Blow-fill-seal aseptic processing container

The blow/fill/seal process is a complete packaging technique that integrates the extrusion or IBM and container filling steps. This can provide for aseptic filling of the hot as-blown container and is used for pharmaceutical, food, and cosmetic products. The process employs a two-part mold in which the container body mold cavity blocks are separate from the neck-forming members. 

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 technology is an aseptic process whereby the container is formed from thermoplastic granules, filled with sterile solution and sealed, all within one automatic operation. The bulk solution should have a low bioburden and is delivered to the machine through a filling system that has been previously sanitized and steam sterilized in situ. Concern has been expressed that the machine itself may generate particles. The plastic granules are composed usually of polyethylene, polypropylene or one of their copolymers and are heat extruded at 200°C into a tube. The two halves of a mould close around this tube and seal the base. The required quantity of sterile fluid is filled into the container, which is then sealed. Products packed in this way include intravenous solutions, and small volume parenteral, ophthalmic and nebulizer solutions. The... 

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