Process Analytical Technology (PAT) Capabilities and Implementations under QbD Principles QbD and PAT Department
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1 Process Analytical Technology (PAT) Capabilities and Implementations under QbD Principles QbD and PAT Department K1 Competence Center Initiated by the Federal Ministry of Transport, Innovation & Technology (MMVIT) and the Federal Ministry of Economics & Labour (BMWA). Funded by FFG, Land Steiermark and Steirische Wirtschaftsförderung (SFG).
2 Overview and Concepts Actual situation: Variable raw material properties + Fixed manufacturing process = Variable product quality (variable output) Quality check of raw materials Input Pharmaceutical manufacturing Process Fixed Process and low knowledge Quality Control (QC) of the final product Output Product waste Time delay Jan Page 2
3 Overview and Concepts Desired situation: Variable raw material parameters + Variable manufacturing process = Fixed output Quality check of raw materials Input Pharmaceutical manufacturing Process Variable Process and Mechanistic Understanding Quality Control (QC) of the final product (Prediction of Quality) Output PAT Product waste Real Time Release (RTR) Jan Page 3
4 Prior Knowledge Quality by Design Approach Pharmaceutical Quality System Pharmaceutical Quality System (ICH Q10) Quality Manual (ICH Q10) Quality Risk Management (ICH Q9) Criticality Assessment Risk Analysis Product Understanding critical Quality Attributes (cqas) Quality Target Product Profile (QTPP) Risk Analysis Process Understanding Process Analysis Inputs Outputs Process Analytical Technologies Process Modelling and Simulation Design of Experiment Operating Space Design Space Knowledge Space Risk Analysis Process Control Control Process Strategy Analytical for Technologies cpps Control Feedback Strategy Control for Loops cpps Real Feedback Time Release Control Loops Real Time Release Regulatory Implementation Knowledge Management (Q10) QbD documentation Product & Process Continuous Improvement Jan Page 4
5 Process Analytical Technology Analytical in the context of PAT includes much more than measuring, it is all about an overall process understanding! Measurement of Critical Attributes/Parameters Process analysers for in-line noninvasive quality monitoring Data Analysis and Management Design of Experiment (DoE) and Multivariate Data Analysis (MVDA) Process Control Knowledge based process understanding developement of a Design Space (DS) Jan Page 5
6 CFD-Simulation under QbD principles Fermentation Process Simulation-based design of a fermentation process and simulation validation Problem: No reliable simulation-based tools for bioreactor design exist Goal: Prediction of fermentation process performance depending on reactor design and operational parameters Concept: Use of CFD-simulation under QbD principles and validation of the simulation by means of literature and experimental data CFD bioreactor characterisation 1) oxygen saturation after air injection 2) bubble injection 3) velocity field Jan Page 6
7 ASA TAB MCC ASA*ASA TAB*TAB MCC*MCC ASA*TAB ASA*MCC TAB*MCC Application of Statistical Science Creation of Design Spaces Multivariate analyses of data Computation of parameter relations N=19 R2=0,774 RSD=0,8343 DF=13 Q2=0,374 Conf. lev.=0,95 Jan Page 7
8 Investigation of knowledge management application areas in pharma Development of an overall knowledge management platform and ensure essential functionalities Closing gap of information management and knowledge application Jan Page 8
9 PAT for Process Monitoring Multi-Probe-NIR-Spectrometer Prototype Testing and implementing a spectrometer prototype by EVK GmbH, Austria. Compact spectrometer with wavelength dispersion system 25 standardized ports for monitoring 25 fiber optic probes at once Simultaneous online monitoring of multiple process spots process steps multiple processes without differences between spectrometers no time delays Jan Page 9
10 PAT at Pharmaceutical Extrusion Monitoring and Supervisory Control Input parameters: Barrel temperatures Adapter temperature Screw speed Feed rate Output parameters: Barrel temperatures Adapter temperature Screw speed Feed rate Material pressure Material temperature Torque Spectrum Closed-Loop Control: Feedback connection via SIPAT Integration of Simca, Matlab, Camo into SIPAT system Jan Page 10
11 Monitoring of Continuous Processing Pharmaceutical Extrusion Monitoring of API content variations and residence time distribution with PLS model Investigation of the influence of kneading elements on API content fluctuations kneading screw standard deviation for 30 % API: 0.41 conveying screw standard deviation for 30 % API: 0.71 Jan Page 11
12 absorption units [a.u.] 2 nd principal component PAT at Tablet Press Monitoring of Powder Homogeneity Sentro probe Principle Component Analysis (PCA) shows clear differences over time Definition of limits (regions in PCA plot) to differentiate in spec and out of spec Filling shoe minor deviation main excipient API possible major deviation (last 30 sec of process) visible fluctuations wavelength [nm] 1 st principal component Jan Page 12
13 measured coating / desired coating level PAT at Tablet Coating in a Fluid Bed Monitoring of Coating Thickness Monitoring with NIR and Spatial Filter Velocimetry 100 % 0 % Parsum IPP 70-S 1.2 window fouling ( ) crystal coating ( ) % 100 % Time (h) Time (h) Time (h) Jan Page 13
14 Coatingprocess New PAT-Tool for Tablet Coating Optical Coherence Tomography Development of Pharma conform sensor Algorithm for coating thickness out of moving tablet bed Project Goal: In-line monitoring of coating process Jan Page 14 In cooperation with
15 Excerpt of Scientific Publications Adam, S., Suzzi, D., Radeke, C., Khinast, J. G., An integrated Quality by Design (QbD) approach towards design space definition of a blending unit operation by Discrete Element Method (DEM) simulation, Eur. J. Pharm. Sci. 42 (2011), 1-2, Koller D. M., Hannesschläger, G., Leitner, M., Khinast, J. G, Non-Destructive Analysis of Tablet Coatings with Optical Coherence Tomography, Eur. J. Pharm. Sci. 44 (2011), Hodzic, A., Llusa, M., Fraser, S. D., Scheibelhofer, O., Koller, D., Reiter, F., Laggner, P., D. M., Khinast, J. G., Small- and Wide-Angle X-Ray Scattering (SWAXS) for Quantification of Aspirin Content in a Binary Powder Mixture, Int. J. Pharm. 428 (2012), 1 2, Heigl, N., Hodzic, A., Llusa, M., Tritthart, W., Reiter, F., Fraser, S., Laggner, P., Khinast, J. G., Potential of Raman Spectroscopy for Evaluating Crushing Strength of Tablets, J. Pharm. Innov. 7 (2012), Hodzic, A., Llusa, M., Heigl, N., Tritthart, W., Fraser, S. D., Laggner, P., Khinast, J. G., Effect of process variables on the Small and Wide Angle X-Ray Scattering (SWAXS) patterns of powders, granules and pharmaceutical tablets, Powd. Tech. 221 (2012), Scheibelhofer, O., Hohl, R., Salar-Behzadi, S., Haack, D., Koch, K., Kerschhaggl, P., Sacher, S., Menezes, J., Khinast, J. G., Fluid bed in a Flash, AIChE Annual Meeting 2012, Pittsburgh Wahl, P., Markl, D., Treffer, D., Menezes, J., Koscher, G., Roblegg, E., Khinast, J. G., PAT for Pharmaceutical Extrusion Monitoring and Supervisory Control, AIChE Annual Meeting 2012, Pittsburgh Scheibelhofer, O., Balak, N., Wahl, P., Koller, D., Glasser, B. J., Khinast, J. G., Monitoring Blending of Pharmaceutical Powders with Multipoint NIR Spectroscopy, AAPS Pharm. Sci. Tech. (2012), in press Scheibelhofer, O., Balak, N., Koller, D., Khinast, J. G., Spatially Resolved Monitoring of Powder Mixing Processes via Multiple NIR-Probes, Powd. Tech., accepted for publication Jan Page 15
16 Concluding Remarks RCPE: the one stop point for QbD & PAT pre-industrial research projects Pharmaceutical Engineering Matching specific PAT tools with user requirements Interaction of PAT-tools, models and control software Risk Analysis with state-of-art tools Design of Experiments, Design-space development Multivariate Data Analysis QbD implementations and training Qualification of equipment and analytical methods Jan Page 16
17 Contacts Dr. Thomas K. Klein Director Business Dr. Stephan Sacher Team Leader QbD/PAT Contacts: phone: +43/316/873/30959 Prof. Dr. Johannes G. Khinast Director Science Contacts: phone: +43/316/873/7978 Contacts: phone: +43/316/873/30900 Dr. Simon Fraser, ppa. Deputy Director Contacts: phone: +43/316/873/30907 Massimo Bresciani Director Scientific Operations Contacts: phone: +43/316/873/30915 Jan Page 17
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