Blow-fill-seal process

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. 

Filling and packaging by blow/fill/seal technology has gained wider acceptance for use in the biotechnology industry in the past decade. The blow/fill/ seal process is one continual, integrated operation in which the container is formed by blowing a molten... 

Jones, D. Topping, P. Sharp, J. Environmental challenges to an aseptic blow-fill-seal process a practical study. J. Pharm. Sci. Tech. 1995, 49 (5), 226-234. 

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. 

LDPE is generally used for small volume blow moulded articles, mainly for household, domestic, and pharmaceutical applications. Due to its high purity, LDPE is the preferred raw material for medical and pharmaceutical packaging applications. In the pharmaceutical field, blow moulded articles have a particular importance because they can be filled under sterile conditions immediately after production, while still in the blow moulding machine (blow-fill-seal process). To ensure sterilisation, higher density LDPE is preferred. 

Process design 3.2.4 Isolator and blow/fill/seal technology... 

Deborah J. Jones, B.Sc. Microbiology Manager, Norton Steripak, Runeom, Cheshire, England Blow-Fill-Seal Aseptic Processing... 

The process is used for high volume BM of very small containers such as pharmaceutical vials and whiskey bottles. A multi-cavity mold is used with an extruded parison whose circumference approaches twice the total width of the closely spaced cavities. Before the mold closes, the parison is stretched and semi-flattened laterally so that it extends across the full width of the cavities. The process is usually combined with blow/fill/seal techniques. 

Process simulation test contamination rates approaching zero should be achievable using automated production lines in well-designed aseptic processing facilities, blow-fill- seal and form-fill-seal and in isolator-based systems. 

Wu, V.L. Leo, F.N. Advances in blow/fill/seal technology a case study in the qualification of a biopharmaceutical product. In Biotechnology and Biopharmaceutical Manufacturing, Processing, and Purification, Avis, K.E., Wu, V.L., Eds. Interpharm Press, Inc. Buffalo Grove, Illinois, 1996 265-292. 

Blow-Fill-Seal Advanced Aseptic Processing... 

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. 

Nebulizer solutions are typically filled as unit dosages in plastic containers. The latter uses blow-fill-seal technology [33]. Thus drug formulation compatibility with plastics is an important factor. Characterization of any sorption processes of plasticizer, monomer, and extractables or leachables is critical during long-term product-evaluation studies. Such sterile unit-dose formulations, in essence, do not require chemical preservation. 

Offer a wide range of moulding processes, enabling designs to be produced with fewer assembly operations, resulting in less labour-intensive activities can be produced by form, fill, seal processes thereby giving low particulate levels with low microbial levels, e.g. blow, fill seal. 

All the above processes can also be used in a form fill seal process with, for example, thermoforming and cold forming blister packs. Rommelag type bottle pack systems use an extrusion process where the container is formed by either blowing or vacuum (smaller sizes). Immediately after this, containers are filled, and the pack is sealed (welded) by using the residual heat in an extension to the main body of the container. 

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