Research Article
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Tıbbi sterilizasyonun kontrolünde kullanılan biyoindikatör sistemi tasarlanması

Year 2021, Volume: 2 Issue: 2, 60 - 67, 30.08.2021
https://doi.org/10.51753/flsrt.972920

Abstract

Sterilizasyon, hastane enfeksiyonlarını kontrol etmek için en etkili yöntemlerden biridir ve uluslararası standardizasyon kuruluşunun belirlediği standartlara göre uygulanmaktadır. Sterilizasyon yöntemi, tıbbi malzemenin fiziksel özelliklerine göre seçilmektedir. Bu çalışmada biyolojik indikatörler, işlemin uygulanacağı malzeme ve zaman parametresi değerlendirilerek üretilmiştir. Geobacillus stearothermophilus spor formda olup, biyolojik indikatör yapımında yaygın olarak kullanıldığından bu çalışma için seçilmiştir. Vejetatif formda olması ve düşük sıcaklıktaki sterilizasyon yöntemlerine verdiği cevap süresiyle seçilen bir diğer bakteri de Escherichia coli olmuştur. Seçilen iki bakteriyle çiftli kontrol yapılmıştır. G. stearothermophilus ve E. coli bakterilerinin büyümesi için glukoz ve nişasta besin maddesi olarak kullanılmıştır. Ardunio Uno ve TCS3200 renk sensörü ile hazırlanan sistemden bakteri ve besin maddelerinden hangisinin daha hızlı sonuç verdiği test edilmiştir. Çalışmanın sonuçlarına göre iki bakterinin de otoklav biyoindikatörü olarak kullanıma uygun, halk sağlığı çalışmaları açısından yeterli olduğu görülmüştür. Bu çalışmadan elde edilen sonuçlar, elektronik ve optik donanımı sayesinde insan gözünden daha hızlı ve doğru okuyabilen, analitik veriler ile optimize edilip, kayıt altına alınabilen bir cihazla kalite kontrol süreçlerinin daha doğru yapılabileceğini göstermiştir.

Supporting Institution

PAMUKKALE ÜNİVERSİTESİ

Thanks

Bu çalışma Pamukkale Üniversitesi Fen Bilimleri Enstitüsü Yüksek Lisans Tezinden alınmıştır.

References

  • Albert, H., Davies, D. J. G., Woodson, L. P., & Soper, C. J. (1998). Biological indicators for steam sterilization: characterization of a rapid biological indicator utilizing Bacillus stearothermophilus spore‐associated alpha‐glucosidase enzyme. Journal of Applied Microbiology, 85(5), 865-874.
  • Arduino Türkiye, (2021). Arduino Uno Resmi Web Sayfası, http://arduinoturkiye.com/arduino-uno/, Son erişim 4 Temmuz 2021.
  • Baev, M., Baev, D., Radek, A. & Campbell, J. (2006). Growth of Escherichia coli MG1655 on LB medium: monitoring utilization of sugars, alcohols, and organic acids with transcriptional microarrays. Applied Microbiology and Biotechnology, 310-316.
  • Belaich, A., & Belaich, J. P. (1976). Microcalorimetric study of the anaerobic growth of Escherichia coli: measurements of the affinity of whole cells for various energy substrates. Journal of Bacteriology, 125(1), 19-24.
  • Black, J. (1993). Microbiology. (pp. 1-334). Prentice Hall.
  • Cabbari, H., Alikhah, H., Alamdari, N., Behzad, M., Mehrabi, E., Borzui, L. & Bakhshian, F. (2012). Developing the use of quality ındicators in sterilization practices. Iranian Journal of Public Health, 64-69.
  • Castillo, R. B. (2017). Establishment of penetration time on medical device product families based on ISO 17665-3 during performance qualification of steam sterilization: a case study. 18th Word Sterilization Congress, Bonn, Germany, 4-7.
  • Caylan, R. (2003). Sterilitenin Kontrolü, https://www.das.org.tr/kitaplar/kitap2003/05.htm, Son erişim 4 Temmuz 2021.
  • Dlugokenski, R. E., Sella, S. R., Guizelini, B. P., Vandenberghe, L. P., Woiciechowski, A. L., Soccol, C. R., & Minozzo, J. C. (2011). Use of soybean vinasses as a germinant medium for a Geobacillus stearothermophilus ATCC 7953 sterilization biological indicator. Applied Microbiology and Biotechnology, 90(2), 713-719.
  • Genc, B. N. (2020). Critical management of COVID-19 pandemic in Turkey. Frontiers in Life Sciences and Related Technologies, 1(2), 69-73.
  • Gillis, J., Mosley, G., Kowalski, J., Krushefski, G., Nirgenau, P., & McCauley, K. (2010). Understanding biological indicator grow-out times. Journal of Pharmaceutical Technology, 34, 1-9.
  • Guizelini, B. P., Vandenberghe, L. P., Sella, S. R. B., & Soccol, C. R. (2012). Study of the influence of sporulation conditions on heat resistance of Geobacillus stearothermophilus used in the development of biological indicators for steam sterilization. Archives of Microbiology, 194(12), 991-999.
  • Hansen J., M., Fidopiastis N., Bryans T., Luebke M. & Rymer T. (2020). Radiation sterilization: Dose is dose. Biomedical Instrumentation Technology, 54(1), 45-52.
  • Hossain, M., Balakrishnan, V., Rahman, N. N. N. A., Sarker, M., Islam, Z., & Kadir, M. O. A. (2012). Treatment of clinical solid waste using a steam autoclave as a possible alternative technology to incinertion. International Journal of Environmental Research and Public Health, 9(3), 855-867.
  • ISO 11138-1, (2017). Sterilization of health care products - Biological indicators - Part 1: General requirements.
  • ISO 11140-1, (2014). Sterilization of health care products - Chemical indicators - Part 1: General requirements.
  • ISO 13485, (2016). Medical devices - Quality management systems - Requirements for regulatory purposes.
  • ISO 14161, (2009). Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results.
  • Kim, J. S., Kim, A. H., Oh, H. B., Goh, B. J., Lee, E. S., Kim, J. S., ... & Jun, J. H. (2015). Simple LED spectrophotometer for analysis of color information. Bio-Medical Materials and Engineering, 26(s1), 1773-1780.
  • Laskaris, T., & Chaney, A. L. (1969). Reliability of biologic autoclave sterilization indicators. American Journal of Clinical Pathology, 52(4_ts), 495-500.
  • Lendenmann, U., & Egli, T., (1995). Is Escherichia coli growing in glucose-limited chemostat culture able to utilize other sugars without lag?, https://www.microbiologyresearch.org/docserver/fulltext/micro/141/1/mic-141-71.pdf?expires=1605721776&id=id&accname=guest&checksum=BF39A4A3CE8AAF93AB4857F5F2336640, Son erişim 4 Temmuz 2021.
  • Mtimet, N., Trunet, C., Mathot, A. G., Venaille, L., Laguerinel, I., Coroller, L., & Couvert, O. (2015). Modeling the behavior of Geobacillus stearothermophilus ATCC 12980 throughout its life cycle as vegetative cells or spores using growth boundaries. Food Microbiology, 48, 153-162.
  • Okamoto, S., Chin, T., Nagata, K., Takahashi, T., Ohara, H., & Aso, Y. (2015). Production of itaconic acid in Escherichia coli expressing recombinant α-amylase using starch as substrate. Journal of Bioscience and Bioengineering, 119(5), 548-553.
  • Panta, G., Richardson, A. K., Shaw, I. C., Chambers, S., & Coope, P. A. (2019). Effectiveness of steam sterilization of reusable medical devices in primary and secondary care public hospitals in Nepal and factors associated with ineffective sterilization: A nation-wide cross-sectional study. Plos One, 14(11), e0225595.
  • Pflug, I. J., & Odlaug, T. E. (1986). Biological indicators in the pharmaceutical and medical device industry. Journal of Parenteral Science and Technology, 40, 242-248.
  • Robotistan, (2021). TCS3200 ve Arduino ile Renk Algılama Uygulaması, https://maker.robotistan.com/tcs3200-ile-renk-algilama-uygulamasi/#Gerekli-Malzemeler, Son erişim 4 Temmuz 2021.
  • Royalty-Hann, W. (2007). Solutions for biological indicator problems from a quality assurance viewpoint. Biocontrol Science, 12(2), 77-81.
  • Rutala, W. A., & Weber, D. J. (2001). New disinfection and sterilization methods. Emerging Infectious Diseases, 7(2), 348-353.
  • Rutala, W. A., & Weber, D. J. (2013). Disinfection and sterilization: an overview. American Journal of Infection Control, 41(5), 2-5.
  • Shintani, H. (1996). Factors in the preparation of biological indicators that affect the decimal reduction time. Biomedical Instrumentation & Technology, 30(5), 449-453.
  • Shintani, H. (2011). Validation of sterilization procedures and usage of biological indicators in the manufacture of healthcare products, Biocontrol Science, 1-4.
  • Sigwarth, V., & Moirandat, C. (2000). Development and quantification of H2O2 decontamination cycles. PDA Journal of Pharmaceutical Science and Technology, 54(4), 286-304.
  • Smerilli, M., Neureiter, M., Wurz, S., Haas, C., Frühauf, S., & Fuchs, W. (2015). Direct fermentation of potato starch and potato residues to lactic acid by Geobacillus stearothermophilus under non‐sterile conditions. Journal of Chemical Technology & Biotechnology, 90(4), 648-657.
  • Soylu, T. (2005). Sterilizasyonun kontrolü. In: Gunaydin, M., Sarnic, A., Gurler, B. (eds). 4. Ulusal Sterilizasyon Dezenfeksiyon Kongresi, İstanbul, 87-98.
  • Tao, H., Bausch, C., Richmond, C., Blattner, F. R., & Conway, T. (1999). Functional genomics: expression analysis of Escherichia coli growing on minimal and rich media. Journal of Bacteriology, 181(20), 6425-6440.
  • Thill, S. A., & Spaltenstein, M. (2020). Toward efficient low-temperature ozone gas sterilization of medical devices. Ozone: Science & Engineering, 42(5), 386-398.
  • Vesley, D., Langholz, A. C., Rohlfing, S. R., & Foltz, W. E. (1992). Fluorimetric detection of a Bacillus stearothermophilus spore-bound enzyme, α-d-glucosidase, for rapid indication of flash sterilization failure. Applied and Environmental Microbiology, 58(2), 717-719.
  • Wallace, C. A. (2016). New developments in disinfection and sterilization. American Journal of Infection Control, 44(5), 23-27.
  • Watcharasukarn, M., Kaparaju, P., Steyer, J. P., Krogfelt, K. A., & Angelidaki, I. (2009). Screening Escherichia coli, Enterococcus faecalis, and Clostridium perfringens as indicator organisms in evaluating pathogen-reducing capacity in biogas plants. Microbial Ecology, 58(2), 221-230.

Designation of bioindicator system for controlling the medical sterilization

Year 2021, Volume: 2 Issue: 2, 60 - 67, 30.08.2021
https://doi.org/10.51753/flsrt.972920

Abstract

Sterilization is one of the most effective methods to control hospital infections, and is applied according to the standards set by the international standardization organization. The sterilization method is selected according to the physical properties of the medical material. In this study, biological indicators were produced by evaluating the material and time parameters of the process. Geobacillus steorothermophilus is in spore form and was chosen for use in this study because it is widely used in making biological indicators. Escherichia coli was another bacterium selected for its vegetative form and its response time to low-temperature sterilization methods. Paired control was performed with two selected bacteria. Glucose and starch were used as nutrients for the growth of G. stearothermophilus and E. coli bacteria. It was tested which of the bacteria and nutrients gave faster results from the system prepared with the Arduino Uno and TCS3200 color sensor. According to the results of the study, it was seen that both bacteria were suitable for use as autoclave bioindicators and were sufficient for studies in terms of public health. The results obtained from this study showed that quality control processes can be done more accurately using a device, which read faster and more accurately than the human eye and be optimized and recorded with analytical data with its electronic and optical equipment.

References

  • Albert, H., Davies, D. J. G., Woodson, L. P., & Soper, C. J. (1998). Biological indicators for steam sterilization: characterization of a rapid biological indicator utilizing Bacillus stearothermophilus spore‐associated alpha‐glucosidase enzyme. Journal of Applied Microbiology, 85(5), 865-874.
  • Arduino Türkiye, (2021). Arduino Uno Resmi Web Sayfası, http://arduinoturkiye.com/arduino-uno/, Son erişim 4 Temmuz 2021.
  • Baev, M., Baev, D., Radek, A. & Campbell, J. (2006). Growth of Escherichia coli MG1655 on LB medium: monitoring utilization of sugars, alcohols, and organic acids with transcriptional microarrays. Applied Microbiology and Biotechnology, 310-316.
  • Belaich, A., & Belaich, J. P. (1976). Microcalorimetric study of the anaerobic growth of Escherichia coli: measurements of the affinity of whole cells for various energy substrates. Journal of Bacteriology, 125(1), 19-24.
  • Black, J. (1993). Microbiology. (pp. 1-334). Prentice Hall.
  • Cabbari, H., Alikhah, H., Alamdari, N., Behzad, M., Mehrabi, E., Borzui, L. & Bakhshian, F. (2012). Developing the use of quality ındicators in sterilization practices. Iranian Journal of Public Health, 64-69.
  • Castillo, R. B. (2017). Establishment of penetration time on medical device product families based on ISO 17665-3 during performance qualification of steam sterilization: a case study. 18th Word Sterilization Congress, Bonn, Germany, 4-7.
  • Caylan, R. (2003). Sterilitenin Kontrolü, https://www.das.org.tr/kitaplar/kitap2003/05.htm, Son erişim 4 Temmuz 2021.
  • Dlugokenski, R. E., Sella, S. R., Guizelini, B. P., Vandenberghe, L. P., Woiciechowski, A. L., Soccol, C. R., & Minozzo, J. C. (2011). Use of soybean vinasses as a germinant medium for a Geobacillus stearothermophilus ATCC 7953 sterilization biological indicator. Applied Microbiology and Biotechnology, 90(2), 713-719.
  • Genc, B. N. (2020). Critical management of COVID-19 pandemic in Turkey. Frontiers in Life Sciences and Related Technologies, 1(2), 69-73.
  • Gillis, J., Mosley, G., Kowalski, J., Krushefski, G., Nirgenau, P., & McCauley, K. (2010). Understanding biological indicator grow-out times. Journal of Pharmaceutical Technology, 34, 1-9.
  • Guizelini, B. P., Vandenberghe, L. P., Sella, S. R. B., & Soccol, C. R. (2012). Study of the influence of sporulation conditions on heat resistance of Geobacillus stearothermophilus used in the development of biological indicators for steam sterilization. Archives of Microbiology, 194(12), 991-999.
  • Hansen J., M., Fidopiastis N., Bryans T., Luebke M. & Rymer T. (2020). Radiation sterilization: Dose is dose. Biomedical Instrumentation Technology, 54(1), 45-52.
  • Hossain, M., Balakrishnan, V., Rahman, N. N. N. A., Sarker, M., Islam, Z., & Kadir, M. O. A. (2012). Treatment of clinical solid waste using a steam autoclave as a possible alternative technology to incinertion. International Journal of Environmental Research and Public Health, 9(3), 855-867.
  • ISO 11138-1, (2017). Sterilization of health care products - Biological indicators - Part 1: General requirements.
  • ISO 11140-1, (2014). Sterilization of health care products - Chemical indicators - Part 1: General requirements.
  • ISO 13485, (2016). Medical devices - Quality management systems - Requirements for regulatory purposes.
  • ISO 14161, (2009). Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results.
  • Kim, J. S., Kim, A. H., Oh, H. B., Goh, B. J., Lee, E. S., Kim, J. S., ... & Jun, J. H. (2015). Simple LED spectrophotometer for analysis of color information. Bio-Medical Materials and Engineering, 26(s1), 1773-1780.
  • Laskaris, T., & Chaney, A. L. (1969). Reliability of biologic autoclave sterilization indicators. American Journal of Clinical Pathology, 52(4_ts), 495-500.
  • Lendenmann, U., & Egli, T., (1995). Is Escherichia coli growing in glucose-limited chemostat culture able to utilize other sugars without lag?, https://www.microbiologyresearch.org/docserver/fulltext/micro/141/1/mic-141-71.pdf?expires=1605721776&id=id&accname=guest&checksum=BF39A4A3CE8AAF93AB4857F5F2336640, Son erişim 4 Temmuz 2021.
  • Mtimet, N., Trunet, C., Mathot, A. G., Venaille, L., Laguerinel, I., Coroller, L., & Couvert, O. (2015). Modeling the behavior of Geobacillus stearothermophilus ATCC 12980 throughout its life cycle as vegetative cells or spores using growth boundaries. Food Microbiology, 48, 153-162.
  • Okamoto, S., Chin, T., Nagata, K., Takahashi, T., Ohara, H., & Aso, Y. (2015). Production of itaconic acid in Escherichia coli expressing recombinant α-amylase using starch as substrate. Journal of Bioscience and Bioengineering, 119(5), 548-553.
  • Panta, G., Richardson, A. K., Shaw, I. C., Chambers, S., & Coope, P. A. (2019). Effectiveness of steam sterilization of reusable medical devices in primary and secondary care public hospitals in Nepal and factors associated with ineffective sterilization: A nation-wide cross-sectional study. Plos One, 14(11), e0225595.
  • Pflug, I. J., & Odlaug, T. E. (1986). Biological indicators in the pharmaceutical and medical device industry. Journal of Parenteral Science and Technology, 40, 242-248.
  • Robotistan, (2021). TCS3200 ve Arduino ile Renk Algılama Uygulaması, https://maker.robotistan.com/tcs3200-ile-renk-algilama-uygulamasi/#Gerekli-Malzemeler, Son erişim 4 Temmuz 2021.
  • Royalty-Hann, W. (2007). Solutions for biological indicator problems from a quality assurance viewpoint. Biocontrol Science, 12(2), 77-81.
  • Rutala, W. A., & Weber, D. J. (2001). New disinfection and sterilization methods. Emerging Infectious Diseases, 7(2), 348-353.
  • Rutala, W. A., & Weber, D. J. (2013). Disinfection and sterilization: an overview. American Journal of Infection Control, 41(5), 2-5.
  • Shintani, H. (1996). Factors in the preparation of biological indicators that affect the decimal reduction time. Biomedical Instrumentation & Technology, 30(5), 449-453.
  • Shintani, H. (2011). Validation of sterilization procedures and usage of biological indicators in the manufacture of healthcare products, Biocontrol Science, 1-4.
  • Sigwarth, V., & Moirandat, C. (2000). Development and quantification of H2O2 decontamination cycles. PDA Journal of Pharmaceutical Science and Technology, 54(4), 286-304.
  • Smerilli, M., Neureiter, M., Wurz, S., Haas, C., Frühauf, S., & Fuchs, W. (2015). Direct fermentation of potato starch and potato residues to lactic acid by Geobacillus stearothermophilus under non‐sterile conditions. Journal of Chemical Technology & Biotechnology, 90(4), 648-657.
  • Soylu, T. (2005). Sterilizasyonun kontrolü. In: Gunaydin, M., Sarnic, A., Gurler, B. (eds). 4. Ulusal Sterilizasyon Dezenfeksiyon Kongresi, İstanbul, 87-98.
  • Tao, H., Bausch, C., Richmond, C., Blattner, F. R., & Conway, T. (1999). Functional genomics: expression analysis of Escherichia coli growing on minimal and rich media. Journal of Bacteriology, 181(20), 6425-6440.
  • Thill, S. A., & Spaltenstein, M. (2020). Toward efficient low-temperature ozone gas sterilization of medical devices. Ozone: Science & Engineering, 42(5), 386-398.
  • Vesley, D., Langholz, A. C., Rohlfing, S. R., & Foltz, W. E. (1992). Fluorimetric detection of a Bacillus stearothermophilus spore-bound enzyme, α-d-glucosidase, for rapid indication of flash sterilization failure. Applied and Environmental Microbiology, 58(2), 717-719.
  • Wallace, C. A. (2016). New developments in disinfection and sterilization. American Journal of Infection Control, 44(5), 23-27.
  • Watcharasukarn, M., Kaparaju, P., Steyer, J. P., Krogfelt, K. A., & Angelidaki, I. (2009). Screening Escherichia coli, Enterococcus faecalis, and Clostridium perfringens as indicator organisms in evaluating pathogen-reducing capacity in biogas plants. Microbial Ecology, 58(2), 221-230.
There are 39 citations in total.

Details

Primary Language Turkish
Subjects Engineering
Journal Section Research Articles
Authors

Nurseli Kanyılmaz This is me 0000-0002-2329-5222

Ahmet Koluman 0000-0001-5308-8884

Publication Date August 30, 2021
Submission Date July 24, 2021
Published in Issue Year 2021 Volume: 2 Issue: 2

Cite

APA Kanyılmaz, N., & Koluman, A. (2021). Tıbbi sterilizasyonun kontrolünde kullanılan biyoindikatör sistemi tasarlanması. Frontiers in Life Sciences and Related Technologies, 2(2), 60-67. https://doi.org/10.51753/flsrt.972920

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