The GSK Parma Facility is a biopharmaceutical manufacturing site in Italy that specializes in bringing new products to market for the science-led global healthcare company GlaxoSmithKline and other third parties. In 2020, management began a capital project to replace the sterile manufacturing facility at the site with one based on new technology. A key objective for the project was to minimize risk to the supply of critical biopharmaceutical drugs.
For analysis, planning, and decision support on the project, GSK worked with the award-winning tech application company Decision Lab.
Problem: Pharmaceutical manufacturing capacity planning
To meet regulatory requirements for manufacturing in a sterile environment, the GSK's facility in Parma, Italy, needed to upgrade its pharmaceutical production line. Key challenges to successfully carrying out these works included minimizing risk to the supply of critical pharmaceutical drugs, while also managing increased and volatile demand forecasts.
Before commencing with construction, management decided to simulate the manufacturing facility. Simulation modeling would allow safe testing and optimization of processes before work commenced on the new pharmaceutical facility, but it would need to account for a large set of input parameters.
Success would result from understanding and accurately predicting overall facility capacity regarding machinery and operations. For machinery, planners wanted to account for the quantity, size, and capacity of key equipment. And, for operational aspects, they needed to consider staff numbers, shift patterns, cleaning schedules, and more.
With a simulation model, management wanted a decision support tool that would inform equipment purchases and perform throughput optimization to improve capacity. The model would also help build the business case for potential design solutions and evaluate them against key value drivers:
- Capital expenditure (capex)
- Operational expenditure (opex)
- Spare capacity
- Equipment size
- Net present value (NPV)
- Cost of goods (COG)
- Utilization levels
Solution: Pharmaceutical production simulation
Decision Lab and GSK created the production simulation model in two phases. Phase one included the production processes and used Discrete Event simulation to account for the complex manufacturing activities at the GSK Parma facility.
Phase two was about information delivery, visualization, and the creation of a digital twin of the facility.
Using the DXF CAD file import facility of the AnyLogic simulation modeling software, the model designers accurately represented the facility site plan. Machine processes, operator activities, and other processes were modeled and visualized in a way that clearly defined the major and sub-processes.
Thanks to the custom extensibility of the AnyLogic simulation modeling platform, the designers could add a custom heatmap to show operator activity. This feature was important for the sterile facility because it helped focus cleaning activities.
Each part of the model was constructed to help with site planning, with the result that the design was highly flexible. For example, to compare scenarios, the model operator could easily adjust parameters, such as the number of machines and operators.
Pharmaceutical production facility decision support
During the facility design phase, planners used the model to analyze over 200 potential business scenarios. The results from simulation runs were easy to read thanks to the work in phase two on the visualization characteristics of the model.
A dashboard laid out the processes in a way that abstracts away from the underlying complexity and parallel processes. Production could be viewed on a Gantt chart to understand process timings, and in 3D to comprehend how they were being performed. With an easy way to see how long processes would take, the model could inform decisions about when to start them.
The 3D view helped engage stakeholders at all levels, demonstrating that the model was not just a ‘black box providing answers’ and strengthened design phase arguments.
Result: Optimized pharmaceutical manufacturing
The dynamic simulation approach, enabled by AnyLogic, provided meaningful insight into how the future production line should be configured and operated, unlike traditional analytical tools. The simulation model gave planners quick and extensive scenario and options analysis that uncovered key constraints and sensitivities in the original design.
The robustness of the modeling phases, and the strength of support the model gave decision-makers, led to fast approval of the project. At stage-gate approval, there were no delays, and the next phase of the project could start on time.
Furthermore, cost savings came from accurately determining equipment needs and not over-purchasing. The overall capital expenditure is expected to be 20% lower thanks to confidence in equipment requirements.
In the future, engineers at the GSK Parma facility will continue using the model for planning, and are looking to test machine learning to find further process optimization.
The project and its findings were presented by Joy Kuo of Decision Lab and Giovani Giorgio from the GSK Parma Facility at the AnyLogic Conference 2021 - Manufacturing simulation for a new pharma facility concept to support key design decisions.