미생물학회지 (Korean Journal of Microbiology)

  • 제45권4호
  • /
  • Pages.346-353
  • /
  • 2009
  • /
  • 0440-2413(pISSN)
  • /
  • 2383-9902(eISSN)
한국미생물학회 (The Microbiological Society of Korea)
권호 표지

이식을 위한 사람 양막의 소독 및 멸균공정에 의한 감염성 위해인자 불활화 효과

Inactivation of Infectious Microorganisms by Disinfection and Sterilization Processes for Human Amniotic Membrane Grafts

  • 배정은 (한남대학교 생명.나노과학대학 생명과학과 & 바이오의약품안전성검증센터) ;
  • 김찬경 (한남대학교 생명.나노과학대학 생명과학과 & 바이오의약품안전성검증센터) ;
  • 김인섭 (한남대학교 생명.나노과학대학 생명과학과 & 바이오의약품안전성검증센터)
  • Bae, Jung-Eun (Department of Biological Sciences, Hannam University) ;
  • Kim, Chan-Kyung (Department of Biological Sciences, Hannam University) ;
  • Kim, In-Seop (Department of Biological Sciences, Hannam University)
  • 투고 : 2009.11.06
  • 심사 : 2009.12.07
  • 발행 : 2009.12.31
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

이식을 위해 사용하는 사람 양막은 기증자로부터 수혜자에게 바이러스, 세균, 진균과 같은 감염성 위해인자를 전파할 위험이 있다. 따라서 적절한 소독 및 멸균 공정을 통해 이식용 양막 내재 또는 혼입 가능한 감염성 위해인자를 완벽하게 불활화하여야 한다. 본 연구에서는 인체조직은행에서 사용하고 있는 소독 공정과 멸균 공정의 바이러스 및 세균, 진균 불활화 효과를 검증하기 위해 국제적 가이드에 따라 5종의 바이러스[human immunodeficiency virus type 1 (HIV-1), bovine herpes virus (BHV), bovine viral diarrhoea virus (BVDV), hepatitis A virus (HAV), porcine parvovirus (PPV)]와 2종의 세균(Escherichia coli, Bacillus subtilis), 1종의 진균(Candida albicans)을 생물학적 지표로 사용하였다. 양막에 각 생물학적 지표를 첨가한 후 70% 에탄올 소독 공정, 감마선 조사 공정, 산화에틸렌 가스 멸균 공정을 실시한 다음 각 바이러스, 세균, 진균을 회수하여 정량한 후 불활화 정도를 비교하였다. 70% 에탄올 처리 공정에서 HIV-1, BHV, BVDV 같은 외피 바이러스는 처리 시간 2.5분 안에 불활화되었지만, HAV와 PPV 같은 비-외피 바이러스는 에탄올에 매우 큰 저항성을 나타내었다. 감마선 2.5 kGy 조사에 의해 HIV-1, BHV, BVDV는 검출한계 이하로 완벽하게 불활화되었다. HAV와 PPV는 각각 5 kGy와 25 kGy 조사에 의해 검출한계 이하로 불활화되었다. 산화에틸렌 가스 처리에 의해 본 연구에 사용한 모든 바이러스가 검출한계 이하로 불활화되었다. 70% 에탄올 처리 공정에서 E. coli와 C. albicans는 모두 5분 안에 완벽하게 사멸하였다. 하지만 B. subtilis는 큰 저항성을 나타내었다. 감마선 조사 공정과 산화에틸렌 가스 멸균 공정에서 E. coli, B. subtilis, C. albicans 모두 완벽하게 불활화되었다.

Viral, bacterial, and fungal infection can be transmitted from donor to recipient via transplantation of human amniotic membrane. Therefore human amniotic membrane for transplantation should be disinfected and sterilized before use. The purpose of this study was to examine the efficacy of the disinfection process and sterilization processes used at human tissue bank in the inactivation of viruses, bacteria, and fungi. A variety of experimental model viruses, bacteria, and fungus for human pathogens, including the human immunodeficiency virus type 1 (HIV-1), bovine herpes virus (BHV), bovine viral diarrhoea virus (BVDV), hepatitis A virus (HAV), porcine parvovirus (PPV), Escherichia coli, Bacillus subtilis, and Candida albicans were all selected for this study. Enveloped viruses such as HIV-1, BHV, and BVDV were effectively inactivated to undetectable levels by 70% ethanol treatment, gamma irradiation process, and ethylene oxide (EO) gas sterilization process. Also non-enveloped viruses such as HAV and PPV were effectively inactivated to undetectable levels by gamma irradiation and EO gas treatment. However HAV and PPV showed high resistance to 70% ethanol treatment. E. coli and C. albicans were effectively inactivated to undetectable levels by 70% ethanol treatment, gamma irradiation process, and EO gas treatment. Also B. subtilis was effectively inactivated to undetectable levels by gamma irradiation process and EO gas treatment. However it showed high resistance to 70% ethanol treatment.

키워드

참고문헌

  1. 이은영. 2005. 조직은행에서 채취한 동종조직의 세균 배양평가. 대한구강악안면외과학회지 31, 31-38
  2. 이은영, 김경원, 엄인웅. 2006. 동종조직이식술시 전염성질환의 이환가능성에 대한 고찰 I: 동종골조직. 대한악안면성형재건외과학회지 28, 365-370
  3. 이은영, 김경원, 엄인웅. 2006. 동종조직이식술시 전염성질환의 이환가능성에 대한 고찰 II: 동종연조직. 대한악안면성형재건외과학회지 29, 262-267
  4. Adds, P.J., C. Hunt, and S. Hartley. 2001. Bacterial contamination of amniotic membrane. Br. J. Ophthalmol. 85, 228-230 https://doi.org/10.1136/bjo.85.2.228
  5. Beggs, W.H. 1989. Development of phenotypic resistance to direct lethal miconazole action by Candida albicans entering stationary phase. Mycopathol. 108, 201-206 https://doi.org/10.1007/BF00436226
  6. Bohatyrewicz, A., R. Bohatyrewicz, R. Klek, A. Kaminski, K. Dobiecki, P. Bialecki, M. Kedzierski, M. Zienkiewicz, and A. Dziedzic-Goclawska. 2006. Factors determining the contamination of bone tissue procured from cadaveric and multiorgan donors. Transplant. Proc. 38, 301-304 https://doi.org/10.1016/j.transproceed.2005.11.087
  7. Cebrian, G., N. Sagarzazu, R. Pagan, S. Condon, and P. Manas. 2007. Heat and pulsed electric field resistance of pigmented and non-pigmented enterotoxigenic strains of Staphylococcus aureus in exponential and stationary phase of growth. Int. J. Food Microbiol. 118, 304-311 https://doi.org/10.1016/j.ijfoodmicro.2007.07.051
  8. Choi, Y.W. and I.S. Kim. 2008. Viral clearance during the manufacture of urokinase from human urine. Biotechnol. Bioprocess Eng. 13, 25-32 https://doi.org/10.1007/s12257-007-0140-7
  9. Eastlund, T. 1995. Infectious disease transmission through cell, tissue, and organ transplantation: reducing the risk through donor selection. Cell Transplant. 4, 455-477 https://doi.org/10.1016/0963-6897(95)00035-V
  10. Gomes, J.A., A. Roman, M.S. Santos, and H.S. Dua. 2005. Amniotic membrane use in ophthalmology. Curr. Opin. Ophthalmol. 16, 233-240 https://doi.org/10.1097/01.icu.0000172827.31985.3a
  11. Goyal, R., S.M. Jones, M. Espinosa, V. Green, and K.K. Nischal. 2006. Amniotic membrane transplantation in children with symblepharon and massive pannus. Arch. Ophthalmol. 124, 1435-1440 https://doi.org/10.1001/archopht.124.10.1435
  12. Grieb, T.A., R.Y. Forng, R.E. Stafford, J. Lin, J. Almeida, S. Bogdansky, C. Ronholdt, W.N. Drohan, and W.H. Burgess. 2005. Effective use of optimized, high-dose (50 kGy) gamma irradiation for pathogen inactivation of human bone allografts. Biomaterials 26, 2033-2042 https://doi.org/10.1016/j.biomaterials.2004.06.028
  13. Hilmy, N., A. Febrida, and A. Basril. 2000. Validation of radiation sterilization dose for lyophilized amnion and bone grafts. Cell Tissue Bank 1, 143-148 https://doi.org/10.1023/A:1010129720363
  14. Hornicek, F.J., J.E. Woll, and D. Kasprisin. 2002. Standards for tissue banking, pp. 31-45. American Association of Tissue Banks, Bethesda, Maryland, USA
  15. International Organization for Standardization. 1994. Medical devices - Validation and routine control of ethylene oxide sterilization. Geneva, Switzerland
  16. International Organization for Standardization. 1998. Sterilization of medical devices-Microbiological methods. Part 2: Test of sterility performed in the validation of a sterilization process. Geneva, Switzerland
  17. International Organization for Standardization. 2002. Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches. Geneva, Switzerland
  18. Kärber, J. 1931. Beitrag zur kollectiven behandlung pharmakologische reihenversuche. Arch. Exp. Path. Pharmak. 162, 480-483 https://doi.org/10.1007/BF01863914
  19. Kim, I.S., Y.W. Choi, Y. Kang, H.M. Sung, K.W. Sohn, and Y.S. Kim. 2008. Improvement of virus safety of an antihemophilic factor IX by virus filtration process. J. Microbiol. Biotechnol. 18, 1317-1325
  20. Kim, I.S., Y.W. Choi, Y. Kang, H.M. Sung, K.W. Sohn, and J.S. Shin. 2008. Dry-heat treatment process for enhancing viral safety of an antihemophilic factor VIII concentrate prepared from human plasma. J. Microbiol. Biotechnol. 18, 997-1003
  21. Lambrecht, J.T., B. Glaser, and J. Meyer. 2006. Bacterial contamination of filtered intraoral bone chips. Int. J. Oral Maxillofac. Surg. 235, 996-1000 https://doi.org/10.1016/j.ijom.2006.06.001
  22. Lavanchy, D. 2008. Hepatitis B virus transmission in organ, tissue, and cell transplantation. Gastroenterol. 135, 1041-1043 https://doi.org/10.1053/j.gastro.2008.08.028
  23. Lee, S.H. and S.C. Tseng. 1997. Amniotic membrane transplantation for persistent epithelial defects with ulceration. Am. J. Ophthalmol. 123, 303-312 https://doi.org/10.1016/S0002-9394(14)70125-4
  24. Maillard, J.Y. and A.D. Russell. 1997. Virucidal activity and mechanism of action of biocides. Sci. Prog. 30, 287-315
  25. McDonnell, G.E. 2007. Antisepsis, disinfection, and sterilization, pp. 32-54. ASM Press, American Society for Microbiology, Washington, D.C., USA
  26. McDonnell, G.E. 2007. Antisepsis, disinfection, and sterilization, pp. 62-63. ASM Press, American Society for Microbiology, Washington, D.C., USA
  27. McDonnell, G.E. 2007. Antisepsis, disinfection, and sterilization, pp. 191-197. ASM Press, American Society for Microbiology, Washington, D.C., USA
  28. McDonnell, G. and A.D. Russell. 1999. Antiseptics and disinfectants: activity, action, and resistance. Clin. Microbiol. Rev. 12, 147-179
  29. Moore, T.M., E. Gendler, and E. Gendler. 2004. Viruses adsorbed on musculoskeletal allografts are inactivated by terminal ethylene oxide disinfection. J. Orthop. Res. 22, 1358-1361 https://doi.org/10.1016/j.orthres.2004.05.002
  30. Nakamura, T., M. Yoshitani, H. Rigby, N.J. Fullwood, W. Ito, T. Inatomi, C. Sotozono, T. Nakamura, Y. Shimizu, and S. Kinoshita. 2004. Sterilized, freeze-dried amniotic membrane: a useful substrate for ocular surface reconstruction. Invest. Ophthalmol. Vis. Sci. 45, 93-99 https://doi.org/10.1167/iovs.03-0752
  31. Nakamura, T., T. Inatomi, E. Sekiyama, L.P. Ang, N. Yokoi, and S. Kinoshita. 2006. Novel clinical application of sterilized, freezedried amniotic membrane to treat patients with pterygium. Acta Ophthalmol Scand. 84, 401-405 https://doi.org/10.1111/j.1600-0420.2006.00667.x
  32. Paridaens, D., H. Beekhuis, W. van den Bosch, L. Remeyer, and G. Melles. 2001. Amniotic membrane transplantation in the management of conjunctival malignant melanoma and primary acquired melanosis with atypia. Br. J. Ophthalmol. 85, 658-661 https://doi.org/10.1136/bjo.85.6.658
  33. Pires, R.T., S.C. Tseng, P. Prabhasawat, V. Puangsricharer, S.L. Maskin, J.C. Kim, and D.T.H. Tan. 1999. Amniotic membrane transplantation for symptomatic bullous keratopathy. Arch. Ophthalmol. 117, 1291-1297 https://doi.org/10.1001/archopht.117.10.1291
  34. Pruss, A., M. Kao, T. Garrel, L. Frommelt, L. Gurtler, F. Benedix, and G. Pauli. 2003. Virus inactivation in bone tissue transplants (femoral heads) by moist heat with the 'Marburg bone bank system'. Biologicals 31, 75-82 https://doi.org/10.1016/S1045-1056(02)00095-7
  35. Riau, A.K., R.W. Beuerman, L.S. Lim, and J.S. Mehta. 2010. Preservation, sterilization and de-epithelialization of human amniotic membrane for use in ocular surface reconstruction. Biomaterials 31, 216-225 https://doi.org/10.1016/j.biomaterials.2009.09.034
  36. Sangwan, V.S., S. Burman, S. Tejwani, S.P. Mahesh, and R. Murthy. 2007. Amniotic membrane transplantation: A review of current indications in the management of ophthalmic disorders. Curr. Ophthalmol. 55, 251-260 https://doi.org/10.4103/0301-4738.33036
  37. Singh, R., S. Purohit, M.P. Chacharkar, P.S. Bhandari, and A.S. Bath. 2007. Microbiological safety and clinical efficacy of radiation sterilized amniotic membranes for treatment of seconddegree. Burns 33, 505-510 https://doi.org/10.1016/j.burns.2006.08.004
  38. von Versen-Hoeynck, F., A.P. Steinfeld, J. Becker, M. Hermel, W. Rath, and U. Hesselbarth. 2008. Sterilization and preservation influence the biophysical properties of human amnion grafts. Biologicals 36, 248-255 https://doi.org/10.1016/j.biologicals.2008.02.001
  39. von Versen-H$\ddot{o}$ynck, F., U. Hesselbarth, and D.E. M$\ddot{o}$ller. 2004. Application of sterilised human amnion for reconstruction of the ocular surface. Cell Tissue Bank 5, 57-65 https://doi.org/10.1023/B:CATB.0000022222.41304.de
  40. Wang, S., C. Zinderman, R. Wise, and M. Braun. 2007. Infections and human tissue transplants: review of FDA MedWatch reports 2001-2004. Cell Tissue Bank 8, 211-219 https://doi.org/10.1007/s10561-007-9034-3