Blow aseptic

F. Leo, Blow /Fill/Seal Aseptic Packaging Technology in Aseptic Pharmaceutical Technology for the 1990 s, Interpharm Press, Prairie View, IL. 1989, pp. 195-218. 

Blow-Fill-Seal (BFS) technology was developed in the early 1960s and was initially used for filling many liquid product categories, for example, nonsterile medical devices, foods, and cosmetics. The technology has been developed to an extent that today BFS systems are used to aseptically produce sterile pharmaceutical products such as respiratory solutions, ophthahnics, and wound-care products throughout the world. 

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

Figure 3.29. Photographic representation of a blow-fill-seal machine, which can be particularly useful in the aseptic filling of liquid products (refer to text for details). While used fairly extensively in facilities manufacturing some traditional parenteral products, this system has not yet found application in biopharmaceutical manufacture. This is due mainly to the fact that many biopharmaceutical preparations are sold not in liquid, but in freeze-dried format. Also, some proteins display a tendancy to adsorb onto plastic surfaces. Photo courtesy of Rommelag a.g., Switzerland...

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. 

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. 

The filling of plastic containers is accomplished using two very different approaches. Pre-formed containers can be sterilized in bulk, introduced into the aseptic suite via air locks, oriented (unscrambled), and filled. Blow-fill-seal prepares sterile bottles (most often LDPE) on line just prior to filling and sealing. 

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. 

Blow-Fill-Seal Advanced Aseptic Processing... 

The pharmaceutical BFS process combines the formation of plastic containers by blow/vacuum molding extruded pharmaceutical grade polymers, with an aseptic solution filling system. 

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. 

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... 

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. 

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