Blow-fill-seal filling environment

Blow/fill/seal units are purpose-built pieces of equipment, which carry out these three steps in a continuous process within a controlled environment. Containers, which are formed from thermoplastic granules, are blown to form the correct shape, filled and heat-sealed. These units are fitted with a grade A air shower and operated in a grade C environment for aseptic manufacture and a grade D background for products which are to be terminally sterilized. 

Blow/fill/seal units are purpose built machines in which, in one continuous operation, containers are formed from a thermoplastic granulate, filled and then sealed, all by the one automatic machine. Blow/fill/seal equipment used for aseptic production which is fitted with an effective grade A air shower may be installed in at least a grade C environment, provided that grade A/ clothing is used. The environment should comply with the viable and non-viable limits at rest and the viable limit only when in operation. Blow/fill/seal equipment used for the production of products for terminal sterilisation should be installed in at least a grade D environment... 

Two process variants exist. In both, the first step is to provide sterility for the blowing operation, including the air used in forming the container. In the blow and hold process, the bottle is sealed in the mold to preserve its sterility, and can then be released into a non-sterile environment. In a subsequent filling operation, it is cut open under sterile conditions, filled, and sealed again. In the blow-fill-seal process, the bottle is blown, filled with product (often while still in the mold), and sealed, all within the sterile environment of the blow molding machine, either at a single station or at multiple stations. 

There are several machine systems available for aseptically filling glass and plastic bottles for still juices. (Aseptic filling of drink cartons is covered in Section 9.7.) Carbonated drinks are not aseptically filled. There are two main aseptic filling workflows, with a third workflow used less frequently. The first system sterilises the container, fills and seals it the second takes a sealed, precleaned bottle, removes the seal in a sterile environment, fills and re-seals the container. The third system blows a bottle and while it is still sterile fills it and then seals it, all within the same machine, this is known as a form-fill-seaF (FFS) system. 

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