Process Analytical Technology
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The document discusses Process Analytical Technology (PAT), which uses modern monitoring and process control tools to understand and control manufacturing processes. PAT aims to understand all sources of variability and ensure quality. Its framework involves process understanding through identifying variability sources and using tools like multivariate data analysis, modern process analyzers like UV/Vis probes, and continuous improvement software. The document outlines how PAT can be applied in mixing processes using probes to monitor solid particle size and liquid properties like turbidity and color. PAT allows for real-time monitoring to decrease production time and assure quality.
![References
CIURCZAK, EW. 2008. A spectroscopy guide to PAT. [online]. [Accessed 29 August 2012]. Available from World Wide
Web: <http://www.pharmamanufacturing.com/articles/2008/103.html?page=full>
EL-HAGRASY AS, Drennen JK. 2006. A Process Analytical Technology approach to near-infrared process control of
pharmaceutical powder blending. Part III: Quantitative near-infrared calibration for prediction of blend homogeneity
and characterization of powder mixing kinetics. Journal of pharmaceutical sciences., pp.422-434.
FOOD AND DRUG ADMINISTRATION. 2004. Guidance for industry PAT - a framework for innovative pharmacetical
development, manufacturing and quality assurance. USA: FDA.
HUSSAIN, AS. 2005. The Desired State: PAT and the Road to Enlightenment. [online]. [Accessed 29 August 2012].
Available from World Wide Web: <http://www.pharmamanufacturing.com/articles/2005/278.html?page=full>
NAICKER, KKilian, G, Mandela, N and Olivier, J. 2007. Introducing PAT, Using NIR Analysis, to a Pharmaceutical Blending
Process. [online]. [Accessed 29 August 2012]. Available from World Wide Web:
<http://www.pharmamanufacturing.com/articles/2007/081.html?page=full>
SHI Z, Cogdill RP, Short SM, Anderson CA. 2008. Process characterization of powder blending by near-infrared
spectroscopy: blend end-points and beyond. Journal of pharmaceutical and biomedical analysis., pp.738-745.](https://image.slidesharecdn.com/pat-mixing-120926103248-phpapp02/85/Process-Analytical-Technology-25-320.jpg)
Process Analytical Technology
- 2. Outline I. Process Analytical Technology A.Definition and Goals B. Framework 1. Process Understanding 2. Tools II. Traditional Methods VS PAT III. Application of PAT in Mixing
- 3. PAT: Definition a system for designing, analyzing, and controlling manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes (US Food and Drug Administration, 2009)
- 4. PAT: Goals • understand and control the manufacturing process • design and develop processes that can consistently ensure a predefined quality at the end of the manufacturing process (US Food and Drug Administration, 2009)
- 5. PAT: Framework • Process Understanding – all critical sources of variability are identified and explained – variability is managed by the process – product quality attributes can be accurately and reliably predicted over the design space established for materials used, process parameters, manufacturing, environmental, and other conditions. (US Food and Drug Administration, 2009)
- 6. PAT: Framework • PAT Tools – Multivariate data acquisition and analysis tools – Modern process analyzers – Process and endpoint monitoring and control tools – Continuous improvement and knowledge management tools (US Food and Drug Administration, 2009)
- 7. PAT: Framework • PAT Tools – Modern process analyzers • At-line (US Food and Drug Administration, 2009)
- 8. PAT: Framework • PAT Tools – Modern process analyzers • At-line • On-line (US Food and Drug Administration, 2009)
- 9. PAT: Framework • PAT Tools – Modern process analyzers • At-line • On-line • In-line (US Food and Drug Administration, 2009)
- 11. Traditional
- 12. PAT
- 13. PAT IN MIXING
- 14. Process Analyzers • Probes in manufacturing equipment – UV/Vis • Monitors reactions • Monitors the concentration of one or more components in a liquid mix • Monitors pH changes (Ciurczak, 2004)
- 15. Process Analyzers • Probes in manufacturing equipment – Infrared (Naicker and Kilian, 2006)
- 16. Process Analyzers • Probes in manufacturing equipment – Light-Induced fluorescence • Originally used laser instead of light • High light flux induce fluorescence in materials not normally considered in fluorescence analysis • Applicable in determination of blend uniformity (Ciurczak, 2004)
- 17. Process Analyzers • Probes in manufacturing equipment – Other probes used • HPLC • Chemical Imaging • Raman Spectroscopy (Ciurczak, 2004)
- 18. PAT: Mixing • Applications – Mixing of Solids • Determination of particle size and shape • Determination of endpoint of mixing – Mixing in Liquids • Turbidity Sensor • Color Sensor
- 19. PAT: Mixing • Determination of particle size Particle Shape and Particle Size Analyzer WS Tyler
- 20. PAT: Mixing • Determination of particle size Particle Shape and Particle Size Analyzer WS Tyler
- 21. PAT: Mixing • Determination of endpoint of mixing
- 22. PAT: Liquids • Turbidity Sensor – Turbidimetry (Endress+Hauser, Inc., 2007)
- 23. PAT: Liquids • Color Sensor – Reads the wavelength – Avoids batch differences (Endress+Hauser, Inc., 2007)
- 24. Conclusion • PAT – decreases production time – assures product quality during the process – promotes automation thereby reduces risks for errors – provides real time continuous process monitoring
- 25. References CIURCZAK, EW. 2008. A spectroscopy guide to PAT. [online]. [Accessed 29 August 2012]. Available from World Wide Web: <http://www.pharmamanufacturing.com/articles/2008/103.html?page=full> EL-HAGRASY AS, Drennen JK. 2006. A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending. Part III: Quantitative near-infrared calibration for prediction of blend homogeneity and characterization of powder mixing kinetics. Journal of pharmaceutical sciences., pp.422-434. FOOD AND DRUG ADMINISTRATION. 2004. Guidance for industry PAT - a framework for innovative pharmacetical development, manufacturing and quality assurance. USA: FDA. HUSSAIN, AS. 2005. The Desired State: PAT and the Road to Enlightenment. [online]. [Accessed 29 August 2012]. Available from World Wide Web: <http://www.pharmamanufacturing.com/articles/2005/278.html?page=full> NAICKER, KKilian, G, Mandela, N and Olivier, J. 2007. Introducing PAT, Using NIR Analysis, to a Pharmaceutical Blending Process. [online]. [Accessed 29 August 2012]. Available from World Wide Web: <http://www.pharmamanufacturing.com/articles/2007/081.html?page=full> SHI Z, Cogdill RP, Short SM, Anderson CA. 2008. Process characterization of powder blending by near-infrared spectroscopy: blend end-points and beyond. Journal of pharmaceutical and biomedical analysis., pp.738-745.
Editor's Notes
- #5: quality cannot be tested into products; it should be built-in or should be by design.
- #7: Multivariate Data Acquisitionunderstanding of the relevant multi-factorial relationships (e.g., between formulation, process, and quality attributes)means to evaluate the applicability of this knowledge in different scenarios (i.e., generalization)experiments conducted during product and process development can serve as building blocks of knowledge that grow to accommodate a higher degree of complexity throughout the life of a productModern Process Analyzersat-line: Measurement where the sample is removed, isolated from, and analyzed in close proximity to the process stream. on-line: Measurement where the sample is diverted from the manufacturing process, and may be returned to the process stream. in-line: Measurement where the sample is not removed from the process stream and can be invasive or noninvasive Process and endpoint monitoring and control toolsContinuous improvement and knowledge management toolsthrough data collection and analysis over the life cycle of a productthese data can contribute tojustifying proposals for postapproval changes
- #8: Modern Process Analyzersat-line: Measurement where the sample is removed, isolated from, and analyzed in close proximity to the process stream. on-line: Measurement where the sample is diverted from the manufacturing process, and may be returned to the process stream. in-line: Measurement where the sample is not removed from the process stream and can be invasive or noninvasive
- #9: Modern Process Analyzersat-line: Measurement where the sample is removed, isolated from, and analyzed in close proximity to the process stream. on-line: Measurement where the sample is diverted from the manufacturing process, and may be returned to the process stream. in-line: Measurement where the sample is not removed from the process stream and can be invasive or noninvasive
- #10: Modern Process Analyzersat-line: Measurement where the sample is removed, isolated from, and analyzed in close proximity to the process stream. on-line: Measurement where the sample is diverted from the manufacturing process, and may be returned to the process stream. in-line: Measurement where the sample is not removed from the process stream and can be invasive or noninvasive
- #20: Determination of particle shape and sizeAnalyzes 10 000 particles per secondAtline type analyzer
- #21: Determination of particle shape and sizeAnalyzes 10 000 particles per secondAtline type analyzer