- RealDev acts as a bridge between the client and the manufacturer to ensure the highly customized Automated Transfer Units are designed according to operational and spatial constraints.
- RealDev provides support in defining needs and managing expectations on both sides.
2. Ensuring Production Continuity
- Equipment installation and commissioning will be planned to avoid interfering with ongoing operations.
- Particular attention will be given to scheduling work during shutdown windows.
3. Multi-Vendor Coordination
- RealDev centralizes communication between the client and multiple equipment vendors.
- This ensures alignment, technical coherence, and risk reduction across all interfaces.
4. Compliance and Documentation
- RealDev ensures that all equipment integration complies with industry regulations and quality standards.
- The team will assist with the creation and review of all required validation documentation.
Expected Outcomes
Increased production capacity through the strategic integration of 12 new equipment units
A compliant and validated process aligned with GMP and data integrity standards
A seamless project execution with minimal disruption to existing operations
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!
