Blow-fill-seal

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

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. 

Jones, D., Topping, P., and Sharp, J., Environmental Challenges to an Aseptie Blow-Fill-Seal Proeess—a Praetieal Study, PDA J. Pharm. TechnoL, 49(5), (1995). 

Bradley, A., Probert, S., Sinclair, C.S., and Tallentire, A., Airborne Mierobial Challenges of Blow-Fill-Seal Equipment A case study, PDA J. Pharm. TechnoL, July/Aug., (1990). 

Whyte, W., Matheis, W., Dean-Netcher, M. and Edwards, A., Airborne Contamination during Blow-Fill-Seal Pharmaceutical Production, PDA J. Pharm. TechnoL, 52(3), (1998). 

Birch, C.J., and Sinclair, C.S., Blow-Fill-Seal Extrusion of Spore Contaminated Polymer An exploratory study, BPS News, BFS Operators Association, Sept. 1998. 

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...

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. 

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. 

Sharp, J. Manufacture of sterile pharmaceutical products using blow-fill-seal technology. The Pharm. J. 1987, 259(106), 22. 

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... 

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... 

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