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Research ArticleResearch

Multicenter Study on Incubation Conditions for Environmental Monitoring and Aseptic Process Simulation

Roland Guinet, Nicole Berthoumieu, Philippe Dutot, Julien Triquet, Medhi Ratajczak, Michel Thibaudon, Philippe Bechaud, Christophe Arliaud, Edith Miclet, Florine Giordano, Marjorie Larcon and Catherine Arthaud
PDA Journal of Pharmaceutical Science and Technology January 2017, 71 (1) 43-49; DOI: https://doi.org/10.5731/pdajpst.2016.006791
Roland Guinet
1Leo-Pharma, Vernouillet, France;
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  • For correspondence: rolandguinet@hotmail.fr
Nicole Berthoumieu
1Leo-Pharma, Vernouillet, France;
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Philippe Dutot
2NovoNordisk Productions SAS, Chartres, France;
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Julien Triquet
3Aspen, Notre Dame de Bondeville, France;
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Medhi Ratajczak
3Aspen, Notre Dame de Bondeville, France;
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Michel Thibaudon
4Indicia, Saint Genis l'Argentière, France; and
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Philippe Bechaud
5Biomerieux, Craponne, France
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Christophe Arliaud
5Biomerieux, Craponne, France
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Edith Miclet
5Biomerieux, Craponne, France
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Florine Giordano
5Biomerieux, Craponne, France
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Marjorie Larcon
5Biomerieux, Craponne, France
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Catherine Arthaud
5Biomerieux, Craponne, France
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  • Article
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References

  1. 1.↵
    Eudralex Volume 4, EU GMP Annex 1. Manufacture of Sterile Medicinal Products, November 2008.
  2. 2.↵
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    PI 007-05, Recommendation on the validation of aseptic processes, PIC/S, July 2009.
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    U.S. Food and Drug Administration. Guide on Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice. Guidance for Industry, September 2004.
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    PDA Technical Report 22. Process Simulations for Aseptically Filled Products; Parenteral Drug Association: Bethesda, MD, 2011.
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    Pharmaceutical and Healthcare Sciences Society (PHSS). Technical Monograph 20. Bio-contamination, September 2014.
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    PDA Technical Report No. 13. Fundamentals of an Environmental Monitoring Program; Parenteral Drug Association: Bethesda, MD, 2014.
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    Facility-Based Case Study: A Comparison of the Recovery of Naturally Occuring Species of Bacteria and Fungi on Semi-Solid Media When Incubated under Standard and Dual Temperature Conditions and Its Impact on Environmental Monitoring Approach. Eur. J. Par. Pharm. Sci. 2016, 21 (1), 7–15.
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    Propositions de Modifications Spécifiques de l'Annexe 1. La Vague 2015, 47 (September), 27–32.
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    , Résultats du Vote sur les Propositions du GIC A3P de Modifications Envisageables de l'Annexe 1. La Vague 2015, 44 (January), 7–8.
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    Comparative Mold and Yeast Recovery Analysis (The Effect of Differing Incubation Temperature Ranges and Growth Media). PDA J. Pharm. Sci. Technol. 1998, 52 (4), 165–169.
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    Comparison of Different Fungal Agar for the Environmental Monitoring of Pharmaceutical-Grade Cleanrooms. PDA J. Pharm. Sci. Technol. 2013, 67 (6), 621–633.
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    Optimal Media for Use in Air Sampling To Detect Cultivable Bacteria and Fungi in the Pharmacy. J. Clin. Microbiol. 2013, 51 (10), 3172–3175.
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PDA Journal of Pharmaceutical Science and Technology: 71 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 1
January/February 2017
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Multicenter Study on Incubation Conditions for Environmental Monitoring and Aseptic Process Simulation
Roland Guinet, Nicole Berthoumieu, Philippe Dutot, Julien Triquet, Medhi Ratajczak, Michel Thibaudon, Philippe Bechaud, Christophe Arliaud, Edith Miclet, Florine Giordano, Marjorie Larcon, Catherine Arthaud
PDA Journal of Pharmaceutical Science and Technology Jan 2017, 71 (1) 43-49; DOI: 10.5731/pdajpst.2016.006791

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Multicenter Study on Incubation Conditions for Environmental Monitoring and Aseptic Process Simulation
Roland Guinet, Nicole Berthoumieu, Philippe Dutot, Julien Triquet, Medhi Ratajczak, Michel Thibaudon, Philippe Bechaud, Christophe Arliaud, Edith Miclet, Florine Giordano, Marjorie Larcon, Catherine Arthaud
PDA Journal of Pharmaceutical Science and Technology Jan 2017, 71 (1) 43-49; DOI: 10.5731/pdajpst.2016.006791
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Keywords

  • Environmental Monitoring
  • Aseptic process simulation
  • Primary isolation of microorganisms
  • Incubation conditions
  • Incubation temperature
  • Microbiology
  • Cleanroom

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