Temperature is everyone’s first question. How does temperature play a major role?
We always hear the question of how is the heat from the BFS process going to affect my drug project. We have other videos on the series on this topic but I’m going to first give a quick explainer on the important points the BFS process requires heating plastic to a molten state so it can be molded into a container. Shortly after the body of the container is molded, it’s filled with drug product, sealed, rapidly cooled, and then down the line for inspection and packaging. The Crux of this whole thing revolves around the question of how much heat is in that system when the drug product is filled into that just-formed container and how is that residual Heat going to affect my drug product.
Does the heat affect the drug product? When we talk about affecting drug products in this context we’re mainly concerned with some type of heat degradation that will affect the drugs shelf life and efficacy. As for the question of whether heat affects the drug product, it depends on a series of factors the fill volume of the drug in the container. The robustness of the drug itself and the BFS container design, very importantly, the design of the whole BFS process.
How is the temperature controlled?
All right. So let’s frame this up into two systems before they become the first system is the molten plastic that’s extruded to form the BFS container heat is removed from this system as soon as that molten plastic exits the extruder first from ambient conditions and then the heat is very rapidly removed. As the actively cooled mold forms the bottom part of the container, the other system is the drug product which is formulated and stored in an actively cooled process tape until the moment of fill heat exchangers are integrated into the product line along the way to ensure the drug product is maintained as cool as possible.
So now, we’re ready to combine those two systems into one and that’s when the drug product is filled into the BFS container. When this happens conditions are optimized to be as cool as possible while maintaining the parameters required to properly form and seal the container. After the BFS containers leave the molding and filling stage heat is further stripped from the system as it proceeds through the inspection and packaging area.
