Software delivery for bioprocess expansion in the pharmaceutical sector (UK)
Centif provided the complete process control software for the scaling of cGMP biopharma production, with a strong focus on quality, validation, and scalability.
For an end customer in the pharmaceutical sector, Centif delivered the complete software solution as part of a large-scale expansion of their cGMP microbial biopharma CDMO capacity. The customer invested significantly in scaling up their production environment, with a clear focus on cGMP-compliant fermentation and purification processes up to 1,000 liters.
Within this project, Centif took full responsibility for the design, development, and implementation of the process control software. The approach combined in-depth domain knowledge with a structured engineering methodology, tailored to the strict quality and validation requirements within the pharmaceutical industry.
Scope and approach
Software engineering
Complete development and implementation of process control software for critical bioprocesses, including the construction of a SCADA platform based on iFIX HMI/SCADA. The PLC logic was implemented in Siemens TIA Portal and integrated with GE Batch for advanced recipe management, batch control, and monitoring.
Process integration
Control and monitoring of various critical process units, including three bioreactors, a CIP system, a homogenizer and a centrifuge. Additionally, support was provided for complex transfer routines and seamless integration between the different process steps.
Quality & compliance
All software was developed and validated according to the applicable cGMP guidelines, with a strong focus on traceability, data integrity and auditability. The solution is fully aligned with the strict quality and compliance requirements within the pharmaceutical sector and supports smooth validation and auditing.
The result
Scalable automation platform
The implemented automation platform today serves as the backbone of the client's bioprocessing activities. The solution is designed with scalability and reliability in mind, allowing new process units and expansions to be easily integrated without impacting existing operations. This enables the client to future-proof their production capacity within a stable and high-performing environment.
Complete process control and transparency
Through the seamless integration of PLC control, SCADA visualization, and batch management, the customer has complete control and real-time insight into all process steps. From raw material input to the release of the final product, each phase is closely monitored and recorded. This end-to-end transparency not only enhances operational efficiency but also supports consistent product quality and rapid problem-solving.
cGMP-validated
scaling
The system has been successfully validated according to the applicable cGMP guidelines and meets the strict requirements regarding data integrity, traceability and auditability. This allows the client to confidently scale their CDMO activities and meet the expectations of pharmaceutical partners and regulatory authorities. This provides a solid foundation for further growth in a competitive and highly regulated market.
Impact and added value
With this realization, the client has a future-proof automation platform that guarantees both operational efficiency and compliance. The combination of scalability, integration and validation makes it possible to support further growth without compromising on quality or control. This project underscores the role of Centif as a reliable partner for complex and regulated automation projects in the pharmaceutical sector.