Our client asked:

• How hot does the biologic inside a packet get when the packet is heat sealed during a filling process?
• Can we develop a mathematical model to characterise heat transfer and mitigate the biologic heating?

The project story:

• Our client wanted to expand the range of drugs that can be delivered by their device to include temperature sensitive biologics
• It was crucial to understand whether the process used to heat seal the packaging, heated the drug enough to degrade it
• Sagentia Innovation made initial estimates to identify the key heat transfer mechanisms in the process
• These were used to inform the set-up of a numerical simulation of the heat-sealing process in COMSOL
• The model demonstrated excellent agreement with validation data provided by the client, providing a high degree of confidence in the model outputs

Results: deliverables and outcomes

The model was able to:

• Identify radiative heating as the major source of heating in the drug
• Inform options proposed by Sagentia Innovation for reducing the radiative heating without compromising the heat-sealing process
• Calculate an upper limit for the temperature the drug experiences in the current process

Sagentia Innovation also provided a knowledge transfer session to deliver the model to the client. The client will be able to evaluate the impact of future design changes on drug heating.