In order to reduce the variations of the product quality in batch processes, multivariate statistical process control methods according to multi-way principal component analysis (MPCA) or multi-way projection to laten...In order to reduce the variations of the product quality in batch processes, multivariate statistical process control methods according to multi-way principal component analysis (MPCA) or multi-way projection to latent structure (MPLS) were proposed for on-line batch process monitoring. However, they are based on the decomposition of relative covariance matrix and strongly affected by outlying observations. In this paper, in view of an efficient projection pursuit algorithm, a robust statistical batch process monitoring (RSBPM) framework,which is resistant to outliers, is proposed to reduce the high demand for modeling data. The construction of robust normal operating condition model and robust control limits are discussed in detail. It is evaluated on monitoring an industrial streptomycin fermentation process and compared with the conventional MPCA. The results show that the RSBPM framework is resistant to possible outliers and the robustness is confirmed.展开更多
Wet granulation-a unit operation involving mixing polymeric binders with powdered formulations-is well established in the pharmaceutical industry,playing a major role in the manufacturing of oral solid dosage forms an...Wet granulation-a unit operation involving mixing polymeric binders with powdered formulations-is well established in the pharmaceutical industry,playing a major role in the manufacturing of oral solid dosage forms and improving the physical properties of granules(size,density,shape factor,etc.)before tableting.The foaming properties of aqueous polymeric binders prove useful for binder delivery within the mixing vessel,with foamed binders leading to enhanced process efficiency(binder distribution,drying time,and temperature)and product quality(heat-sensitive components)during granulation.Given the importance of this stage in producing oral solid dosage forms,understanding the relationship between critical process parameters and critical quality attributes is essential.The process analytical technology(PAT)framework enables process design,analysis,and control and facilitates process development via in-line spectroscopy combined with multivariate data analysis to yield critical product information during the unit operation.Herein,we used in-line NIR spectroscopy to monitor granule size in foam granulations of a pharmaceutical compound.The mean granule diameter was predicted using a partial least squares regression(PLSR)model(with a prediction error of 11.8μm)and combined with a batch statistical process control(BSPC)approach for the temporal monitoring of granule size during three foam granulations.展开更多
文摘In order to reduce the variations of the product quality in batch processes, multivariate statistical process control methods according to multi-way principal component analysis (MPCA) or multi-way projection to latent structure (MPLS) were proposed for on-line batch process monitoring. However, they are based on the decomposition of relative covariance matrix and strongly affected by outlying observations. In this paper, in view of an efficient projection pursuit algorithm, a robust statistical batch process monitoring (RSBPM) framework,which is resistant to outliers, is proposed to reduce the high demand for modeling data. The construction of robust normal operating condition model and robust control limits are discussed in detail. It is evaluated on monitoring an industrial streptomycin fermentation process and compared with the conventional MPCA. The results show that the RSBPM framework is resistant to possible outliers and the robustness is confirmed.
文摘Wet granulation-a unit operation involving mixing polymeric binders with powdered formulations-is well established in the pharmaceutical industry,playing a major role in the manufacturing of oral solid dosage forms and improving the physical properties of granules(size,density,shape factor,etc.)before tableting.The foaming properties of aqueous polymeric binders prove useful for binder delivery within the mixing vessel,with foamed binders leading to enhanced process efficiency(binder distribution,drying time,and temperature)and product quality(heat-sensitive components)during granulation.Given the importance of this stage in producing oral solid dosage forms,understanding the relationship between critical process parameters and critical quality attributes is essential.The process analytical technology(PAT)framework enables process design,analysis,and control and facilitates process development via in-line spectroscopy combined with multivariate data analysis to yield critical product information during the unit operation.Herein,we used in-line NIR spectroscopy to monitor granule size in foam granulations of a pharmaceutical compound.The mean granule diameter was predicted using a partial least squares regression(PLSR)model(with a prediction error of 11.8μm)and combined with a batch statistical process control(BSPC)approach for the temporal monitoring of granule size during three foam granulations.
