Process analytical technology (PAT): new paradigm for the state-of-the-art analytical technology

공정분석기술: 첨단 분석기술의 새로운 패러다임

  • Kim, Jong-Yun (Korea Atomic Energy Research Intitute) ;
  • Park, Yong Joon (Korea Atomic Energy Research Intitute) ;
  • Yeon, Jei-Won (Korea Atomic Energy Research Intitute) ;
  • Woo, Young-Ah (Korea United Pharm. Inc.) ;
  • Kim, Hyo-Jin (Department of Pharmacy, Dongduk Women's) ;
  • Song, Kyuseok (Korea Atomic Energy Research Intitute)
  • 김종윤 (한국원자력연구원 원자력화학연구부) ;
  • 박용준 (한국원자력연구원 원자력화학연구부) ;
  • 연제원 (한국원자력연구원 원자력화학연구부) ;
  • 우영아 ((주) 한국유나이티드제약 제제연구소) ;
  • 김효진 (동덕여자대학교 약학과) ;
  • 송규석 (한국원자력연구원 원자력화학연구부)
  • Received : 2008.08.19
  • Accepted : 2008.10.06
  • Published : 2008.10.25

Abstract

Process analytics has been already widely utilized in a large-scale continuous production line such as petroleum industries for several decades. Although the process analytics has a long history, a concept of "Process Analytical Technology (PAT)" has been rapidly adopted as a new paradigm for the process monitoring in the production process of various industries. In this review, current status and recent developments of PAT in various research bodies have been introduced, including the introduction of various types of analytical instruments, chemometrics tools, and perspectives and future applications of PAT as well as the fundamentals on PAT such as terminology and its historical background.

Keywords

Process analytical technology;process analytical chemistry;chemometrics;design of experiment;process monitoring;process analytics

Acknowledgement

Supported by : 과학기술부

References

  1. Y. Arikawa, Analytical Sciences, 17, i571-i573(2001) https://doi.org/10.2116/analsci.17.571
  2. J. Workman, M. Koch and D. Veltkamp, Anal. Chem., 77, 3789-3806(2005) https://doi.org/10.1021/ac050620o
  3. J. Workman, M. Koch and D. Veltkamp, Anal. Chem., 75, 2589-2876(2003)
  4. M. Birch, S. J. Fussell, P. D. Higginson, N. McDowall and I. Marziano, Org. Process Res. Dev., 9(3), 360-364(2005) https://doi.org/10.1021/op0500077
  5. M. J. Kim, H. Chung, Y. Woo and M. S. Kemper, Anal. Chim. Acta., 587, 190-197(2007)
  6. R. D. McDowall, Analyt. Chim. Acta., 391, 149-158(1999) https://doi.org/10.1016/S0003-2670(99)00107-5
  7. K. H. Norris and J. R. Hart, Proc. 1963 Intern. Symp. on Humidity and Moisture in Liquids and Solids, Direct Spectrophotometric Determination of Moisture Content of Grains and Seeds, A. Wexler(Ed.), Reinhold, New York, 19(1965)
  8. Y.-A. Woo and H.-J. Kim, Microchem. J., 78, 167-173(2004) https://doi.org/10.1016/j.microc.2004.04.004
  9. J. Kim, J. Noh, H. Chung, Y.-A. Woo, M. S. Kemper and Y. Lee, Anal. Chim. Acta., 598, 280-285(2007) https://doi.org/10.1016/j.aca.2007.07.049
  10. IAEA-TECDOC-1459, Technical data on nucleonic gauges, IAEA, Vienna, Austria (2005)
  11. T.-J. Kim, Y.-H. Cho, I.-K. Choi, J.-G. Kang, K. Song and K.-Y. Jee, J. Nucl. Mater., 375(2), 275-279(2008) https://doi.org/10.1016/j.jnucmat.2007.12.002
  12. '원자력산업 적용 첨단 방사화학 기술' 워크샵, 춘계한국원자력학회, 2008
  13. J. R. McConell, K. P. Barton, M. A. LaPack and M. A. DesJardin, Org. Process Res. Dev., 6, 700-705(2004) https://doi.org/10.1021/op0255332
  14. K. L. Vora, G. Buckton and D. Clapham, Eur. J. Pharm. Sci., 22, 97-105(2004) https://doi.org/10.1016/j.ejps.2004.01.009
  15. C.-K. Lai and C. C. Cooney, J. Pharm. Sci., 93(1), 60-70(2004) https://doi.org/10.1002/jps.10478
  16. N. Wang, N. Zhang and M. Wang, Computers and Electronics in Agriculture, 50, 1-14(2006) https://doi.org/10.1016/j.compag.2005.09.003
  17. P. Barrett, B. Smith, J. Worlitschek, V. Bracken, B. O'Sullivan and D. O'Grady, Org. Process Res. Dev., 9, 348-355(2005) https://doi.org/10.1021/op049783p
  18. G. Fevotte, J. Calas, F. Puel and C. Hoff, Int. J. Pharm., 273, 159-169(2004) https://doi.org/10.1016/j.ijpharm.2004.01.003
  19. E. Verpoorte, Electrophoresis, 23, 677-712(2002) https://doi.org/10.1002/1522-2683(200203)23:5<677::AID-ELPS677>3.0.CO;2-8
  20. P. D. Coates, S. E. Barnes, M. G. Sibley, E. C. Brown, H. G. M. Edward and I. J. Scowen, Polymer, 44, 5937- 5949(2003) https://doi.org/10.1016/S0032-3861(03)00544-5
  21. D. R. Unger and F. J. Muzzio, J. AIChE., 45(12), 2477-2486(1999) https://doi.org/10.1002/aic.690451203
  22. K. Lundstedt-Enkel, J. Gabrielsson, H. Olsman, E. Seifert, J. Pettersen, P. M. Lek, A. Boman and T. Lundstedt, Chemometrics and Intelligent Laboratory Systems, 84, 201-207(2006) https://doi.org/10.1016/j.chemolab.2006.05.013
  23. N. E. Mathis, Measurement of Thermal Conductivity Anisotropy in Polymer Materials, Chemical Engineering Department, Fredericton, N. B, Canada, 1996
  24. R. B. Shah, M. A. Tawakkul and M. A. Khan, J. Pharm. Sci., 96, 1356-1365(2007) https://doi.org/10.1002/jps.20931
  25. K. Thurow, B. Gode, U. Dingerdissen and N. Stoll, Org. Process Res. Dev., 8, 970-982(2004) https://doi.org/10.1021/op040017s
  26. C. Cimander and C.-F. Mandenius, J. Chem. Technol. Biotechnol., 77, 1157-1168(2002) https://doi.org/10.1002/jctb.691
  27. M. Halstensen, P. de Bakker and K. H. Esbensen, Chemometrics and Intelligent Laboratory Systems, 84, 88-97(2006) https://doi.org/10.1016/j.chemolab.2006.05.012
  28. K. J. Clevett, 'Process Analyzer Technology', John Wiley & Sons, New York, 1986
  29. J. P. Chauvel, W. W. Henslee and L. A. Melton, Anal. Chem., 74, 381A-384A(2002)
  30. Y.-A. Woo, J.-W. Ahn, I.-K. Chun and H.-J. Kim, Anal. Chem., 73, 4964-4971(2001) https://doi.org/10.1021/ac0102563
  31. K. Huikko, R. Kostiainen and T. Kotiaho, Eur. J. Pharm. Sci., 20, 149-171(2003) https://doi.org/10.1016/S0928-0987(03)00147-7
  32. K. A. Bakeev (Ed.), 'Process Analytical Technology: Spectroscopic Tools and Implementation Strategies for the Chemical and Pharmaceutical Industries Blackwell Publishing Professional', Wiley Blackwell, Ames, IA, 2005
  33. P.-A. Auroux, D. Iossifidis, D. R. Reyes and A. Manz, Anal. Chem., 74, 2637-2652(2002) https://doi.org/10.1021/ac020239t
  34. S. Martini, C. Bertoli, M. L. Herrera, I. Neeson and A. Marangoni, JAOCS, 82(5), 305-312(2005) https://doi.org/10.1007/s11746-005-1071-8
  35. Y.-A. Woo, H.-R. Lim, H.-J. Kim and H. Chung, J. Pharm. Biomed. Anal., 33, 1049-1057(2003) https://doi.org/10.1016/S0731-7085(03)00420-5
  36. R. A. Crocombe, spectrosc. eur., 16(3), 16-19(2004)
  37. M. Daszykowski and B. Walczak, Trends in Analytical Chemistry., 25(11), (2006)
  38. P. Gemperline, G. Puxty, M. Maeder, D. Walker, F. Tarczynski and M. Bosserman, Anal. Chem., 76, 2575-2582(2004) https://doi.org/10.1021/ac035356i
  39. B. Lavine and J. Workman, Anal. Chem., 80, 4519-531(2008) https://doi.org/10.1021/ac800728t
  40. M. J. Kim, H. Chung, Y. Woo and M. S. Kemper, Anal. Chim. Acta., 579, 209-216(2006) https://doi.org/10.1016/j.aca.2006.07.036
  41. C. -K. Lai, D. Holt, J. C. Leung, C. L. Cooney, G. K. Raju and P. Hansen, J. AIChE., 47(11), 2618-2622(2001) https://doi.org/10.1002/aic.690471124
  42. T. Pan and E. M. Sevick-Muraca, Anal. Chem., 74, 4228-4234(2002) https://doi.org/10.1021/ac011267z
  43. Z. Shi, R. P. Cogdill, S. M. Short and C. A. Anderson, J. Pharm. Biomed. Anal., 47, 738-745(2008) https://doi.org/10.1016/j.jpba.2008.03.013
  44. P. Mougin, A. Thomas, D. Wilkinson, G. White, K. J. Roberts, N. Herrmann, R. Jack and R. Tweedie, J. AIChE., 49(2), 373-378(2003) https://doi.org/10.1002/aic.690490209
  45. J. Bo Holm-Nielsen, C. K. Dahl and K. H. Esbensen, Chemometrics and Intelligent Laboratory Systems, 83, 114-126(2006) https://doi.org/10.1016/j.chemolab.2006.02.002
  46. 대한화학회, 화학용어술어집 개정 5판, 2007
  47. G. S. Constable, A. J. Lesser and E. B. Coughlin, J. Polym. Sci. Part B: Polym. Phys. 41, 1323-1333(2003) https://doi.org/10.1002/polb.10448
  48. T. Davies, P. Lampen, M. Fiege, T. Richter and T. Frohlich, Spectrosc. Eur., 15(5), 25-28(2003)
  49. J. Workman, M. Koch and D. Veltkamp, Anal. Chem., 79, 4345-4364(2007) https://doi.org/10.1021/ac070765q
  50. F. McLennan and B. R. Kowalski (Eds.), 'Process Analytical Chemistry', Chapman & Hall, London, 1995
  51. C. H. Legge, J. Chem. Educ., 79(2), 173-178(2002) https://doi.org/10.1021/ed079p173
  52. Z. Sun, Y. Huang and E. M. Sevick-Muraca, Rev. Sci. Instrum., 73, 383-393(2002) https://doi.org/10.1063/1.1427303
  53. T. Chapman, Nature, 421, 661-666(2003)
  54. 정용주, 연제원, 김원호, 한국특허등록 0629609(2006)
  55. F. Alba, G. M. Crawley, J. Fatkin, D. M. J. Higgs and P. G. Kippax, Phsiochem. Eng. Asp., 15, 495-502(1999)
  56. S. Barthe and R. W. Rousseau, Chem. Eng. Tech., 29, 206-211(2006) https://doi.org/10.1002/ceat.200500364
  57. M.-S. Hwang, S.-H. Cho, H. Chung and Y.-A. Woo, J. Pharm. Biomed. Anal., 38, 210-215(2005) https://doi.org/10.1016/j.jpba.2004.12.031
  58. D. Brennan, J. Alderman and L. Sattler, B. O'Connor, Measurement, 33, 67-4(2003) https://doi.org/10.1016/S0263-2241(02)00019-2
  59. S. J. Lee and S. Y. Lee, Appl. Microbiol. Biotechnol., 64, 289-299(2004) https://doi.org/10.1007/s00253-003-1515-0
  60. R. Belchamber, Spectrosc. Eur., 15(6), 26-27(2003)
  61. J. L. Lippert and S. C. Switalski, Uncalibrated in-line Raman data as a lower cost process consistency tool for a multi-product process control, IFPAC, Arlington, VA (2004)
  62. J. B. Callis, D. L. Illman and B. R. Kowalski, Anal. Chem., 59, 624A(1987) https://doi.org/10.1021/ac00136a001
  63. M. T. Rube and D. J. Eustace, Anal. Chem., 62, 65A(1990) https://doi.org/10.1021/ac00201a001
  64. Z. Sun, S. Torrance, F. K. Mcneil-Watson and E. M. Sevick-Muraca, Anal. Chem., 75, 1720-1725(2003) https://doi.org/10.1021/ac0261597
  65. S. D. Brown, Appl. Spectrosc., 49, 14A-31A(1995)
  66. J. Workman, K. E. Creasy, S. Doherty, L. Bond, M. Koch, A. Ullman and D. Veltkamp, Anal. Chem., 73, 2705-2718(2001) https://doi.org/10.1021/ac010364p
  67. T. Pan, D. Barber, D. Coffin-Beach, Z. Sun and E. M. Sevick-Muraca, J. Pharm. Sci., 93, 635-645(2004) https://doi.org/10.1002/jps.10576
  68. F. Sistare, L. St. Pierre Berry and C. A. Mojica, Org. Process Res. Dev., 9, 332-336(2005) https://doi.org/10.1021/op0402127
  69. G. Macaloney, J. W. Hall, M. J. Rollins, I. Draper, K. B. Anderson, J. Preston, B. G. Thomson and B. McNeil, Bioprocess Eng., 17, 157-167(1997)
  70. S. J. Doherty and A. J. Lange, Trends in Analytical Chemistry, 25(11), (2006)
  71. E. Martinelli, C. Falconi, A. D'Amico and C. Di Natale, Sens. Actuators B, 95, 132-139(2003) https://doi.org/10.1016/S0925-4005(03)00422-2
  72. S. S. Sekulic, H. W. Ward III, D. R. Brannegan, E. D. Stanley, C. L. Evans, S. T. Sciavolino, P. A. Hailey and P. K. Aldridge, Anal. Chem., 68, 509-513(1996) https://doi.org/10.1021/ac950964m
  73. H. Hotelling, J. Educ. Psychol., 24, 417-441(1933) https://doi.org/10.1037/h0071325
  74. R. G. Brereton, 'Chemometrics: Data Analysis for the Laboratory and Chemical Plant', Wiley, Chichester, UK, 2003
  75. Guidance for Industry, PAT: A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary, Medicine (CVM), Office of Regulatory Affairs (ORA), Pharmaceutical CGMPs, September 2004. URL: http://www.fda.gov/cder/guidance/6419fnl.htm