Filling of Parenterals

Blow–Fill–Seal Technology

Blow–fill–seal (BFS) technology is an automated process by which containers are formed, filled and sealed in a continuous operation.

Most BFS machines operate using the following steps:

  1. Extrusion: An endless sterile plastic tube is continuously extruded from the melted granulate in the filling cavity of the mold.
  2. Blowing: Final container is produced by blowing sterile air at high pressure.
  3. Filling: After the container is formed inside the mold, sterile liquid product is introduced into the container.
  4. Sealing: The filled container is sealed in place by closing the seal-mold form onto the container top.
  5. Mold Opening: Upon completion of filling and sealing steps, the mold is separated, producing the sterile filled and sealed container.

Advantage Over Conventional Filling Process

  1. There is no need to purchase and stock a range of pre-fabricated container and closures.
  2. Cleaning and sterilizing pre-fabricated container and closures are not required.
  3. The cost of material, transport, storage and inventory control is reduced.
  4. Validation requirements are reduced.
  5. There is a large choice in the shapes of necks and opening devices.
  6. Less labor is involved.
  7. The code number and variables can be molded into the container.
  8. With BFS process, a one-piece aseptically filled container with a built- in safety seal is produced.
  9. The BFS process is suitable for thermolabile products.

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