Expanding the Use of Moist Heat for Terminal Sterilization

References

1. 1.↵
   U.S. Food and Drug Administration. Use of Aseptic Processing and Terminal Sterilization in the Preparation of Sterile Pharmaceuticals for Human and Veterinary Use. Fed. Regist. 1991, 56 (198), 51354–51358.

   OpenUrl
2. 2.↵
   European Medicines Agency. Guideline on the Sterilisation of the Medicinal Product, Active Substance, Excipient and Primary Container; EMA/CHMP/CVMP/QWP/850374/2015; EMA: London, 2019.
3. 3.↵
   World Health Organization. Good Manufacturing Practices for Pharmaceutical Products: Main Principles. WHO: Geneva, 2003.
4. 4.↵
   Ministry of Health Labour and Welfare of Japan. Guidance on the Manufacture of Sterile Pharmaceutical Products Produced by Terminal Sterilization. MHLW: Tokyo, 2012.
5. 5.↵
   U.S. Food and Drug Association. 21 CFR Part 212—Current Good Manufacturing Practices in the Manufacture, Processing, Packing or Holding of Large Volume Parenterals. Fed. Regist. 1976, 41 (106), 22202–22219.

   OpenUrl
6. 6.↵
   U.S. Pharmacopeial Convention. General Chapter <1117> Microbiological Best Laboratory Practices. In USP 35–NF 30, USP: Rockville, MD, 2012.
7. 7.↵
   European Medicines Agency. Annex 1: Manufacture of Sterile Medicinal Products, EMA: London, 2022.
8. 8.↵
   Council of Europe, Methods of Preparation of Sterile Products, Chapter 5.1.1. In European Pharmacopoeia (Ph. Eur.), 6th Edition, Council of Europe: Strasbourg, France, 2008.
9. 9.↵
   1. Agalloco J.

   Understanding Overkill Sterilization: Putting an End to the Confusion. Pharm. Technol. 2007, 30 (5, supplement), S18–S25.

   OpenUrl
10. 10.↵
    1. Pflug I. J.,
    2. Odlaug T. C.

    Biological Indicators in the Pharmaceutical and the Medical Device Industry. J. Parenter. Sci. Technol. 1986, 40 (5), 242–248.

    OpenUrlPubMed
11. 11.↵
    1. Gaughran E. R. L.,
    2. Kereluk K.

    1. Pflug I.,
    2. Smith G.

    The Use of Biological Indicators for Monitoring Wet Heat Sterilization Processes. In Sterilization of Medical Products; Gaughran E. R. L., Kereluk K., Eds.; Johnson & Johnson: New Brunswick, NJ, 1997; pp 193–230.
12. 12.↵
    Parenteral Drug Association Inc. Technical Report No. 1 (Revised 2007). Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control, J. PDA J. Parenter. Sci. Technol. 2007, 61 (S-1).
13. 13.↵
    U.S. Pharmacopeial Convention. General Chapter <1229> Sterilization of Compendial Articles. In USP 40–NF 37, USP: Rockville, MD, 2013.
14. 14.↵
    1. Agalloco J.

    Too Much by Half: Misapplication of the Half-Cycle Approach to Sterilization. Pharm. Manuf 2016, 15 (11), S2. Continued online at Pharmamanufacturing.com

    OpenUrl
15. 15.↵
    1. Pflug I. J.

    Microbiology and Engineering of Sterilization Processes, 14th ed.; Environmental Sterilization Laboratory: Minneapolis, MN, 2010.
16. 16.↵
    1. Avallone H.

    Current Regulatory Issues Regarding Parenteral Inspections. J. Parenter. Sci. Technol. 1989, 43 (1), 3–7.

    OpenUrlPubMed
17. 17.↵
    1. Whyte W.,
    2. Bailey P.

    Reduction of Microbial Dispersion by Clothing. J. Parenter. Sci. Technol. 1985, 39 (1), 51–60.

    OpenUrlPubMed
18. 18.↵
    1. Reinmuller B.

    Dispersion and Risk Assessment of Airborne Contaminants in Pharmaceutical Cleanrooms. Royal Institute of Technology, Building Services Engineering Bulletin 56, 2001.
19. 19.↵
    1. Sandle T.

    A Review of Cleanroom Microflora: Types, Trends, and Patterns. PDA J. Pharm. Sci. Technol. 2011, 65 (4), 392–403.

    OpenUrlAbstract/FREE Full Text
20. 20.↵
    1. Cundell A.

    Microbial Testing in Support of Aseptic Processing. Pharm. Technol. 2004, 28 (6), 56–66.

    OpenUrl
21. 21.↵
    Parenteral Drug Association Inc. Points to Consider for Aseptic Processing; Bethesda, MD, 2015.
22. 22.↵
    1. Perkins J. J.

    Thermal Destruction of Microorganisms. In Principles and Methods of Sterilization in Health Sciences, 2nd ed.; Charles Thomas: Springfield, IL, 1983.
23. 23.↵
    1. Agalloco J. P.

    Kill the Bioburden, Not the Biological Indicator. BioPharm Int. 2017, 30 (4), 50–52.

    OpenUrl
24. 24.↵
    Kilmer Conference. Kilmer Glossary of Terms for Microbiological Quality and Sterility Assurance, 2021.
25. 25.↵
    1. Jen Y.,
    2. Manson J. E.,
    3. Stumbo C. R.,
    4. Zahradnik J. W.

    A Procedure for Estimating Sterilization of and Quality Factor Degradation in Thermally Processed Foods. J. Food Sci. 1971, 36 (4), 693–698.

    OpenUrl
26. 26.↵
    1. Smith J. M.

    Chemical Engineering Kinetics, Second Edition, McGraw Hill: New York, 1970.
27. 27.↵
    1. Agalloco J.,
    2. De Santis P.,
    3. Grilli A.,
    4. Pavell A.

    1. DeSantis P.

    Steam Sterilization in Autoclaves. In Handbook of Validation of Pharmaceutical Processes, 4th Edition; Agalloco J., De Santis P., Grilli A., Pavell A., Eds.; CRC Press: Boca Raton, FL, 2021.
28. 28.↵
    1. Agalloco J. P.,
    2. Akers J. E.,
    3. Madsen R. E.

    Moist Heat Sterilization—Myths and Realities. PDA J. Pharm. Sci. Technol. 1998, 52 (6), 346–350.

    OpenUrlFREE Full Text
29. 29.↵
    1. Agalloco J.,
    2. Akers J.,
    3. Madsen R.

    Revisiting the Moist Heat Sterilization Myths. PDA J. Pharm. Sci. Technol. 2009, 63 (2), 89–102.

    OpenUrlAbstract/FREE Full Text
30. 30.↵
    1. Gedam K.,
    2. Prasad R.,
    3. Vijay V.

    The Study on UHT Processing of Milk: A Versatile Option for Rural Sector. World J.Dairy Food Sci. 2007, 2 (2), 49–53.

    OpenUrl
31. 31.↵
    1. Bernuzzi M.

    Thermal Treatment of Hyaluronic Acid Prefilled Syringes: Challenges to Overcome. Presented at PDA Japan, 2017.
32. 32.↵
    1. Agalloco J.

    Post-Aseptic Fill Lethal Treatment Task Force Looks at Safety and Operational Improvements in Injectable Drug Manufacturing. PDA Letter 2011, 47 (4), 14–16.

    OpenUrl
33. 33.↵
    1. Agalloco J.

    Risk Based Thinking & Production of Sterile Products. Presented at PDA Italy, 2010.
34. 34.↵
    1. Agalloco J.,
    2. Akers J.

    Achieving Balance in Sterile Product Manufacturing. Pharm. Technol. 2015, 39 (12), 36–41.

    OpenUrl
35. 35.↵
    1. Izumi M.,
    2. Fujifuru M.,
    3. Okada A.,
    4. Takai K.,
    5. Takahashi K.,
    6. Udagawa T.,
    7. Miyake M.,
    8. Naruyama S.,
    9. Tokuda H.,
    10. Nishioka G.,
    11. Yoden H.,
    12. Aoki M.

    Evaluation of Bacillus oleronius as a Biological Indicator for Terminal Sterilization of Large-Volume Parenterals. PDA J. Pharm. Sci. Technol. 2016, 70 (1), 30–38.

    OpenUrlAbstract/FREE Full Text
36. 36.↵
    International Organization for Standardization, ISO 15883 Washer-Disinfectors—Part 1: General Requirements, Definitions and Tests. ISO: Geneva, 2006
37. 37.↵
    1. McCormick P.,
    2. Schoene M. J.,
    3. Dehmler M. A.,
    4. McDonell G.

    Moist Heat Disinfection and Revisiting the A₀ Concept. Biomed. Instrum. Technol. 2016, 50 (Suppl 3), 19–25.

    OpenUrlPubMed
38. 38.↵
    1. Brock T. D.

    1. Stetter K. O.

    , Diversity of Extremely Thermophilic Archaebacteria. In Thermophiles: General, Molecular and Applied Microbiology; Brock T. D., Ed.; John Wiley & Sons, Inc: New York, 1986; pp 39–74
39. 39.↵
    1. Brock T.

    Thermophilic Microorganisms and Life at High Temperatures; Springer-Verlag: New York, 1978.
40. 40.↵
    1. Agalloco J.,
    2. Akers J.,
    3. Aydlett J.,
    4. Frieborn W.,
    5. Mestrandrea L.

    PDA Response. FDA Proposal to Amend cGMP’s Entitled: Use of Aseptic Processing and Terminal Sterilization in the Preparation of Sterile Pharmaceuticals for Human and Veterinary Use. J. Parenter. Sci. Technol. 1992, 46 (3), 65–68.

    OpenUrlPubMed