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Expert Content LibraryIntro To BFS

Chapter 27: Areas of a Blow-Fill-Seal Line

A Blow-Fill-Seal manufacturing line is a compact filling suite that takes bulk drug product, aseptically fills it in newly formed BFS resin containers, ensures the filled units meet quality standards, and preps the containers for secondary and tertiary packaging.

In the following video chapters, we will divide up the BFS line into a series of subjective areas to outline the steps a BFS container should go through from filling to initial secondary packaging.

For this example, we will use a bottelpack 460 rotary BFS machine on a 0.5mL filled product, at 25 units per cycle. As a result, some of the details will vary by BFS machine.

However, the overall process of filling and sealing the drug product in the BFS container, preparing the filled containers for packaging, and testing to ensure quality is upheld is consistent across all BFS filling suites.

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