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;
Annalaura Carducci
2Department of Biology, Hygiene Institute, University of Pisa, Pisa, Italy;
Giulia Davini
1University of Pisa and Abiogen Pharma S.p.A., Pisa, Italy;
Marco Macchia
3Department of Pharmacy, University of Pisa, Pisa, Italy;
Simone Bertini
3Department of Pharmacy, University of Pisa, Pisa, Italy;
Sandra Vecchiani
4Abiogen Pharma S.p.A., Ospedaletto, Pisa, Italy;
Stefano Ceccanti
5Quality Unit, Abiogen Pharma S.p.A., Ospedaletto, Pisa, Italy

References
- 1.↵
- Greff-Mirguet G.
- 2.↵
- Pérola O. Magalhães,
- et al.
- 3.↵
- Palsson-McDermott EM.,
- O'Neill LA.
- 4.↵
- Kevin L. Williams
- 5.↵
- Andrej A. Romanovsky,
- Alexandre Steiner,
- Kiyoshi Matsumura
- 6.↵
- Thorn Jörgen,
- et al
- 7.↵
- James C. Hurley
- 8.↵European Phamacopoeia. 8.8th edition, chapter 5.1.10 - «Guidelines for using the test for bacterial endotoxins» - 2016.
- 9.↵United States Pharamacopeia, 35th edition, chapter <85> - «Bacterial endotoxins test» - 2016.
- 10.↵European Phamacopoeia. 8.8th edition, chapter 2.6.14 - «Bacterial endotoxins» - 2016.
- 11.↵The Japanese Pharmacopoeia 16th edition, chapter G4 Microorganisms - «Decision of limit for Bacterial Endotoxins» - 2011.
- 12.↵The Japanese Pharmacopoeia 16th edition, chapter 4.01 - «Bacterial Endotoxins Test» - 2011.
- 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.↵
- Cervelli F.,
- Quilici M.,
- Bazzichi A.
- 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.↵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.↵
- Robert S. Dungan,
- April. B. Leytem
- 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.↵
- 20.↵
- Suzanne Spaan,
- et al
- 21.↵
- Suzannne Spaan,
- et al
- 22.↵European Committee for Standardization - «Determination of airborne endotoxins - Workplace atmospheres. EN 14031:2003» - Brussels, Belgium, 2003.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 6
November/December 2017
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
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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