Application of Near-Infrared Spectroscopy to statistical control in freeze-drying processes.
Control chart
Discriminant analysis
Freeze-drying
Multivariate analysis
Near-Infrared Spectroscopy
Statistical control
Journal
European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V
ISSN: 1873-3441
Titre abrégé: Eur J Pharm Biopharm
Pays: Netherlands
ID NLM: 9109778
Informations de publication
Date de publication:
Nov 2021
Nov 2021
Historique:
received:
20
05
2021
revised:
06
08
2021
accepted:
19
08
2021
pubmed:
27
8
2021
medline:
28
1
2022
entrez:
26
8
2021
Statut:
ppublish
Résumé
Batch freeze-drying of pharmaceutical products in vials may result in a high degree of intra-batch variability due to several reasons, e.g. non uniform heating rate in the drying chamber. Therefore, product quality in the final product has to be checked in a statistically significant number of samples, in particular in the stage of process development. Here, Fourier-Transform Near-Infrared Spectroscopy is proposed as a fast, non-destructive technique for an off-line Statistical Quality Control application. At first, results obtained in a batch where product features are satisfactory are used to identify a target quality threshold. Then, a statistical controller is developed in such a way that in a production run it is possible to quickly check if product quality exceeds the desired threshold or not. Two approaches based on multivariate analysis are presented: one employs the Hotelling T
Identifiants
pubmed: 34438021
pii: S0939-6411(21)00213-7
doi: 10.1016/j.ejpb.2021.08.009
pii:
doi:
Substances chimiques
Pharmaceutical Preparations
0
Water
059QF0KO0R
Sucrose
57-50-1
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
26-37Informations de copyright
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