ABSTRACT
Blow fill seal (BFS) involves the manufacture and filling of plastic containers in one continuous operation. This chapter focuses on the fundamentals of operation and a discussion of basic validation techniques and approaches. In the mid-1960s, BFS technology was developed as an attempt to shorten long bottle-formation cycles. As more companies considered BFS for the manufacture of sterile pharmaceuticals, the emphasis began to shift toward machine and support system design. Machines were placed in controlled environments and cleanrooms. Validation techniques, such as temperature mapping of the product lines and media fills, were conducted. In an effort to address Food and Drug Administration concerns over aseptic processing while continuing to manufacture these types of products, the industry has turned to advanced aseptic processing alternatives. The pharmaceutical biotech and medical device industries are interested in BFS as a cost-effective method for increasing the quality of sterile and clean products.
