Case Study: Integrating Facility Fit Models With Operational Data

Goal: To create a facility fit model that produces highly accurate models of new processes before they enter production.

High level summary

• An Operational Facility Fit model was built, integrating a new process with detailed operational considerations
• Completed Operational Facility Fit model included all tanks and key resources, allowing the plant to check the main process fit as well as supporting operations
• Accurate operational data ensured highly accurate run-rate estimates, that were subsequently confirmed in the facility
• Enabled the effect of the new process to be accurately quantified years before it entered the target facility.

The Brief

Traditional Facility Fit models provide estimates for overall process durations and fit based on chemical and mass-balance equations. This approach is important to produce a working process, but does not guarantee that the installed process will perform as expected since it fails to account for variability and all the resources in the plant. Many companies have performed technology transfer only to find that their operational run rates are much lower than expected. What is missing is a view of the completed process as it will actually perform in the facility.

Bioproduction Group's brief was to integrate operational data from existing processes at the facility to show 'complete' operational feasibility. The goal was to enable the biopharmaceutical manufacturer to accurately predict the final run rate of the product, as well as operational considerations to guide the technology transfer process.

How We Did It

Bioproduction Group's key insight was that simulation technology could integrate unit operations from the company's existing facility fit model with existing activities in the plant. Using this approach, Bio-G found that more than 30% of the overall processing time was not accounted for in the theoretical facility fit model, meaning the facility fit model would suggest much better results than were actually possible.

Figure 2. traditional facility fit models drastically underestimate operational process times

The operational facility fit model used simulation to predict resource shortages between shared equipment that could further affect throughput. By combining operational data with a theoretical model, the simulation facility fit model suggested more than just a process design: it showed the actual operation of that process within the facility.

Results

Bio-G's simulation facility fit modeling provided a considerably more robust facility fit model that incorporated all supporting operations as well as operational data. The resulting model showed that variability was of considerable importance in designing the process for the facility.

Figure 3. Complete product feasibility

More importantly, the outputs of the simulation facility fit model was then used by automation equipment and technology transfer staff to implement the new process. This approach significantly lowered technology transfer time, increasing the manufacturer's speed to market and operational patent lifetime.