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- W2278792723 abstract "This chapter provides a description of the motivation for the development and application of real-time, on-line process monitoring techniques for pharmaceutical lyophilization. A high-level survey of both batch average and single vial measurement techniques is provided and is summarized in Table 25.1. Many of these techniques have been used for decades, but a few new measurement techniques have been recently introduced, including gas plasma spectroscopy (Lyotrack) and tunable diode laser absorption spectroscopy (LyoFlux). A detailed description of the TDLAS technique is provided, including a description of the spectroscopy principles that underpin the development and application of the measurement technique. TDLAS measurements have been combined with established heat and mass transfer models to provide determinations of important in-process product parameters such as product temperature and product resistance to drying. Additional experimentation is required to demonstrate the application of this and other new techniques within manufacturing scale dryers, allowing the use of PAT tools from laboratory-scale process development through scale-up to routine monitoring and control of product manufacturing. Continued application of PAT tools will result in improved product quality and should ultimately lead to improved efficiency and lower production costs." @default.
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- W2278792723 date "2015-01-01" @default.
- W2278792723 modified "2023-10-05" @default.
- W2278792723 title "Application of PAT in Real-time Monitoring and Controlling of Lyophilization Process" @default.
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- W2278792723 doi "https://doi.org/10.1007/978-1-4939-2316-8_25" @default.
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