23 Inline and Online Process Analytical Technology with an Outlook …
589
Literature
1. R.W. Kessler, W. Kessler, Best practice and performance of hardware in Process Analytical
Technology (PAT), chapter 61.1., in Comprehensive Chemometrics 2nd edition: Chemical and
Biochemical Data Analysis (in print, Elsevier BV, 2020)
2. Industrial Internet of things (IIoT), Wikipedia: https://en.wikipedia.org/wiki/Industrial_Inte
rnet_of_Things, and references therein, Industrial Internet Consortium, in Industrial Internet
Reference Architecture Technical Report, version 1.9, (2019). https://www.iiconsortium.org/
IIRA. Accessed 01 Oct 2019
3. Industrie 4.0, https://www.plattform-i40.de/PI40/Navigation/EN/Home/home.html, online
library: https://www.plattform-i40.de/PI40/Navigation/EN/InPractice/Online-Library/onlinelibrary.html. Accessed 01 Oct 2019
4. A. Kandelbauer, M. Rahe, R.W. Kessler, Process control and quality assurance–industrial
perspectives, in Handbook of Biophotonics, Vol.3: Photonics in Pharmaceutics, Bioanalysis
and Environmental Research, 1st ed., eds. by J. Popp, V.V. Tuchin, A. Chiou, A. Heinemann
(Wiley-VCH Verlag GmbH & Co. KGaA, 2012), Chapter 1, pp. 1–69
5. European Medicines Agency, 2014: Guideline on the use of near infrared spectroscopy by the
pharmaceutical industry and the data requirements for new submissions and variations: www.
ema.europa.eu, EMEA/CHMP/CVMP/QWP/17760/2009 Rev2, Accessed 01 Oct 2019
6. K.H. Esbensen, P. Geladi, A. Larsen, The replication myth 1. NIR News 24(1), 17–20 (2013)
7. K.H. Esbensen, P. Geladi, A. Larsen, The replication myth 2: Quantifying empirical sampling
plus analysis variability. NIR News 24(3), 15–19 (2013)
8. K.H. Esbensen, P. Geladi, A. Larsen, Myth: Process near infrared calibration spectra and
reference samples can always be made to match properly. NIR News 24(4), 23–25 (2013)
9. European Pharmacopoeia Monographs, Near Infrared spectroscopy (9th edition: 9.0, 2018): Ph.
Eur. Monograph 2.2.40 Near-infrared Spectroscopy, p. 64–69, Process analytical technology
(10 th edition 10.0, effective from 1 st January 2020): Ph. Eur. Monograph 5.25 Process analytical
technology
10. The ICH International Conference on Harmonization (ICH), Quality guidelines (ICHQ): https://
www.ich.org/page/quality-guidelines, Validation of analytical procedures ICH Q2 (R1, R2),
Guideline on analytical procedure development Q14, Accessed 01 Oct 2019
11. US Food and drug administration FDA PAT guidance, PAT Guidance for industry: https://
www.fda.gov/downloads/drugs/guidances/ucm070305.pdf, Process Validation: https://www.
fda.gov/downloads/drugs/guidances/ucm070336.pdf, Accessed 01 Oct 2019
12. K.A. Bakeev (ed.), Process Analytical Technology: Spectroscopic Tools and Implementation
Strategies for the Chemical and Pharmaceutical Industries, 2nd ed., (John Wiley and Sons,
Chicester, UK, 2010)
13. R.W. Kessler (ed.), Prozessanalytik- Strategien und Fallbeispiele aus der industriellen Praxis
(Wiley – VCH, Weinheim, 2006)
14. H. Kagermann, R. Anderl, J. Gausemeier, G. Schuh, W. Wahlster (eds.), Industrie 4.0 in
a Global Context: Strategies for Cooperating with International Partners (acatech study),
Munich (Herbert Utz Verlag, 2016). The original version of this publication is available at
www.utzverlag.de or www.acatech.de
15. Kessler R. W., Perspectives in Process Analysis, J. Chemometrics 2013, 27, 369–378
16. T. Bieringer, S. Buchholz, N. Kockmann, Future production concepts in the chemical industry:
Modular—Small-Scale—Continuous. Chem. Eng. Technol. 36, 900–910 (2013)
17. T. Seifert, S. Sievers, C. Bramsiepe, G. Schenbecker, Small scale, modular and continuous: a
new approach in plant design. Chem. Eng. Process. 52, 140–150 (2012)
18. S. Kern, L. Wander, K. Meyer, S. Guhl, A.R.G. Mukkula, M. Holtkamp, M. Salge, C. Fleischer,
N. Weber, R. King, S. Engell, A. Paul, M.P. Remelhe, M. Maiwald, Flexible automation with
compact NMR spectroscopy for continuous production of pharmaceuticals. Anal. Bioanal.
Chem. 411, 3037–3046 (2019)
19. The Industrial Internet of Things Volume G1, Reference Architecture, Version 1.9, June 19,
2019, https://www.iiconsortium.org/pdf/IIRA-v1.9.pdf. Accessed 01 Oct 2019
589
Literature
1. R.W. Kessler, W. Kessler, Best practice and performance of hardware in Process Analytical
Technology (PAT), chapter 61.1., in Comprehensive Chemometrics 2nd edition: Chemical and
Biochemical Data Analysis (in print, Elsevier BV, 2020)
2. Industrial Internet of things (IIoT), Wikipedia: https://en.wikipedia.org/wiki/Industrial_Inte
rnet_of_Things, and references therein, Industrial Internet Consortium, in Industrial Internet
Reference Architecture Technical Report, version 1.9, (2019). https://www.iiconsortium.org/
IIRA. Accessed 01 Oct 2019
3. Industrie 4.0, https://www.plattform-i40.de/PI40/Navigation/EN/Home/home.html, online
library: https://www.plattform-i40.de/PI40/Navigation/EN/InPractice/Online-Library/onlinelibrary.html. Accessed 01 Oct 2019
4. A. Kandelbauer, M. Rahe, R.W. Kessler, Process control and quality assurance–industrial
perspectives, in Handbook of Biophotonics, Vol.3: Photonics in Pharmaceutics, Bioanalysis
and Environmental Research, 1st ed., eds. by J. Popp, V.V. Tuchin, A. Chiou, A. Heinemann
(Wiley-VCH Verlag GmbH & Co. KGaA, 2012), Chapter 1, pp. 1–69
5. European Medicines Agency, 2014: Guideline on the use of near infrared spectroscopy by the
pharmaceutical industry and the data requirements for new submissions and variations: www.
ema.europa.eu, EMEA/CHMP/CVMP/QWP/17760/2009 Rev2, Accessed 01 Oct 2019
6. K.H. Esbensen, P. Geladi, A. Larsen, The replication myth 1. NIR News 24(1), 17–20 (2013)
7. K.H. Esbensen, P. Geladi, A. Larsen, The replication myth 2: Quantifying empirical sampling
plus analysis variability. NIR News 24(3), 15–19 (2013)
8. K.H. Esbensen, P. Geladi, A. Larsen, Myth: Process near infrared calibration spectra and
reference samples can always be made to match properly. NIR News 24(4), 23–25 (2013)
9. European Pharmacopoeia Monographs, Near Infrared spectroscopy (9th edition: 9.0, 2018): Ph.
Eur. Monograph 2.2.40 Near-infrared Spectroscopy, p. 64–69, Process analytical technology
(10 th edition 10.0, effective from 1 st January 2020): Ph. Eur. Monograph 5.25 Process analytical
technology
10. The ICH International Conference on Harmonization (ICH), Quality guidelines (ICHQ): https://
www.ich.org/page/quality-guidelines, Validation of analytical procedures ICH Q2 (R1, R2),
Guideline on analytical procedure development Q14, Accessed 01 Oct 2019
11. US Food and drug administration FDA PAT guidance, PAT Guidance for industry: https://
www.fda.gov/downloads/drugs/guidances/ucm070305.pdf, Process Validation: https://www.
fda.gov/downloads/drugs/guidances/ucm070336.pdf, Accessed 01 Oct 2019
12. K.A. Bakeev (ed.), Process Analytical Technology: Spectroscopic Tools and Implementation
Strategies for the Chemical and Pharmaceutical Industries, 2nd ed., (John Wiley and Sons,
Chicester, UK, 2010)
13. R.W. Kessler (ed.), Prozessanalytik- Strategien und Fallbeispiele aus der industriellen Praxis
(Wiley – VCH, Weinheim, 2006)
14. H. Kagermann, R. Anderl, J. Gausemeier, G. Schuh, W. Wahlster (eds.), Industrie 4.0 in
a Global Context: Strategies for Cooperating with International Partners (acatech study),
Munich (Herbert Utz Verlag, 2016). The original version of this publication is available at
www.utzverlag.de or www.acatech.de
15. Kessler R. W., Perspectives in Process Analysis, J. Chemometrics 2013, 27, 369–378
16. T. Bieringer, S. Buchholz, N. Kockmann, Future production concepts in the chemical industry:
Modular—Small-Scale—Continuous. Chem. Eng. Technol. 36, 900–910 (2013)
17. T. Seifert, S. Sievers, C. Bramsiepe, G. Schenbecker, Small scale, modular and continuous: a
new approach in plant design. Chem. Eng. Process. 52, 140–150 (2012)
18. S. Kern, L. Wander, K. Meyer, S. Guhl, A.R.G. Mukkula, M. Holtkamp, M. Salge, C. Fleischer,
N. Weber, R. King, S. Engell, A. Paul, M.P. Remelhe, M. Maiwald, Flexible automation with
compact NMR spectroscopy for continuous production of pharmaceuticals. Anal. Bioanal.
Chem. 411, 3037–3046 (2019)
19. The Industrial Internet of Things Volume G1, Reference Architecture, Version 1.9, June 19,
2019, https://www.iiconsortium.org/pdf/IIRA-v1.9.pdf. Accessed 01 Oct 2019