Blow-fill-seal sterile pharmaceutical products

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. 

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

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. 

---