At the center of the Blow-Fill-Seal process are the BFS molds. The mold is very important as it ensures good dose delivery with the unit dose capability of BFS.
The BFS mold is installed into the BFS machine to form the container shape and size.
The requirements for the BFS mold vary by machine. Shuttle machines and certain rotary machine models require a single BFS mold.
However, several rotary machine models require a set of up to 20 duplicate BFS molds.
A single BFS mold will typically allow for multiple BFS containers to be created and filled at the same time. The number of containers a single mold will support varies based on the machine model and the size and shape of the BFS container.
Production BFS molds are typically made of a steel-brass alloy. Completed molds are taken through factory acceptance testing and, once they arrive at the facility, site acceptance testing.
The shape of the BFS mold is very important, as it will impact both the performance of the container as well as the ability of the drug product to be successfully filled and survive stability testing.
Likewise, pharmaceutical companies may want to create a unique mold shape for brand differentiation or intellectual property protection.