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Expert Content LibraryIntro To BFS

Chapter 23: Blow-Fill-Seal Equipment

The number of machines on a Blow-Fill-Seal line may vary, but most BFS lines will contain some version of the following:

• Drug formulation vessel that feeds the drug product into the BFS machine
• The BFS machine
• Engraving or Labeler which can either be done by laser immediately after BFS containers are made and filled, or prior to secondary packaging
• Punch machine to remove the excess resin • Separator to break apart the BFS strips into cards
• Leak detector
• Visual inspection unit
• Foil wrapper for secondary packaging
• Cartoning and Case packing

For those who are familiar with glass filling line setups, BFS does not require washing and depyrogenation tunnels on the vial infeed. In addition, there a no need for stoppering and capping stations on the outlet side of the filler.

Lastly, if the filling and packaging processes are separated, the BFS cards can be loaded into trays and stored as work in process, which can later be packed in sublots for different markets and presentations.