Improved sterilization of sensitive biomaterials with supercritical carbon dioxide at low temperature

PLoS ONE

Volumn 10, Issue 6, 2015, Pages

  Bernhardt, Anne ^a   Wehrl, Markus ^b   Paul, Birgit ^a   Hochmuth, Thomas ^b   Schumacher, Matthias ^a   Schütz, Kathleen ^a   Gelinsky, Michael ^a  

^a DRESDEN UNIVERSITY OF TECHNOLOGY   (Germany)

^b Wfk Cleaning Technology Research Institute   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ACETIC ANHYDRIDE; AGAROSE; ALGINIC ACID; BIOPOLYMER; CARBON DIOXIDE; COLLAGEN; ETHYLENE OXIDE; HYDROGEN PEROXIDE; MINERAL; PERACETIC ACID; POLYSACCHARIDE; WATER; BIOMEDICAL AND DENTAL MATERIALS;

ADULT; ANCYLOSTOMA BRAZILIENSE; ARTICLE; BACILLUS ATROPHAEUS; BACILLUS CEREUS; BACILLUS PUMILUS; BACTERIAL ENDOSPORE; BACTERIOPHAGE; BIOCOMPATIBILITY; BIOMECHANICS; BIORESORBABLE SCAFFOLD; BIPHASIC COLLAGEN SCAFFOLD; BONE MARROW DERIVED MESENCHYMAL STEM CELL; CANDIDA ALBICANS; CELL PROLIFERATION; CELL VIABILITY; CONIDIUM; ENTEROCOCCUS FAECIUM; ENTEROCOCCUS HIRAE; EXPOSURE; FLOW KINETICS; GAMMA IRRADIATION; GEOBACILLUS STEAROTHERMOPHILUS; GEOBACILLUS THERMOLEOVORANS; GRAM NEGATIVE BACTERIUM; GRAM POSITIVE BACTERIUM; HUMAN; HUMAN CELL; HYDROGEL; HYGIENE; IMPLANT; IN VITRO STUDY; INSTRUMENT STERILIZATION; INTERMETHOD COMPARISON; KLEBSIELLA PNEUMONIAE; LOW TEMPERATURE; MALE; MICROBIAL ACTIVITY; MYCOBACTERIUM; MYCOBACTERIUM TERRAE; NONHUMAN; NORMAL HUMAN; POROSITY; PROCESS CHALLENGE DEVICE; PSEUDOMONAS AERUGINOSA; SERRATIA MARCESCENS; STAPHYLOCOCCUS AUREUS; WATER VAPOR; YEAST; COLD; PROCEDURES;

BACTERIA (MICROORGANISMS); CORYNEBACTERINEAE; FUNGI; POSIBACTERIA;

BIOMEDICAL AND DENTAL MATERIALS; CARBON DIOXIDE; COLD TEMPERATURE; STERILIZATION;

EID: 84936104146     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0129205     Document Type: Article

References (45)

1. Phillip E Jr, Murthy NS, Bolikal D, Narayanan P, Kohn J, Lavelle L, et al. Ethylene oxide's role as a reactive agent during sterilization: effects of polymer composition and device architecture. J Biomed Mater Res B Appl Biomater. 2013; 101: 532-40. doi: 10.1002/jbm.b.32853 PMID: 23296710
2. Ahmed M, Punshon G, Darbyshire A, Seifalian AM. Effects of sterilization treatments on bulk and surface properties of nanocomposite biomaterials. J Biomed Mater Res B Appl Biomater. 2013; 101: 1182-90. doi: 10.1002/jbm.b.32928 PMID: 24039066
3. Murray KA, Kennedy JE, McEvoy B, Vrain O, Ryan D, Cowman R, et al. Effects of gamma ray and electron beam irradiation on the mechanical, thermal, structural and physicochemical properties of poly (ether-block-amide) thermoplastic elastomers. J Mech Behav Biomed Mater. 2013; 17: 252-68. doi: 10.1016/j.jmbbm.2012.09.011 PMID: 23131791
4. Delgado LM, Pandit A, Zeugolis DI. Influence of sterilisation methods on collagen-based devices stability and properties. Expert Rev Med Devices. 2014; 11: 305-14. doi: 10.1586/17434440.2014.900436 PMID: 24654928
5. Dillow AK, Dehghani F, Hrkach JS, Foster NR, Langer R. Bacterial inactivation by using near- and supercritical carbon dioxide. Proc Natl Acad Sci U S A. 1999; 96: 10344-8. PMID: 10468610
6. Spilimbergo S, Bertucco A. Non-thermal bacterial inactivation with dense CO(2). Biotechnol Bioeng. 2003; 84: 627-38. PMID: 14595775
7. White A, Burns D, Christensen TW. Effective terminal sterilization using supercritical carbon dioxide. J Biotechnol. 2006; 123: 504-15. PMID: 16497403
8. Zhang J, Davis TA, Matthews MA, Drews MJ, LaBerge M, An YH. Sterilization using high-pressure carbon dioxide. The Journal of Supercritical Fluids. 2006; 38: 354-372.
9. Watanabe T, Furukawa S, Hirata J, Koyama T, Ogihara H, Yamasaki M. Inactivation of Geobacillus stearothermophilus spores by high-pressure carbon dioxide treatment. Appl Environ Microbiol. 2003; 69: 7124-9. PMID: 14660357
10. Hemmer JD, Drews MJ, LaBerge M, Matthews MA. Sterilization of bacterial spores by using supercritical carbon dioxide and hydrogen peroxide. J Biomed Mater Res B Appl Biomater. 2007; 80: 511-8. PMID: 16838346
11. EN 556-1 Beuth Verlag, Burggrafenstr. 6, 10787 Berlin, Germany.
12. Zhang J, Burrows S, Gleason C, Matthews MA, Drews MJ, Laberge M, et al. Sterilizing Bacillus pumilus spores using supercritical carbon dioxide. J Microbiol Methods. 2006; 66: 479-85. PMID: 16516991
13. Shieh E, Paszczynski A, Wai CM, Lang Q, Crawford RL. Sterilization of Bacillus pumilus spores using supercritical fluid carbon dioxide containing various modifier solutions. J Microbiol Methods. 2009; 76: 247-52. doi: 10.1016/j.mimet.2008.11.005 PMID: 19111835
14. Checinska A, Fruth IA, Green TL, Crawford RL, Paszczynski AJ. Sterilization of biological pathogens using supercritical fluid carbon dioxide containing water and hydrogen peroxide. J Microbiol Methods. 2011; 87: 70-5. doi: 10.1016/j.mimet.2011.07.008 PMID: 21787810
15. Donati I, Benincasa M, Foulc MP, Turco G, Toppazzini M, Solinas D, et al. Terminal sterilization of BisGMA-TEGDMA thermoset materials and their bioactive surfaces by supercritical CO2. Biomacromolecules. 2012; 13: 1152-60. doi: 10.1021/bm300053d PMID: 22452822
16. Park HS, Choi HJ, Kim MD, Kim KH. Addition of ethanol to supercritical carbon dioxide enhances the inactivation of bacterial spores in the biofilm of Bacillus cereus. Int J Food Microbiol. 2013; 166: 207-12. doi: 10.1016/j.ijfoodmicro.2013.07.015 PMID: 23973829
17. Karajanagi SS, Yoganathan R, Mammucari R, Park H, Cox J, Zeitels SM, et al. Application of a dense gas technique for sterilizing soft biomaterials. Biotechnol Bioeng. 2011; 108: 1716-25. doi: 10.1002/bit.23105 PMID: 21337339
18. Qiu QQ, Leamy P, Brittingham J, Pomerleau J, Kabaria N, Connor J. Inactivation of bacterial spores and viruses in biological material using supercritical carbon dioxide with sterilant. J Biomed Mater Res B Appl Biomater. 2009; 91: 572-8. doi: 10.1002/jbm.b.31431 PMID: 19582844
19. Herdegen V., Felix A., Haseneder R., Repke J.-U., Leppchen-Fröhlich K., Prade I. et al. Sterilization of Medical Products from Collagen by Means of Supercritical CO2. Chem. Eng. Technol. 2014 doi: 10.1002/ceat.201300679
20. Nichols A, Burns DC, Christopher R. Studies on the Sterilization of Human Bone and Tendon Musculoskeletal Allograft Tissue Using Supercritical Carbon Dioxide. J. Orthopaedics 2009; 6: e9.
21. Russell N, Rives A, Bertollo N, Pelletier MH, Walsh WR. The effect of sterilization on the dynamic mechanical properties of paired rabbit cortical bone. J Biomech. 2013; 46:1670-5. doi: 10.1016/j.jbiomech.2013.04.006 PMID: 23664240
22. Russell N, Rives A, Pelletier MH, Wang T, Walsh WR.The effect of supercritical carbon dioxide sterilization on the anisotropy of bovine cortical bone. Cell Tissue Bank. 2014 doi: 10.1007/s10561-014-9447-8
23. Russell N, Oliver RA, Walsh WR. The effect of sterilization methods on the osteoconductivity of allograft bone in a critical-sized bilateral tibial defect model in rabbits. Biomaterials. 2013; 34: 8185-94. doi: 10.1016/j.biomaterials.2013.07.022 PMID: 23891084
24. Baldini T, Caperton K, Hawkins M, McCarty E. Effect of a novel sterilization method on biomechanical properties of soft tissue allografts. Knee Surg Sports Traumatol Arthrosc. 2014 doi: 10.1007/s00167-014-3221-0
25. Dillow A, Langer RS, Foster N, Hrkach JS. Supercritical fluid sterilization method WO 1999066960 A3.
26. Reverchon E, Della Porta G, Adami R. Medical Device Sterilization Using Supercritical CO 2 Based Mixtures. Recent Patents on Chemical Engineering. 2010; 3: 142-148.
27. Gelinsky M, Welzel PB, Simon P, Bernhardt A, König U. Porous three dimensional scaffolds made of mineralised collagen: preparation and properties of a biomimetic nanocomposite material for tissue engineering of bone. Chem Engin J. 2008; 137: 84-96.
28. Oyane A, Kim HM, Furuya T, Kokubo T, Miyazaki T, Nakamura T. Preparation and assessment of revised simulated body fluids. J Biomed Mater Res A. 2003; 65:188-95. PMID: 12734811
29. Bernhardt A, Lode A, Mietrach C, Hempel U, Hanke T, Gelinsky M. In vitro osteogenic potential of human bone marrow stromal cells cultivated in porous scaffolds from mineralized collagen. J Biomed Mater Res A. 2009; 90: 852-62. doi: 10.1002/jbm.a.32144 PMID: 18615470
30. Sabirzyanov AN, A. P. Il'in AP, Akhunov AR, Gumerov FM. Solubility of Water in Supercritical Carbon Dioxide. High Temperature, 2002; 40: 203-206
31. Francis W. Ternary system of liquid CO2. J. Phys. Chem.1954; 58: 1099-1106.
32. Jiménez A, Zhang J, Matthews MA. Evaluation of CO2-based cold sterilization of a model hydrogel. Biotechnol Bioeng. 2008; 101: 1344-52. doi: 10.1002/bit.21983 PMID: 18571803
33. Kume T, Takehisha M. Effect of Gamma-irradiation on Sodium Alginate and Carrageenan Powder Agricultural and Biological Chemistry 1983; 47, 889-890.
34. Lee DW, Choi WS, Byun MW, Park HJ, Yu YM, Lee CM. Effect of gamma-irradiation on degradation of alginate. J Agric Food Chem. 2003; 51: 4819-23. PMID: 14705918
35. Kong HJ, Smith MK, Mooney DJ. Designing alginate hydrogels to maintain viability of immobilized cells. Biomaterials. 2003; 24: 4023-9. PMID: 12834597
36. Cardoso DA, Ulset AS, Bender J, Jansen JA, Christensen BE, Leeuwenburgh SC. Effects of physical and chemical treatments on the molecular weight and degradation of alginate-hydroxyapatite composites. Macromol Biosci. 2014; 14: 872-80. doi: 10.1002/mabi.201300415 PMID: 24436203
37. Hu T, Yang Y, Tan L, Yin T, Wang Y, Wang G. Effects of gamma irradiation and moist heat for sterilization on sodium alginate. Biomed Mater Eng. 2014; 24:1837-49. doi: 10.3233/BME-140994 PMID: 25201397
38. Ofori-Kwakye K, Gary P. Martin GP. Viscoelastic characterization of alginate gels intended for wound healing. Journal of Science and Technology (Ghana). 2005; 25: 46-52.
39. Stoppel WL, White JC, Horava SD, Henry AC, Roberts SC, Bhatia SR. Terminal sterilization of alginate hydrogels: efficacy and impact on mechanical properties. J Biomed Mater Res B Appl Biomater. 2014; 102: 877-84. doi: 10.1002/jbm.b.33070 PMID: 24259507
40. Fatimi A, Tassin JF, Axelos MA, Weiss P. The stability mechanisms of an injectable calcium phosphate ceramic suspension. J Mater Sci Mater Med. 2010; 21: 1799-809. doi: 10.1007/s10856-010-4047-z PMID: 20229185
41. Matthews KH, Stevens HN, Auffret AD, Humphrey MJ, Eccleston GM. Gamma-irradiation of lyophilised wound healing wafers. Int J Pharm. 2006; 313: 78-86. PMID: 16503387
42. Olde Damink LH, Dijkstra PJ, Van Luyn MJ, Van Wachem PB, Nieuwenhuis P, Feijen J. Influence of ethylene oxide gas treatment on the in vitro degradation behavior of dermal sheep collagen. J Biomed Mater Res. 1995; 29: 149-55. PMID: 7738061
43. Chang L, Chen YJ, Chen YP, Yu WH. Biocompatibility of human bone allograft powder processed by supercritical CO2. Formosan Journal of Musculoskeletal Disorders 2011; 2: 55-61.
44. Matuska AM, McFetridge PS. The effect of terminal sterilization on structural and biophysical properties of a decellularized collagen-based scaffold; implications for stem cell adhesion. J Biomed Mater Res B Appl Biomater. 2014 doi: 10.1002/jbm.b.33213
45. Wehmeyer JL, Natesan S, Christy RJ. Development of a sterile amniotic membrane tissue graft using supercritical carbon dioxide. Tissue Eng Part C Methods. 2014 doi: 10.1089/ten.TEC.2014.0304