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Process Analytical Technology- A Tool for Better Quality
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| Author:
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PRASAD VINAY RAO, MAHENDRAN BHASKARAN, HEMANTH KUMAR S, PREETHI SOMANNA, AMIT B PATIL
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| Abstract:
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Process analytical technology (PAT) has been characterized as system for configuration, dissect and monitor ways of pharmaceutical configuration of basic procedure parameters which influence quality properties. PAT checks the nature of crude material properties both physically and artificially (for example at disconnected, on-line, in-line). PAT spares a tremendous measure of time and money required for testing and investigation of pharmaceutical products. In the current article we shall discuss about the different PAT tools used for monitoring processing parameters during different stages of manufacturing of oral solid dosage form (granulation, compression and coating of tablets), liquid parenteral and lyophilization. The principle of operation of the currently used tools like near infra-red spectroscopy (NRI), high speed imaging, Acoustic resonance spectroscopy etc. are described. The increasing research in the area of PAT is aimed at monitoring product quality in real time, providing active feedback and process control. Regulatory approval time can be considerably reduced since the data is generated in real time with compliance to all regulatory requirements of data integrity and authenticity.Understanding the process knowledge has been shown to strongly support commercial strategies, mistake proofing of operations and excellent regulatory compliance in a complex business scenario.
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| Keyword:
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NIR; High Speed Imaging; Terahertz pulsed imaging (TPI); Acoustic resonance spectroscopy; Dielectric Spectroscopy.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.02.027
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| Download:
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Request For Article
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