Revisiting the Moist Heat Sterilization Myths

References

1. 1.↵
   1. Akers J.,
   2. Agalloco J.,
   3. Madsen R.,

   Moist heat sterilization—myths and realities. PDA J. Pharm. Sci. Technol. 1998, 52 ( 6), 346– 350.

   OpenUrlFREE Full Text
2. 2.↵
   European Pharmacopoeia, 4th ed.; Council of Europe: Strasbourg, 2002.
3. 3.↵
   1. Sasaki T.,

   Parametric release for moist heated pharmaceutical products in Japan. PDA J. GMP Validation Jpn 2002, 4 ( 1), 7– 10.

   OpenUrl
4. 4.↵
   PDA. PDA Technical Report #1, Revised, “Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control, major revision of PDA Technical Monograph”, Volume 61, Supplement S-1, 2007.
5. 5.↵
   1. Sharp J.,

   What do we mean by “sterility”? PDA J. Pharm. Sci. Technol. 1995, 49 ( 2), 90– 92.

   OpenUrlFREE Full Text
6. 6.↵
   International Conference on Harmonisation. ICH Q9, Quality Risk Management, 11 2005.
7. 7.↵
   FDA. Pharmaceutical CGMPS for the 21st Century—A Risk-based Approach, 2004.
8. 8.↵
   FDA, CFSAN, Risk Assessment for Food Terrorism and Other Food Safety Concerns, 2003
9. 9.↵
   1. Agalloco J.,

   Understanding overkill sterilization: putting an end to the confusion. Pharm. Technol 2007, 30 ( 5) S18, 60– 76.

   OpenUrl
10. 10.↵
    United States Pharmacopeia. USP 30 〈1035〉 Biological Indicators—Resistance Performance Tests, 2008.
11. 11.↵
    United States Pharmacopeia. USP 30 〈55〉 Biological Indicators for Moist Heat, Dry Heat, and Gaseous Modes of Sterilization, Metal or Plastic Carriers and Biological Indicators for Moist Heat, Dry Heat, and Gaseous Modes of Sterilization, Liquid Spore Suspensions, 2008.
12. 12.↵
    Health Technical Memorandum 2010 (HTM-2010) Part 3: Validation and Verification; Her Majesty's Stationary Office: London, 1994.
13. 13.↵
    Engineering definition of steam quality..
14. 14.↵
    1. Phillips G. B.,
    2. Morrissey R. F.,

    1. Young J. H.,

    “Sterilization with Steam under Pressure” in Sterilization Technology, Phillips G. B., Morrissey R. F., Eds.; Van Nostrand and Reinhold: New York, 1993; pp 120– 151.
15. 15.↵
    www.engineeringtoolbox.com.
16. 16.↵
    1. Bigelow W. D.,

    The logarithmic nature of thermal death time curves. J. Infect. Dis, 1921, 29, 528– 536.

    OpenUrlFREE Full Text
17. 17.↵
    1. Barker H. A.,

    The effect of water content upon the rate of heat denaturation of crystallizable egg albumin. J. Gen. Physiol. 1933, 17, 21– 34.

    OpenUrlAbstract/FREE Full Text
18. 18.↵
    1. Lewith S.,

    Ueber die ursache der widerstandsfahhigkieit der sporen gegen hohe temperaturen. Arch. Exp. Path. Pharmakol. 1890, 26, 341– 354.

    OpenUrl
19. 19.↵
    1. Wang D.,
    2. Schorer I.,
    3. Humphrey A. E.,

    Kinetics of death of bacterial spores at elevated temperature. Appl. Microbiol. 1964, 12, 451– 454.

    OpenUrlPubMed
20. 20.↵
    1. Angelotti R.,
    2. Maryanski J. H.,
    3. Butler T. F.,
    4. Peeler J. T.,
    5. Campbell J. E.,

    Influence of spore moisture content on dry heat resistance of B. Subtilis var. niger. Appl. Microbiol 1968, 16 ( 5), 735– 745.

    OpenUrlPubMed
21. 21.↵
    1. Block. S. S.,

    1. Pflug I.,
    2. Holcomb R.,

    Principles of Thermal Destruction of Microorganisms. In Disinfection, Sterilization and Preservation, 3rd ed.; Block. S. S., Ed.; Lea & Febiger: Philadelphia, PA, 1983; pp 759– 783.
22. 22.↵
    1. Hougen O.,
    2. Watson K.,
    3. Ragatz R.,

    Chemical Process Principles. Part II—Thermodynamics; John Wiley & Sons: New York, 1959.
23. 23.↵
    1. Haw M. D.,

    Colloidal suspensions, Brownian motion and molecular reality: a short history. J. Phys.: Condens. Matter 2002, 14, 7769– 7779. Einstein Letter to Perrin, 1909.

    OpenUrl
24. 24.↵
    1. Frederick Soddy,

    1. Perrin J.,

    1909 Annales de Chimie et Physique—“Atoms”, translated by Frederick Soddy, Taylor & Francis: London, 1920.
25. 25.↵
    FDA. Proposed Current Good Manufacturing Practices in the Manufacture, Processing, Packing or Holding of Large Volume Parenterals, Federal Register 22202–22219, 6 1, 1976, Rescinded December 31, 1993.
26. 26.↵
    FDA. Proposed Current Good Manufacturing Practices in the Manufacture, Processing, Packing or Holding of Large Volume Parenterals, Federal Register 22202–22219, 6 1, 1976, Rescinded December 31, 1993.
27. 27.↵
    PDA, Technical Monograph #1, Validation of Moist Heat Sterilization, Philadelphia, 1978.
28. 28.↵
    PDA. PDA Technical Report #1, Revised, “Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control, major revision of PDA Technical Monograph”, Volume 61, Supplement S-1, 2007.
29. 29.↵
    1. Perry R. H.,
    2. Green D. W.,

    Perry's Chemical Engineer's Handbook; McGraw-Hill: New York, 1984.
30. 30.↵
    HTM-2010, Part 3: Validation and Verification, Her Majesty's Stationary Office, 1994.
31. 31.↵
    ISO (International Organization for Standardization). “Sterilization of Health Care Products—Requirements for Validation and Routine Control—Industrial Moist Heat Sterilization, ISO 11134”, 1994.
32. 32.↵
    European Norm 285, Sterilization—Steam sterilizers—Large sterilizers, 2006 Draft.
33. 33.↵
    Bioquell. Hydrogen Peroxide Vapour, Biological Efficacy (revised Kill Data) Version V2.5 February 2003.
34. 34.↵
    FDA. Guideline on Sterile Drug Products Produced by Aseptic Processing, 2004.
35. 35.↵
    1. Pflug J.,

    Microbiology and Engineering of Sterilization Processes; Environmental Sterilization Laboratory: Minneapolis, MN, 1995.
36. 36.↵
    1. Perkins J. J.,

    Principles and Methods of Sterilization in Health Sciences; Charles Thomas: Springfield, IL, 1973.
37. 37.↵
    1. Phillips G. B.,
    2. Morrissey R. F.,

    Sterilization Technology Phillips G. B., Morrissey R. F., Eds.; Van Nostrand and Reinhold: New York, 1993.
38. 38.↵
    1. Russell A. D.,
    2. Hugo W. B.,
    3. Ayliffe G. A. J.,

    Principles and Practice of Disinfection, Preservation and Sterilisation; Russell A. D., Hugo W. B., Ayliffe G. A. J., Eds.; Blackwell Scientific: Oxford, 1982.