Blow-fill-seal technology

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

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. 

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. 

Price J. Blow-fill-seal technology Part II, design optimization of a particulate control system. Pharm Technol February 1999. 

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.J. Blow-fill-seal. In Encyclopedia of Pharmaceutical Technology, 2nd Ed. Swarbrick, J., Boylan, J.C., Eds. Marcel Dekker, Inc. New York, 2002 282-288. 

Bradley, A., Probert, S. P., Sinclair, C. S., and Tallentire, A. (1991). Airborne microbial challenges of blow/fill/seal equipment A case study. Journal of Parenteral Science and Technology 45 187-192. 

Blow/Fdl/Seal Technology Blow/fill/seal units are specialist purpose built equipment in which, in one continuous operation, containers are formed from thermoplastic granule, filled and then... 

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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