Sterilization Method for Borosilicate Glass Vials and Chlorobutyl,  Bromobutyl Rubbers for Medical Purposes

I.S. Karapetyan; H.R. Petrosyan

doi:10.18321/ectj1564

Authors

I.S. Karapetyan Radioisotope Production Center, 38/7 Halabyan str., 0036 Yerevan, Armenia
H.R. Petrosyan Yerevan State University, 1 A. Manoogian str., 0025 Yerevan, Armenia

DOI:

https://doi.org/10.18321/ectj1564

Keywords:

borosilicate vials, chlorobutyl rubbers, bromobutyl rubbers, sterilization, endotoxins, moist and dry heat

Abstract

For surgical and medical tools to prevent the spreading of infectious microorganisms to patients, disinfection and sterilization must be achieved by the use of disinfectants and sterilization procedures. Health care regulations must determine whether cleaning, disinfection, or sterilization is essential based largely on the item’s intended use because sterilizing all patient care equipment is unnecessary. In this work, successful sterilization of vials and rubbers used for medical purposes has been implemented. It can be claimed that the sequence of moist and dry heat is more practical for sterilizing primary packaging materials used in diagnostic or treatment facilities, especially for borosilicate vials and chlorobutyl, bromobutyl rubbers. It has been shown that the suggested sterilization method provides sterile and endotoxin-free vials and rubbers that can be used for medical purposes. Endotoxins and sterility tests have been implemented for microbiological analysis of borosilicate vials and chlorobutyl, and bromobutyl rubbers. Endotoxin levels in all vials and rubbers tested were within acceptable limits, and no microbial growth was observed in test specimens based on sterility tests. The suggested sterilization method was effective in producing sterile and endotoxin-free vials and rubbers suitable for medical use.

References

(1). N.P. Tipnis, D.J. Burgess, Int. J. Pharm. 544 (2018) 455–460. Crossref DOI: https://doi.org/10.1016/j.ijpharm.2017.12.003

(2). A. Iuliano, A. Fabiszewska, K. Kozik, et al., J. Polym. Environ. 29 (2021) 1489. Crossref DOI: https://doi.org/10.1007/s10924-020-01972-9

(3). W. Sopwith, T. Hart, P. Garner, BMC Infect. Dis. 2 (2002). Crossref DOI: https://doi.org/10.1186/1471-2334-2-4

(4). T.A.M. Valente, D.M. Silva, P.S. Gomes, et al., ACS Appl. Mater. Interfaces 8 (2016) 3241. Crossref DOI: https://doi.org/10.1021/acsami.5b10869

(5). A. Srinivasan, L.L. Wolfenden, X. Song, et al., N. Engl. J. Med. 348 (2003) 221. Crossref DOI: https://doi.org/10.1056/NEJMoa021808

(6). S.L. Percival, L. Suleman, C. Vuotto, G. Donelli, J. Med. Microbiol. 64 (2015) 323. Crossref DOI: https://doi.org/10.1099/jmm.0.000032

(7). W.J. Rogers, Sterilisation of Biomaterials and Medical Devices. 2012, 20–55. Crossref DOI: https://doi.org/10.1533/9780857096265.20

(8). C. Jinadatha, S. Simmons, C. Dale, et al., Am. J. Infect. Control. 43 (2015) 412. Crossref DOI: https://doi.org/10.1016/j.ajic.2015.01.013

(9). S. Mohapatra, Sterilization and Disinfection. Essentials of Neuroanesthesia. 2017, 929–944. Crossref DOI: https://doi.org/10.1016/B978-0-12-805299-0.00059-2

(10). J.I. Sasaki, S. Imazato, J. Prosthodont. Res. 64 (2019) 239–242. Crossref DOI: https://doi.org/10.1016/j.jpor.2019.07.013

(11). M.J. Pascoe, A. Robertson, A. Crayford, et al., J. Hosp. Infect. 106 (2020). Crossref DOI: https://doi.org/10.1016/j.jhin.2020.07.008

(12). R. Singh, D. Singh, A. Singh, World. J. Radiol. 8 (2016) 355–369. Crossref DOI: https://doi.org/10.4329/wjr.v8.i4.355

(13). S. Sharifi, M.M. Islam, H. Sharifi, et al., Macromol. Biosci. 21 (2021) 2000379. Crossref DOI: https://doi.org/10.1002/mabi.202000379

(14). W.A. Rutala, D.J. Weber, Am. J. Infect. Control. 41 (2013) S2–S5. Crossref DOI: https://doi.org/10.1016/j.ajic.2012.11.005

(15). I. Aguado-Maestro, M. De Frutos-Serna, A. Gonzalez-Nava, et al., Injury 52 (2021) 1341–1345. Crossref DOI: https://doi.org/10.1016/j.injury.2020.09.014

(16). H. Shintani, Biocontrol. Sci. 22 (2017). Crossref DOI: https://doi.org/10.4265/bio.22.1

(17). C.R. Harrell, V. Djonov, C. Fellabaum, V. Volarevic, Int. J. Med. Sci. 15 (2018) 274–279. Crossref DOI: https://doi.org/10.7150/ijms.22644

(18). S. Tone, M. Hasegawa, G. Pezzotti, et al., Acta Biomate. 55 (2017) 455–465. Crossref DOI: https://doi.org/10.1016/j.actbio.2017.03.040

(19). M. Kiaii, O. Djurdjev, M. Farah, et al., Jama 306 (2011) 1679–1687. Crossref DOI: https://doi.org/10.1001/jama.2011.1499

(20). O. Mrad, J. Saunier, C.A. Chodur, et al., Radiat. Phys. Chem. 79 (2010) 93–103. Crossref DOI: https://doi.org/10.1016/j.radphyschem.2009.08.038

(21). S. Lerouge, M.R. Wertheimer, L. Yahia, Plasms. Polyms. 6 (2001) 175–188. Crossref DOI: https://doi.org/10.1023/A:1013196629791

(22). I.A. Ansari, A.K. Datta, Food Bioprod. Process. 81 (2003) 57‒65. Crossref DOI: https://doi.org/10.1205/096030803765208670

(23). F. Vahidpour, J. Oberländer, M.J. Schöning, Phys. Status Solidi A 215 (2018) 1800044. Crossref DOI: https://doi.org/10.1002/pssa.201800044

(24). F. Vahidpour, E. Guthmann, J. Arreola, et al., Foods 11 (2022) 660. Crossref DOI: https://doi.org/10.3390/foods11050660

(25). G.C. Mendes, T.R.S Brandão, C.L.M. Silva, Sterilisation of Biomaterials and Medical Devices 71 (2012) 71–96. Crossref DOI: https://doi.org/10.1533/9780857096265.71

(26). S. Govindaraj, M.S. Muthuraman, Int. J. ChemTech Res. 8 (2015) 897–911.

(27). B. Ratner, A. Hoffman, F. Schoen, J. Lemons. An introduction to materials in medicine. Biomaterial Science; 2004. eBook ISBN: 9780080470368.

(28). G. Mancini, R.M. Lopes, P. Clemente, et al., Eur. J. Lipid. Sci. Technol. 117 (2015) 1947–1959. Crossref DOI: https://doi.org/10.1002/ejlt.201400431

(29). E.M. Darmady, K.E.A. Hughes, J.D. Jones, et al., J. Clin. Path. 14 (1961) 38. Crossref DOI: https://doi.org/10.1136/jcp.14.1.38

(30). A.A.L. Pande, World J. Pharm. Res. 9 (2019) 1047‒1067.

(31). A. Hasegawa, M. Gulmezian-Sefer, Y. Cheng, R. Srikumar (2021). Microbiological Considerations for Ophthalmic Products: Sterility, Endotoxin Limits, and Preservatives. In: Neervannan, S., Kompella, U.B. (eds) Ophthalmic Product Development. AAPS Advances in the Pharmaceutical Sciences Series, vol. 37. Springer. Crossref DOI: https://doi.org/10.1007/978-3-030-76367-1_9