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

공정분석기술: 첨단 분석기술의 새로운 패러다임

  • 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.

이미 석유화학산업 등 대규모 산업공정에서 널리 활용되고 있는 공정분석화학 및 공정분석기술의 역사는 오래되었지만, 최근 "공정분석기술(Process Analytical Technology: PAT)"의 새로운 개념이 매우 빠르게 일부 산업분야의 생산공정에 보급되고 있다. 본 총설에서는 이미 오래 전부터 대규모 연속식 생산라인에서 널리 활용되어 왔던 공정분석화학 및 공정분석기술의 신개념 첨단 분석기술로서의 태동 배경과 용어 정의 등을 명확히 하였다. 또한, 공정최적화를 위한 공정분석화학 혹은 공정분석기술의 기본개념, 계량화학 등의 공정분석화학 핵심요소, 국내외 산/학/연의 기술 및 활동 현황 등에 관하여 다루었고, PAT에서 주로 활용되고 있는 공정분석기기의 종류와 현황, 그리고 미래 유망기술 및 활용분야에 대해서도 소개하였다.

Keywords

Acknowledgement

Supported by : 과학기술부

References

  1. Y. Arikawa, Analytical Sciences, 17, i571-i573(2001) https://doi.org/10.2116/analsci.17.571
  2. 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
  3. J. B. Callis, D. L. Illman and B. R. Kowalski, Anal. Chem., 59, 624A(1987) https://doi.org/10.1021/ac00136a001
  4. M. T. Rube and D. J. Eustace, Anal. Chem., 62, 65A(1990) https://doi.org/10.1021/ac00201a001
  5. J. Workman, M. Koch and D. Veltkamp, Anal. Chem., 79, 4345-4364(2007) https://doi.org/10.1021/ac070765q
  6. J. Workman, M. Koch and D. Veltkamp, Anal. Chem., 77, 3789-3806(2005) https://doi.org/10.1021/ac050620o
  7. J. Workman, M. Koch and D. Veltkamp, Anal. Chem., 75, 2589-2876(2003)
  8. 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
  9. 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
  10. 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
  11. 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
  12. S. J. Doherty and A. J. Lange, Trends in Analytical Chemistry, 25(11), (2006)
  13. 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
  14. F. McLennan and B. R. Kowalski (Eds.), 'Process Analytical Chemistry', Chapman & Hall, London, 1995
  15. K. J. Clevett, 'Process Analyzer Technology', John Wiley & Sons, New York, 1986
  16. M. J. Kim, H. Chung, Y. Woo and M. S. Kemper, Anal. Chim. Acta., 587, 190-197(2007)
  17. R. B. Shah, M. A. Tawakkul and M. A. Khan, J. Pharm. Sci., 96, 1356-1365(2007) https://doi.org/10.1002/jps.20931
  18. K. Thurow, B. Gode, U. Dingerdissen and N. Stoll, Org. Process Res. Dev., 8, 970-982(2004) https://doi.org/10.1021/op040017s
  19. T. Chapman, Nature, 421, 661-666(2003)
  20. R. D. McDowall, Analyt. Chim. Acta., 391, 149-158(1999) https://doi.org/10.1016/S0003-2670(99)00107-5
  21. H. Hotelling, J. Educ. Psychol., 24, 417-441(1933) https://doi.org/10.1037/h0071325
  22. 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)
  23. B. Lavine and J. Workman, Anal. Chem., 80, 4519-531(2008) https://doi.org/10.1021/ac800728t
  24. 대한화학회, 화학용어술어집 개정 5판, 2007
  25. M. Daszykowski and B. Walczak, Trends in Analytical Chemistry., 25(11), (2006)
  26. R. G. Brereton, 'Chemometrics: Data Analysis for the Laboratory and Chemical Plant', Wiley, Chichester, UK, 2003
  27. 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
  28. J. P. Chauvel, W. W. Henslee and L. A. Melton, Anal. Chem., 74, 381A-384A(2002)
  29. Y.-A. Woo and H.-J. Kim, Microchem. J., 78, 167-173(2004) https://doi.org/10.1016/j.microc.2004.04.004
  30. 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
  31. 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
  32. 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
  33. 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
  34. 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
  35. IAEA-TECDOC-1459, Technical data on nucleonic gauges, IAEA, Vienna, Austria (2005)
  36. 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
  37. 정용주, 연제원, 김원호, 한국특허등록 0629609(2006)
  38. '원자력산업 적용 첨단 방사화학 기술' 워크샵, 춘계한국원자력학회, 2008
  39. 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
  40. R. A. Crocombe, spectrosc. eur., 16(3), 16-19(2004)
  41. S. J. Lee and S. Y. Lee, Appl. Microbiol. Biotechnol., 64, 289-299(2004) https://doi.org/10.1007/s00253-003-1515-0
  42. C. H. Legge, J. Chem. Educ., 79(2), 173-178(2002) https://doi.org/10.1021/ed079p173
  43. 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
  44. P.-A. Auroux, D. Iossifidis, D. R. Reyes and A. Manz, Anal. Chem., 74, 2637-2652(2002) https://doi.org/10.1021/ac020239t
  45. 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
  46. N. E. Mathis, Measurement of Thermal Conductivity Anisotropy in Polymer Materials, Chemical Engineering Department, Fredericton, N. B, Canada, 1996
  47. R. Belchamber, Spectrosc. Eur., 15(6), 26-27(2003)
  48. F. Alba, G. M. Crawley, J. Fatkin, D. M. J. Higgs and P. G. Kippax, Phsiochem. Eng. Asp., 15, 495-502(1999)
  49. 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
  50. 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
  51. 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
  52. 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
  53. D. R. Unger and F. J. Muzzio, J. AIChE., 45(12), 2477-2486(1999) https://doi.org/10.1002/aic.690451203
  54. T. Pan and E. M. Sevick-Muraca, Anal. Chem., 74, 4228-4234(2002) https://doi.org/10.1021/ac011267z
  55. 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
  56. Z. Sun, Y. Huang and E. M. Sevick-Muraca, Rev. Sci. Instrum., 73, 383-393(2002) https://doi.org/10.1063/1.1427303
  57. 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
  58. F. Sistare, L. St. Pierre Berry and C. A. Mojica, Org. Process Res. Dev., 9, 332-336(2005) https://doi.org/10.1021/op0402127
  59. S. Barthe and R. W. Rousseau, Chem. Eng. Tech., 29, 206-211(2006) https://doi.org/10.1002/ceat.200500364
  60. 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
  61. 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
  62. C. Cimander and C.-F. Mandenius, J. Chem. Technol. Biotechnol., 77, 1157-1168(2002) https://doi.org/10.1002/jctb.691
  63. T. Davies, P. Lampen, M. Fiege, T. Richter and T. Frohlich, Spectrosc. Eur., 15(5), 25-28(2003)
  64. C.-K. Lai and C. C. Cooney, J. Pharm. Sci., 93(1), 60-70(2004) https://doi.org/10.1002/jps.10478
  65. 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
  66. 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
  67. S. D. Brown, Appl. Spectrosc., 49, 14A-31A(1995)
  68. 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
  69. 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
  70. 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)
  71. 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
  72. 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)
  73. 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
  74. 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
  75. 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