Research ArticleResearch
Microbial Contamination and Isolator Gloves: If It All Came Down to the Size of a Hole?
Edith Filaire, Vincent Rochette, Elodie Pierre, Franck Arethuse, Pascal Champagnat, Patrick Coppens, Eric Gohier, Cyril Mounier, Antoine Toussaint, Julien Triquet and Christian Poinsot
PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 699-706; DOI: https://doi.org/10.5731/pdajpst.2023.012913
Edith Filaire
1Groupe Icare, 6 Rue Emile Duclaux, 63360 Saint-Beauzire, France;
Vincent Rochette
1Groupe Icare, 6 Rue Emile Duclaux, 63360 Saint-Beauzire, France;
Elodie Pierre
1Groupe Icare, 6 Rue Emile Duclaux, 63360 Saint-Beauzire, France;
Franck Arethuse
2PIERCAN, Impasse des Macareux Z.I. Huppain, 14520 Port-en-Bessin, France;
Pascal Champagnat
3Boehringer Ingelheim, 29 Av. Tony Garnier, 69007 Lyon, France;
Patrick Coppens
4ISOTEC’XEL, 16 rue Sainte Marguerite, 21200 Beaune, France;
Eric Gohier
5JCE Biotechnology, ZA Bioparc, Rue Michel Renaud, 03270 Hauterive, France;
Cyril Mounier
6Getinge Life Science, 1 rue du Comité de Donegal, 41102 Vendôme, France;
Antoine Toussaint
7GSK, Avenue Fleming 20, 1300 Wavre, Belgium; and
Julien Triquet
8CSL Behring, Carré Suffren, 31-35 rue de la Fédération, 75015 Paris, France
Christian Poinsot
1Groupe Icare, 6 Rue Emile Duclaux, 63360 Saint-Beauzire, France;

References
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- Gessler A.,
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- 2.↵U.S. Food and Drug Administration, Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing. Center for Biologics Evaluation Research, U.S. Department of Health and Human Services: Rockville, MD, 2004.
- 3.↵European Commission. EudraLex—The Rules Governing Medicinal Products in the European Union, Volume 4: Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 1: Manufacture of Sterile Medicinal Products. European Commission: Brussels, 2022.
- 4.↵
- Sandle T.
- 5.↵
- Maier C.,
- Drinkwater J. L.
- 6.↵Members of the Working Group: Barrier Technology. Microbiological Study on the Management of Holes in Gloves for Isolators. La Vague 2022, (72), 27–31.
- 7.↵
- 8.↵
- Kindscher A.,
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 6
November/December 2024
Microbial Contamination and Isolator Gloves: If It All Came Down to the Size of a Hole?
Edith Filaire, Vincent Rochette, Elodie Pierre, Franck Arethuse, Pascal Champagnat, Patrick Coppens, Eric Gohier, Cyril Mounier, Antoine Toussaint, Julien Triquet, Christian Poinsot
PDA Journal of Pharmaceutical Science and Technology Nov 2024, 78 (6) 699-706; DOI: 10.5731/pdajpst.2023.012913
Microbial Contamination and Isolator Gloves: If It All Came Down to the Size of a Hole?
Edith Filaire, Vincent Rochette, Elodie Pierre, Franck Arethuse, Pascal Champagnat, Patrick Coppens, Eric Gohier, Cyril Mounier, Antoine Toussaint, Julien Triquet, Christian Poinsot
PDA Journal of Pharmaceutical Science and Technology Nov 2024, 78 (6) 699-706; DOI: 10.5731/pdajpst.2023.012913
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