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Aseptic manufacturing processes have evolved over a long period of time and are capable of producing high quality parenteral products. The current growth in sterile biopharmaceutical products brings challenges as well as opportunities to the industry in terms of developing in-process monitoring and control strategies that keep processes in a state of control and minimize the risk of product defects. Contributing to our understanding of aseptic manufacturing processes are new advanced test and measurement technologies. The objective of this white paper is to describe one relatively new method in detail and discuss one of its important applications. The method is laser-based non-destructive headspace analysis and the application is 100% container closure inspection of sterile vials after capping to ensure the maintenance of sterility and stability.

The ability to measure headspace gas composition and headspace pressure rapidly and non-destructively allows manufacturers to monitor a number of quality parameters such as container closure integrity,oxygen content, and moisture content simultaneously. Historically these quality parameters were monitored using off-line destructive technologies or older in-line technologies that have weaknesses such as limited dynamic range and high false reject rates. Common individual product defects include leaks caused by cracks in the glass or improperly seated stoppers, and common process issues include insufficient drying of individual products during lyophilization cycles and insufficient removal of oxygen from oxygen-sensitive liquid products during the fill and finish stage of production.