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PDA Journal of Pharmaceutical Science and Technology

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Article CommentaryCommentary

Something for Nothing

James Agalloco
PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 248-252; DOI: https://doi.org/10.5731/pdajpst.2022.012736
James Agalloco
Agalloco & Associates
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References

  1. 1.↵
    1. Moldenhauer J.
    1. Sutton S.
    The Sterility Tests. In Rapid Sterility Testing; Moldenhauer J., Ed.; PDA/DHI: Bethesda, MD, 2011; pp 7–24.
  2. 2.↵
    Federal Standard 209: Clean Room and Work Station Requirements, Controlled Environment, 1963.
  3. 3.↵
    World Health Organization. Technical Report Series No. 530: Annex 4, General Requirements for the Sterility of Biological Substances. Part A, Section 2. WHO: Geneva, 1973.
  4. 4.↵
    1. Knudsen L. F.
    Sample Size of Parenteral Solutions for Sterility Testing. J. Am. Pharm. Assoc., Sci. Ed. 1949, 38 (6), 332–337.
    OpenUrl
  5. 5.↵
    1. Bryce D. M.
    Tests for the Sterility of Pharmaceutical Preparations; the Design and Interpretation of Sterility Tests. J. Pharm. Pharmacol. 2011, 8 (1), 561–572.
    OpenUrl
  6. 6.↵
    1. Bowman F. W.
    The Sterility Testing of Pharmaceuticals. J. Pharm. Sci. 1969, 58 (11), 1301–1308.
    OpenUrlPubMed
  7. 7.↵
    U.S. Food and Drug Administration, Guideline on Sterile Drug Products Produced by Aseptic Processing. Center for Biologics Evaluation and Research, U.S. Department of Health and Human Services: Rockville, MD, 1987.
  8. 8.↵
    European Medicines Agency. Annex 1, Sterile Medicinal Products. EMA: London, 2001.
  9. 9.↵
    U.S. Food and Drug Administration, Guideline on Sterile Drug Products Produced by Aseptic Processing. Center for Biologics Evaluation and Research, U.S. Department of Health and Human Services: Rockville, MD, 2004.
  10. 10.↵
    European Medicines Agency. Annex 1, Sterile Medicinal Products draft revision, EMA: London, 2017.
  11. 11.↵
    USP <71> Sterility Tests. Pharmacopeial Forum 2008, 34 (6), 1418–1425.
    OpenUrl
  12. 12.↵
    Department of Health and Social Services. Guide to Good Manufacturing Practices. HMSO, 1983.
  13. 13.↵
    1. Agalloco J.
    Personal recollection, 1984.
  14. 14.↵
    European Medicines Agency. Annex 1, Sterile Medicinal Products draft revision, EMA: London, 2020.
  15. 15.↵
    World Health Organization. WHO/BS/73.1062: Sterility and Sterility Testing of Pharmaceutical Preparations and Biological Substances. WHO: Geneva, 1973.
  16. 16.↵
    1. Akers J.,
    2. Agalloco J.
    Environmental Monitoring: Myths and Misapplications. PDA J. Pharm. Sci. Technol. 2001, 55 (3), 176–184.
    OpenUrlFREE Full Text
  17. 17.↵
    1. Madsen R.,
    2. Agalloco J.
    Unknown and Unknowable. Pharm. Technol. 2019, 2019 (1), 4–9.
    OpenUrl
  18. 18.↵
    1. Agalloco J.,
    2. Akers J.
    The Myth Called Sterility. Pharm. Technol. 2010, 34 (3), S44–S45.
    OpenUrl
  19. 19.↵
    USP <1211> Sterility Assurance. Pharmacopeial Forum 2020, 43 (5), 101–125.
    OpenUrl
  20. 20.↵
    EMA, Annex 1, Sterile Medicinal Products, 2022.
  21. 21.↵
    1. Akers J.,
    2. Agalloco J.,
    3. Madsen R.
    What is Advanced Aseptic Processing? Pharm. Manuf. 2006, 4 (2), 25–27.
    OpenUrl
  22. 22.↵
    Parenteral Drug Association Inc. Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals. PDA Technical Report No. 28, Revised. PDA J. Pharm. Sci. Technol. 2006, 60 (Suppl S-2), 1–22.
    OpenUrlAbstract/FREE Full Text
  23. 23.↵
    1. Agalloco J.
    Closed Systems and Environmental Control: Application of Risk Based Design. Am. Pharm. Rev. 2004, 7 (4), 26–29.
    OpenUrl
  24. 24.↵
    1. Agalloco J.
    Straight Talk on Closed Systems. BioPharm Int. 2020, 20 (5), 32–36.
    OpenUrl
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 77 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 3
May/June 2023
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Something for Nothing
James Agalloco
PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 248-252; DOI: 10.5731/pdajpst.2022.012736

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PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 248-252; DOI: 10.5731/pdajpst.2022.012736
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More in this TOC Section

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  • Retrospective Evaluation of Cycled Resin in Viral Clearance Studies—A Multiple Company Collaboration—Post ICH Q5A(R2) Review
  • A Risk Based Approach for Pre-Use/Post-Sterilization Integrity Test Simulation During Bacterial Retention Testing as Part of the Process Specific Filter Validation of Sterilizing Grade Filters
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Keywords

  • Closed systems
  • Aseptic processing
  • Isolation technology
  • Sterility testing
  • Environmental Monitoring
  • Process simulation

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