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	In-Line and Real-Time Process Monitoring of a Freeze Drying Process Using Raman and NIR Spectroscopy as Complementary Process Analytical Technology (PAT) Tools
	De Beer, T. R. M. ; Vercruysse, P. ; Burggraeve, A. ; Quinten, T. ; Ouyang, J. ; Zhang, X. ; Vervaet, C. ; Remon, J. P. ; Baeyens, W. R. G.
	2010-10-12 ; 2010-10-12
关键词	process analytical technology (PAT) Raman spectroscopy NIR spectroscopy freeze drying process monitoring principal component analysis (PCA) multivariate curve resolution (MCR) NEAR-INFRARED SPECTROSCOPY MANOMETRIC TEMPERATURE-MEASUREMENT CURVE RESOLUTION D-MANNITOL CRYSTALLIZATION LYOPHILIZATION DIFFERENTIATION CHEMOMETRICS MIXTURES MOISTURE Chemistry, Medicinal Chemistry, Multidisciplinary Pharmacology & Pharmacy
中文摘要	The aim of the present study was to examine the complementary properties of Raman and near infrared (NIR) spectroscopy as PAT tools for the fast, noninvasive, non-destructive and in-line process monitoring of a freeze drying process. Therefore, Raman and NIR probes were built in the freeze dryer chamber, allowing simultaneous process monitoring. A 5% (w/v) mannitol solution was used as model for freeze drying. Raman and NIR spectra were continuously collected during freeze drying (one Raman and NIR spectrum/min) and the spectra were analyzed using principal component analysis (PCA) and multivariate curve resolution (MCR). Raman spectroscopy was able to supply information about (i) the mannitol solid state throughout the entire process, (ii) the endpoint of freezing (endpoint of mannitol crystallization), and (iii) several physical and chemical phenomena occurring during the process (onset of ice nucleation, onset of mannitol crystallization). NIR spectroscopy proved to be a more sensitive tool to monitor the critical aspects during drying: (i) endpoint of ice sublimation and (ii) monitoring the release of hydrate water during storage. Furthermore, via NIR spectroscopy some Raman observations were confirmed: start of ice nucleation, end of mannitol crystallization and solid state characteristics of the end product. When Raman and NIR monitoring were performed on the same vial, the Raman signal was saturated during the freezing step caused by reflected NIR light reaching the Raman detector. Therefore, NIR and Raman measurements were done on a different vial. Also the importance of the position of the probes (Raman probe above the vial and NIR probe at the bottom of the sidewall of the vial) in order to obtain all required critical information is outlined. Combining Raman and NIR spectroscopy for the simultaneous monitoring of freeze drying allows monitoring almost all critical freeze drying process aspects. Both techniques do not only complement each other, they also provided mutual confirmation of specific conclusions. (C) 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:3430-3446, 2009
语种	英语 ; 英语
出版者	JOHN WILEY & SONS INC ; HOBOKEN ; 111 RIVER ST, HOBOKEN, NJ 07030 USA
内容类型	期刊论文
源URL	[http://hdl.handle.net/123456789/80784]
专题	清华大学
推荐引用方式 GB/T 7714	De Beer, T. R. M.,Vercruysse, P.,Burggraeve, A.,et al. In-Line and Real-Time Process Monitoring of a Freeze Drying Process Using Raman and NIR Spectroscopy as Complementary Process Analytical Technology (PAT) Tools[J],2010, 2010.
APA	De Beer, T. R. M..,Vercruysse, P..,Burggraeve, A..,Quinten, T..,Ouyang, J..,...&Baeyens, W. R. G..(2010).In-Line and Real-Time Process Monitoring of a Freeze Drying Process Using Raman and NIR Spectroscopy as Complementary Process Analytical Technology (PAT) Tools..
MLA	De Beer, T. R. M.,et al."In-Line and Real-Time Process Monitoring of a Freeze Drying Process Using Raman and NIR Spectroscopy as Complementary Process Analytical Technology (PAT) Tools".(2010).

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