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Article CommentaryCommentary

Steam Sterilization Chemical Indicators Are Not Adequate for Monitoring Real Steam Sterilization Cycles

Paulo Roberto Laranjeira, Rafael Queiroz de Souza, Jeane Aparecida Gonzales Bronzatti and Kazuko Uchigawa Graziano
PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 435-438; DOI: https://doi.org/10.5731/pdajpst.2019.009886
Paulo Roberto Laranjeira
1Cardinal Health, 7000 Cardinal Place, Dublin, OH 43017; and
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  • For correspondence: prlaranjeira@gmail.com
Rafael Queiroz de Souza
2 Nursing School (EEUSP), University of São Paulo, Brazil.
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Jeane Aparecida Gonzales Bronzatti
2 Nursing School (EEUSP), University of São Paulo, Brazil.
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Kazuko Uchigawa Graziano
2 Nursing School (EEUSP), University of São Paulo, Brazil.
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References

  1. 1.↵
    Association for the Advancement of Medical Instrumentation. American National Standard ANSI/AAMI ST79: 2017 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. AAMI: Arlington, VA, 2017.
  2. 2.↵
    International Organization for Standardization, ISO 11140-1:2014 Sterilization of Health Care Products—Chemical Indicators—Part 1: General Requirements. ISO: Geneva, 2014.
  3. 3.↵
    International Organization for Standardization, ISO 18472:2018 Sterilization of Health Care Products—Biological and Chemical Indicators—Test Equipment. ISO: Geneva, 2018.
  4. 4.↵
    1. van Doornmalen J.,
    2. Hermsen R. J.,
    3. Kopinga K.
    Six Commercially Available Class 6 Chemical Indicators Tested against Their Stated Values. Central Service 2012, 6 (6), 400–404.
    OpenUrl
  5. 5.↵
    1. Schneider P. M.,
    2. Reich R. R.,
    3. Kirckof S. S.,
    4. Foltz W. G.
    Performance of Various Steam Sterilization Indicators under Optimum and Sub-Optimum Exposure Conditions. Am. J. Infect. Control 2005, 33 (5 Suppl. 2), 55–67.
    OpenUrlCrossRefPubMed
  6. 6.↵
    International Organization for Standardization, ISO 17665-1:2006 Sterilization of Health Care Products. Moist Heat—Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices. ISO: Geneva, 2006.
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PDA Journal of Pharmaceutical Science and Technology: 74 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 4
July/August 2020
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Steam Sterilization Chemical Indicators Are Not Adequate for Monitoring Real Steam Sterilization Cycles
Paulo Roberto Laranjeira, Rafael Queiroz de Souza, Jeane Aparecida Gonzales Bronzatti, Kazuko Uchigawa Graziano
PDA Journal of Pharmaceutical Science and Technology Jul 2020, 74 (4) 435-438; DOI: 10.5731/pdajpst.2019.009886

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Steam Sterilization Chemical Indicators Are Not Adequate for Monitoring Real Steam Sterilization Cycles
Paulo Roberto Laranjeira, Rafael Queiroz de Souza, Jeane Aparecida Gonzales Bronzatti, Kazuko Uchigawa Graziano
PDA Journal of Pharmaceutical Science and Technology Jul 2020, 74 (4) 435-438; DOI: 10.5731/pdajpst.2019.009886
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Keywords

  • Chemical indicators
  • Cycle monitoring
  • Process indicators
  • Biological indicators
  • Steam sterilization, Medical device

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