Blow-Fill-Seal technology refers to the manufacturing technique used to produce small, (0.1mL) and large volume, (500mL +) liquid filled containers. Blow-Fill-Seal technology was originally developed in Europe in the 1930s and was introduced in the United States in the 1960s, but over the last 20 years it 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.
The basic concept of blow fill seal (BFS) is that a container is formed, 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.
The process is multi-stepped, firstly pharmaceutical-grade plastic resin is vertically heat extruded through a circular throat, 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. The mould is transferred to the filling zone, or sterile filling space where filling needles mandrels are lowered and used to inflate the plastic to form the container within the mould. Following the formation of the container, the mandrel is used to fill the container with liquid, following filling the mandrels are retracted and a secondary top mould seals the container. All actions take place inside a sterile shrouded chamber inside the machine. The product is then discharged to a non-sterile area for labelling, packaging and distribution.
Blow fill seal technology reduces personnel intervention making it a more robust method for the aseptic preparation of sterile pharmaceuticals. BFS is used for the filling of vials for parenteral preparations and infusions, optphalmic products and inhalation products for example Respules (TM). Generally the plastic containers are made up of polyethylene and polypropylene. Polypropylene is more commonly used to form containers which are further sterilised by autoclaving as Polypropylene has greater thermostability.
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