Blow-Fill-Seal Aseptic Packaging For Heat Sensitive Biotech Products

By Dr. Otto E. Schubert, Stephan Gschwind, and Tim Kram

Blow fill-seal (BFS) processing and containers are widely used for efficient packaging for respiratory, ophthalmic and parenterals products ranging from less than 0.1 mL to more than 1000 mL. The BFS process utilizes plastic extrusion and in-situ blow molding, filling and container closure to produce a product with high aseptic assurance. Due to the heat inherently present in the BFS process there is concern about the impact this heat can have on the packaged product. Biopharmaceutical products are typically sensitive to heat [4]. CoolBFSTM is the process in which mechanical systems are applied to the BFS system that can precisely control the product temperature during the BFS process. This experiment was performed to define the BFS process characteristics that have significant influence over the final filled product temperature.