Case Study with a TDLAS-based Semi-automated Media Fill Inspection Platform
Media fills are process simulations imitating the aseptic filling procedure with microbial culture medium instead of the liquid drug product. The visual inspection on turbidity of fill-finished media fills represents the control of filling line asepticity and is a rather time-consuming activity. Former studies have discussed the feasibility of automating this visual media fill inspection by tunable diode laser absorption spectroscopy (TDLAS) benchtop devices. The idea of using TDLAS was based on determining non-invasively CO2 and O2 headspace concentration changes as indicator for microbial growth in test samples. Since the results from former studies were highly promising in terms of detecting contaminated media fill samples, a follow-up case study was performed with a semi-automated system provided by Wilco AG, enabling high-throughput detection (100 vials per minute). The study delivered very promising results in terms of media fill inspection automation and gives evidence for a more efficient design of the entire media fill process. Therefore, an implementation in aseptic drug product manufacturing is highly recommendable.