Blow-fill-seal pharmaceutical

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). 

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. 

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. 

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

Points to Consider for Pharmaceutical Blow/Fill/Seal Manufacturing, Sept. 1998 Draft. 

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. 

The Bottlepack system (Rommelag, Germany) and a similar process by Automatic Liquid Packaging (USA)—blow fill seal— continue to be successfully used for pharmaceutical products. These processes are now found throughout the world and container manufacturing details are covered in previous chapters. 

Most plastic ampoules are from the blow-fill-seal types of containers. These containers are formed, filled and closed in one production lane and are therefore not available as an empty container for small scale filling. Some of these plastic containers are known as bottle-pack. These plastic containers are designed for sterile liquid pharmaceutical preparations, which can be opened by tearing, screwing or perforating. The bottle-pack-assortment contains a wide range of containers from ampoules to bottles (1-1,000 mL). 

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. 

This method is slow because of the multiple operations on a shuttle machine. The heat of extmsion sterilizes the bottle, which is not readily achieved after molding. Blow-mold/fill/seal systems are used commercially for beverages and for pharmaceutical packaging. 

---