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Research ArticleTechnology/Application

The Relation Between the Load, Duration, and Steam Penetration Capacity of a Surface Steam Sterilization Process: A Case Study

Josephus P.C.M. van Doornmalen, Ralph A.C. van Wezel and Klaas Kopinga
PDA Journal of Pharmaceutical Science and Technology May 2019, 73 (3) 276-284; DOI: https://doi.org/10.5731/pdajpst.2017.008490
Josephus P.C.M. van Doornmalen
1Department of Applied Physics, Eindhoven University of Technology, P.O. Box 513, 5600 MB, Eindhoven, The Netherlands;
2Steelco Benelux B.V., de Limiet 2, 4131 NR Vianen, The Netherlands; and
3Department of Clinical Pharmacy, Catharina Hospital, P.O. Box 1350, 5602 ZA Eindhoven, The Netherlands
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  • For correspondence: j.p.c.m.v.doornmalen@tue.nl
Ralph A.C. van Wezel
3Department of Clinical Pharmacy, Catharina Hospital, P.O. Box 1350, 5602 ZA Eindhoven, The Netherlands
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Klaas Kopinga
1Department of Applied Physics, Eindhoven University of Technology, P.O. Box 513, 5600 MB, Eindhoven, The Netherlands;
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References

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    Moist heat sterilization–myths and realities. PDA J. Pharm. Sci. Technol. 1998, 52 (6), 346–350.
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    1. Agalloco J.P.
    Maximum and Minimum Loads in Steam Sterilization: A Cycle Development Strategy that Fulfills Regulatory Requirements. Pharmaceutical Manufacturing [Online] 2018, https://www.pharmamanufacturing.com/articles/2018/maximum-and-minimum-loads-in-steam-sterilization/ (accessed July 18, 2018).
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    Working Party on Pressure-Steam Sterilizers of the Medical Research Council. Sterilisation by steam under increased pressure. Lancet 1959, 273, 425–435.
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    Standard ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Association for the Advancement of Medical Instrumentation/American National Standards Institute, 2017.
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    Standard EN 285 Sterilization. Steam sterilizers. Large sterilizers. European Committee for Standardization, 2015.
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    Standard ISO 17665 part 1: Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices. International Organization for Standardization, 2006.
  8. 8.↵
    1. van Doornmalen J.P.C.M.,
    2. Riethoff W.J.C.
    A case study of steam penetration monitoring indicates the necessity of Every Load Monitoring of steam sterilization processes. Central Service 2016, 5 (5), 320–325.
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  9. 9.↵
    1. Pavell A.,
    2. Hughes K.A.
    A Risk-Based Approach to Variable Load Configuration Validation in Steam Sterilization: Application of PDA Technical Report 1 Load Equivalence Topic. PDA J. Pharm. Sci. Technol. 2010, 64 (2), 124–136.
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    1. Russell A.D.,
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    Preservation and Sterilization. Blackwell Scientific Publications, Oxford, 2nd edition, 1992.
  11. 11.↵
    1. Perkins J.J.
    Principles and Methods of Sterilization; Charles C Thomas: Springfield, IL, 1956.
  12. 12.↵
    Standard ISO 11140-4: Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration. International Organization for Standardization, 2007.
  13. 13.↵
    Standard ISO 11140-5: Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests. International Organization for Standardization, 2007.
  14. 14.↵
    1. Benoit F.,
    2. Merger D.,
    3. Hermsen R.J.,
    4. van Doornmalen J.P.C.M.
    A comparison of four commercially available electronic steam penetration tests according to ISO 11140 part 4. Central Service 2011, 3 (3), 180–184.
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  15. 15.↵
    1. van Doornmalen J.P.C.M.,
    2. Kopinga K.
    Measuring non-condensable gases in steam. Rev. Sci. Instrum. 2013, 84 (11), 115–106.
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  16. 16.↵
    1. Bowie J.H.,
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    The Bowie and Dick autoclave tape test. The Lancet 1963, 281, 568–569.
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  17. 17.↵
    1. van Wezel R.A.C.,
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    3. de Ranitz A.,
    4. van Doornmalen J.P.C.M.
    Following trends in steam sterilizer performance by quantitative monitoring of non-condensable gases. J. Hosp. Infect. 2017, 97 (4), 357–362.
    OpenUrl
  18. 18.↵
    1. van Wezel R.A.C.,
    2. van Doornmalen H.W.J.M.,
    3. de Geus J.,
    4. Rutten S.,
    5. van Doornmalen J.P.C.M.
    Second case study on the orientation of phaco hand pieces during steam sterilization. J. Hosp. Infect. 2016, 94 (2), 194–197.
    OpenUrl
  19. 19.↵
    1. van Doornmalen J.P.C.M.,
    2. Kopinga K.
    Steam penetration in thin-walled channels and helix shaped process challenge devices. Central Service 2015, 6 (6), 429–433.
    OpenUrl
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PDA Journal of Pharmaceutical Science and Technology: 73 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 3
May/June 2019
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The Relation Between the Load, Duration, and Steam Penetration Capacity of a Surface Steam Sterilization Process: A Case Study
Josephus P.C.M. van Doornmalen, Ralph A.C. van Wezel, Klaas Kopinga
PDA Journal of Pharmaceutical Science and Technology May 2019, 73 (3) 276-284; DOI: 10.5731/pdajpst.2017.008490

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The Relation Between the Load, Duration, and Steam Penetration Capacity of a Surface Steam Sterilization Process: A Case Study
Josephus P.C.M. van Doornmalen, Ralph A.C. van Wezel, Klaas Kopinga
PDA Journal of Pharmaceutical Science and Technology May 2019, 73 (3) 276-284; DOI: 10.5731/pdajpst.2017.008490
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