On-line monitoring of blend uniformity in continuous drug product manufacturing process—The impact of powder flow rate and the choice of spectrometer: Dispersive vs. FT
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- 作者：Zhenqi Shi ; shi_zhenqi@lilly.com" class="auth_mail" title="E-mail the corresponding author ; Kathryn C. McGhehey ; Ian M. Leavesley ; Leo F. Manley
- 关键词：Near infrared spectroscopy ; Process analytical technology ; Continuous manufacturing process ; Blending uniformity ; Multivariate figures of merit
- 刊名：Journal of Pharmaceutical and Biomedical Analysis
- 出版年：2016
- 出版时间：25 January 2016
- 年：2016
- 卷：118
- 期：Complete
- 页码：259-266
- 全文大小：2064 K
文摘
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The use of a partial least squares (PLS)-based spectral pretreatment to counter the impact of flow rate on spectroscopy-based process monitoring of blend uniformity.
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Equivalent error statistics between a FT-NIRS and a dispersive NIRS method given appropriate co-adds used in both instruments.
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Advantageous sensitivity and specificity of a FT-NIRS method in comparison to a dispersive NIRS method.
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NIRS method performance on monitoring blend uniformity on flowing powder in continuous manufacturing of drug product shall be evaluated with respect to both multivariate FOM and measurement time consideration.