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;
Nicole Berthoumieu
1Leo-Pharma, Vernouillet, France;
Philippe Dutot
2NovoNordisk Productions SAS, Chartres, France;
Julien Triquet
3Aspen, Notre Dame de Bondeville, France;
Medhi Ratajczak
3Aspen, Notre Dame de Bondeville, France;
Michel Thibaudon
4Indicia, Saint Genis l'Argentière, France; and
Philippe Bechaud
5Biomerieux, Craponne, France
Christophe Arliaud
5Biomerieux, Craponne, France
Edith Miclet
5Biomerieux, Craponne, France
Florine Giordano
5Biomerieux, Craponne, France
Marjorie Larcon
5Biomerieux, Craponne, France
Catherine Arthaud
5Biomerieux, Craponne, France

References
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- 3.↵PI 007-05, Recommendation on the validation of aseptic processes, PIC/S, July 2009.
- 4.↵U.S. Food and Drug Administration. Guide on Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice. Guidance for Industry, September 2004.
- 5.↵PDA Technical Report 22. Process Simulations for Aseptically Filled Products; Parenteral Drug Association: Bethesda, MD, 2011.
- 6.↵USP 35 <1116> Microbiological Control and Monitoring of Aseptic Processing Environments.
- 7.↵USP 34 <1116> Microbiological Evaluation of Clean Rooms and Other Controlled Environments.
- 8.↵World Health Organization. Environmental Monitoring of Clean Rooms in Vaccine Manufacturing Facilities, November 2012.
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- 11.↵Pharmaceutical and Healthcare Sciences Society (PHSS). Technical Monograph 20. Bio-contamination, September 2014.
- 12.↵PDA Technical Report No. 13. Fundamentals of an Environmental Monitoring Program; Parenteral Drug Association: Bethesda, MD, 2014.
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 1
January/February 2017
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
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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