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Supervisory control system for monitoring a pharmaceutical hot melt extrusion process.
AAPS PharmSciTech 2013; 14(3):1034-44AP

Abstract

Continuous pharmaceutical manufacturing processes are of increased industrial interest and require uni- and multivariate Process Analytical Technology (PAT) data from different unit operations to be aligned and explored within the Quality by Design (QbD) context. Real-time pharmaceutical process verification is accomplished by monitoring univariate (temperature, pressure, etc.) and multivariate (spectra, images, etc.) process parameters and quality attributes, to provide an accurate state estimation of the process, required for advanced control strategies. This paper describes the development and use of such tools for a continuous hot melt extrusion (HME) process, monitored with generic sensors and a near-infrared (NIR) spectrometer in real-time, using SIPAT (Siemens platform to collect, display, and extract process information) and additional components developed as needed. The IT architecture of such a monitoring procedure based on uni- and multivariate sensor systems and their integration in SIPAT is shown. SIPAT aligned spectra from the extrudate (in the die section) with univariate measurements (screw speed, barrel temperatures, material pressure, etc.). A multivariate supervisory quality control strategy was developed for the process to monitor the hot melt extrusion process on the basis of principal component analysis (PCA) of the NIR spectra. Monitoring the first principal component and the time-aligned reference feed rate enables the determination of the residence time in real-time.

Authors+Show Affiliations

Research Center Pharmaceutical Engineering GmbH, Graz, Austria.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

23797304

Citation

Markl, Daniel, et al. "Supervisory Control System for Monitoring a Pharmaceutical Hot Melt Extrusion Process." AAPS PharmSciTech, vol. 14, no. 3, 2013, pp. 1034-44.
Markl D, Wahl PR, Menezes JC, et al. Supervisory control system for monitoring a pharmaceutical hot melt extrusion process. AAPS PharmSciTech. 2013;14(3):1034-44.
Markl, D., Wahl, P. R., Menezes, J. C., Koller, D. M., Kavsek, B., Francois, K., ... Khinast, J. G. (2013). Supervisory control system for monitoring a pharmaceutical hot melt extrusion process. AAPS PharmSciTech, 14(3), pp. 1034-44.
Markl D, et al. Supervisory Control System for Monitoring a Pharmaceutical Hot Melt Extrusion Process. AAPS PharmSciTech. 2013;14(3):1034-44. PubMed PMID: 23797304.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Supervisory control system for monitoring a pharmaceutical hot melt extrusion process. AU - Markl,Daniel, AU - Wahl,Patrick R, AU - Menezes,José C, AU - Koller,Daniel M, AU - Kavsek,Barbara, AU - Francois,Kjell, AU - Roblegg,Eva, AU - Khinast,Johannes G, PY - 2013/03/04/received PY - 2013/06/11/accepted PY - 2013/6/26/entrez PY - 2013/6/26/pubmed PY - 2014/4/9/medline SP - 1034 EP - 44 JF - AAPS PharmSciTech JO - AAPS PharmSciTech VL - 14 IS - 3 N2 - Continuous pharmaceutical manufacturing processes are of increased industrial interest and require uni- and multivariate Process Analytical Technology (PAT) data from different unit operations to be aligned and explored within the Quality by Design (QbD) context. Real-time pharmaceutical process verification is accomplished by monitoring univariate (temperature, pressure, etc.) and multivariate (spectra, images, etc.) process parameters and quality attributes, to provide an accurate state estimation of the process, required for advanced control strategies. This paper describes the development and use of such tools for a continuous hot melt extrusion (HME) process, monitored with generic sensors and a near-infrared (NIR) spectrometer in real-time, using SIPAT (Siemens platform to collect, display, and extract process information) and additional components developed as needed. The IT architecture of such a monitoring procedure based on uni- and multivariate sensor systems and their integration in SIPAT is shown. SIPAT aligned spectra from the extrudate (in the die section) with univariate measurements (screw speed, barrel temperatures, material pressure, etc.). A multivariate supervisory quality control strategy was developed for the process to monitor the hot melt extrusion process on the basis of principal component analysis (PCA) of the NIR spectra. Monitoring the first principal component and the time-aligned reference feed rate enables the determination of the residence time in real-time. SN - 1530-9932 UR - https://www.unboundmedicine.com/medline/citation/23797304/Supervisory_control_system_for_monitoring_a_pharmaceutical_hot_melt_extrusion_process_ L2 - https://dx.doi.org/10.1208/s12249-013-9992-7 DB - PRIME DP - Unbound Medicine ER -