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Research ArticleTechnology/Application

Development of Methods for Recovering Endotoxins from Surfaces and from Air in Production Environment of Injectable Drugs

Frucci Fiammetta, Annalaura Carducci, Giulia Davini, Marco Macchia, Simone Bertini, Sandra Vecchiani and Stefano Ceccanti
PDA Journal of Pharmaceutical Science and Technology November 2017, 71 (6) 502-510; DOI: https://doi.org/10.5731/pdajpst.2017.007674
Frucci Fiammetta
1University of Pisa and Abiogen Pharma S.p.A., Pisa, Italy;
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Annalaura Carducci
2Department of Biology, Hygiene Institute, University of Pisa, Pisa, Italy;
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  • For correspondence: annalaura.carducci@unipi.it
Giulia Davini
1University of Pisa and Abiogen Pharma S.p.A., Pisa, Italy;
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Marco Macchia
3Department of Pharmacy, University of Pisa, Pisa, Italy;
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Simone Bertini
3Department of Pharmacy, University of Pisa, Pisa, Italy;
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Sandra Vecchiani
4Abiogen Pharma S.p.A., Ospedaletto, Pisa, Italy;
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Stefano Ceccanti
5Quality Unit, Abiogen Pharma S.p.A., Ospedaletto, Pisa, Italy
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References

  1. 1.↵
    1. Greff-Mirguet G.
    , - «Échantillonnage et analyse des endotoxines dans l'air. Cahiers de notes documentaires» - Hygiène et sécurité du travail, vol. 187, p. 73–87, 2002.
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  2. 2.↵
    1. Pérola O. Magalhães,
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    - «Signal transduction by the lipopolysaccharide receptor, Toll-like receptor-4» Immunology, vol. 113, p. 153–162, 2004.
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  4. 4.↵
    1. Kevin L. Williams
    “Endotoxins: Pyrogens, LAL testing and depyrogenation” – 3rd ed. Informa Helathcare, New York NY, 2007.
  5. 5.↵
    1. Andrej A. Romanovsky,
    2. Alexandre Steiner,
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    - «Cells that trigger fever» - Cell Cycle, p. 2195–2197, 2006. available at http://www.tandfonline.com/doi/pdf/10.4161/cc.5.19.3321.
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    1. Thorn Jörgen,
    2. et al
    . - «Measurement strategies for the determination of airborne bacterial endotoxin in sewage treatment plants» - Ann. Occup. Hyg., vol. 46 (6) p. 549–554, 2002-
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  7. 7.↵
    1. James C. Hurley
    - «Endotoxemia: Methods of Detection and Clinical Correlates» - Clinical microbiology reviews, vol. 8, No. 2, p. 268–292, 1995.
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  8. 8.↵
    European Phamacopoeia. 8.8th edition, chapter 5.1.10 - «Guidelines for using the test for bacterial endotoxins» - 2016.
  9. 9.↵
    United States Pharamacopeia, 35th edition, chapter <85> - «Bacterial endotoxins test» - 2016.
  10. 10.↵
    European Phamacopoeia. 8.8th edition, chapter 2.6.14 - «Bacterial endotoxins» - 2016.
  11. 11.↵
    The Japanese Pharmacopoeia 16th edition, chapter G4 Microorganisms - «Decision of limit for Bacterial Endotoxins» - 2011.
  12. 12.↵
    The Japanese Pharmacopoeia 16th edition, chapter 4.01 - «Bacterial Endotoxins Test» - 2011.
  13. 13.↵
    Emmanuelle Brun - «Expert forecast on Emerging Biological Risks related to Occupational Safety and Health». European Agency for Safety and Health at Work, Luxembourg, 2007.
  14. 14.↵
    1. Cervelli F.,
    2. Quilici M.,
    3. Bazzichi A.
    - «Evaluation of the exposure to airborne endotoxins in several working environments in Tuscany» - Italian Jour. Occupational and Env. Hygiene; vol. 1 (3–4), p.139–145, 2010.
    OpenUrl
  15. 15.↵
    Food and Drug Administration, Inspection guide - «Validation of cleaning processes (7/93)» - March 2016, available at http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074922.htm.
  16. 16.↵
    Tim Sandle - «A Comparative Study of Different Methods for Endotoxin Destruction» - American Pharmaceutical Review, Supplement (6), 2013, available at http://www.americanpharmaceuticalreview.com/Featured-Articles/148858-A-Comparative-Study-of-Different-Methods-for-Endotoxin-Destruction/.
  17. 17.↵
    1. Robert S. Dungan,
    2. April. B. Leytem
    - «The effect of extraction, storage, and analysis techniques on the measurement of airborne endotoxin from a large dairy» - Aerobiologia, vol. 25, p. 265–273, 2009.
    OpenUrlCrossRefWeb of Science
  18. 18.↵
    Health Council of the Netherlands, publication No. 2010/04OSH - «Endotoxins. Health-based recommended occupational exposure limit» - July 15, 2010, available at https://www.gezondheidsraad.nl/en/task-and-procedure/areas-of-activity/healthy-working-conditions/endotoxins-health-based-recommended.
  19. 19.↵
    1. Laitinen S. K.
    - «Importance of sampling, extraction and preservation for the quantitation of biologically active endotoxin» - Ann. Agric. Environ. Med., vol. 6, p. 33–38; 1999.
    OpenUrlPubMed
  20. 20.↵
    1. Suzanne Spaan,
    2. et al
    . - «Effect of Extraction and Assay Media on Analysis of Airborne Endotoxin» - Appl. Env. Microbiol., vol. 74, No. 12, p. 3804–3811, 2008.
    OpenUrlAbstract/FREE Full Text
  21. 21.↵
    1. Suzannne Spaan,
    2. et al
    . - «Optimization of Airborne Endotoxin Exposure Assessment: Effects of Filter Type, Transport Conditions, Extraction Solutions, and Storage of Samples and Extracts» - Appl. Env. Microbiol., Vol. 73, No. 19, p. 6134–6143; 2007.
    OpenUrlAbstract/FREE Full Text
  22. 22.↵
    European Committee for Standardization - «Determination of airborne endotoxins - Workplace atmospheres. EN 14031:2003» - Brussels, Belgium, 2003.
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PDA Journal of Pharmaceutical Science and Technology: 71 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 6
November/December 2017
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Development of Methods for Recovering Endotoxins from Surfaces and from Air in Production Environment of Injectable Drugs
Frucci Fiammetta, Annalaura Carducci, Giulia Davini, Marco Macchia, Simone Bertini, Sandra Vecchiani, Stefano Ceccanti
PDA Journal of Pharmaceutical Science and Technology Nov 2017, 71 (6) 502-510; DOI: 10.5731/pdajpst.2017.007674

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Development of Methods for Recovering Endotoxins from Surfaces and from Air in Production Environment of Injectable Drugs
Frucci Fiammetta, Annalaura Carducci, Giulia Davini, Marco Macchia, Simone Bertini, Sandra Vecchiani, Stefano Ceccanti
PDA Journal of Pharmaceutical Science and Technology Nov 2017, 71 (6) 502-510; DOI: 10.5731/pdajpst.2017.007674
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Keywords

  • Airborne
  • Bacterial endotoxins
  • pharmaceutical quality control
  • swabs
  • Test for bacterial endotoxins.

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