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Is Gamma Irradiation as a Secondary Sterilization Procedure Required for Decellularized Xenogenic Tissue Material?


Affiliations
1 Rehabilitation Bioengineering Group, Department of Engineering Design, Indian Institute of Technology Madras, Chennai 600 036, India
2 Indira Gandhi Centre for Atomic Research, Kalpakkam 603 102, India
 

Biological tissues for clinical use typically require gamma irradiation to achieve targeted sterility assurance level (SAL). Gamma radiation produces deleterious changes to physical and surface properties of tissues. In this study, we evaluate the requirement of gamma irradiation as a secondary sterilization procedure by comparing it with non-irradiated chemically treated xenograft tissues. Sixty four bovine pericardia (BP) were decellularized and subjected to nonconventional (glutaraldehyde free) cross-linking. Xenograft samples were screened for bacterial and fungal contaminations both at pre- and post-processing stages, after cross-linking and preservation. Microbial evaluations performed revealed that the xenografts were rendered 'microbe free' by subjecting to a new multistaged decellularization technique and cross-linking. Five of these cross-linked tissues were subjected to gamma irradiation as recommended by IAEC and were tested for surface and mechanical properties to understand the ultrastructure, surface and bulk properties. Surface tension and thrombogenicity parameters were also evaluated. Gamma-irradiated specimen showed reduced physical and mechanical properties of these xenogenic tissues significantly along with biological property. Validation and analysis led us to conclude that this microbe-free decellularization method and subsequent processing for xenogenic tissues is a viable alternative for clinical usage without the deleterious secondary sterilization using gamma irradiation.

Keywords

Bovine Pericardium, Decellularized Xenograft, Gamma Irradiation, Thrombogenicity.
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  • Roberto, S. B., Use of radiation in biomaterials science. Nucl. Inst. Meth. B, 2001, 191(1–4), 752–757.

  • Hafeez, Y. M. et al., Effect of freeze-drying and gamma irradiation on biomechanical properties of bovine pericardium. Cell Tissue Bank, 2005, 6, 85–89.

  • Lobo, G. A., Tissue banking in India: Gamma-irradiated allografts. Cell Tissue Bank., 2003, 4, 203–211.

  • Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose, ISO 11137-2: 2013.

  • Tokuhiro, I., Victor, J. F., Michael, J., Steven, W. B., Boyce, B. A. and William, C. R., Structure of bovine parietal pericardium and of unimplanted Ionescu–Shiley pericardial valvular bioprostheses. J. Thorac. Cardiovasc. Surg., 1981, 81, 747–757.

  • Balasundari, R. et al., Post processing complete microbe free porcine xenograft suitable for clinical use. Indian J. Thorac. Cardiovasc. Surg., 2007, 23, 240–245.

  • Guhathakurta, S. et al., Thrombogenicity studies of three different variants of processed bovine pericardium. IRBM, 2008, 29(4), 223–230.

  • Guhathakurta, S. et al., Technique to process xenogenic tissues for cardio vascular implantation. Curr. Sci., 2006, 91(8), 1068– 1073.

  • Simmons, A., Sterilization of medical devices business briefing. Graduate school of Biomedical Engineering, The University of New South Wales, Business briefing: Medical device manufacturing and technology, 2004.

  • Rimnac, C. M., Klein, R. W., Betts, F. and Wright, T. M., Postirradiation aging of ultra-high molecular weight polyethylene. J. Bone Joint Surg., 1994, 76(7), 1052–1056.

  • Cheung, D. T., Perelman, N., Tong, D. and Nimne, M. E., The effect of gamma-irradiation on collagen molecules, isolated alpha chains, and cross-linked native fibres. J. Biomed. Mater. Res., 1990, 24(5), 581–589.

  • Hill, D. J. T., Lewis, D. A., O’Donnell, J. H. and Whittaker, A. K., The crosslinking mechanism in gamma irradiation of polyarylsulfone: evidence for Y-links. Polym. Adv. Technol., 1998, 9(1), 45–51.

  • Oral, E. and Muratoglu, O. K., Radiation cross-linking in ultrahigh molecular weight polyethylene for orthopaedic applications. Nucl. Instrum. Methods Phys. Res. B, 2007, 265(1), 18–22.

  • Verin, V. et al., Intraarterial beta irradiation prevents neointimal hyperplasia in a hypercholesterolemic rabbit restenosis model. Circulation, 1995, 92, 2284–2290.

  • Hehrlein, C., Zimmermann, M., Metz, J., Fehsenfeld, P. and von Hodenberg, E., Radioactive coronary stent implantation inhibits neointimal proliferation in non-atherosclerotic rabbits. Circulation, 1993, 88(s1), 1–651.

  • Hehrlein, C., Riessen, R., Gollan, T., Dsnges, K., Fehsenfeld, P. and von Hodenberg, E., Arterial wall cell distribution after implantation of radioactive stents. Circulation, 1994, 90(s1), 1–597.

  • Stein, P. D., Alpert, J. S., Dalen, J. E., Horstkotte, D. and Turpie, A. G., Antithrombotic therapy in patients with mechanical and biological prosthetic heart valves. Chest, 1998, 114, 602s–610s.

  • Forti, F. L., Goissis, G. and Plepis, A. M. G., Modifications on collagen structures promoted by 1,4-dioxane improve thermal and biological properties of bovine pericardium as a biomaterial. J. Biomat. Appl., 2006, 20, 267–285.

  • Kennedy, J. F., Phillips, G. O. and Williams, P. A., Sterilisation of Tissues Using Ionising Radiations, ISBN-10: 0849337976/ISBN13: 978-0849337970, CRC Press, 2005.

  • Mukherjee, R. N., Radiation: A Means of Sterilization, Radiation Biology, Division of Life Sciences, IAEA; http://www.iaea.org/ Publications/Magazines/Bulletin/Bull176/17605882837.pdf


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  • Is Gamma Irradiation as a Secondary Sterilization Procedure Required for Decellularized Xenogenic Tissue Material?

Abstract Views: 402  |  PDF Views: 165

Authors

S. Guhathakurta
Rehabilitation Bioengineering Group, Department of Engineering Design, Indian Institute of Technology Madras, Chennai 600 036, India
V. Balasubramanian
Rehabilitation Bioengineering Group, Department of Engineering Design, Indian Institute of Technology Madras, Chennai 600 036, India
B. V. R. Tata
Indira Gandhi Centre for Atomic Research, Kalpakkam 603 102, India
S. Ponraju
Indira Gandhi Centre for Atomic Research, Kalpakkam 603 102, India

Abstract


Biological tissues for clinical use typically require gamma irradiation to achieve targeted sterility assurance level (SAL). Gamma radiation produces deleterious changes to physical and surface properties of tissues. In this study, we evaluate the requirement of gamma irradiation as a secondary sterilization procedure by comparing it with non-irradiated chemically treated xenograft tissues. Sixty four bovine pericardia (BP) were decellularized and subjected to nonconventional (glutaraldehyde free) cross-linking. Xenograft samples were screened for bacterial and fungal contaminations both at pre- and post-processing stages, after cross-linking and preservation. Microbial evaluations performed revealed that the xenografts were rendered 'microbe free' by subjecting to a new multistaged decellularization technique and cross-linking. Five of these cross-linked tissues were subjected to gamma irradiation as recommended by IAEC and were tested for surface and mechanical properties to understand the ultrastructure, surface and bulk properties. Surface tension and thrombogenicity parameters were also evaluated. Gamma-irradiated specimen showed reduced physical and mechanical properties of these xenogenic tissues significantly along with biological property. Validation and analysis led us to conclude that this microbe-free decellularization method and subsequent processing for xenogenic tissues is a viable alternative for clinical usage without the deleterious secondary sterilization using gamma irradiation.

Keywords


Bovine Pericardium, Decellularized Xenograft, Gamma Irradiation, Thrombogenicity.

References





DOI: https://doi.org/10.18520/cs%2Fv110%2Fi3%2F337-344