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By Andrew W. Goll Technical Sales Manager, Weiler Engineering, Inc.

The aseptic blow-fill-seal (B/F/S) process has proven to be an ideal system for the creation of a wide variety of container shapes and sizes used for packaging sterile pharmaceutical liquids. B/F/S is well suited to producing closed aseptic containers, like injectable products, that need to be opened under critically sterile conditions within a clinical environment such as a hospital, as well as sterile products opened by individuals in work-a-day environments like ophthalmic dropper units. These products must meet the mandates of drug manufacturers and government regulators that require sterile products that will stay sterile until the time of use. Manufacturers also desire the most cost-efficient packaging systems to achieve these ends without any loss of product integrity. One of the more recent improvements in aseptic B/F/S processing that facilitates these goals is the advance in insertion technology. The latest generation of aseptic B/F/S machines incorporates dedicated isolators adapted specifically for insertion applications. These modular insertion isolators are typically located outside of the classified machine room, separate from but directly connected to the B/F/S unit through a transfer tunnel. The isolator and tunnel are typically sterilized with vaporized hydrogen peroxide and the Class 100 environment within it is maintained by HEPA filtration. This new addition to the aseptic B/F/S system has not only streamlined the insertion process, but has provided a higher level of sterility assurance for products with tip-and-caps and rubber/silicone stoppers inserted under aseptic conditions.