RecognitionDecember 2, 2019 2021-11-16 9:01
The DFF sensor provides data rich process fingerprint in-line and in real-time with significantly higher sensitivity and data density (500 data points/s) to enable process design, scale-up, monitoring, and control applications. These studies indicate that DFF sensor can be valuable tool for wet granulation formulation and process development and scale-up; as well as for routine monitoring and control during manufacturing.
DFF sensors are robust instruments capable of detecting small differences in the properties of process materials with a high degree of sensitivity. These results show sensor’s ability to identify different phases of a mixing process and detect the point at which blend becomes homogeneous…These findings underline the relevance and value of DFF measurement as a technique for real-time powder process monitoring.
The data presented here demonstrate that in-line DFF measurements can be used to monitor the variation in granule properties during a HSWG process. The resulting FPM correlates with parameters delivered by at-line powder rheology techniques that have previously been shown to provide valuable data for optimizing HSWG processes in order to generate granules suitable for downstream processing.
Studies indicate that DFF sensor can be a valuable tool for wet granulation formulation and process development and scale-up, as well as for routine monitoring and control during manufacturing. Although this study did not intend to identify ideal granulation end point, these PAT tools can be correlated to end point established independently, such as by statistically significant correlations established through design-of-experiment studies of the effect of process parameters on drug product CQAs.
DFF sensor can be used as a tool to identify the end point of a WG process with respect to granule densification or wet mass consistency, and as a parameter to enable robust formulation and process design and efficient scale-up of WG processes. Overall, drag force measurement using a cylindrical probe appears to be a promising technology for real-time monitoring and control of HSWG.