Blow fill seal

Blow-Fill-Seal, also spelled as Blow/Fill/Seal, in this article abbreviated as BFS, is an automated manufacturing process by which plastic containers, such as bottles or ampoules are, in a continuous operation, blow-formed, filled, and sealed. It takes place in a sterile, enclosed area inside a machine, without human intervention, and thus can be used to aseptically manufacture sterile pharmaceutical or non-pharmaceutical liquid/semiliquid unit-dosage forms. BFS is an advanced aseptic processing technology that is typically used for filling and packaging of certain sterile liquid formulations like liquid ophthalmics, inhalational anesthetics, or lavaging agents, but can also be used for injectables, parenteral medicines, and several other liquid or semiliquid medications, with fill volumes ranging from 0.1...1000 cm3. Compared against traditional glass ampoules, BFS ampoules are inexpensive, lightweight, and shatterproof.

History

BFS was developed in the early 1960s at Rommelag. In 1963, Gerhard Hansen applied for a patent on the BFS process. Originally, it was used for packaging of non-sterile products, such as non-sterile medical devices, food, and cosmetics. In the early 1970s, Rommelag's Bottelpack system was first used for packing large volume pharmaceutical solutions. By the late 1980s, BFS had been well-established in the packaging industry, especially for packaging pharmaceutical and healthcare products. During the 1980s and 1990s, BFS came into use for the now common small volume unit-dosage forms.