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Blow-Fill-Seal technology refers
to the manufacturing technique used to produce small, (0.1mL+ ) and large volume, (500mL +) liquid filled containers. Over the years BFS has become more prevalent within the pharmaceutical industry, and it is now widely considered to be the superior form of aseptic processing by various medicine regulatory agencies including the U.S. Food and Drug Administration (FDA) in the packaging of pharmaceutical and healthcare products. Blow fill seal technology reduces
Personnel intervention making it a more robust method for the aseptic preparation of sterile pharmaceuticals.
The basic concept of blow fill seal (BFS) is that a container is formed (Blow moulded), filled, and sealed in a continuous process without human intervention, in a sterile enclosed area inside a machine. Thus this technology can be used to aseptically manufacture sterile pharmaceutical liquid dosage forms.
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Extruding : The process is multi-stepped, firstly pharmaceutical-grade plastic resin is vertically heat extruded through a circular die ring, to form a hanging tube called the Parison. This extruded tube is then enclosed within a two-part mould, and the tube is cut above the mould. |
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Moulding : The mould is transferred to the filling zone, or sterile filling space where filling mandrels are lowered and used to inflate the plastic to form the container within the mould. |
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Filling : Following the formation of the container, the mandrel is used to fill the container with specified volumes using time pressure dosing system. |
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Sealing : After the special mandrel unit retracts, the head mould closes and forms the required seal by vacuum. |
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Mould Opening/Transfer : With the opening of the blow mould, the container exits from the machine and the cycle repeats itself. Transfer for further processing is achieved by means of a conveying system. The product is then discharged to a non-sterile area for labelling, packaging and distribution |
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